Section 1861 (t)(2)(B)(ii)(I) of the Social Security Act lists three drug compendia that may be used in determining the “medically accepted indication” of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen:
The AMA-DE is no longer in publication. The USP-DI has new ownership and will cease publication under that name, continuing under a new name.
CMS has received requests for official recognition of successor and additional compendia under the following authorities:
§1861(t)(2)(B), which allows the Secretary to revise the list of compendia in clause (ii)(I); and
§1873, which allows the Secretary to recognize a successor publication if one of the statutorily designated publication changes its name
The Medicare Coverage Advisory Committee will review and evaluate the evidence on the desirable characteristics of compendia used for this purpose, and the quality of currently published compendia.
Alan M. Garber, MD, PhD, Chairperson
Alex Krist, MD, Vice-Chairperson
Steve Phurrough, MD, MPA, Coverage and Analysis Group
Michelle Atkinson, Executive Secretary
March 30, 2006 MCAC DRAFT Questions 012705
Compendia for coverage of off-label uses of drugs and biologicals in an anti-cancer chemotherapeutic regimen
1. A good compendium should be evidence-based. What additional characteristics are desirable and of high priority in a robust, evidence-based compendium? Rate each characteristic below on its desirability and on the priority of that desirability rating. This list is provided as a reference. The MCAC may amend this list.
Extensive breadth of listings
Quick throughput from application for inclusion to listing
Detailed description of the evidence reviewed for every individual listing
Use of prespecified published criteria for weighing evidence
Use of prespecified published process for making recommendations
Publicly transparent process for evaluating therapies
Explicit “Not Recommended” listings when validated evidence is appropriate
Bias toward “Recommended” when validated evidence is equivocal
Bias toward “Not Recommended” when validated evidence is equivocal
Explicit listing of appropriate combinations of therapies
Explicit recommendations on the sequential use of a therapy or combination in relation to other therapies
Silence, i.e. no listing, when validated evidence is equivocal
Explicit “Equivocal” listing when validated evidence is equivocal
Public identification of the members of the advisory/scientific review committee
Public notification of reviewers’ and committee members’ conflict(s) of interest, including institutional funding sources
Public notification of all funding sources of the compendium and its parent and sibling organization(s), including unrestricted grants and gifts
Net benefit analysis based on potential harm and potential benefit
Explicit stratification of the risks of available therapies
2. How confident are you that the AHFS and USPDI compendia have adequately stated evidence-based criteria and processes?
3. How confident are you that the AHFS and USPDI compendia adhere to evidence-based criteria and processes in making recommendations?
4. Considering each separately, how confident are you that compendia other than the AHFS and USPDI have adequately stated evidence-based criteria?
5. Considering each separately, how confident are you that compendia other than the AHFS and USPDI adhere to evidence-based criteria and processes in making recommendations?
6. Considering each compendium separately, please rate it on each of the desired characteristics. The list below is provided for reference. The MCAC should apply the characteristics as amended by its response to Question 1.
Not well done
7. Do you believe that the interests of the Medicare program and its beneficiaries are best served by having a particular number or type of available published compendia on the off-label use of anti-cancer drugs and biologicals for cancer treatment?
8. If the answer to question 7 is yes, what is the minimum and/or maximum number or type of compendia that should be available?
9. How confident are you that prescribers can rely on currently available published compendia to determine appropriate off-label uses of drugs and biologicals for anti-cancer chemotherapy?
Validity - CMS uses “validity” or related terms here as defined by Meinert, “Validity, in the context of a treatment difference, refers to the extent to which that difference can be reasonably attributed to a treatment assignment.” (Meinert CL. Clinical Trials, Overview. In: Redmond CK, Colton T, eds. Biostatistics in clinical trials. Wiley and Sons, 2001. pp. 37-51). This encompasses all issues of methodologic framework, study design, observed results, biological rationale, etc.
Net health benefit - Balance between risks and benefits including complications of treatment
Alan M. Garber, M.D, Ph.D.
Director, Center for Primary Care and Outcomes Research
Alexander H. Krist, MD
Fairfax Family Practice Center
Deborah S. Cummins, PhD
Director of Research and Evidence Analysis
American Dietetic Association
Deborah Schrag, MD, MPH
Memorial Sloan-Kettering Cancer Center
New York, NY
Robert S. McDonough, MD
Clifford Goodman, PhD
The Lewin Group
Falls Church, VA
Daniel D. Foley, MD
Vice President, Medical Affairs and Medical Director
United Hospital of St. Paul
Allina Health System
St. Paul, MN
Norman S. Kato MD, FACC, FCCP, FACS, FAHA
Cardiac Care Medical Group, Inc.
Alexander Emyr Ommaya, ScD, MA Director, Clinical Research Roundtable Institute of Medicine, The National Academies Washington, DC
Nora A. Janjan, MD
Professor, Dept of Radiation Oncology
University of Texas
M.D. Anderson Cancer Center
Catherine A. Glennon, RN
Private Diagnostic at Duke Oncology Services Health Center
Mark Fendrick, MD
Professor, Internal Medicine and Health Management & Policy
Co-Editor in Chief, American Journal of Managed Care
Ann Arbor, MI
Nancy Davenport-Ennis, BA
Patient Advocate Foundation
Newport News, VA
Kim K. Kuebler, MN, RN
Palliative Care Nurse Practitioner
Linda A. Bergthold, PhD
Santa Cruz, CA
Guest Expert Panelists:
Richard W. Whitten, MD, FACP
Contractor Medical Director, Medicare B for AK, HI & WA
Mark Clanton, MD, MPH
Deputy Director, National Cancer Institute and Deputy Director for Cancer Care Delivery Systems
Steve Phurrough, MD, MPA
Director, Coverage and Analysis Group
This Statement Must Be Completed and Read For The Record By EVERYONE That Addresses The Committee. (This includes scheduled public speakers, invited guests, and members of the public who will speak during the open public comment period.)
Occupation and Employer-
Speaking on behalf of:
Have you ever received financial support from any drug compendium or any manufacturer of anti-cancer drugs or biologics
(This includes speaking fees, salaries, grants and other support)? If so, please disclose details.
Who paid for your transportation and/or related expenses for today’s meeting?
Were you contacted by any party prior to this meeting to discuss today’s topic? If so, please disclose details.
I certify that the above statements are accurate and true.