National Coverage Analysis (NCA) View Public Comments

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Public Comments

Commenter Comment Information
Lalime, Melody Valoree Title: Mrs.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

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Weinstein, EM Title: MD
Date: 02/10/2022
Comment:
I am in 100% agreement with the CMS decision that Medicare NOT pay for Aduhelm and other similar drugs except in good clinical trials that use actual measures of effectiveness. As a retired physician as well as caretaker of a [PHI Redacted] who lived with dementia for 12 years, I was appalled at the FDA decision to approve this drug in the face of a lack of evidence for its clinical effectiveness. There is essentially no good evidence that this drug helps. In fact the FDA

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Dumser, N. Date: 02/10/2022
Comment:
Aduhelm must be restricted to only patients enrolled in clinical trials. Medicare cannot be bankrupted by using it to prevent or treat Alzheimer's. may not be effective at preventing or treating Alzheimer’s.
walheim, andrea Title: President
Organization: primaldiva farmette
Date: 02/10/2022
Comment:
This drug has NOT been clinically proven to work and costs $56,000 per year of taxpayer money! Are you kidding me? Please use money to support treatments and lifestyle changes that actually work.
Brown, Christine Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Bhuiyan Khan, Beena Organization: Duke-Margolis Center for Health Policy
Date: 02/10/2022
Comment:
Download comment.
Arena, Eileen Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Smith, Laura Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Monge, Cristy Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Crutcher, Eeerthieer Date: 02/10/2022
Comment:
Support government to help offer the medical and security for all ages and low income individuals and families
Cohen, Jason Title: MD
Organization: Montefiore Medical Center & Albert Einstein College of Medicine
Date: 02/10/2022
Comment:

Regarding: National Coverage Analysis (NCA) Proposed Decision Memo: Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease CAG-00460N

I compliment CMS on the thoughtful analysis in the proposed National Coverage Analysis (NCA), “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease [CAG-00460N],” but I hope it will take into consideration the following comments for the final coverage determination.

My

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Snee, Patricia Date: 02/10/2022
Comment:

I strongly support the proposed CMS decision when it come to Medicare covering Aduhlem only in clinical trial settiings. Please follow their recommendation and not the lobbying points of the pharmaceutical industry.

Alzheimer's patients need services that support their ability to carry out daily activities of life. They deserve to be protected from drugs that have harmful side effects. The evidence is missing that this monoclonal antibody is benefitting patients which means you

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Johnston, Steve Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Funk, Sarah Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Haller, Maggie Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Bernick, Charles Title: MD
Organization: University of Washington
Date: 02/10/2022
Comment:

I strongly urge reconsideration of the proposed National Coverage for aducanumab for the following reasons:

1) There is reasonable evidence suggesting a clinical benefit in slowing symptomatic and functional decline which is supported by biomarker findings and initial results of similar drugs in it's class that are currently in clinical trials
2) The published data indicate that the potential adverse effects of the drug ( ARIA) can be safely managed with proper

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johansson, robert Title: Mr.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Schulz, Paul Title: Professor of Neurology
Organization: UTHealth Houston
Date: 02/10/2022
Comment:

By way of background, I am a neurologist who specializes in dementia. I have been involved in many clinical treatment trials for Alzheimer’s disease (AD) over the last 30+ years. I have also been involved in many studies of the mechanisms underlying AD. I direct a large group of investigators.

In my opinion, the anti-amyloid antibodies, as a class, are useful for slowing the progression of AD. Six were positive in Phase II trials. And one, aducanumab, was positive, in two Phase

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Robison, Marie Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Monge Franco, Vicky Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

DAVIS, ERIKA Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Monge Rosales, Roberto Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

DeCoster, Karen Date: 02/10/2022
Comment:
As a former caregiver for my [PHI Redacted] who had AD, I FULLY support and applaud CMS’s decision regarding the approval of Aducanumab only in clinical trials. I have been following discussions amongst hundreds of doctors and researchers regarding this medication and I am appalled that the FDA approved it when the efficacy is VERY questionable, the costs are outrageous, and dangers to patients exist. I am outraged by Biogen’s efforts to ram this through and their recent

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Powell, Krista Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Ogden, David Date: 02/10/2022
Comment:
The drug you are contemplating to approve has not been shown to have a significant impact on the effects of Alzheimer’s in patients and is very expensive. Please do not approve this drug.
Goins, Sandra Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Mackler, Donald Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Klungnesm, Lester Title: Mr.
Organization: Microenvironmental
Date: 02/10/2022
Comment:
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials,

More

Fellman, Bruce Date: 02/10/2022
Comment:

Friends,
The FDA's ill-advised decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. These perilous days, we can't afford this.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a

More

templin, scott Date: 02/10/2022
Comment:
This drug should not be approved for treatment of Alzheimers.
Green, Susan Date: 02/10/2022
Comment:
Senior citizens have just been charged an unaffordable increase in our monthly Medicare premiums. Many of us really cannot afford another increase in the premium. Medicare should try negotiating the cost of drugs in America. It’s simply outrageous that those who live in other countries can buy the same drugs for far less money.
Chen, Elizabeth Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Strout, Catherine Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Daly, Margaret Title: MD
Date: 02/10/2022
Comment:
I am writing to applaud the Centers for Medicare and Medicaid Services (CMS) for their proposed national coverage decision regarding “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease” issued on January 11, 2022. I am a practicing physician and, like many other clinicians, I was deeply disturbed by the Food and Drug Administration’s (FDA) recent decision to approve the Alzheimer’s disease drug, aducanumab, despite the significant lack of evidence

More

Mebane, Margaret Title: Mrs
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Siegel, Sol Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a disregard for science and ignored the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been gravely damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to

More

Modola, Lisa Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Harger, Shia Date: 02/10/2022
Comment:
Hello,
My name is Shia Harger and I live in Wisconsin. My [PHI Redacted] was born last year and surprised us with an extra chromosome (Down syndrome). As I have learned more about his disability and how best to prepare for his future, it's so important to me that he has access to any treatments that will be developed in the future. I strongly believe that CMS should not move forward with any coverage process that excludes people with Down syndrome and other

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Hult, Philip Date: 02/10/2022
Comment:

I was bothered by the Food and Drug Administration’s highly questionable decision to approve Aduhelm for treatment of Alzheimer’s disease. It showed a disregard for science and violated the agency’s standards for approving new drugs. Because of this action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data

More

Lundgren, Judith Date: 02/10/2022
Comment:

I am responding to the upcoming decision of the use of Monoclonal Antibodies for Alzheimer’s. I would like to make the following suggestions to modify the report decision:

The drug be covered for all patients that fit the criteria listed in the research study and follows the protocol that was done in the study.
The drug should only be administered by clinics that are accredited~ not just hospital based~ it should be enough that they were either part of the study or adhere to

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Isaacs, Angela Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Platt, Emily Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

miller, russell Title: MD
Organization: self
Date: 02/10/2022
Comment:
DO NOT allow drug companies to use the federal government to such money from senior citizens. Aduhelm is not worth it. We are watching.
Dwyer, John Title: President
Organization: Global Alzheimer's Platform Foundation. Inc.
Date: 02/10/2022
Comment:

Global Alzheimer’s Platform Foundation Comment

CMS Draft National Coverage Determination
Monoclonal Antibodies Directed Against Amyloid for the
Treatment of Alzheimer’s Disease
February 10, 2022

Mr. Secretary and Madame Administrator:

Thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) proposed National Coverage Determination (NCD). The Global Alzheimer’s Platform Foundation (GAP) is a patient

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Glymour, M. Maria Title: Professor
Organization: University of California, San Francisco
Date: 02/10/2022
Comment:

I applaud the CMS’ proposed decision to provide Coverage with Evidence Development (CED) for monoclonal antibody anti-amyloid treatments for Alzheimer’s Disease (AD), restricting coverage to individuals participating in a CMS-approved or NIH-funded randomized trial and requiring diverse study participants. This decision will provide access to safe and effective medications for CMS’ beneficiaries and advance us more quickly towards effective therapies for people with AD. The evidence for

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Martin, Geraldline Title: Retired Registered Nurse
Date: 02/10/2022
Comment:
It is so tragic, frustrating and wrong that in one of the richest countries in the world all the money and power belong to one percent of the people. Capitalism is run amok. Big pharma, big teck and too many of our politicians just fall in line with each other to secure their wealth and power. It seems that the people are speaking up and demanding their constitutional rights. If they are not heard and headed we will become a totalitarian government soon.
JONES, DANIEL Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Braver, Elisa Title: Adjunct Associate Professor of Epidemiology
Organization: University of Maryland School of Medicine
Date: 02/10/2022
Comment:
I am writing in support of the CMS proposal to restrict coverage of aducanumab or other anti-amyloid monoclonal antibodies for the treatment of Alzheimer’s disease to the setting of randomized controlled clinical trials under Coverage for Evidence Development. I am an epidemiologist who has worked on the safety of drugs used to treat neuropsychiatric conditions and am concerned that aducanumab poses unacceptable safety risks to vulnerable patients that are not counterbalanced by clinically

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Price, Pamela Title: Deputy Director
Organization: The Balm In Gilead, Inc
Date: 02/10/2022
Comment:

February 9, 2022

Tamara Syrek Jensen
Director, Coverage and Analysis Group Center for Clinical Standards and Quality Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Chiquita Brooks-LaSure Administrator
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination for Monoclonal Antibodies Directed Against Amyloid for the

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Schroeder, L. Joy Title: Ms.
Date: 02/10/2022
Comment:
I do not want my tax dollars given to drug companies that offer questionable results for Alzheimer's Disease treatment at inflated prices. My [PHI Redacted] was treated for years with Aricept, which may or may not have slowed the progression of her dementia, but did seem to keep her behavior more cooperative . When drug companies are given outrageous profits for drugs which may not help the suffering of families, it is wrong! It is and has been wrong for drug companies to

More

Brace, Sharron Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Diekemper, Margaret Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Smith, Barbara Title: Mrs.
Organization: self
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Henderson, Randall Organization: Rev.
Date: 02/10/2022
Comment:
It is a travesty that Big Pharma can price gouge the federal government and American citizens. This must not happen! Our national health care will suffer a devastating blow purely due to greed and power, not due to any concern for the "public welfare."
Herlacher, Thomas Title: engineer
Organization: HAA, LLC
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

SAEED, DANISH Organization: Lehigh Family & Geriatrics Associates
Date: 02/10/2022
Comment:

I want to take this opportunity to write about Aduhelm which is a promising miracle drug for Alzheimers Disease. This is exciting not only for the patients who are suffering or at risk of developing this devastating disease but also for the Physicians who were treating these patients with frustration and no hope for possible cure.

