An Assessment of Real-World Evidence and Other Sources Supporting Payer Coverage Decisions for Pharmacogenomic...

Background: Sources and evidence cited to inform payer coverage decisions on pharmacogenomic (PGx) testing in psychiatry are presently underexplored. Methods: We conducted a qualitative and quantitative assessment of publicly available coverage policies from 14 US payers, examining the number and both the type and source of citations across policies and coverage decisions. Payers were classified as for-profit or mutual fund versus non-profit or government, and their coverage decisions were categorized as either coverage (limited or specified) or no coverage. Results: Among 32 unique sources cited, peer-reviewed literature as a single source was most frequently cited across all policies. Of 207 peer-reviewed papers cited across all policies, 40% (n = 83) were psychiatry-specific real-world evidence (RWE) studies. No statistically significant relationships were observed when comparing variance in the number of citations per policy by payer type (p = 0.22) or coverage decision (p = 0.75; unadjusted variance of 61.25 and an adjusted variance of 60.98 for both comparisons). For-profit or mutual fund payers and/or payers providing no coverage cited systematic reviews and non-randomized controlled cohort RWE studies most often. Non-profit or government payers and/or payers providing coverage cited case series or case-control RWE studies most often. Six psychiatry-specific RWE studies and contributions from 13 distinct sources were often cited, regardless of payer type or coverage decision. Conclusions: RWE, among several sources, are cited in many forms and to varying degrees among payers providing coverage decisions for PGx testing in psychiatry, with coverage determinations being largely based on how certain payers interpret evidence on the clinical value of testing.