That is the question a new paper by Chambers et al. (2025) aims to answer. The authors use data from the Specialty Drug Evidence and Coverage (SPEC) Database, which contains coverage policies related to specialty pharmacy 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 find that:
Among 541 indication-plan pair coverage policies, 9 (1.7%) denied coverage. Of the remaining 532 policies, 256 (48.1%) were consistent 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 noncancer than cancer indications (62.7% [141 of 225] vs 44.0% [135 of 307]; P < .001).
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