In my opinion it will be unfair to limit access of Aduhelm for patients who have very little other treatment options. Aduhelm should be available for

More

Thayer, Ruth Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Reis, Linda Date: 02/10/2022
Comment:
Due to the lack of scientific rigor and huge cost to the patient's this drug should not be used by CMS.
Wartman, Gretchen Title: Vice President for Policy and Program
Organization: National Minority Quality Forum
Date: 02/10/2022
Comment:

ELECTRONIC SUBMISSION

February 10, 2022

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services

RE: Proposed National Coverage Determination with Evidence Development for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N)

Dear Ms. Syrek Jensen:

The National Minority Quality Forum (NMQF) is

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Laugesen, Miriam Title: Associate Professor
Organization: Columbia University
Date: 02/10/2022
Comment:

I support the CMS proposal to limit the coverage of a new Alzheimer’s drug aducanumab, (marketed by Biogen under the name Aduhelm) to experimental settings.

The scientific evidence on the benefits of this drug is limited. The cost of providing this drug, which would be borne by Medicare, and US taxpayers, is unreasonable and excessive, especially relative to the limited benefits the drug apparently provides.

Thank you for your consideration of this comment.

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Tucker, Julie Date: 02/10/2022
Comment:
Please consider making sure this drug is covered by insurance. It has helped my [PHI Redacted] tremendously.
Timmer, Suzanne Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Nadeau, Darlene Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Good, Jodi Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Cobb, c Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Renshaw, Arlene Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Wharton, Melody D Title: Mrs
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Doyle, Kevin Title: MD
Date: 02/10/2022
Comment:

I strongly support the Medicare administrators decision not to pay for aducanumab.

As a physician I was deeply disturbed by the Food and Drug Administration’s (FDA) recent decision to approve the Alzheimer’s disease drug, aducanumab, despite the significant lack of evidence regarding its efficacy as well as concerns about the drug’s safety. While the FDA has defended this decision by noting that they granted accelerated approval to aducanumab, which only requires the drug to

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Cohen, Miriam Date: 02/10/2022
Comment:
I don't want to see a huge amount of money spent on a drug or research that does not work. I am on disability and if my Medicare premium goes up I won't have money for myself.
Klein, Keavney Title: Senior Counsel
Organization: Kaiser Permanente
Date: 02/10/2022
Comment:

Kaiser Permanente[1] appreciates the opportunity to provide comments in response to the proposed National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. Given the controversy surrounding the approval of the first-in-class Aduhelm™ (aducanumab), Kaiser Permanente appreciates the thoughtfulness and objectivity with which CMS has approached the NCD process to determine whether and to what extent Aduhelm™ and

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Tilson, Dale Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

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Macioce, Kat Title: General Coverage for Aducanumab is Unkind (FHH)
Organization: University of Pittsburgh
Date: 02/10/2022
Comment:

If CMS adopts general coverage for aducanumab, they will be complicit in providing families and patients false hope, given the marginal results and significant side effects documented in the studies concerning the Biogen distribution of aducanumab, branded as Aduhelm. In addition to this, Doctor GC Alexander (2021) discusses that general coverage of aducanumab will force clinicians into some unusual disclosure with patients about the uncertainty of whether or not there are actual benefits

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Smith, James Title: Mr
Organization: Self
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Rushford, Robert Date: 02/10/2022
Comment:

he Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Hammond, Janette Date: 02/10/2022
Comment:
PLEASE reconsider the approval of this drug.
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a

More

Stewart, Theresa Date: 02/10/2022
Comment:

Dear Sir or Madam:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the

More

Benmoshe, Danny Title: M.D.
Date: 02/10/2022
Comment:
As a neurologist with specific focus on degenerative disorders including Alzheimer's I would like to point out that we finally an option that provides a fighting chance against this devastating disease to both the patient and their loved ones. The current available widely used drugs such as Aricept and Namenda are not anywhere close to providing the same opportunity to our patients as they are not medications that could help in delaying progression of disease. I believe that ultimately the

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Beavins, M Title: `
Date: 02/10/2022
Comment:

The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Wenz, Meredith Date: 02/10/2022
Comment:
It’s imperative that we continue to put time, effort, and funds behind any drug or treatment that can stop or slow the progression of Alzheimer’s. This disease is taking lives slowly and painfully, and not just for the person who receives the diagnosis. Family members are often forced to make major life changes in order to become caregivers. We need to do all that we can to support the researchers, doctors, and all treatments available. We cannot afford to lose any hope or momentum in the

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Laird, Rosemary Title: MD, MHSA
Date: 02/10/2022
Comment:

Mr. Secretary:

While I appreciate the well-reasoned counterarguments to this opinion and given the FDA "accelerated" approval, I think Medicare should cover this drug with carefully constructed guidelines crafted through collaboration with the FDA and reflecting the role of CMS to equitably protect beneficiary health and well-being and ensure safety.

Of all the illnesses and conditions that afflict humans, Alzheimer's disease is among the most tragic. For its victims, this

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MCKLVEEN, ROBERT Title: MD
Date: 02/10/2022
Comment:
I am writing to express my concern regarding the status of aducanumab. I applaud Medicare administrators' restriction of coverage of aducanumab, and encourage you to continue or further tighten this restriction.
The American public's faith and trust in our nation's health care administration is in crisis, with extremely high numbers of citizens having lost that faith an trust in the public health administration doing the right thing for the public health. The FDA approval of aducanumab

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Terry, George Title: Retired
Date: 02/10/2022
Comment:
I am a senior citizen on Medicare [PHI Redacted]. I am writing to support your decision to require proof - from an experimental study - that this drug works before asking all of the American taxpayers to pay for it. There is no evidence is a cure for Alzheimer's disease and Biogen's study failed to show removing plaque slowed cognitive decline at all - let alone in a clinically meaningful way. There is also no evidence that removing plaque and the amount removed correlates

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Steever, Dee Title: Retired teacher
Date: 02/10/2022
Comment:
I am 63 years old and I am a grandma to eight healthy grandchildren! However, I have friends who have children or grandchildren that have down syndrome. I truly feel that everyone including down syndrome individuals should have access to testing to help prevent or cure that horrible disease – Alzheimer’s. After all, about 30% of the individuals with down syndrome will present some symptoms of Alzheimer’s in their 50s or even earlier.! With one out of 700 babies carrying and presenting DS

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Tahmoush, Eileen Date: 02/10/2022
Comment:
Please stop price-gouging for prescrition drugs, especially bogus ones that do not work like the one from Biogen.
Mills, Damon Title: Mr
Date: 02/10/2022
Comment:

As an American citizen, I am against the FDA decision to approve Aduhelm. The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that

More

Turry, Alan Title: Managing Director
Organization: Nordoff-Robbins Center for Music Therapy at NYU Steinhardt
Date: 02/10/2022
Comment:
Like most citizens, my family has been touched by the disease of Alzheimers. I have worked as a therapist with those suffering from Alzheimers. I know there are services that help people with dementia - dementia-friendly communities, intensive day services, family support groups, home health aides (to help with dressing, bathing, cooking). I am an expert in the benefits of music therapy. Music brings awareness and memory to the forefront even as other faculties diminish. It brings joy.

