PNS167 A REVIEW OF EVALUATION CRITERIA AND STRATEGIES FOR INSURANCE COVERAGE OF PERSONALIZED MEDICINE: U.S. PAYER PERSPECTIVES

Abstract

Personalized medicine (PM) such as pharmacogenomics tests and whole genome sequencing can be used to support treatment decision and improve health outcomes via more accurate risk-stratification and better prevention. The objectives of the study were: 1) Understand payer strategies and evaluation criteria for PM; 2) Identify opportunities and barriers to their coverage. A targeted review of the literature was conducted in EMBASE and PubMed. Selection criteria were used to identify payer perspectives and strategies for coverage of PM. Reviews from both public and private payers were included, and name of payer was captured if reported. 1078 studies were captured by our search strategy and 27 were included for extraction. Overall, 21 studies reported key evaluation criteria for reimbursement from both private and public payers. Payers perceived PM as useful if it allowed targeting responders specifically and reducing costs downstream. They are, however, cautious that this would expand populations for drugs and increase budgets. The top four attributes reportedly used by payers in their decision-making were clinical utility, analytic validity and efficacy, role in medical decision-making as well as cost offsets. One study reported that formulary management varied more among private payers. From the reviews, six studies included payer strategies: two payers offered coverage with evidence development, four offered coverage with conditions, and one payer used external services to price diagnostic tests based on value. For PM technologies to be adopted by all types of payers, manufacturers need to demonstrate that it accurately informs treatment decisions while showing both clinical and cost benefits. Assessment of the added value of PM remains complex and uncertain. Overall, generating evidence for PM meeting payers’ expectations is challenging. Payers, PM manufacturers and other stakeholders ought to collaborate to come up with innovative approaches for coverage, leading to better access for patients.