Researchers from the University of Mississippi School of Pharmacy and St. Jude Children’s Research Hospital have taken on one of the crucial barriers remaining in the movement of pharmacogenetic testing to the clinic--coverage and reimbursement of the preemptive pharmacogenetic testing by health insurance payers. The results appeared recently online in Genetics in Medicine.
Reimbursement of pharmacogenetic testing varies widely across settings and payers. Little is known about reimbursement for preemptive pharmacogenetic testing where testing is completed proactively and integrated into the electronic health record to be available to clinicians at the point of prescribing. The current study provides an in-depth look into the decision making processes of insurance payers regarding the coverage policies for preemptive pharmacogenetic testing.
In-depth interviews with pharmacy and medical directors from a variety of regional and national health plans as well as pharmacy benefit management companies were conducted. The authors were interested in these decision-makers’ knowledge and opinions on the preemptive testing model for pharmacogenetic testing. Numerous issues from the clinical, economic, and policy domains were identified that impact coverage decisions for preemptive pharmacogenetics.
Although insurance payers understood the potential clinical and economic benefits for both patients and the health system by using preemptive pharmacogenetics, payers seemed reluctant to cover germ-line pharmacogenetic testing because of the difficulty in seeing an immediate return on the investment in the testing cost. Payers often think in a one-year time frame, but the value of preemptive testing accrues over years. Payers found great value in the work of the Clinical Pharmacogenetics Implementation Consortium (CPIC) to guide clinical decision making for pharmacogenetics. (CPIC is an international consortium interested in facilitating use of pharmacogenetic tests for patient care.) CPIC is focused on providing clinicians guidance when pharmacogenetic information is available, but many of the payers wanted an organization such as CPIC to define who should be tested.
Payers were asked about the clinical evidence they needed to cover preemptive pharmacogenetics. Some payers remained focused on randomized controlled trials (RCT). Others expressed a willingness to consider alternative study designs, and some found value in learning from the experiences of sites currently implementing pharmacogenetics.
The costs of the medications that would be modified based on pharmacogenetic information entered into the decision making process for these payers. They expressed a willingness for a trial-and-error approach when the medication is inexpensive. However, there was great interest in pharmacogenetics for expensive medications where the testing may indicate if the patient should receive the medication. For most other medications, potential downstream economic benefits and improved patient safety are important predictors of utility to some payers.
Government entities like the Centers for Medicare & Medicaid Services (CMS) and the US Food & Drug Administration (FDA) were key reference points for the payers interviewed. The workings of the CMS “coverage with evidence development” program was used a benchmark to discuss similar programs among payers. While some thought themselves willing to take on pilot-type studies, others believed that CMS would have to lead the setting of coverage policies in this space and others would follow suit. FDA labeling remains an important reference for coverage to these payers even though the FDA label may not always contain all the information needed to guide pharmacogenetic testing. One payer noted the United States Preventive Services Task Force (USPSTF) could identify pharmacogenetic testing as a priority for routine screening. An endorsement from a group like the USPSTF would prompt reimbursement and could be a mechanism for widespread coverage.
This study brings to light the mental model of payers and their remaining barriers and facilitators to coverage in preemptive pharmacogenetics. The pharmacogenetics community will likely find the results of this study valuable as they continue to design and implement the research and implementation projects that demonstrate the clinical and economic utility of pharmacogenetics.
Blog by James M. Hoffman, PharmD, MS
See more about CPIC guidelines on PharmGKB and the CPIC website. See more about FDA labels with PGx information on PharmGKB.