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Barovich, Marny Date: 02/10/2022
Comment:
I oppose Medicare coverage of Aduhelm. It has not been proven to be efficacious & would therefore be a colossal waste of taxpers’ dollars to support the cost of the drug. And it would therefore unnecessarily increase the cost of Medicare for all!
Mirkle, Sharon Title: Mrs
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Fitzgerald, Mary Title: Aduhelm
Date: 02/10/2022
Comment:
We OPPOSE Medicare coverage for this drug! This drug is NOT helpful!
McCoy, Kristine Title: Family Physician
Date: 02/10/2022
Comment:
I congratulate CMS on making the decision to carefully restrict the use of aducanumab. As a family physician and family member of a person with dementia my understanding of the desperation of patients for effective therapy is broad and deep. What our patients depend upon us for as professionals is ensuring their safety and carefully elucidating and guiding them through known risks. I trust the agency will continue to uphold this standard and not endorse this medication for payment except as

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Thomas, Kelsey Title: Physician
Date: 02/10/2022
Comment:
I congratulate Medicare Administrators for their bold decision to only fund Aduhelm administration for those in a randomized clinical trial. Not only is there woefully sparse evidence that this drug benefits patients, but in over one third of patients it causes brain swelling or bleeding. Medicare should be prioritizing reimbursement for cost-effective treatments with robust evidence of benefit.
Caguiat, Carlos Date: 02/10/2022
Comment:
I request that CMS not approve the drug Aduhelm excluding it for Medicare recipients. While the object of the drug is laudable, it did not prove to be effective in one clinical study that was stopped because of this reason. The second study did not improve thinking, memory or the ability to function. FDA's own advisory panel recommended that FDA not approve the drug but it as approved anyway. The studies were faulty. In addition the cost is tremendous and will adversely impact the

More

Juister, Linda Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Smith, Sara Title: Ms.
Date: 02/10/2022
Comment:

The decision of the Food and Drug Administration to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Seyfried, Mike Date: 02/10/2022
Comment:

Dear Sirs:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the

More

Oliver, Robert Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Durnell, Susan Organization: retired
Date: 02/10/2022
Comment:
This is a damaging price rise for a drug that shows little value even for those for whom it's indicated. The cost of its off-label use would be staggering, and most likely a waste. It should continue to be used only in approved clinical trials, and therefore should not require this horrible increase in medicare premiums.
Bickle, Robin Title: Mrs
Date: 02/10/2022
Comment:
Im Robin, live in indiana, I have [PHI Redacted] who has Down syndrome, and I need to plan now for her future. I know that she is more likely than other people to develop Alzheimer’s disease, not only due to her DS but also because I've had [PHI Redacted] decline from Alzheimers disease. So even though there’s no cure now, it’s very important to me that she has access to any treatments that will be developed in the future. I’ve become aware that the Centers

More

Droughton, Vinny Title: Mr.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Hider, Sue Organization: St Francis Hospital
Date: 02/10/2022
Comment:
The treatment is something that families and patients should have the right to deside if they would like to use. All I hear about is the cost. Really with contracts that facilities and physicians negotiate the cost of this drug is not as costly as the media has made it out to be. Reality is that the cost of this drug is not even close to some drugs that are used but the link that keeps coming up is to Medicare costs. That is a big deterant to patients because of what they read. Do they

More

Oliver, Linda Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Johnson, Carol Title: Licensed Clinical Social Worker
Date: 02/10/2022
Comment:
My [PHI Redacted] has mild, 1st stage AD. He has had 9 Aduhelm infusions with no side effects and hopes to have 3 more. Our hope is that it will take several years for the amyloid to build back up and [PHI Redacted]. When he was diagnosed, we were looking at a depressing future of his loss of self, incontinence, and death. Because of this treatment, he has remained able to drive, volunteer at a community garden and participate in an active family, church,

More

galyon, john Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

NORRIS, LINDA Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Pillinger, Hal Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Federman, Ellen Date: 02/10/2022
Comment:
This procedure for addressing Alzheimers Disease has no validity. It should not be paid for by Medicare unless as part of a trial.
Siegfried, Frances Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Terry, Terri Date: 02/10/2022
Comment:
I am a citizen who has family members touched by Alzheimer's disease. People with Alzheimers deserve more than false hope. I commend your standing up to the FDA's ill-advised approval that seems to be based on a too cozy relationship with Biogen. Please don't change your mind about requiring an experimental study showing Aduhelm works before approving payment under Medicare. From what I read, Biogen conducted two identical studies. One showed a nominal benefit versus placebo (not

More

Means, Robert Date: 02/10/2022
Comment:

Hi Folks,

The former guy did all he could to make money during his time in office. It sounds like that included pushing along the approval of a drug that is not ready for prime time. Because he destroyed so many records, we don't know who greased his palm, but "grift" would be the easiest explanation for this.

Our democracy depends upon trust in our government. The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease

More

Rhein, Sandy Organization: USPS
Date: 02/10/2022
Comment:
Aduhelm was approved by the FDA to treat Alzheimer's, even though it has not been shown to be effective and it causes dangerous side effects. It also costs a whopping $28,000 a year. I agree with Medicare not to fund this dangerous ineffective drug. There needs to be much more research and the cost needs to be lowered so that it is affordable before it is put on the market. Families of Alzheimer patients struggle to care for their loved ones. An effective and reasonably priced needs to be found.
Martinez, Dave Date: 02/10/2022
Comment:
I agree with the CMS decision to not have Medicare cover the cost of Aduhelm
Attanasio, Shannon Title: Vice President, Government Relations and Advocacy
Organization: Medicaid Health Plans of America (MHPA)
Date: 02/10/2022
Comment:

MHPA
1575 Eye Street, NW Suite 300 Washington, D.C. 20005
TEL (202) 857-5720 FAX (202) 857-5731 www.medicaidplans.org

February 10, 2022
The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: Proposed National Coverage Determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Dear Administrator

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Behler, Lynelle Date: 02/10/2022
Comment:
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials,

More

Gitles, Toni Title: CEO
Organization: Heart Light Enterprises, LLC
Date: 02/10/2022
Comment:

I urge the CMS to modify their decision on Aduhelm and not create the harsh limitations on anti-amyloid monoclonal antibody drug trials currently in Phase 3 as well as any further similar drug trials. Alzheimer’s and dementia make up the #6 cause of death among Americans and is the ONLY killer without any cure, control, or prevention.

I am utterly appalled that the CMS is now rejecting FDA approval for aducanumab (Aduhelm). This will make Medicare support for Aduhelm only

More

Seaver, Stacy Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

winter, lauren Date: 02/10/2022
Comment:

The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Hamilton-Ditty, Marcelle Date: 02/10/2022
Comment:
We rely on our experts to keep us safe
Thank you
Hoch, Susan Title: MD
Organization: retired
Date: 02/10/2022
Comment:
I am a retired rheumatologist immunologist. While I was initially hopeful that the monoclonal technology that created aducanumab would provide an effective agent for Alzheimers. Unfortunately the data suggests it is not particularly helpful in improving cognitive function in early disease although it apparently removes amyloid plaques. Over 40 years ago I worked at Harvard alongside people who were working on the hypothesis that amyloid causes Alzheimer's. Their data was marginal at that

More

Flaten, Carolee Date: 02/10/2022
Comment:
Curtail big Pharma Profits now.
Vazquez, Laurie Title: Mrs.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Campagna, William Date: 02/10/2022
Comment:
You must continue on with restriction of the unproven Alzheimer drug to reimbursement for those in trials only. Senior citizens on fixed budgets cannot afford the bump in Medicare fees caused by the general support of this drug, one which, I might add, has been denigrated by responsible scientists and doctors.
Phillips, Thair Title: Former President/CEO RetireSafe
Date: 02/10/2022
Comment:

Comment concerning the Centers for Medicare and Medicaid Services’ (CMS) proposed National Coverage Determination (NCD) to restrict coverage for drugs used to treat patients suffering from Alzheimer’s.

There are many levels of controversy concerning CMS’s proposed determination concerning the Alzheimer’s approved drug amyloid. I wish to comment on, what I feel should be, the highest level of concern.

The FDA approved the use of amyloid for the treatment of Alzheimer’s

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Punday, Nicole Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Cantino, Laura Title: Physician
Date: 02/10/2022
Comment:
I strongly support the proposed coverage decision for aducanamab. In the proposed decision, CMS has recognized the need for further investigation to protect older and disabled adults. Importantly, CMS has suggested requiring that the drug be tested through well-designed, randomized controlled trials within patients representative of populations most impacted by Alzheimer’s disease, including racial and ethnic minorities. Patients and their families need this information in order to make

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Parsons, Deirdre Title: Sr Dir, Global Public Policy & Gov't Relations
Organization: Alnylam Pharmaceuticals
Date: 02/10/2022
Comment:

February 10, 2022

VIA ELECTRONIC FILING —- https://www.cms.gov/medicare-coverage-database/reports/national-coverage-ncacal-status-report.aspx?ncacaldoctype=NCA&status=Open%20for%20Public%20Comment

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
Department of Health and Human Services
ATTN: CAG – 004460N
7500 Security Blvd.
Baltimore, MD 21244-1850

RE: NATIONAL COVERAGE

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Standen, Ilene Organization: - None -
Date: 02/10/2022
Comment:

Would you commit to paying $20 per month ($240 per year) on a drug for your child that doesn't work? Of course not. So why would every Medicare subscriber be forced to spend this amount on an Alzheimer's drug that is of no benefit to Alzheimer's patients?

The FDA's decision to approve Aduhelm showed a disregard for science and for process and standards for approving new drugs. The FDA has not been a shining light throughout the Covid pandemic and this has added to its credibility

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Peschin, Susan Title: President and CEO, Alliance for Aging Research
Organization: Alzheimer's Disease Policy Task Force
Date: 02/10/2022
Comment:
Download comment
Long, Denise Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Ninteau, Kacy Organization: Right Care Alliance
Date: 02/10/2022
Comment:
I am a member of the Right Care Alliance and I hope to one day become a geriatrician. I am invested in making sure that all drugs approved by the FDA, and specially those mainly for older adults, work and that their benefits outweigh their risks. Thank you for requiring Biogen to show just that, and thank you for requiring that their trial is experimental, not observational. With the stakes as high as they are given the population of people with Alzheimer's, it does not make sense to

More

Wemett, David Title: Mr.
Date: 02/10/2022
Comment:

Please do not continue with the FDA's decision to approve "Aduhelm" for treatment of Alzheimer’s disease at this time. The process by which the approval was done was flawed, and the drug may not be of any benefit at all.

