Rates of approval for proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are low, even for patients who appear to meet labeled indications; however, a combination of clinical characteristics increases the likelihood of approval. This according to a retrospective, descriptive cohort study that examined payer approvals and rejections, and patient characteristics for successful PCSK9 prescribing. Data from >220 million patients from all 50 states and all payer types with 5,140 health plans were included and PCSK9 inhibitor prescriptions were submitted for 51,466 patients. The main outcome was approval and rejection PCSK9 inhibitors in the US. Researchers found:
- 47% of patients who were prescribed a PCSK9 inhibitor were approved for coverage by a payer.
- Variables that were associated with PCSK9 inhibitor approval included age >65 years, history of atherosclerotic cardiovascular disease (CVD), prescription by a cardiologist or nonprimary care provider, statin intolerance, longer statin duration, and noncommercial payers.
- Higher LDL-C levels were not associated with higher approval rates.
- Medicare had the highest approval rates (60.9%).
Hess GP, Natarajan P, Faridi KF, Fievitz A, Valsdottir L, Yeh RW. Proprotein convertase subtilisin/kexin type 9 inhibitor therapy. Payer approvals and rejections, and patient characteristics for successful prescribing. [Published online ahead of print October 30, 2017]. Circulation. doi:10.1161/CIRCULATIONAHA.117.028430.
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