Coverage for drugs recently approved by the FDA can take months to solidify, according to the Institute for Clinical and Economic Review’s “Launch Price and Access Report,” published Oct. 23.
Researchers reviewed 24 drugs from Boston-based Tufts Medical Center’s specialty drug evidence and coverage database, including information on specialty drug coverage decisions from up to 18 commercial health plans.
The study found some coverage policies took several months, sometimes up to a year, after FDA approval to address the majority of these drugs. As of December 2024, drugs approved in the first six months of the year were more likely to have policies in place. For drugs approved in the second half of 2024, only half of payers had policies available.
Coverage policies were often delayed by six months, even for first-in-class drugs like Miplyffa. Despite being approved in September 2024, only 11% of available policies clearly covered this treatment — the first approved for Type C Niemann-Pick disease — by the end of 2024. Policy coverage increased by 50% by April 2025.
In April, six evaluated drugs still lacked available policies from more than 50% of payers. That same month, two out of the 24 drugs had policies that indicated they would not be covered.