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s

More

Lanspery, Susan Date: 02/10/2022
Comment:

The Food and Drug Administration’s approval of Aduhelm for treatment of Alzheimer’s disease showed a disturbing disregard for scientific evidence and eviscerated the agency’s own standards for approving new drugs. As a result, the agency’s credibility has been damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a data review found that the trials, if continued to completion, were highly

More

Thientunyakit, Tanyaluck Title: Associate Professor
Organization: Faculty of medicine Siriraj Hospital, Mahidol University
Date: 02/10/2022
Comment:

Thank you for the opportunity to comment on the national coverage analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (AD) (CAG-00460N) proposed decision published on January 11, 2022. My name is Tanyaluck Thientunyakit and I am a member of The Society of Nuclear Medicine and Molecular Imaging (SNMMI) and current board member of the Brain Imaging Council.

We appreciate efforts by the Centers for Medicare & Medicaid Services

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Finocchiaro, Lyle Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Kantrowitz, Edith Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Chamness, John Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Girardin, Josephine Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Isenberg, Nancy Title: Medical Director
Organization: Center for Healthy Aging, SNI
Date: 02/10/2022
Comment:
In their proposed decision for coverage of aducanumab and other such monoclonal antibodies, CMS has recognized the need for further investigation to protect older and disabled adults. Importantly, CMS has suggested requiring that the drug be tested through well-designed, randomized controlled trials within patients representative of populations most impacted by Alzheimer’s disease, including racial and ethnic minorities. We see this as correcting the precedent set forth by the FDA in awarding

More

Ponder, William Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a serious disregard for science and a complete disregard for the agency’s standards for approving new drugs, thus damaging the agency’s credibility.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were

More

Garcia, Anna Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

DeMatteis, Candace Title: Policy Director
Organization: Partnership to Fight Chronic Disease
Date: 02/10/2022
Comment:

Thank you for the opportunity to share comments on the proposed National Coverage Determination requiring Coverage with Evidence Development (NCD with CED) for monoclonal antibodies (mABs) targeting amyloid for the treatment of Alzheimer’s disease. We have several serious concerns about the proposed NCD with CED and urge you to reconsider, remove CED requirements in this NCD, and allow coverage for FDA-approved uses of these Alzheimer’s disease therapies for Medicare beneficiaries

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Horn, Kathy Date: 02/10/2022
Comment:
Hello, my name is Kathy Horn, and I’m from Lyons, Ne. I have a [PHI Redacted] with Down syndrome. I believe that people with Down syndrome and other disabilities should have the same right to health care as everyone else. I have recently become aware of a new Alzheimer’s drug called aducanumab and that CMS has proposed coverage that excludes people with Down syndrome and other intellectual and developmental disabilities. I understand the need to make sure treatments are safe,

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Creighton, Mark Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and ignored the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

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Walker, Michael Date: 02/10/2022
Comment:
Do not approve this unproven drug. Do not charge Medicare to include this drug.
Lafleur, Todd Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Kewman, Donald Title: Retiree
Date: 02/10/2022
Comment:

I am writing to you regarding the Proposed National Coverage Determination (NCD) for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. This proposed decision most immediately affects five anti-amyloid treatments, including the Food and Drug Administration (FDA) approved Alduhelm.

Under the proposed NCD, the Centers for Medicare and Medicaid Services (CMS) would only cover this class of treatments for people enrolled in randomized

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Jennings, Belinda Title: Nurse / Former Caregiver /Advocate
Organization: Belinda Jennings
Date: 02/10/2022
Comment:

As a nurse & former caregiver I am truly concerned regarding the direction this is taking in limiting care to those in need. I serve our American Heros in a rural community. Many of them are being diagnosed with Alzheimer's and other related Diseases. The limitation on approval and lack of payment would keep many if not all of them from getting the care they need and deserve. Many of them do not have access to participate in a clinical trial, for various reasons.

As a former

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Marcisz, Thomas Title: MD, PhD
Organization: Tri City Medical Center, Palomar Medical Center
Date: 02/10/2022
Comment:

I am in support of the current CMS standing concerning limiting further use of aducanumab to only RCT study.

The Amyloid Cascade Hypothesis surfaced in 1992. Since that time much has been learned about Alzheimer's disease at the cellular and molecular level. Hundreds of different monoclonal antibodies have been developed through the years to try to halt cognitive decline and all have failed for various reasons.

Recently a new monoclonal antibody was submitted for

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La Sota, Nancy Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Thoman, James Title: Mr
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Eliasoph, Sarah Title: Retired Nonprofit CEO
Date: 02/10/2022
Comment:
This increase in Part B premiums, regardless of the patient’s need for Alzheimer’s medications, is unfair, unwarranted and an example of governmental overreach. No private insurance company could get this approved, why should Medicare?
Nguyen, May Date: 02/10/2022
Comment:
I applaud CMS’s proposal to restrict coverage of anti-amyloid monoclonal antibodies such as aducanumab for the treatment of Alzheimer’s disease only in the setting of randomized-controlled trials under Coverage for Evidence Development (CED) as such a coverage decision prioritizes and protects patients above all else. As a practicing physician, we urge CMS to adopt this proposal as their final national coverage determination to ensure that our patients have access to truly effective and safe

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Getty, Joseph Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

MacKenzie, Joseph Title: Mr
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Quinonez, Ricardo Title: MD
Date: 02/10/2022
Comment:
This is a drug with minimal to no benefit that costs many thousands of dollars. It would be irresponsible for CMS to cover this drug and put patients at risk for all the side effects while offering marginal to little benefit. It was an extraordinarily bad decision by the FDA to approve this drug, but there is nothing preventing forward thinking government agencies from not having to pay for the FDA's mistake. Please to the right thing to protect patients.
MccalluM, Mike Date: 02/10/2022
Comment:
The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials,

More

Petersen, Ronald Title: Professor of Neurology
Organization: Mayo Clinic
Date: 02/10/2022
Comment:

Dear Secretary Becerra and Administrator Brooks-LaSure,

I am a neurologist at the Mayo Clinic in Rochester, MN,, Director of the Mayo Clinic Alzheimer’s Disease Research Center and former Chair of the Advisory Council on Research, Care and Services for the US Plan to Address Alzheimer’s Disease.

The CMS proposal for Coverage with Evidence Determination (CED) for monoclonal antibodies represents a reasonable decision given the circumstances surrounding the accelerated

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Kernisan, MD, Leslie Title: Geriatrician
Organization: Better Health While Aging
Date: 02/10/2022
Comment:

As a board-certified geriatrician and a former health services researcher, I am strongly in favor of CMS's plan to only pay for Aduhelm in the setting of a clinical trial, and I urge CMS administrators to finalize this plan.

I work with patients and families affected by Alzheimer's. I understand how desperately they are seeking for cures, treatments, or ways to delay the progression of the disease. But so far there is very little evidence that Aduhelm provides meaningful benefit,

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Eng, Marilyn Date: 02/10/2022
Comment:
Do not permit a private pharmaceutical company to manipulate Medicare in their favor. I am a Medicare recipient and this is very concerning to me.
Greenspan, Carol Organization: KOPN Radio (longtime active volunteer)
Date: 02/10/2022
Comment:
The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
Piascik, Jim Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

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Hoksbergen, Michael Organization: Salutation*
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

May, Don Title: SVP Policy
Organization: Federation of American Hospitals
Date: 02/10/2022
Comment:

February 10, 2022

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

RE: Proposed National Coverage Determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N)

Dear Administrator Brooks-LaSure:

The

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Elliot, Rebecca Date: 02/10/2022
Comment:

Hello
It is time to stop supporting Big Pharma insatiable greed. There is no way to justify Aduhelm's outrageous cost ($56k a year). No way at all.

I seem to remember that the process to certify Aduhelm was flawed and that the process was accelerated to accommodate the pharmaceutical giant. The FDA's advisory committee DID NOT recommend approval so why did the FDA overruled its own advisory committee and approve a drug with NO therapeutic benefit.

It's time to stop

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Schilhab, Arthur Title: Mr
Date: 02/10/2022
Comment:
Medicare needs the right to negotiate drug prices with Big Pharma. That is the American way.
McDonald, Michael Date: 02/10/2022
Comment:
The FDA’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease shows a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged. The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion , were

More

Paire, S Date: 02/10/2022
Comment:
FDA’s accelerated approval to aducanumab is a HORRIFYING, UNACCEPTABLE BLOW to millions impacted by Alzheimer’s disease. Aducanumab has NO DATA showing effectiveness compared to placebo. Worse, it caused life threatening side effects (brain swelling & bleeding) in 40% receiving an FDA approved dose. First, DO NO HARM!!! Life threatening injuries (brain swelling & bleeding) caused by a drug no better than placebo? If anyone collected data on suffering, it would include: pain, suffering, death,

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MORMAN, GAIL Date: 02/10/2022
Comment:

The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Wedge, David Title: MR
Organization: Medtronic Diabetes
Date: 02/10/2022
Comment:
The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Rose, William Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Young, Regina Title: Global Head Market Access
Organization: GE Healthcare
Date: 02/10/2022
Comment:

Dear Administrator Brooks-LaSure:

On behalf of GE Healthcare, thank you for the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) National Coverage Analysis (NCA) Proposed Decision for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease. As a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through

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Casey, Kathleen Title: Attorney, concerned citizen
Date: 02/10/2022
Comment:

I have been following the story of this drug in the news, and have spoke to a number of physician friends, including geriatric doctors. Unwarranted approval of drugs like these do nothing but line the pockets of big Pharma and give false hope to patients and their families. It is simply wrong to approve drugs that have not faced rigorous and comprehensive scrutiny and trials.
In their proposed decision for coverage of aducanumab and other such monoclonal antibodies, CMS has recognized

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Moore, Nancy Title: Ms.
Organization: Retired investment banker
Date: 02/10/2022
Comment:
Protect at all cost.
Sanders, Amy Title: MD, FAAN
Organization: Hartford Healthcare
Date: 02/10/2022
Comment:

Nearly a decade ago, CMS consigned amyloid PET to "coverage with evidence development." Despite the fact that three FDA ligands had already been approved even before the decision was rendered, in 2022 I still cannot order an amyloid PET for patients who might benefit greatly from the increased diagnostic precision afforded by such imaging.

