PMU34 The Influence of Expedited Approval Designations on Health PLAN Coverage: An Empirical Evaluation

Abstract

FDA expedites the review of drugs that address unmet clinical needs through four programs: priority review, accelerated approval, breakthrough therapy, and fast-track. These programs aim to speed patient access to substantial clinical advances. We examined whether health plans prioritize access to FDA expedited drugs. We used the Tufts Medical Center Specialty Drug and Evidence Coverage database, which contains information on specialty drug coverage decisions issued by 17 large US commercial health plans and details coverage restrictions (e.g., patient subgroups, step therapy protocols). We included drugs that FDA approved after January 1, 2013 to coincide with implementation of the breakthrough therapy designation program. We categorized drugs as included in no FDA expedited program, one program, or multiple programs. Our dichotomous dependent variable was: coverage with no restrictions vs. coverage with restrictions. We controlled for these drug characteristics: cancer treatment; drug type (biosimilar or otherwise); availability of alternatives; pediatric indication; years since FDA approval; administration (self- or physician-administered); annual cost; and disease prevalence. We analyzed the data using univariate analysis and multivariable logistic regression. We included 3,733 coverage decisions (current as of August, 2020). Univariate analysis found that plans were less likely to restrict coverage of drugs included in an expedited program (one program; OR=0.54, p<.01; multiple programs OR=0.46, p<.01). Multivariable regression analysis found that plans were neither more nor less likely to restrict coverage of drugs included in an expedited program (one program; OR=1.11, p=0.43; multiple programs OR=0.95, p=0.63). Plans were more likely to restrict a drug’s coverage (p<0.05) if it was not a cancer treatment, not a biosimilar, more recently approved, physician administered, had a higher annual cost, or treated a highly prevalent disease. When controlling for other characteristics, we found no association between a drug’s inclusion in an FDA expedited program and health plan coverage restrictiveness.