EXPIRED
Tuesday, December 17, 2002
Thomas Scully, Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201
RE: Drug reimbursement should not impact medical decision making.
66718 Federal Register / Vol. 67, No. 212 / Friday, November 1, 2002 / Rules and Regulations (Full text: http://lymphomation.org/hopps%20update.pdf)
“Now, as a result of the increasing number of novel therapies on the market and the impact of new drugs and biologicals on the Medicare program, it is prudent for Medicare to perform its traditional coverage analysis for appropriate drugs and biologicals as it does for all other items and services to ensure that it only pays for those products that are clinically effective. For drugs and biologicals, Medicare will continue to use FDA approval as a default for a reasonable and necessary determination of an FDA-approved indication unless CMS decides otherwise.” …
… CMS may choose to perform a reasonable and necessary determination in several circumstances, including, but not limited to the following: the drug or biological in question represents a novel, complex or controversial treatment, may be costly to the Medicare program, may be subject to overutilization or misuse, or received marketing approval based on the use of surrogate outcomes.
Dear Mr. Scully:
Patients Against Lymphoma, representing the undersigned cancer patients, their loved ones, and the public, are writing to express a serious concern about a Medicare coverage policy announced in the preamble to the final rule on the Hospital Outpatient Prospective Payment System (HOPPS), 67 Federal Register 66755-56 (Nov. 1, 2002) copied above.
The policy deflates the morale of the lymphoma patient community and leads us to question the priorities of the Centers for Medicare & Medicaid Services (CMS). We view this policy as a threat to the survival and quality of life of patients fighting lymphoma, who must live with the disease and the consequences of available and often toxic standard therapies.
Specifically, Patients Against Lymphoma and the undersigned believe that the stated policy:
- Adds an unnecessary bureaucratic level to the treatment decision process – replacing the judgment of trained physicians who are dedicated and qualified to provide the best treatment possible to patients. The policy uses vague language such as “traditional coverage analysis,” “novel”, “complex,” and “controversial treatments.” We question the medical qualifications of CMS to make these characterizations and to apply them appropriately to the personalized treatment of people living with lymphomas and other cancers.
- Cannot adequately address the complex treatment circumstances of patients fighting lymphoma, including treatment histories, age, performance status, ability to tolerate standard therapies, and the need for interventions to improve quality of life, and more.
- Assumes that doctors prescribe new or novel therapies based on insufficient evidence when, in fact, all therapies have side effects and the reality is that both patients and doctors avoid therapies that do not provide clinical benefit.
- Could well deny access to cutting-edge therapies and less toxic frontline therapies for patient with lymphomas that are not curable with standard therapies. It forces these patients to first use toxic therapies proven not to cure and which often compromise the cancer patient’s ability to benefit from emerging therapies.
- Could well limit to only the specific disease studied in clinical trials the availability to novel therapies that have won FDA approval for closely related indications. This exclusion could be implemented even when there is clear evidence of benefit to closely related disease subtypes, based on smaller clinical studies, and an understanding of the mechanisms of action on these cancers.
- May well deny access to therapies approved under the FDA Accelerated Approval path, which was implemented in order to more rapidly approve therapies based on “surrogate endpoints” when the treatment addresses an unmet needs for patients fighting serious life threatening diseases. These study endpoints have been thoughtfully determined by experts and must reasonably predict clinical benefit. For example, a treatment may be approved if it delays the time to progression compared to standard treatments. Will the CMS deny patients access to such drugs, and require instead proof of survival benefit, which may be impossible to prove in cancers that have a long clinical course? The language indicates it can.
- May lead drug developers to abandon or not initiate the development of novel cancer drugs – to the detriment of the millions of Americans who fight cancer now and in future.
- Undermines the authority of the FDA, and the expert advisors who participate in the drug review process – a rigorous and widely respected process that determines clinical benefit, often times based on “surrogate endpoints” that measure delay of disease progression and/or improved quality of life as indicators of clinical benefit. Let us underscore that the improved survival of HIV patients is in part due to the approval of "novel" drugs evaluated in this way.
- Was formed without authorization from Congress, which represents the public interest, and without input from the individuals the policy affects. Furthermore, it should be noted that one in three Americans will be diagnosed with cancer in their lifetime, making this policy a matter of broad concern.
- Undermines the authority of Congress which, in 1993, already restricted the discretion of the CMS to deny coverage for cancer drugs. (42 U.S.C. §1395x (t)(2)(A and B).)
Thank you for your attention to this important matter of concern. We ask you to amend the policy statement and to pursue other and more humane ways to reduce costs. Individuals fighting lymphoma and other cancers have enough to bear. These are the sad statistics: Each year approximately 56,200 individuals are diagnosed with non-Hodgkin’s lymphoma in the United States, and there are approximately 26,300 deaths.
We look forward to your comments addressing our concerns.
Respectfully,
Karl Schwartz
President, Patients Against Lymphoma
And the undersigned. See attachment.
cc: The Subcommittee on Health Michael Bilirakis, Chairman
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