Prior Authorization Policies for PCSK9 Inhibitors Burdensome, Says Study

PA requirements are more extensive for PCSK9is than for other cardiometabolic drugs
PA requirements are more extensive for PCSK9is than for other cardiometabolic drugs

HealthDay News — Prior authorization (PA) requirements are greater for proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) than for other cardiometabolic drugs, according to a study published online January 11 in Circulation: Cardiovascular Quality and Outcomes.

Jalpa A. Doshi, PhD, from the University of Pennsylvania in Philadelphia, and colleagues analyzed 2016 formulary coverage and PA data for Americans with prescription drug coverage (275.3 million lives) within 3,872 plans across the major insurance sectors (commercial, health insurance exchange, Medicare, and Medicaid). 

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The researchers found that 82 to 97% of individuals were enrolled in plans implementing PA for PCSK9is; one-third to two-thirds of these enrollees faced PAs that restricted prescribing of PCSK9is to a specialist. Diagnostic confirmation via genetic testing or meeting minimum clinical scores/criteria was required for patients with familial hypercholesterolemia. Compared with other cardiometabolic drugs, for PCSK9is, PA requirements were more extensive (three to 11 times the number of PA criteria or fields on PA forms; more often needed submission of medical documents).

"PA requirements for PCSK9is are greater than for selected other drugs within the cardiometabolic disease area, raising concerns about whether payer policies to discourage inappropriate use may also be restricting access to these drugs in patients who need them," the authors write.

Two authors disclosed financial ties to pharmaceutical companies, including Sanofi, which funded the study along with Regeneron.

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