That’s the question a new paper by Chambers et al. (2025) aims to provide answers. The authors use data from the Specialty Drug Evidence and Coverage (SPEC) database, which contains specialty pharmacy-related coverage policies for a large number of US health plans, to examine how N = 25 cell and gene therapies are being covered by US commercial health plans. With these data, they found that:
Of the 541 indication-plan pair coverage policies, 9 (1.7%) denied coverage. Of the remaining 532 policies, 256 (48.1%) were compliant with FDA labeling and 276 (51.9%) imposed additional coverage restrictions, including 220 (79.7%) using patient subgroup requirements; 25 (9.1%), step therapy protocols; and 31 (11.2%), both. Additional restrictions were more common for non-cancer than cancer indications (62.7%) [141 of 225] vs 44.0% [135 of 307]p < .001).
You can read the full article Here,
