Preemptive pharmacogenetic testing: exploring the knowledge and perspectives of US payers

Abstract

PURPOSE Preemptive pharmacogenetic testing aims to optimize medication use by having genetic information at the point of prescribing. Payers’ decisions influence implementation of this technology. We investigated U.S. payers’ knowledge, awareness, and perspectives on preemptive pharmacogenetic testing. METHODS A qualitative study was conducted using semi-structured interviews. Participants were screened for eligibility through an online survey. A blended inductive and deductive approach was used to analyze the transcripts. Two authors conducted an iterative reading process to code and categorize the data. RESULTS Medical or pharmacy directors from 14 payer organizations covering 122 million U.S. lives were interviewed. Three concept domains and ten dimensions were developed. Key findings include: clinical utility concerns and limited exposure to preemptive germline testing, continued preference for outcomes from randomized controlled trials, interest in guideline development, importance of demonstrating an impact on clinical decision making, concerns of downstream costs and benefit predictability, and the impact of public stakeholders such as the FDA and CMS. CONCLUSION Both barriers and potential facilitators exist to developing cohesive reimbursement policy for pharmacogenetics, and there are unique challenges for the preemptive testing model. Prospective outcome studies, more precisely defining target populations, and predictive economic models are important considerations for future research.

Systematic review of the evidence on the cost-effectiveness of pharmacogenomics-guided treatment for cardiovascular diseases

“…However, further studies are needed to fill in significant gaps in evidence that can help us understand the existing barriers, including lack of guidance on how to use PGx information and skepticism from payers regarding the effect of PGx-guided therapy on outcomes, aversion to adverse drug events, and evidence of long-term benefits. 41,42 Therefore, the value of pre-emptive panel testing should be investigated and the barriers to implementing these tests should be addressed.…”

The landscape of pharmacogenetic testing in a US managed care population

“…35 While these recent developments are promising, the reimbursement landscape for pharmacogenetic tests, particularly multiple-gene tests, still remains uncertain, as payers grapple with questions about clinical utility and application, economic utility, and impact on coverage policies. [36][37][38][39] Lack of evidence is often cited as a major barrier to pharmacogenetic test use and insurance coverage. Phillips and colleagues suggested some potential solutions for remedying this evidence gap: (1) document what evidence is lacking, (2) standardize testing procedures and interpretation, (3) provide incentives for closing evidence gaps, and (4) develop creative approaches to obtaining evidence.…”

Pharmacogenomics: An evolving clinical tool for precision medicine

“…In particular, they pointed out that many low-cost generic drugs are often available that patients could be prescribed before resorting to a new drug that would require panel genotyping before safely using it. 39 But several studies have shown that preemptive pharmacogenomic testing could not only benefi t patients, it may also be costeffective over the long term. In a systematic review, Verbelen et al 40 assessed 44 economic evaluations that covered 10 of the known pharmacogenomic-associated drugs listed by the FDA.…”