| Summary: | Section 641 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) calls for a demonstration that would pay for drugs and biologicals that are prescribed as replacements for drugs currently covered under Medicare Part B. The demonstration project will be national in scope and will be limited to 50,000 beneficiaries or $500,000,000 in funding, whichever comes first. Forty percent of the funding for this demonstration will be reserved for oral anti-neoplastic drugs. CMS has requested an assessment of the efficacy of selected oral cancer therapies included in the demonstration relative to drugs currently covered under Medicare Part B. This assessment will provide information that will be used to evaluate the likely effects of the demonstration on patient outcomes and may also provide underlying information to be used for cost-effectiveness analyses that will be completed by CMS. The scope of the assessment will be limited to the following demonstration drugs and conditions: ® Imatinib for treatment of chronic myeloid leukemia;® Imatinib for treatment of gastrointestinal stromal cancer;® Gefitinib for treatment of non-small cell lung cancer;® Thalidomide for treatment of multiple myeloma. This report is responsive to the third item: an assessment of gefitinib for the treatment of non-small cell lung cancer. After work on this report was begun, the parameters were modified to include the closely related orally administered epidermal growth factor tyrosine kinase inhibitor, erlotinib. This was done for three reasons: 1) pivotal trial data suggested that gefitinib had little clinical efficacy; 2) a large number of studies were forthcoming on erlotinib suggesting that this drug may have greater clinical efficacy than gefitinib; and 3) erlotinib was added to the demonstration project in January 2005
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