Nesiritide for Treatment of Heart Failure Patients

I think that it is an injustice to the ever growing population of the chronic decompensated heart failure patient to be denied treatment of Nesiritide in the outpatient setting. Patients can, and have been safely and effectively managed, and monitored in an outpatient setting under the direction of heart failure specialists. I am pleading for those patients who I have seen dramatic improvement in their quality of life. Please re-evaluate the evidence and allow coverage of nesiritide for the chronic decompensated heart failure patient.

Less

As the administrative manager for the heart failure program at Hackensack University Medical Center and a strong patient advocate, I have had the opportunity to see many patients benefit with much improved quality of life while receiving outpatient infusion of nesiritide. Recently I attended a heart failure nursing conference at which time many of my nurse colleagues reported their experience with patients who had been doing well on outpatient nesiritide and now have become "frequent flyers" once again. They also described the death of many patients who had otherwise been thriving with the addition of outpatient nesiritide to their regimen. I do think that we have to wait for the results of the FUSION II trial before we discontinue further programs thereby subjecting patients and their families to the scenario described above.Thank you, Lenore Blank RN

Less

Advanced heart failure patients also referred to as chronic decompensated heart failure (CDHF)patients have a high rate of recidivism and a poor quality of life even after optimal medical therapy as tolerated. I believe that we should think of CDHF as a subset of acute decompensated heart failure (ADHF) in which case outpatient use of nesiritide on an as needed basis can be a powerful means to prevent readmission and improve the life quality of patients with advanced NYHA Class III (IIIb) and IV heart failure. This has been the basis for our present and revised medicare approved outpatient program. The impact on longevity is significant in our cohort of patients and a significant reversal of their disease has occurred over a reasonable time period leading them to an improvement in NYHA Class leading ultimately to independence from both rehosptialization as well as outpatient nesiritide therapy.

Our heart failure program is a JCAHO certified academic program which has both an inpatient heart failure unit and outpatient consultative and management program. The percentage of patients requiring episodic outpatient nesiritide intervention represents less than or equal to 1% of the total patient population. By preventing exacerbations in CDHF patients through treating acute decompensations early on, the deleterious effects of a full blown exacerbation are avoided precluding disease progression in already otherwise maximally treated patients. It should be remembered that nesiritide is the only IV medicine approved for the treatment of ADHF. The use of intermittent inotropes (which is reimbursable) as a surrogate continues to flourish despite a well-documented strong evidence base to the contrary...a hypocritical paradox, indeed.

Remarks noted here with regard to nesiritide mortality could not be further from the truth as are the meta-analyses of S. Bernstein published in Circulation and JAMA. Following publication the hypotheses described in the meta-analyses were further amplified by the pop culture via sensational articles in the common press. There were few deaths in the studies with wide confidence intervals around the hazard ratios making it not feasible to draw any meaningful conclusions on nesiritide's effect on mortality. Moreover, in the subset of patients with increased creatinine (0.5 mg/dl) increases occurred 3-4 weeks after the 2 day trial and were not associated with increased mortality.

Evidence-based may also be interpreted to reflectthe best evidence that we have available to us at this time. There are public comments here which reflects hands-on extremely positive view points. The negative comments which I also urge you to review are rarely made by nurses, physicians or pharmacists with clinical hands-on experience. The opinions of this latter group reflect patient dissociated cold perspectives which in addition, in some cases, are associated with misinformation.

I do believe that specific guidelines are necessary to ensure quality-based administration of nesiritide therapy. These guidelines are well outlined in my previous comments on the first web site. Please note that we must include all comments from the previous website as the paucity of contributions this time around reflects the death of many programs and reportedly the death or near demise of many patients.

Less

To whom it may concern, I am writing to post my experience with out patient use of Natrecor for acutely decompensated patients. I am the director of the CHF clinic for our cardiology group, SJH Cardiology Associates in Syracuse, New York. We are associated with St. Joseph's Hospital in Syracuse. We began an out patient Natrecor clinic in November 2003. We have tracked our data and I would like to share it with you. We infused 49 patients from Nov. 2003-July 2005. 69% of our patients were NYHA class 3 and 31% were class 4. We had 0% mortality . 76% of our patients that were class 3 changed to class 2 after receiving Natrecor infusions; 53% that were class 4 moved to class 3; and 46% that were class 4 had no change. We also monitored renal function and 24% of all patients and NO change in BUN/CR; 49% had a DECREASE in BUN/CR and 24% had increase in BUN/CR (increase average of 0.3).