In the case of aducanumab, I remain agnostic in the great risk/benefit controversy, perhaps leaning slightly toward perceiving risk in excess

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Wolfson, Wendy Title: Scientific writer
Date: 02/10/2022
Comment:
It is a bad idea to reimburse for a drug of uncertain benefit and which could raise risk of stroke.
Speyer, Lara Date: 02/10/2022
Comment:

Dear Friends,
I’m very concerned about your recent decision not to cover Aduhelm except in drug trials.
I have a dear friend who is in one of these trials and it has benefitted him greatly! He has also been hopeful about other similar drugs that are in the pipeline. This decision has taken away the first real hope for people in the Alzheimers community who have been waiting decades.

Please reconsider!

Thank you,

Lara Speyer
Barry, Jessica Title: M.D.
Date: 02/10/2022
Comment:
I am writing to applaud the Centers for Medicare and Medicaid Services (CMS) for their proposed national coverage decision regarding “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease” issued on January 11, 2022. I am a practicing geriatrician and, like many other clinicians, patients, and experts, I was deeply disturbed by the Food and Drug Administration’s (FDA) recent decision to approve the Alzheimer’s disease drug, aducanumab, despite the significant

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Hudson, Alice Title: Ms.
Date: 02/10/2022
Comment:
Please do not raise prices on Medicare prescriptions. The drug makers already charge more than necessary for most prescriptions in order to increase their profits.
GOMOLL, TERRY Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this action, the agency’s credibility has been damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion,

More

Hinds, Ward Title: MD, MPH
Organization: Retired
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was, in my opinion, based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found

More

Spry, Steve Date: 02/10/2022
Comment:
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials,

More

Ziedrich, Linda Date: 02/10/2022
Comment:
The FDA's decision to approve Aduhelm for treatment of Alzheimer’s disease showed a complete disregard for science and contradicted the agency’s standards for approving new drugs. Because of this action, the agency’s credibility has been seriously damaged.
The approval of Aduhelm was based on flawed analyses of trials that were stopped early after a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefited patients with

More

Twerdochlib, Orysia Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Beebe, Natalie Title: Aduhelm
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Smith, Barbara Date: 02/10/2022
Comment:

When I read "Dopesick" and "Empire of Pain" I thought it wouldn't be possible for the FDA to again engage in corrupt practices benefiting a pharmaceutical company like Purdue. Surely any unlikely drug approvals or sweetheart deals would be glaringly obvious and prevent nefarious actions. Unfortunately, the FDA approval of Aduhelm shows that not to be true. Another fabulously expensive drug has been approved based upon junk science following an inappropriate collaboration between the

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Lanset, Stephen Title: Mr
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Freudenberg, Jared Title: The Importance of Trust and Transparency
Organization: University of Pittsburgh
Date: 02/10/2022
Comment:
The responsibility of the FDA, as described by its mission statement, is: "The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs." Why then are they prioritizing the approval of this drug on an accelerated track through backdoor deals and discussions? The FDA approval rating has taken a drastic downturn during the pandemic: "37% of doctors, 27% of nurses, and 41% of WebMD readers said they

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McGarrity, Karen Organization: D-W/McGarrity, Inc.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Stephenson, Joan Organization: self employed
Date: 02/10/2022
Comment:
I support the decision to NOT cover Aduhelm. The FDA's own expert committee noted that it has not been shown to be effective and that it causes dangerous adverse effects. The cost for a drug that has no convincing evidence of effectiveness (and that does have evidence of harm) is absurd. The fact that the drug company halved the price when uptake was poor shows how egregiously overpriced it was initially, and given the likelihood that it doesn't have a meaningful clinical effect means it would

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VandeVrede, Lawren Title: MD/PhD
Organization: UCSF Memory and Aging Center
Date: 02/10/2022
Comment:

I am an Assistant Professor and a cognitive neurologist at the UCSF Memory and Aging Center in the Department of Neurology. I work within our clinical trials division, where we conduct trials for patients with neurodegenerative diseases such as Alzheimer’s and frontotemporal dementia. I was a Sub-Investigator on both the ENGAGE and the EMBARK clinical trials, but I have no financial relationship with Biogen or any other company involved with anti-amyloid antibodies. I believe I am familiar

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KLOF, s Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Garvey, Deborah Title: Dr.
Organization: self
Date: 02/10/2022
Comment:

The Food and Drug Administration’s (FDA’s) June 7, 2021 decision to approve Aduhelm for "treatment" of Alzheimer’s disease showed a stunning disregard for science and the agency’s own standards for approving new drugs. FDA relied on an accelerated approval pathway for a medication of unproven therapeutic benefit, and overruled an FDA advisory committee's nearly unanimous vote against approval. Because of FDA's reckless actions in approving Aduhelm, its credibility as an impartial arbiter of

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Alexander, Gunta Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

LaJeunesse, Richard Date: 02/10/2022
Comment:
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
Rpl
Doshay, BETH Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

rand, douglas Organization: VA
Date: 02/10/2022
Comment:
I support CMS in their efforts to control costs - especially in the case of the new dementia medicine. Consider more limitations on coverage for questionable treatments and me too drugs. Thank you.
Bolan, Nancy Title: Professor
Organization: University of Maryland Baltimore School of Nursing
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Gopinath, Valerie Date: 02/10/2022
Comment:
I support the CMS preliminary coverage determination. There is no sound evidence of a benefit to patients and the part B premium increase should be reassessed. Seniors need support and care, not a rate hike for an unproven drug treatment approach.
Battista, Harry E. Date: 02/10/2022
Comment:
To: The Food and Drug Administration.
To whom this may concern,
After the Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs; because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that

More

SAUNDERS, SARAH Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Hunt, Teresa Date: 02/10/2022
Comment:

I protest!!!

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the

More

Whitten, Michelle Title: President and CEO
Organization: Global Down Syndrome Foundation
Date: 02/10/2022
Comment:

February 10, 2022

Ms. Chiquita Brooks La-Sure
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: CMS Proposed Decision Memorandum on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

Dear Administrator La-Sure:

On behalf of the Global Down Syndrome Foundation and our partner organizations striving to improve the lives of Americans with

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Hollywood, Michael Title: Registered Nurse
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Sharp, Matthew Title: Advocacy Manager
Organization: The Association for Frontotemporal Degeneration
Date: 02/10/2022
Comment:

The Association for Frontotemporal Degeneration (AFTD) is the only non-profit organization solely dedicated to improving the quality of life of people affected by frontotemporal degeneration (FTD) and driving research to a cure for all FTD disorders. Aduhelm’s path to approval and potential coverage by Medicare has been fraught with controversy. AFTD appreciates the challenges the Centers for Medicare & Medicaid Services (CMS) faced in navigating the complex and changing environment

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Dulniak, Dennis Title: President
Organization: Nana's Books Foundation
Date: 02/10/2022
Comment:

[PHI Redacted] died January 2021 at age [PHI Redacted] after being diagnosed for 7 years with Early Onset Alzheimer’s. During that time, she participated in 8 drug trials, none of which was successful in obtaining FDA approval. However, among our new network of friends with mild forms of dementia, three of the four had positive responses to the Aducanumab drug trials that we truly believe showed improvement among their cognitive abilities and extended the

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Klepper, Brian Organization: Worksite Health Advisors
Date: 02/10/2022
Comment:
That the agencies charged with protecting us should approve a drug with such questionable evidence is shameful, a true scandal, and proof of systemic dysfunction. CMS needs to reassert an evidence-based framework to restore the public's faith in its ability to do its job.
Markman, John Title: Professor of Neurosurgery and Neurology
Organization: University of Rochester
Date: 02/10/2022
Comment:
I am writing as a neurologist and clinical researcher to recommend against coverage for this drug until there is an evidence base that supports clinically significant benefit for aducanumab in a subpopulation of patients with Alzheimer's disease.
White, Steven Title: M.D.
Date: 02/10/2022
Comment:
Unfortunately, FDA’s decision to award accelerated approval to aducanumab based on an unproven surrogate endpoint has not only likely falsely raised hope for patients and their families suffering from Alzheimer’s disease, but has also created a much larger and more dangerous precedent. In response to FDA’s approval of aducanumab, other manufacturers have pivoted to investigating other monoclonal antibodies with similar, uncertain mechanisms of action in hopes of also receiving accelerated

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Bradley, Mark Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Bateman, Randall Title: Distinguished Professor of Neurology
Organization: Washington University School of Medicine
Date: 02/10/2022
Comment:

As Director of the Dominantly Inherited Alzheimer's Network Trials Unit (DIAN-TU), a research scientist and principal investigator of a lab that studies Alzheimer's disease, and as a physician who evaluates and treats patients and families with Alzheimer's disease, I would like to provide my perspective on the proposed CMS decision regarding “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease”. My comments about the proposed decision are

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Dolenz, Brian Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

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Hammond, Eric Date: 02/10/2022
Comment:
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials,

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Moore, James Title: Mr.
Organization: Retired scientist
Date: 02/10/2022
Comment:

I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program.

