Specialty Drug Coverage Varies Across Commercial Health Plans In The US.

Abstract

We analyzed specialty drug coverage decisions issued by the largest US commercial health plans to examine variation in coverage and the consistency of those decisions with indications approved by the Food and Drug Administration (FDA). Across 3,417 decisions, 16percent of the 302 drug-indication pairs were covered the same way by all of the health plans, and 48percent were covered the same way by 75percent of the plans. Specifically, 52percent of the decisions were consistent with the FDA label, 9percent less restrictive, 2percent mixed (less restrictive in some ways but more restrictive in others), and 33percent more restrictive, while 5percent of the pairs were not covered. Health plans restricted coverage of drugs indicated for cancer less often than they did coverage of drugs indicated for other diseases. Using multivariate regression, we found that several drug-related factors were associated with less restrictive coverage, including indications for orphan diseases or pediatric populations, absence of safety warnings, time on the market, lack of alternatives, and expedited FDA review. Variations in coverage have implications for patients' access to treatment and health system costs.