Unfortunately, our clinic closed after the Braunwald panel's recommendation. We have been able to transfer some of our sicker patients to another facility so they may continue to receive out patient Natrecor. We have also had 3 admissions for acutely decompensated heart failure once therapy was stopped in patients that had not had an admission for over 1 years time while receiving therapy. In my opinion this therapy has been extremely valuable for patients who otherwise have very little quality of life. Many of our patients have written letters to our hospital administration requesting that we restart our clinic. I only wish you could hear their touching stories. We do monitor these patients closely, which I think attributes to our success. I hope this information is helpful and all aspects of this therapy is considered. I would happy to answer any further questions. Thank you for your attention to this very important matter.

Less

Nesiritide has been shown to be safe in the Fusion Study and effective in numerous studies including Beck, Golden, Squires, and more.

As an Emergency Physician I face hospital crowding daily. This subsequently leads to Emergency Department delays and prolonged waiting room times. We can not get patients through the hospital quickly enough without the risk of readmission and heart failure plays a major role in this dilemma.

The out patient management of heart failure offers great hope of safely and efficiently managing this problem in a very economical manner.

I have witnessed out patient heart failure clinics that incorporate Nesiritide infusions, to be beneficial to patients, their families, hospitals, and ultimately their communities.

I hope that a means of establishing heart failure clinics utilizing Nesiritide can be reached.

(1) Yancy CW, et al. Safety and feasibility of using serial infusions of nesiritide for the heart failure in an outpatient setting. Am J Cardiol 2004;94:595-601.
(2) Beck W, et al. Is outpatient nesiritide safe for hypotensive heart failure patients? J Card Fail October 2003; 9(5): S98, #365
(3) Golden JS, et al. Is outpatient nesiritide infusion an effective alternative to hospital admission for the treatment of decompensated heart failure. Heart failure society meeting, September 2002, Boca Raton, Florida. Abstract 335.
(4) Squires JP et al. Results from a pilot study to determine the feasibility in transitioning outpatient CHF patients from intermittent intravenous inotrope therapy to nesiritide. J Card Fail October 2003; 9 (5): S90, #334

Less

I'm amazed that all the inadequately informed, media-driven hype about apparent increased morbidity and mortality with the use of nesiritide, the attempt to hard-sell us on a statistically insignificant meta analysis fraught with flaws a novice could see, and the fact that physician authors who don't treat heart failure are trying to drive the management of HF pts by those of us in the trenches, while hoping to enhance their own status, has led so many intelligent providers and Medicare officials to this point.

Without the option to use outpatient nesiritide, patients with end-stage heart failure will have to decompensate enough for hospital admission to get the drug now, if they survive to hospitalization. For anyone actually involved in the day-to-day care of these unfortunate pawns in the politics of heart failure treatment, it isn’t difficult to estimate the numbers of increased hospitalizations and extended lengths-of-stay that will result. One has only to look at what happened this summer when the closure of so many clinics around the country resulted in the rapid deterioration, hospitalization, and deaths of many previously stabilized end-stage patients. And that the suggestion of using inotropes as an option when there is clear and abundant evidence of the increased mortality with which these are associated, leaves me reeling.

I can speak with confidence, having run a hospital-based outpatient heart failure clinic for two years where nesiritide remains an option and statistics have been collected, that there is no increased risk of mortality, nor of even slightly worsened renal function at 30 days, or three months, or six months, or one year! I have graduated dozens from the clinic and never has one ever had to return and resume infusions. Each patient who enters the clinic is made well aware that there is controversy surrounding the drug’s use and yet each chooses to move forward nevertheless. These are desperately ill human beings who want to get back their quality-of-life and have never been sorry they entered the program. That’s what should drive the use of this medication. It should be reimbursed so that patients and their providers can make the choice to use it or not. It should be an option available to them when all else has failed and not be held back because of the unfounded fears of a few with reputations to protect.

