Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies

Type: Consensus Study
Topics: Biomedical and Health Research, Diseases, Health Services, Coverage, and Access
Boards: Board on Health Care Services, Board on Health Sciences Policy

Activity Description

Technological advances have fueled interest in the development and use of biomarker technologies that identify the key attributes of a patient's disease and thus can guide selection of the therapy most likely to benefit a particular patient. These new tools for molecularly targeted therapies pose significant challenges for the systems that regulate the development of drugs and diagnostics, as well as those that deliver and pay for health care. Key issues involve three major areas: regulatory oversight of test development, clinical adoption, and payment processes.

An ad hoc IOM committee will examine key policy issues related to the clinical development and use of biomarker tests (including genomics-based tests) for targeting therapies to patients. The committee will examine specificissues in three broad areas: regulation, reimbursement, and clinical practice. Specificissues may include: the role of various oversight bodies, such as FDA and CMS (under the Clinical Laboratory Improvement Amendments), the effects of laboratory reimbursement schedules and coding systems, the standards of evidence used by CMS and other payers to make coverage decisions, interpretation of molecular tests, clinical decision-making, and implications for clinical practice guidelines.

Using previously published IOM reports as a starting point, the committee will examine opportunities for and challenges to the use of biomarker tests to select optimal therapy. The committee will formulate recommendations to accelerate progress in this field.

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