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

BACKGROUND: 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 rela-tive to drugs that the FDA determined did not qualify from these programs is unclear.OBJECTIVES: To investigate how fast US commercial health plans issued coverage policies for drugs included in different num-bers of FDA-expedited programs. Second, to examine the association between a drug's inclusion in an FDA-expedited program and plan coverage restrictiveness.METHODS: 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 relation-ship 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 restric-tiveness when controlling for other relevant factors (eg, availability of alternatives).RESULTS: 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; P<0.01). After controlling for cancer and orphan status, the number of expedited programs was not associ-ated with faster policy issuance (hazard ratio=0.95; P=0.209). For our second objec-tive, plans imposed coverage restrictions in 33% (672/2,027) of policies for drugs the FDA included in at least 1 FDA-expedited pro-gram 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).CONCLUSIONS: 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 restric-tively than drugs excluded from these programs. Our findings raise questions about why plans do not also accelerate access for these clinical advancements.