I shudder to think what thousands of HF patients would say if they knew a treatment existed that may extend their lives, certainly improve quality of life, and keep them out of the hospital, but they couldn't have it. Their risk with an EF of < /= 20% is for 50% mortality at one year without the drug. Patients ought to have the option. And playing the "off label" use card is a moot point, since we use many drugs "off label" such as Plavix on all our post stent patients. That's off label! And just to be fair, where's the study that says furosemide is safe?

Politics should not get in the way of good patient care. Removing Medicare funding for this effective medication, pending formal study results from FUSION II, while solid safety data exist in FUSION I, is to do an extreme disservice to this population tantamount to abandonment. Please keep the use of outpatient nesiritide as an available, reimbursable choice to be made between the properly selected, suffering heart failure patient and the provider. This is the commitment to optimal patient care we should all be willing to make.

Less

[Submitted via CMS Website and hard copy w/ attachment sent via FedEx for 1/2/05 delivery]

Scios appreciates the opportunity to provide the following comments regarding use of NATRECOR® (nesiritide) in the Medicare population. On December 2, 2005, the Centers for Medicare and Medicaid Services (CMS) released a proposed decision memo with public comment, Nesiritide for Treatment of Heart Failure Patients (CAG-00289N). Per the NCD tracking sheet, this NCD is related to the use of NATRECOR® for “chronic congestive heart failure and maintenance therapy, especially in the outpatient setting.”

NATRECOR® is an intravenous therapy that was approved by the FDA in 2001 for the treatment of patients with acutely decompensated heart failure (ADHF) who have dyspnea at rest or with minimal activity (see attached for full Prescribing Information). While more information is available about NATRECOR® based on controlled clinical trials than exists for any other available therapy for ADHF, Scios concurs that the current data are insufficient to support its routine use as a chronic or maintenance therapy.

It has been, and remains Scios' position that Medicare coverage for the use of NATRECOR® to treat patients presenting to other than a hospital setting should be limited to instances in which its use is part of an "evidence-based process." Scios stated its position in our July 28, 2005 comment letter regarding CMS' national coverage analysis for NATRECOR®, as well as during our December 19, 2005 meeting with CMS' Coverage and Analysis Group. We believe the foundation of this process must be a scientifically rigorous, controlled clinical trial(s) that would contribute to a more comprehensive understanding of new uses of nesiritide. Such a trial(s) should complement and not duplicate studies initiated as part of our clinical development program for NATRECOR®. Per our meeting with CMS on December 19, Scios is interested in further discussions regarding a protocol for a practical clinical trial in partnership with an academic research center, as part of a potential NCD linked to a "coverage with evidence development" (CED) study or trial. Should CMS have an interest in such an option, Scios would be eager to initiate substantive discussions with the FDA, CMS and outside experts to design an appropriate clinical trial(s). We look forward to discussing this possible study with CMS in the near future.

Scios agrees with CMS’ assessment of the importance of heart failure as a major public health issue in the United States. We further agree that options for physicians who treat this condition remain very limited. At the same time, we wish to clarify a number of statements included in the proposed NCD.

In the proposed NCD, CMS cites recent ad hoc analyses, that question the safety of NATRECOR®.(1,2) Specifically, the NCD states, “nesiritide use was associated with worsened renal function and increased mortality.”(3) Sackner-Bernstein et al. drew their conclusions from retrospective analyses of selected clinical trials. In addition, these authors acknowledge their findings are “hypothesis generating” and not conclusive. The statement in the NCD makes it appear that these findings are facts rather than hypotheses requiring further study. With regard to worsened renal function, warnings regarding renal side effects related to the initial dose of NATRECOR® have been documented and communicated in the product labeling since its approval in 2001. At starting doses higher that 0.01 mcg/kg/min., there was an increased incidence of elevation in serum creatinine compared with standard therapies, although there was no increase in the rate of acute renal failure or the need for dialysis.(4) At the recommended infusion dose of 0.01 mcg/kg/min, there is no statistically significant increase in the incidence of elevation of serum creatinine with NATRECOR® added to standard therapy as compared to standard therapy alone.(5) With regard to mortality, none of the seven clinical trials in which NATRECOR® was given for 24 hours or more were designed with an intention of evaluating mortality. The low numbers of deaths, and the variability in the treatment groups make it difficult to draw any meaningful conclusion about mortality.(6) In summary, Scios has serious concerns about the conclusions drawn from these ad hoc analyses of previous studies. While CMS may wish to include a summary of these studies in its NCD, a discussion of their limitations should be included as well. In the management of acute heart failure, NATRECOR® is the only approved treatment that has demonstrated significant clinical benefits: improvement of dyspnea and reduction of cardiac filling pressures.(7) Finally, we agree that although FUSION I shows favorable trends for heart failure patients receiving NATRECOR® particularly among high-risk patients,(8) further studies are needed. Future studies should evaluate not only NATRECOR® as a useful agent in the therapy of chronic heart failure but also the utility of the strategy of intermittent outpatient infusion therapy as a management option for patients with end-stage heart failure.

