The association between US Food and Drug Administration-expedited review designations and health plan specialty drug coverage.

The US Food and Drug Administration (FDA) speeds approval of important clinical advancements through 4 expedited review programs: Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy. Whether health plans prioritize coverage of expedited drugs relative to drugs that the FDA determined did not qualify from these programs is unclear. To investigate how fast US commercial health plans issued coverage policies for drugs included in different numbers of FDA-expedited programs. Second, to examine the association between a drug's inclusion in an FDA-expedited program and plan coverage restrictiveness. We used a separate dataset for each study objective. For the first objective, we created a dataset of policies issued by 17 large commercial health plans for 2018 FDA-approved drugs. Included policies were active exactly 1 year following each drug's FDA approval. We investigated the relationship between the speed of policy issuance and the number of expedited programs. We controlled for cancer and orphan indication. For the second objective, we analyzed a dataset of commercial health plan specialty drug coverage policies. We categorized drugs with respect to the number of expedited programs (0, 1, or 2+ programs). Coverage policies were categorized as whether plans imposed restrictions beyond a drug's FDA-approved labeling, for example, step therapy requirements. We used regression analysis to examine the association between FDA-expedited review and coverage restrictiveness when controlling for other relevant factors (eg, availability of alternatives). For our first objective, plans issued 62% (742/1,190) of policies within a year of a drug's FDA approval. In unadjusted analysis, policy issuance speed increased with each additional expedited program (hazard ratio=1.15; <0.01). After controlling for cancer and orphan status, the number of expedited programs was not associated with faster policy issuance (hazard ratio=0.95; =0.209). For our second objective, plans imposed coverage restrictions in 33% (672/2,027) of policies for drugs the FDA included in at least 1 FDA-expedited program vs 51% (870/1,706) of policies for drugs the FDA excluded from these programs. In multivariable regression, we did not find an association between FDA-expedited review and coverage restrictiveness after controlling for other decision-making factors (including disease prevalence, annual cost, etc). After controlling for other decision-making factors, we did not find that FDA-expedited approval was associated with faster coverage policy issuance, nor did we find that plans covered drugs the FDA included in expedited review programs less restrictively than drugs excluded from these programs. Our findings raise questions about why plans do not also accelerate access for these clinical advancements. This study was funded by Janssen Scientific Affairs, LLC. Mr Ingham is an employee of Janssen Scientific Affairs, LLC, and is a stockholder of Johnson & Johnson. Dr Chambers reports grants from Janssen Scientific Affairs, LLC, during the conduct of the study.