Excerpt

The topic of this assessment is the evaluation of drug compendia for the purpose of informing the Centers for Medicare & Medicaid Services (CMS) on decisions about coverage of off-label uses of drugs and biologics in anticancer treatment. This coverage is dictated by Section 1861(t)(2)(B) of the Social Security Act, which describes the reliance upon recommendations in compendia, specifically the AMA Drug Evaluations (AMA-DE; no longer in existence), American Hospital Formulary Service Drug Information (AHFS-DI), and United States Pharmacopeia Drug Information (USP-DI).

Contents

• Introduction
  • Scope and Key Questions
• Methods
  • Description of the Methods Used by the Compendia
  • EPC Review of Published Studies on the 14 Off-Label Indications
  • Description of Compendia Listings and Evidence Cited for the 14 Agent-Cancer Combinations
  • Analysis of Compendia Listings in Relation to their Stated Methodologies
• Results
  • Methods Used by the Compendia
  • Studies Identified in the EPC Literature Review
  • Bevacizumab (Avastin®) for Breast Cancer
  • Bevacizumab (Avastin®) for Lung Cancer
  • Oxaliplatin (Eloxatin®) for Breast Cancer
  • Oxaliplatin (Eloxatin®) for Lung Cancer
  • Irinotecan (Camptosar®) for Breast Cancer
  • Docetaxel (Taxotere®) for Esophageal Cancer
  • Docetaxel (Taxotere®) for Gastric Cancer
  • Docetaxel (Taxotere®) for Ovarian Cancer
  • Gemcitabine (Gemzar®) for Biliary Tract Cancer
  • Gemcitabine (Gemzar®) for Bladder Cancer
  • Gemcitabine (Gemzar®) for Ovarian Cancer
  • Rituximab (Rituxan®) for Chronic Lymphocytic Leukemia
  • Erlotinib (Tarceva®) for Head and Neck Cancer
  • Erlotinib (Tarceva®) for Pancreatic Cancer
• Discussion
• References
• Appendices
  • A Search Strategies
  • B Evidence Tables

This report is based on research conducted by the Duke Evidence-based Practice Center (EPC) and the New England Medical Center Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract Nos. [Duke] 290-02-0025 and [NEMC] 290-02-0022). 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 decision-makers; 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.