Once again, Scios appreciates the opportunity to comment on the proposed NCD for NATRECOR®. We also look forward to our future discussions regarding the proposed CED study. If you have any questions regarding these comments, please contact Scios’ Director of Reimbursement, Christopher J. Panarites, Ph.D. at xxx.xxx.xxxx or via e-mail at panarites@sciosinc.com.

Attachments via FedEx: PI

Citations:
1. Sackner-Bernstein JD, et al. “Short-term Risk of Death After Treatment With Nesiritidefor Decompensated Heart Failure: A Pooled Analysis of Randomized Controlled Trials.” JAMA. 2005; 293:1900-1905.
2. Sackner-Bernstein JD, Skopicki HA, Aaronson KD. “Risk of Worsening Renal Function with Nesiritide in Patients with Acutely Decompensated Heart Failure.” Circulation. 2005;111:1487-1491.
3. Nesiritide for Treatment of Heart Failure Patients (CAG-00289N), page 12, available at www.cms.hhs.gov.
4. NATRECOR® (nesiritide), Full Prescribing Information, Scios Inc., Fremont, CA, June 2005.
5. Ibid.
6. Ibid.
7. Publication Committee for the VMAC Investigators (Vasodilation in the Management of Acute CHF). “Intravenous Nesiritide vs. Nitroglycerin for Treatment of Decompensated Congestive Heart Failure: A Randomized Controlled Trial.” JAMA. 2002; 287:1531-1540.
8. Yancy CW, et al. “Safety and Feasibility of Using Serial Infusions of Nesiritide for Heart Failure in an Outpatient Setting (from the FUSION I Trial).” Am J Cardiol. 2004; 94:595–601.

Less

I have found it difficult to identify patients who do not respond to "conventional therapy" who need—and respond to—nesiritide. For instance, the vast majority of ADHF pts. who present with volume overload respond to diuretics either alone or in combination with increased ACEI or nitrates, either NTG or nipride. While it is true that some of these patients develop cardiorenal syndrome sometimes accompanied by diuretic resistance, increasing the RAAS inhibitor and beta blocker (when euvolemic) usually helps. I have not found nesiritide useful in preventing cardiorenal syndrome, though I have had limited use of the drug. As far as intermittent use of drugs, in treating hundreds of HF patients, we have yet to find one in whom regular, intermittent use of nesiritide or any IV rx is needed after titrating up the RAAS inhibitor and beta blocker. We have had several patients referred to us on intermittent rx, but usually these are pts. in whom neurohormonal blockade is not optimized. So I await the results of FUSION II with great interest, though even if (+), I will remain skeptical unless it is convincingly shown that the study population is medicated sufficiently.

Less

In reading through these comments I cannot help but notice that those who urge continued use of outpatient nesiritide are those who actually treat patients and the patients who benefit. To end nesiritide reimbursement would be a tragic error with a potentially devastating impact on very sick patients for whom this therapy has proven to be of great benefit. We have over two years of experience and data showing the efficacy and safety of this natural human hormone in the outpatient treatment of real people at our facility. Hospital readmissions at 30 days are almost 0% among our Nesiritide patients. Readmissions within one year have dropped dramatically. We have had no safety issues. Our patients report improvement in the way they feel, in activity levels, in life style.

The science is unchanged. The data, when the agent is dosed in recommended amounts, show no safety issues. The Fusion II trial on the use of outpatient Nesiritide is almost finished. It is my understanding that it was difficult to enroll patients in this placebo controlled trial when those who treat heart failure already knew that the drug was of great benefit. I support setting eligibility criteria and other limitations but, I urge you to continue reimbursement until the data from that trial is available and a more informed decision can be made.

