PAYER DECISION MAKING FOR PHARMACOGENETIC TESTS- PRELIMINARY RESULTS
Author(s)
Lu CY1, Treadwell S1, Mazor K2, Wu AC1
1Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA, 2University of Massachusetts Medical School, Worcester, MA, USA
OBJECTIVES: Genetic tests are the fastest growing sector of medicine and medical science, yet there is a dearth of research on access to cancer-related pharmacogenetic tests. The study explored payers’ views about management strategies for pharmacogenetic tests, and to describe criteria for coverage decisions, policy challenges and strategies used to overcome these challenges. METHODS: We conducted semi-structured interviews with representatives of seven US private payers and two US public payers. Interviews were recorded and transcribed verbatim. Using a directed qualitative content analysis, two members of the research team performed open coding of the transcripts in an iterative process, building a provisional code book as coding progressed. RESULTS: Payers may not have established coverage policies for single gene tests but even without a policy in place, these are generally accessible on a case-by-case basis. For coverage decision making for pharmacogenetic tests, payers generally followed coverage decision making processes originally established for pharmaceuticals. Some realize that the evidence requirements, which are established for pharmaceuticals, are not applicable to pharmacogenetic tests, particularly because the field is advancing rapidly. ‘Outcomes based’ risk sharing agreements with diagnostic companies are recognized as a possible option to collect evidence and limiting coverage. Some payers are introducing prior authorization requirements for pharmacogenetic tests to better manage utilization because an established coding system for tests is lacking. Another key challenge from payers’ perspective is managing the use of and payment for gene panels. Laboratories provide different combination of genes in their panel tests, thus knowing which genes are tested is a challenge. Some payers do not pay for large gene panels. CONCLUSIONS: Single pharmacogenetic tests are generally readily accessible. However, as we move from single gene tests to gene panels, payers have identified challenges, and ways of overcoming those challenges as the field evolves.
Conference/Value in Health Info
2017-05, ISPOR 2017, Boston, MA, USA
Value in Health, Vol. 20, No. 5 (May 2017)
Code
PCN213
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Oncology