Excerpt

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:

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Imatinib for treatment of chronic myeloid leukemia;

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Imatinib for treatment of gastrointestinal stromal cancer;

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Gefitinib for treatment of non-small cell lung cancer;

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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.

Contents

• Glossary
• Introduction
  • Policy Context of the Current Technology Assessment
  • Clinical Context of the Current Technology Assessment
  • The Technology
  • Scope and Key Questions
• Methods
  • Search Strategy
  • Selection Criteria
  • Data Abstraction
  • Quality Assessment
  • Data Synthesis
• Results
  • Efficacy
  • Adverse Effects/Harms
  • Predictors of Response
• Discussion
  • Current State of Clinical Use
  • Projections for Future Clinical Use
  • Implications for Future Research
• References
• Included Articles
• Excluded Articles
• Appendix A MEDLINE Search Strategy
• Appendix B Quality Criteria

This report is based on research conducted by the Duke Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0025). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.

The information in this report is intended to help health care decisionmakers; patients and clinicians, health system leaders, and policymakers, make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.