Less

I am a hospitalist at a small community hospital, but I dare say, I may know the details of natrecor it's mechanism of action; it's utility; both in the inpatient and outpatient setting, and it's effects on renal function, etc. as well as most cardiologists. I practice evidence-based, data-supported medicine, tempered with my personal experience (which is becoming vast with nesiritide).

I have sat by idly long enough watching the negative press and fall out resulting from the erroneous, ill-founded, and prejudicial suppositions from supposedly learned people with God complexes. Furthermore, I have become frustrated at the lack of fortitude by Scios in challenging these folks (primarily Dr. Sackner-Bernstein and his colleagues).

Nesiritide is one of the MOST studied drugs with large pools of data supporting its safety and efficacy, BOTH IN THE INPATIENT AND OUTPATIENT setting. Since our use in our hospital, BOTH IN THE INPATIENT AND OUTPATIENT SETTING, our LOS stay data and readmission rates have dropped dramatically in the treatment of CHF. My patients who continue on the medicine as an outpatient express significant improvement in the dyspnea scores and quality of life. My personal experience is that with rare exception (and these have been in patients receiving concomittent high dose loop diuretic), renal funcion improves, despite liters of diuresis. Even in the outpatient setting, I have been able to uptitrate the B blockers, ACE-i, reduce the loop diuretic and have seen stability in renal function. In the few that have had their creatinine increase, the increase was usually not significant and not associated with adverse outcome (which is also supported by the large pools of data out there).

The recently convened "expert panel" overstepped their bounds in the first place in even making some of their recommendations, and Scios at least acted with honor by upholding their agreement to follow the panel's recommendation. However, it is time that they fight back. The data is incredible on how well this medication works, BOTH IN THE INPATIENT AND OUTPATIENT SETTING. With few exception, the only ones hurt by this medication are the ones who cannot get it because of new medical-legal fears generated by the supposed experts with known agendae against the medication. SHAME ON THE "EXPERTS."

Hey, I have an idea....let's go back to treating CHF with intermittent inotropic infusion....oh wait, now that truly has been proven to be unsafe. I forgot.

Cut the politics and let us practice good medicine!

A. Brooks Parker, M.D. New York

Less

While not all HF patients should receive Nesiritide there are those patients who can and do greatly benefit from its use. Appropriate use of Outpatient Nesiritide has been shown to reduce hospitalization and all cause mortality (Am J Card; Sept 2004). Essential to the administration of this medication is the appropriate identification of its recipients. As an Advance Practice Nurse for HF patients I have developed a comprehensive HF Program in collaberation with our HF Cardiologists. While a very small portion of this program includes outpatient Nesiritide the benefits have been overwhelming. Patients who are maximized on optimal oral therapy but still presented with multiple exacerbations were provided with an additional option that had safe and tolerable effects. Providing the medication to appropriate patients at the recommended dosage and on an as needed bases allowed for improved quality of life, reduced hospitalizations and reduced all cause mortality for our HF population. It would seem very unfortunate to deny patients the benefits of this medication that has a proven track record. The greater issue may be the appropriate identification of these patients. Perhaps the development of Guidelines for administration of Outpatient Nesiritide, as identified by HF literature, would be a better option than discontinuing coverage for this beneficial medication.

Less

I am an RN who was coordinator for an Outpatient Heart Failure Program in Salem,Oregon from 2000- 2004. During that time we participated in the Fusion I trial (safety trial for Natrecor)and we saw amazing results. Because we saw such improvements in patients we began giving it to patients who were not in the trial, again with the same results. We documented information that was presented at the national meeting for the Heart Failure Society of America in Las Vegas in 2003. We showed data on 28 patients who were treated for HF over a year, and the safety of giving Natrecor in patients with hypotension. This same group of patients treated during this year were not hospitalized for that entire year for heart failure, this same group of patients had been hospitalized the previous year between 5-7 times. Additionally all patients had shown improvement in the 6 minute walk test and had shown improved quality of life on the Minnesota Living with Heart Failure Questionaire. I firmly believe that Natrecor improves the quality of life in patients living with Class III- IV Heart Failure and that it prevents hospitalization that we all understand is much more costly than outpatient infusions of Natrecor.

