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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://www.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.
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| 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.
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| 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.
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| 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 |