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously

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Torday, Darlene Title: Medicare too high because of drug cost
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Freligh, Marc Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Clingham, Gavin Organization: Alliance for Patient Access
Date: 02/10/2022
Comment:

February 10, 2022

The Honorable Chiquita Brooks-LaSure
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

Re: National Coverage Determination for Monoclonal Antibodies for the Treatment of Alzheimer’s Disease

Dear Administrator Brooks-LaSure:

On behalf of the Alliance for Patient Access (AfPA), we thank you for the opportunity to offer comment regarding the CMS National

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Brewer, Virginia Date: 02/10/2022
Comment:
I appreciate being able to participate and respond.
McCormick, Thomas Date: 02/10/2022
Comment:
I support the decision to not cover Aduhelm
Hughes, Keith Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Herrington, Matthew Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Shutes, Leslee Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Young, Susan Date: 02/10/2022
Comment:

I have a relative who is now dealing with Alzheimer's disease. But the Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped

More

Cohen, Joel Organization: Retired
Date: 02/10/2022
Comment:

Having read a number of articles about Aduhelm, I believe it should not be supported by Medicare. Medicare is a necessary system to guarantee retired elders access to medical care and should not be in the business of supporting any pharmaceutical company's testing program. Beyond that restriction, this particular drug has not shown positive effects on Alzheimer's, but has shown a very high incidence of side effects. It should never have been okayed by the FDA. It only offers little hope to

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Crabtree, STEVE Date: 02/10/2022
Comment:
Common sense dictates that CMS NOT APPROVE Aduhelm beyond strict specified limits. Aduhelm has not been absolutely proven to be effective in the treatment of Alzheimer’s and the cost cannot be justified against the overall impact approval would have on Medicare finances. Do not approve Aduhelm beyond strict limited application.
Harker, Eric Title: MD
Organization: Iora Primary Care
Date: 02/10/2022
Comment:
I strongly support the CMS decision NOT to cover this treatment. I've read the studies and find it frankly embarrassing that the FDA moved this medication forward. Even if the drug were offered at a low cost the harms clearly outweigh the benefits, if there are any real clinically meaningful benefits (I've not seen any evidence that there are). It smacks of corruption and surely CMS will get a lot of input from pharma and paid consultants pretending to be patient advocates. I care for elderly

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Socolar, Deborah Date: 02/10/2022
Comment:

I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program. The U.S. Food and Drug Administration (FDA) made a grave error in its June 7, 2021 decision approving Aduhelm on June 7, 2021 for treating Alzheimer’s Disease.

That approval was foolhardy and utterly unscientific. The decision severely undermined both FDA drug approval standards and trust in the agency.

Approving Aduhelm relied on deeply problematic

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Frame, Sean Date: 02/10/2022
Comment:

Please do NOT allow the use of Monoclonal antibodies for the treatment of Alzheimer’s, except as part of clinical trials. Because pharmaceutical companies can charge a virtually unlimited amount for their drugs and we can’t negotiate with them, we cannot pass the cost of this treatment on to all other people on Medicare.

If the drug companies take exception with this, remind them of the hundreds of billions in extra profit they make from the American Public.

Thanks for

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Incze, Michael Title: MD
Organization: University of Utah
Date: 02/10/2022
Comment:

As a primary care physician who treats patients with Alzheimer's disease and has read the primary studies on aducanumab (Aduhelm), I strongly oppose Medicare/Medicaid coverage of this drug outside the realm of clinical research. The equivocal benefits and clear, potentially fatal harms demonstrated by the two large randomized controlled trials evaluating aducanumab demand further research that evaluates this medication over a longer time frame. It would also be reasonable to abandon it as

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Butterweck, Susan Date: 02/10/2022
Comment:
The Food and Drug Administration’s flawed and highly questionable decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and flouted the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been seriously compromised.
The approval of Aduhelm was based on flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Todd, Sam Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Chambers, Janis Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Scott, Duncan Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Kruse, Carole Title: Ms.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Bilisoly, Kandice Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

McCabe, Ann Date: 02/10/2022
Comment:
This price increase is outrageous. It's an almost 20% increase and I can't afford it. And I am enraged to learn that it is due to this Alzheimer's drug - which I followed in the news and listened to many concerns by qualified doctors. I am so tired of the entitled few pounding their fists because they can't have something when they want it - or feel their freedoms are being thwarted when they have no concern for how it will effect others.
Holloway, Karren Date: 02/10/2022
Comment:
We need to confirm this.
McCoy, Tom Title: Executive Director
Organization: Nevada Chronic Care Collaborative
Date: 02/10/2022
Comment:
The Nevada Chronic Care Collaborative (NCCC) strongly urges the Centers for Medicare and Medicaid Services (CMS) to reconsider its proposed National Coverage Determination (NCD) pertaining to breakthrough Alzheimer's treatments. NCCC makes this request not only on behalf of the millions of Alzheimer's patients, families, and caregivers who would be denied access to this class of drugs, but also because of the far-encompassing precedent it would set. CMS would be putting cost concerns over

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Phillips, Sophia Date: 02/10/2022
Comment:

As organizations committed to scientific integrity, we are providing these public comments on the National Coverage Analysis Proposed Decision Memo from the Centers for Medicare and Medicaid Services (CMS). This decision relates to coverage of Aduhelm and similar unproven medical products for the treatment of Alzheimer’s disease.

We share the view of scientists and researchers across the country that the FDA approval of Aduhelm was not scientifically sound and sets a dangerous

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Neves, Lauren Title: Deputy Vice President
Organization: Pharmaceutical Research and Manufacturers of America (PhRMA)
Date: 02/10/2022
Comment:
Download comment
Sullivan, Connie Title: President and Chief Executive Officer
Organization: National Home Infusion Association
Date: 02/10/2022
Comment:

The National Home Infusion Association (NHIA) appreciates the opportunity to provide feedback on the proposed National Coverage Analysis (NCA) decision memorandum, “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease” (CAG-00460N), issued by the Centers for Medicare & Medicaid Services (CMS) on January 11, 2022. NHIA is a trade association that represents companies that provide infusion therapy to patients in their homes, as well as companies that

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Bortz-Johnson, Susan Date: 02/10/2022
Comment:
I expect any part of the US government to be working for humans, not the thieves promoting the wealth of corporations.
Robotti, Suzanne Title: Founder, President
Organization: MedShadow Foundation
Date: 02/10/2022
Comment:

The premise that the approval for this drug was based on its that blocking the growth of amyloid plaques will also slow the progression of Altzheimer’s. But that has never been proven.

The risk of harm is high. 41% of patients on the therapeutic dose of Adhuhelm in clinical trials experienced brain bleeds.

Eventually, Aduhelm may be proven effective at slowing the progression of Alzheimer’s. However, the “accelerated approval” that the FDA granted Aduhelm gives its

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Waldron, Juliet Organization: - Select -
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

maclean, joel Date: 02/10/2022
Comment:
The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless (and possibly unethical) action, the agency’s credibility has been further damaged.
Given the lack of scientific evidence that Aduhelm provides any clinically meaningful benefit in terms of cognitive function outcomes in Alzheimer’s disease patients, the drug

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Fisher, Shelby Date: 02/10/2022
Comment:
I applaud the decision to only pay for Aduhelm in the setting of a clinical trial because the evidence that this monoclonal antibody benefits patients is missing. The goal should be to improve Alzheimer’s patients’ ability to think and carry on the daily activities of life. To date, there is no evidence that Aduhelm achieves these goals. I do not want to pay $11 extra per month for my Part B premium to fund a drug that doesn’t work!
Palodichuk, Veronica Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Jacobs, Eric Title: Mr.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Dube, Tim Title: Vice President, Regulatory Affairs
Organization: PCMA
Date: 02/10/2022
Comment:

February 10, 2022

Submitted electronically via email to CAGinquiries@cms.hhs.gov.

Ms. Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
U.S. Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Proposed National Coverage Determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-0046ON)

Dear Ms. Jensen:

The

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Quadrini, Philip Date: 02/10/2022
Comment:

The Food and Drug Administration’s CRIMINAL decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Sherman, Lisa Date: 02/10/2022
Comment:
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials,

More

Rahman, Naisa Date: 02/10/2022
Comment:

After working in public health across state/local agencies, academic institutions, and in community-based settings, I strongly support the limitation of Aduhelm coverage by CMS.

There are many other more cost-effective and evidence-based ways to prevent Alzheimer's and related dementias. The indications for this drug are poorly understood at best as there is no clear diagnostic criteria for MCI and consensus on how useful that diagnosis is. In addition, granting greater approval

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Eagen, Thomas Date: 02/10/2022
Comment:

As members of the Patient, Consumer, and Public Health Coalition, we are providing these public comments on the National Coverage Analysis Proposed Decision Memo from the Centers for Medicare and Medicaid Services (CMS). This decision relates to coverage of Aduhelm and similar medical products for the treatment of Alzheimer’s disease.

We strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating in clinical trials, because it will

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Weksler, Babette Title: Professor Emerita of Medicine
Organization: Weill Cornell Medicine
Date: 02/10/2022
Comment:
In their proposed decision for coverage of aducanumab and other such monoclonal antibodies, CMS has recognized the need for further investigation to protect older and disabled adults. Importantly, CMS has suggested requiring that the drug be tested through well-designed, randomized controlled trials within patients representative of populations most impacted by Alzheimer’s disease, including racial and ethnic minorities. We see this as correcting the precedent set forth by the FDA in awarding

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Cornacchione, Luanne Date: 02/10/2022
Comment:
It is my personal opinion this this drug works based on my interaction with the patients on drug and their family members over the past number of years.. Both patient and families continue to remark about improvements in ADL’s and cognitive areas. This is the first drug EVER to show any real change based on MRI findings.
If patient, families and doctors say they can find a way to work out the logistics of administering, and Biogen is ready and willing to step up and help the patient and

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Carome, Michael Title: Director, Health Research Group
Organization: Public Citizen
Date: 02/10/2022
Comment:

The following comments are also available at https://www.citizen.org/wp-content/uploads/2618.pdf

Comments Regarding the Centers for Medicare and Medicaid Services’ Proposed National Coverage Decision Memo for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N)

Public Citizen, a consumer advocacy organization with more than 500,000 members and supporters nationwide, strongly supports the

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Caccavale, Dr. John Title: Executive Director
Organization: National Alliance of Professional Psychology Providets
Date: 02/10/2022
Comment:
I, and my organization, strongly support the CMS decision to not reimburse for the drug aducanumab. Reimbursing for drugs that have proven to be effective or safe is bad policy and a health risk. Any reimbursement for this particular drug will achieve nothing more than pad the profits of the company selling it and the providers who will profit from selling hope to those seeking any hope for dementia. The proposed CMS policy on this drug is correct and appropriate and must be implemented.
Anderson, Robert Title: Mr.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Martinelli, Candace Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Whitman, Virginia Title: Policy Manager
Organization: Alliance of Community Health Plans
Date: 02/10/2022
Comment:

February 10, 2022

Administrator Chiquita Brooks-LaSure
Centers for Medicare & Medicaid Services
Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

RE: NCD Determination for Aduhelm

Dear Administrator Brooks-LaSure:

The Alliance of Community Health Plans (ACHP) applauds the Centers for Medicare & Medicaid Services (CMS) on its balanced decision regarding the proposed National Coverage Determination

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Lawsen, Gai Title: Mr
Organization: medicare recipient
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

NO, PHARMA SCAMS!!!

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review

More

Byock, Ira and Title: Founder & Senior VP for Strategic Innovation
Organization: Providence Institute for Human Caring
Date: 02/10/2022
Comment:
I applaud CMS for deciding not to cover Aduhelm. Clinical leadership and stewardship argue against paying for this drug. I worry that highly vulnerable patients - and their scared and loving families - are being seen by the pharmaceutical company as intermediaries for billing Medicare.
You have given clinicians the ability to say to patients and families, CMS agreed with many medical groups that the risks of this medication are not worth the uncertain and minimal benefits.
Thank you
Hutchins, Scott Date: 02/10/2022
Comment:

I am not yet a medicare recipient but this is important.

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were

More

Boyd, JD, MPH, Tammy Title: Chief Policy Officer & Counsel
Organization: Black Women's Health Imperative and Rare Disease Diversity Coalition
Date: 02/10/2022
Comment:

February 10, 2022

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Blvd
Baltimore, MD 21244

Re: Proposed Decision Memo National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N)

Dear Ms. Syrek Jensen:

The Black Women’s Health Imperative (BWHI) and the Rare Disease Diversity Coalition

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Scott, Nicholas Title: Student
Organization: University of Pittsburgh
Date: 02/10/2022
Comment:

There are many aspects of this process that seem worthy of further review, and criticism. Firstly, for a drug whose efficacy is highly limited in scope, and whose determination as successful necessitated post-hoc analysis (WSJ Editorial Board, 2022), I believe Biogen bears responsibility to continue decreasing the price of their drug. I find that a post-hoc analysis is a relatively weak form of evidence to determine efficacy, as opposed to traditional experimental conclusions. Combining

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Pepe, Douglas Date: 02/10/2022
Comment:
Proper investigation into Aduhelm is still needed. I urge you to disapprove this medication.
Kirby, Mary Title: retired
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

STRITE, SHERI Organization: Self
Date: 02/10/2022
Comment:
I support the decision not to cover Aduhelm.
McCarthy, Shirley Title: Dr.
Organization: retired Yale professor
Date: 02/10/2022
Comment:
The Food and Drug Administration’s incorrect decision to approve Aduhelm for treatment of Alzheimer’s disease demonstrated poor review of the science. The agency’s credibility has been definitively harmed.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease

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L, D Date: 02/10/2022
Comment:
Adulhelm should be covered only as a clinical trial drug.
Stein, Michael Title: M.D.
Date: 02/10/2022
Comment:
I am writing to applaud the Centers for Medicare and Medicaid Services (CMS) for their proposed national coverage decision regarding “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease” issued on January 11, 2022. I am a practicing physician and, like many other clinicians, patients, and experts, I was deeply disturbed by the Food and Drug Administration’s (FDA) recent decision to approve the Alzheimer’s disease drug, aducanumab, despite the significant

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Fogg, Rick Date: 02/10/2022
Comment:
From what I understand of this drug it is way over price and dearly useless I believe that medicare should not be paying for and the FDA should not have approved it
Drilling, Martin Date: 02/10/2022
Comment:
I support the decision not to cover aduhelm. This drug has not proven to be effective. Thank you for your decision not to cover it.
McLaughlin, Reese Date: 02/10/2022
Comment:
I support the CMS decision - way to go CMS! You are taking the stand you need to!
Wilson, Margaret-Mary Title: Executive Vice President and Chief Medical Officer
Organization: UnitedHealth Group
Date: 02/10/2022
Comment:

UnitedHealth Group (UHG) is pleased to provide feedback to the Centers for Medicare and Medicaid Services’ (CMS) Proposed National Coverage Determination (NCD) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N) released for comment on January 11, 2022.

UHG is a mission-driven organization dedicated to helping people live healthier lives and helping our health care system work better for everyone through two distinct business

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Atri, Alireza Title: Cognitive Neurologist - AD clinician-researcher
Date: 02/10/2022
Comment:

Dear Secretary Becerra, Administrator Brooks-LaSure, and Members of Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease CMS NCD Committee:

I am a cognitive neurologist and Alzheimer’s disease (AD) clinician-clinical researcher with over 20 years of experience solely devoted to caring for patients with AD and Related Disorders (ADRD) and their care partners, and serving and leading AD/ADRD diagnostics and therapeutics research/trials, and

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Lenzer, Jeanne Date: 02/10/2022
Comment:
FDA's approval of aducanumab sets the scientific bar at FDA so low as to be meaningless - except as a rubber stamp for what Big Pharma claims. This fuels distrust of government agencies and is a tragedy because we need a strong regulator to protect the public interest. Unfortunately, the FDA is not proving it is willing to play that role.
Olsen-Richardson, Janice Organization: Retired
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s

More

Zuckerman, Diana Title: President
Organization: National Center for Health Research
Date: 02/10/2022
Comment:

The National Center for Health Research (NCHR) appreciates the opportunity to provide public comments on the National Coverage Analysis Proposed Decision Memo from the Centers for Medicare and Medicaid Services (CMS). This decision relates to monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.

As a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, we have a particular focus on which prevention

More

Gruenewald, Antje Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Giorgianni, PharmD, S. J. Title: Senior Science Advisor
Organization: Men's Health Network
Date: 02/10/2022
Comment:

Men's Health Network
P. O. Box 77476
Washington, D.C. 20013
202-543-MHN-1 (6461)
Info@menshealthnetwork.org ? www.menshealthnetwork.org

February 10, 2022

Centers For Medicare and Medicaid Services

I am writing on behalf of Men’s Health Network (MHN). MHN is an international non-profit organization whose mission is to reach men, boys, and their families where they live, work, play, and pray with health awareness messages and

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Larson, Steven Title: Mr.
Date: 02/10/2022
Comment:

I urge CMS to issue a national coverage determination that excludes Aduhelm from coverage under the Medicare program. The excessive costs of this questionable drug undermine the physical and financial health of Medicare recipients.

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the

More

Powers-Boss, Mary Date: 02/10/2022
Comment:
I agree with President Biden that the new drug for altzheimers should be paid for by Medicare only if the person it is prescribed for is enrolled in a clinical trial
Zech, Clair Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

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Hasbani, Mayer Title: Neurologist
Organization: M. Hasbani M.D. and M.J. Hasbani M.D.
Date: 02/10/2022
Comment:

I am a private practice general neurologist of 15 years working in the New Haven, CT area. I have taken care of Alzheimer’s Patients for that period of time and am excited that there is a treatment for them which met its endpoint of removal of amyloid. The monoclonal antibodies which are still in research phase have demonstrated greater clinical efficacy than did Aduhelm and therefore I generally believe that this class of medications will be clinically affective.

I do not

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Mattke, Soeren Title: Professor
Organization: University of Southern California
Date: 02/10/2022
Comment:

As a scientist, I don't think it is my place to comment on federal policy decisions. However, I wanted to bring to the Agency's attention a journal article of my team that was published today in Alzheimer & Dementia. In this article, we estimate that a hypothetical Alzheimer's treatment that reduces progression in early disease stages by 30% will generate $5.5 trillion in gross societal value over 20 years in the U.S. alone.

The full article can be found online:

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Manchester, Jennifer Date: 02/10/2022
Comment:

The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Natvig, Julia Title: RN
Organization: Common Grounds
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Tolson, Tommy Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Dehn, Julie Title: Mrs
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Dawson, Seamus Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Whitaker, Barrington Date: 02/10/2022
Comment:

As a Medicare recipient/enrollee I am directly affected by the outcome of the approval decision regarding the drug Aduhelm. Please consider the following statement, and conclude that paying for this ineffective drug must not be forced on our Medicare system.