Less

We agree with CMS’ position that sufficient evidence is not currently available to support the use of nesiritide for the treatment of chronic heart failure for the following reasons:

1. Lack of strong evidence from published studies
FUSION-I is the only controlled clinical trial to evaluate the use of nesiritide for serial infusions in the outpatient setting. This was a pilot study on patients with acutely decompensated heart failure (ADHF). Considering the size, design, and results of this study, as well as other available clinical data, there is inadequate evidence to demonstrate benefit from the routine use of intermittent, serial, or scheduled repetitive infusions of nesiritide for the treatment of chronic heart failure patients. In addition, although there is an ongoing clinical trial in this setting (FUSION II), Scios does not recommend nesiritide for this indication at the present time.

Recommended Resolution: The Nesiritide Advisory Panel recommends that use of nesiritide not only be limited to its labeled indication, but be strictly restricted to patients similar to those enrolled in the largest pivotal trial, who presented to the hospital with ADHF and dyspnea at rest. However, since CMS is not proposing to change existing coverage of nesiritide for ADHF, we recommend that use of nesiritide be restricted, at a minimum, to its FDA-approved labeled indication. We also recommend a re-evaluation of nesiritide for the treatment of chronic heart failure as results of FUSION-II (a large, randomized, double-blind, placebo- controlled study), as well as those of other trials become available.

2. Safety concerns
Results of recently published meta-analyses on the risk of worsening renal function and short- term risk of death with nesiritide in patients with ADHF have raised concerns about the safety of nesiritide. Although these studies had a number of limitations, the findings nonetheless underscore the need for continued pharmacovigilance and further investigation. Recommended Resolution: The need for further exploration of these safety issues contributes to concerns about the net benefits of nesiritide for off-label uses such as in the treatment of chronic heart failure, particularly in the outpatient setting. We recommend a re-evaluation of the safety and efficacy of nesiritide as additional analyses of existing and forthcoming data assessing the effect of nesiritide on renal function and survival become available.

Therefore, consistent with CMS’ Proposed Coverage Decision Memorandum for Nesiritide for Heart Failure Patients, we believe that nesiritide should be reserved for use in ADHF patients for whom benefits appear to outweigh the risks.

Again, thank you for considering our comments. If you require additional information, please feel free to contact me at (***) ***-****.

Less

Our institution has been running a Congestive Heart Failure Clinic for a number of years and a part of the oup-patient care provided has included niseritide infusions; done within the hospital setting, but on class III-IV CHF outpatients. Each patient is evaluated on each visit concerning their need for a niseritide infusion or other change(s)in therapy. Often this has been used as a means to discharge these patients from the hospital. It also has provided the means to keep these patients from being re-hospitalized. Our data suggests that 30 day re-admits can approach 0%. Many private insurance carriers support our program because our 90 day re-admit frequency is also so low.

We have not experienced the worsening of renal function issues that have beeen recently raised. We have not experienced any increase in mortality. We have seen a tendency to revert to dobutamine or primacor infusions; practices which are proven to increase mortality.

I realize that it will take years to demonstrate (or not demonstrate) the benefits of niseritide in outpatients. The data that shows renal deterioration with too high a dose of this drug. I do not believe it shows increased deterioration of any aspects of these patients health when they are treated correctly. I would ask that we be allowed to continue to provide this medication for carefully chosen and significantly ill out-patients.

Less

As a practicing cardiologist well acquanted wiith Nesiritide I strongly recommend that outpatient use be reinstituted. This pharmaceutical has already proven itself. It has improved symptons, helped to maintain patients in a community setting and markedly reduced ER visits and hospitalizations.As a quick purusal of the newspapers over the past few months will indicate, the issues with Nesiritide have become more political than medical. Some very strong medical personalities have tried to make their reputation discussing a pharmaceutical they have little knowledge of.Please get this medication out of the political arena and back into the hands of those of us who know how to use it. Thank you; Richard Iacobucci

Less

I presently work in a CHF clinic and give natrecor on a daily basis. I have seen dramatic improvement in my patients and the decrease in number of times of hospitalizations. I believe it would be and injustice to these patients to change the quality of Life they are now enjoying by cutting medicare to natrecor. These patients are living a more productive life and not spending it in the hospital. The cost in an outpatient clinic seems to far out weigh the cost of in patient status. we presently monitor our patiens lab, ekgs and rhythms on a daily basis. we also have a CNS who watches our patients. please do not decrease or take away our patients coverage for this drug. thanks for listening. these people deserve the quality of life they now have.

