The 130th Annual Meeting of APHA

3169.0: Monday, November 11, 2002 - Board 2

Abstract #41520

State laws concerning clinical trials and off-label drug use for cancer patients

Kristianna G. Pettibone, MS, Health Policy and Legislative Analysis Program, The MayaTech Corporation, 1100 Wayne Ave., Floor 9, Silver Spring, MD 20910, 301-587-1600, ext. 619, kpettibone@mayatech.com and Regina el Arculli, MA, Office of Policy Analysis and Response, National Cancer Institute, Building 31, Room 10A-48, 31 Center Drive, MSC 2580, Bethesda, MD 20892-2580.

Clinical trials for new drugs, and off-label prescriptions for existing drugs, are two mechanisms by which cancer patients can gain access to state-of-the-art medicine. However, enabling legislation requiring insurance to cover, or offer coverage, for the costs associated with clinical trials or off-label drug use is neither uniform nor present in all 50 states.

Using data from the National Cancer Institute's State Cancer Legislative Database (SCLD) Program, this presentation will provide a brief historical overview of clinical trials and off-label drug use, and will show the number of states that have enacted legislation addressing insurance coverage of cancer clinical trials and off-label drug use. Analysis of legislation addressing types of insurers, type of clinical trial (Phase I through Phase IV), restrictions on off-label drug use, and mandatory coverage or offer will be presented by state.

Learning Objectives: At the conclusion of the presentation, participants will be able to

Keywords: Clinical Trails, Access to Health Care

Related Web page: www.scld-nci.net

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: The data presented in this paper are from the National Cancer Institute's State Cancer Legislative Database Program (no conflict of interest).
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

Health Administration Poster Session 4: Regulatory and Policy Issues

The 130th Annual Meeting of APHA