Article Title

Payer Decision-Making for Pharmacogenetic Tests: Preliminary Results

Publication Date



health care financing, insurance, premiums, genetics, genomics


Background: 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 objective is to explore 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 U.S. private 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. Each interview transcript was independently read and coded by two members of the study team.

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.

Conclusion: 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.




June 26th, 2017


August 10th, 2017