Less

I am very familiar with the data regarding the use of nesiritide in chronic heart failure patients. I agree entirely with the CMS decision to not reimburse for the use of this medication in out-patients with heart failure. There is inadequate data available to support this practice. The post-hoc analysis of the use of nesiritide in decompensated heart failure patients showing worsening of renal function and possible increased risk of mortality calls into question the decision of the FDA to approve the use of this medication in any circumstance. You will likely receive an overwhelming number of comments asking for full approval of reimbursement of this medication, as the financial power behind this product is huge. I think that you are going in the correct direction.

Less

PATIENTS WITH HEART FAILURE WHO ARE ELIGIBLE FOR THE MEDICARE HOSPICE BENEFIT deserve separate consideration. Many Hospice patients elect symptom control over survival. For as long as it is effective, aggressive medical management provides the best palliation in heart failure (diuretics, ACE inhibitors, Beta blockers, spironolactone). At end-stage, however, these treatments either lose effect or produce unacceptable side-effects, such as hypotension or renal failure. In such patients, significant improvement in dyspnea can be achieved with NESIRITIDE, provided the patient can tolerate the agent without hypotension. I would propose its use in the Hospice Inpatient environment for patients in whom conventional therapy is failing. The only alternative is symptomatic suppression of air hunger with opioids, which relieves the symptom but does not produce the admittedly transient restoration of quality of life as effectively as nesiritide does.

Less

I applaud your commitment to this issue. The available data do not justify the coverage of nesiritide for outpatient or intermittent, scheduled infusions, as there are no studies of sufficient quality that provide substantial evidence of safety or effectiveness. Moreover, a change in position is a rarity in the medical community, and therefore your proposed decision to alter an existing approach reflects a commitment to establishing correct and appropriate policies. I appreciate that. Jonathan Sackner-Bernstein

Less

I agree fully with the proposed guideline. Nesiritide has not been tested in patients with chronic heart failure and its use, either continuous or intermittent, should not be covered as there simply is not credible data available to justify its benefit. In fact, the recent articles that you have cited bring up concern that the drug may have long-term negative effects on patients.

My view of the drug is in complete agreement with Dr. Eric Topol's very negative piece in the New England Journal in July, 2005. I am particularly concerned that outpatient nesiritide clinics create a situation where the appropriate administration of evidence-proven beneficial medications is not accomplished.

It would be helpful, however, for Medicare to consider ways to appropriately reimburse health care providers for providing the appropriate care to chronic heart failure patients. These patients often need frequent office visits with MD's or NP's, frequent labs, and home monitoring. These therapies are labor-intensive (and not highly reimbursed like "Natrecor Clinics" have been) and have been shown to improve life expectancy and decrease hospital stays.

I have never sent a patient to an outpatient nesiritide clinic and certainly would never run one myself, given the present evidence. I have used it two or three times for acute decompensation, and saw nothing unique (or superior) about it and have not used it in about two years. In fact, I question whether the FDA should continue to allow the drug to be available for acute(ly) decompensated heart failure and am in complete agreement with the NEJM letter by Sackner-Bernstein and Aaronson suggesting that the FDA review the drug for removal from the market.

The "Natrecor Era" has been a puzzling era for many of us in the heart failure community. It has been a costly distraction from the progress made in the 90's with beta blockade, ACE/ARB therapy, spironolactone, and ICD/bi-V pacer therapy treatments that have improved survival. I applaud the proposed changes and feel that the FDA should go another step.

Less

I am in full agreement with the decision taken by CMS. Further study is warranted. Patients who are so ill that they have been felt to require frequent outpatient nesiritide infusions should be referred to heart failure specialists which reside in most communities. Should a physician feel strongly about giving nesiritide in the op setting, a center conducting the FUSION II trial should be sought. Let's have the evidence to guide care, as we have done in large randomized heart failure trials. The VMAC trial tested the drug in a specific population. This is how the drug was approved. This is how the drug should be used, i.e., in hospitalized patients with decompensated heart failure and elevated filling pressures.

Less