CLC SUBMITS COMMENTS ON USP DRAFT
GUIDELINES FOR MEDICARE PART D
(September 17, 2004)
Re: Comments on the Draft Model Guidelines for the Medicare Prescription Drug Benefit
Dear Ms. Lang:
The undersigned organizations, representing cancer patients, physicians, and researchers, urge significant revision of the United States Pharmacopeia draft model guidelines for the Medicare prescription drug benefit. Our comments relate to the treatment of antineoplastics in the proposal.
The draft guidelines
establish a single therapeutic category for antineoplastics, which would
be divided into only nine pharmacologic classes (including one for "antineoplastics,
other") that are based on mechanism of action. We believe the nine
pharmacologic classes in the draft fail to capture the range of antineoplastic
agents, especially when both injectable and oral anticancer agents are
considered for Part D coverage. However, a further subdivision of this
therapeutic category into additional pharmacologic classes will not transform
the draft into an appropriate means of administering the Medicare Part
D benefit. Guidelines that establish classes of drugs and permit a limited
number of drugs to be listed in each class are inconsistent with the practice
Cancer care is protocol-driven, and the protocols that guide the delivery of care are based on specific drugs. A physician treating a cancer patient does not select a drug according to mechanism of action, as the draft guidelines suggest, but instead chooses the drug, or more likely the combination of drugs, determined to be effective in that patient's specific form of cancer. The draft guidelines, which would permit the exclusion of certain drugs in a pharmacologic class, would force the substitution of cancer drugs, a practice that is at odds with cancer care protocols and that may result in a decline in the quality of cancer care. Establishing classes of drugs and allowing the inclusion of only some drugs in each class will violate current standards of cancer care.
For example, among the classes of antineoplastics included in the draft guidelines is the class of "molecular target inhibitors." If these guidelines are adopted, it is possible that only one of the new targeted molecular therapies would be included for coverage through Part D. This action would undermine the value and benefits of the targeted therapies, which may be appropriate for use only in a narrowly defined population of cancer patients but which may be the best therapy for that population. The draft guidelines include a "recommended subdivision" of platinum coordination complexes, and under the standards for Part D, only one of the platinum-based antineoplastics might be listed on the formulary. These compounds are not interchangeable, although the proposed structure would suggest they are.
Comments to the Centers for Medicare & Medicaid Services
We will submit comments
to the Centers for Medicare & Medicaid Services that will recommend
an open formulary for the special population of cancer patients. This
is the most appropriate means of ensuring that individuals with cancer
have access to the antineoplastics that are appropriate for their diagnosis,
as well as the supportive care drugs that are a necessary part of treatment.
If an open formulary approach is not adopted for cancer patients, the
model guidelines must be significantly revised in their treatment of antineoplastics.
We appreciate the opportunity to comment on the draft guidelines and strongly urge that they be modified to reflect a single therapeutic category of antineoplastics, eliminate any classes within that category, and include all antineoplastics in the single therapeutic category.
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