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of

More

Thiel, James Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Climaldi, John Organization: Hawaii Life
Date: 02/10/2022
Comment:
I find it completely inappropriate for Medicare to limit aducanumab to hospital-based research trials. I live in Honolulu, Hawaii, and Medicare is basically sidelining a whole state of AD patients that may qualify for and benefit from the study. Hawaii Pacific Neuroscience currently serves as a trial center for these cutting-edge drugs and therapies. They would not be able to participate under Medicare's proposal.
hancock, christopher Date: 02/10/2022
Comment:

CMS's increasing recognition of Alzheimer's disease (AD) as a severe and highly prevalent disease process that results in tremendous burden to individuals inflicted with AD, to care givers, and to healthcare systems is heartening. AD represents the 6th leading cause of death in the US and 1/3 of deaths in the USA are associated with dementia. More that 6 million currently have AD in the USA and someone develops AD every 65 seconds in the USA. The current cost of care for AD is over $300

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Nicholson, MacKenzie Date: 02/10/2022
Comment:
As someone whose [PHI Redacted] experiences dementia, it is incredibly disheartening to see CMS limit coverage of an entire class of drugs which could potentially pave the way for new treatments or even a cure. If there is a genetic component to Alzheimer's and dementia, like we believe there might be, it is likely that one of [PHI Redacted] may one day experience the currently incurable and fatal disease. Although my [PHI Redacted] is too far

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Appleby, James Title: Chief Executive Officer
Organization: The Gerontological Society of America
Date: 02/10/2022
Comment:

February 10, 2022

Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Center for Medicare & Medicaid Services

RE: Proposed National Coverage Determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N)

Dear Ms. Syrek Jensen and CMS Colleagues:

On behalf of The Gerontological Society of America (GSA), thank you for the opportunity to provide

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castle, gloria Date: 02/10/2022
Comment:
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials,

More

Poornima, Indu Title: MD
Organization: Allegheny Health Network
Date: 02/10/2022
Comment:
I support the CMS decision
Ritter, Leslie Title: AVP, Federal Government Relations
Organization: National MS Society
Date: 02/10/2022
Comment:

Chiquita Brooks La-Sure
Administrator
Centers for Medicare and Medicaid Services
7500 Security Boulevard Baltimore, MD 21244


Re: National Coverage Analysis (NCA): Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease (CAG-00460N)

Dear Administrator Brooks La-Sure:

The National Multiple Sclerosis Society (Society) appreciates the opportunity to provide public comments on the Centers for Medicare and Medicaid

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Daniels, Natalie Date: 02/10/2022
Comment:
The restrictions placed on Aduhelm by president Biden must be kept in place. The pharmaceutical industry must not be allowed to dictate policy or price.
Ruben, Geoffrey Title: MD, MMM
Date: 02/10/2022
Comment:

The CMS made the correct call in agreeing to reimburse for Aducanumab only in the setting of a clinical trial. The data to date demonstrate very limited indications for this monoclonal antibody treatment.

Please do not reverse this decision.

Sincerely,
Geoffrey L. Ruben,MD, MMM
page, michael Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Mindrum, Jeanine Title: Ms.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Taylor, Angela Title: Senior Director, Research and Advocacy
Organization: Lewy Body Dementia Association
Date: 02/10/2022
Comment:

The Lewy Body Dementia Association (LBDA) is writing to submit public comment in response to the Centers for Medicare and Medicaid Services (CMS) proposed National Coverage Determination (NCD) for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.

Lewy body dementia (LBD) is the second-most common progressive dementia after Alzheimer’s disease, affecting approximately 1.4 million Americans and their families. Approximately one-third of those

More

King, Terry Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Kanaga, Elizabeth Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Calhoun, Elizabeth Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Rogus, Stephanie Organization: the Center for Science in the Public Interest
Date: 02/10/2022
Comment:

The Center for Science in the Public Interest (CSPI), an organization that promotes independence, scientific rigor, and transparency, submits the following comments regarding the Centers for Medicare and Medicaid Services’ (CMS) National Coverage Determination (NCD) memorandum on Aduhelm (aducanumab), released on January 11, 2022.

CSPI shares the belief of many scientists and researchers that FDA approval of aducanumab was not based on adequate scientific evidence of the drug’s

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Yearwood, Charlese Organization: - Select -
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Costley, Dee Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Graves, Theresa Title: Mrs.
Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Huber, Betsy Title: President
Organization: The National Grange of the Order of Patrons of Husbandry
Date: 02/10/2022
Comment:

Dear Secretary Becerra:

The National Grange is America’s oldest agricultural and rural life advocacy organization. Since its founding in 1867, the Grange has been the leading voice in advocating for sound public policy impacting rural and small-town citizens. Today, with nearly 1800 state and local chapters in 38 states, the Grange continues its mission to bring attention to issues of concern to rural America, to shed light on the health, economic, and resource disparities which

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Miller, Paula Title: Environmental Compliance Specialist
Organization: Federal Aviation Administration
Date: 02/10/2022
Comment:
I have learned from reading articles and participating in presentations on Aduhelm and Aduhelm trials and studies that, based on recent studies, the very low, statistically insignificant study numbers that purport to show beneficial action of Aduhelm on neural plaques should not be the basis of any approval of the use of Aduhelm. The study numbers that purport to show efficacy are so low, and so statistically insignificant, that no inference should be drawn between the drug and reduction in

More

Goss, Norman Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials, if

More

Montminy, Joe Date: 02/10/2022
Comment:
[PHI Redacted]

I feel that people living with Alzheimer’s disease are being treated unfairly by requiring that they participate in a clinical trial in order to receive CMS coverage of monoclonal antibody treatments for Alzheimer's Disease. Please revise your NCD to make CMS coverage for these treatments available to anyone who is eligible as soon as possible.

CMS has never before limited Medicare coverage like this for any other FDA-approved medication. CMS needs

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Jensen, Gerald Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

linder, owen Title: MD
Organization: solo practice
Date: 02/10/2022
Comment:
#4: I only treat HMO patients
Many of them are senile or might be losing it.
Many have memory loss from statin drugs.
This drug sounds like a Grab.
I applaud CMS’s proposal to restrict coverage of anti-amyloid monoclonal antibodies such as aducanumab for the treatment of Alzheimer’s disease only in the setting of randomized-controlled trials under Coverage for Evidence Development (CED) as such a coverage decision prioritizes and protects patients above all else. As a

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Reed, Dirk Date: 02/10/2022
Comment:
In their proposed decision for coverage of aducanumab and other such monoclonal antibodies, CMS has recognized the need for further investigation to protect older and disabled adults. Importantly, CMS has suggested requiring that the drug be tested through well-designed, randomized controlled trials within patients representative of populations most impacted by Alzheimer’s disease, including racial and ethnic minorities. We see this as correcting the precedent set forth by the FDA in awarding

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Grady, Deborah Title: MD
Organization: University of California San Francisco
Date: 02/10/2022
Comment:
I am writing to support the Centers for Medicare and Medicaid Services (CMS) proposed national coverage decision restricting payment for “Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease” issued on January 11, 2022. As a physician and clinical researcher, I was deeply disturbed by the FDA's decision to approve aducanumab for treatment of Alzheimer's disease, despite the lack of evidence regarding its clinical efficacy and major concerns about safety.

More

Groff, Brant Date: 02/10/2022
Comment:

The Food and Drug Administration’s decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Cuenca, Michael Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Sneiderwine, William Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that

More

Levesque, Claire Title: Chief Medical Officer, Commercial Products
Organization: Point32Health
Date: 02/10/2022
Comment:

On behalf of Point32Health, the combined organization of Harvard Pilgrim Health Care and Tufts Health Plan, we thank the Centers for Medicare and Medicaid Services (CMS) for putting patient safety first by proposing to provide Medicare coverage for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease exclusively in the context of approved clinical trials. We strongly agree that the Coverage with Evidence Development (CED) designation is appropriate and

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Ferino, Fabrice Date: 02/10/2022
Comment:

The Food and Drug Administration’s (FDA’s) decision to approve Aduhelm for treatment of Alzheimer’s disease showed a stunning disregard for science and eviscerated the agency’s standards for approving new drugs.

Two identical phase 3 trials were stopped early because a preliminary review of the data found that these trials, if continued to completion, were unlikely to show the drug benefitted Alzheimer’s disease patients.

However, an unprecedented and inappropriately close

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Willand, Charles Date: 02/10/2022
Comment:
The same coverage that Medicare consistently provides to patients with cancer, heart disease, and HIV/AIDS should be available to patients with Alzheimer's disease. Coverage should include access to affordable, targeted medicines
Manahan, Wayne Date: 02/10/2022
Comment:
The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.
The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the trials,

More

Karkheck, Eric Date: 02/10/2022
Comment:

The Food and Drug Administration’s corrupt decision to approve Aduhelm for treatment of Alzheimer’s disease showed a galling disregard for science and eviscerated the agency’s standards for approving new drugs. Because of this reckless action, the agency’s credibility has been irreparably damaged.

The approval of Aduhelm was based on seriously flawed post hoc analyses of two identical phase 3 trials that were stopped early because a preliminary review of the data found that the

More

Helms, Elizabeth Title: President & CEO
Organization: California Chronic Care Coalition
Date: 02/10/2022
Comment:

The California Chronic Care Coalition (CCCC) strongly urges the Centers for Medicare and Medicaid Services (CMS) to reconsider its proposed national coverage determination regarding the breakthrough Alzheimer's