Prior Authorization Requirements for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Across US Private and Public Payers

Abstract

BACKGROUND:Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is) are an innovative treatment option for patients with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require further lowering of low-density lipoprotein cholesterol. However, the high costs of these agents have spurred payers to implement utilization management policies to ensure appropriate use. We examined prior authorization (PA) requirements for PCSK9is across private and public US payers. METHODS AND RESULTS:We conducted an analysis of 2016 formulary coverage and PA data from a large, proprietary database with information on policies governing >95% of Americans with prescription drug coverage (275.3 million lives) within 3872 plans across the 4 major insurance segments (commercial, health insurance exchange, Medicare, and Medicaid). The key measures included administrative PA criteria (prescriber specialty, number of criteria in PA policy or number of fields on PA form, requirements for medical record submission, reauthorization requirements) and clinical/diagnostic PA criteria (approved conditions, required laboratories or other tests, required concomitant therapy, step therapy requirements, continuation criteria) for each of 2 Food and Drug Administration-approved PCSK9is. Select measures (eg, number of PA criteria/fields, medical record submission requirements) were obtained for 2 comparator cardiometabolic drugs (ezetimibe and liraglutide). Between 82% and 97% of individuals were enrolled in plans implementing PA for PCSK9is (depending on insurance segment), and one third to two thirds of these enrollees faced PAs restricting PCSK9i prescribing to a specialist. For patients with familial hypercholesterolemia, diagnostic confirmation via genetic testing or meeting minimum clinical scores/criteria was also required. PA requirements were more extensive for PCSK9is as compared with the other cardiometabolic drugs (ie, contained 3×-11× the number of PA criteria or fields on PA forms and more frequently involved the submission of medical records as supporting documentation). CONCLUSIONS: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.

A model-based cost-effectiveness analysis of pharmacogenomic panel testing in cardiovascular disease management: preemptive, reactive, or none?

“…First is that identifying candidate groups of patients through PGx panel testing and initiating PGx-guided medication in the first place can result in better outcomes and reduced overall costs. 22,34 FOURIER trial estimated that PGxguided strategy would become cost-effective if the price of PCSK9 inhibitors were to be reduced by 69% (to $4536/ year). 26 Our results upheld that finding.…”

“…21 However, for many insurers, PCSK9 prescription needs a 3-month statin trial proven to be ineffective and also requires prior authorization. 22 PGx testing can flag patients unlikely to benefit from statins, and initiation of PCSK9 therapy instead of statin for them would be a cost-saving and efficient strategy that can avoid statin-related adverse events and circumvent the prior authorization process. Evidence on the costeffectiveness of implementing PGx panel testing, either preemptively or reactively, compared with usual care for any of the gene-drug combinations is scarce.…”

PCSK9 inhibition, atherosclerotic cardiovascular disease, and health economics: Challenges at the crossroads

“…If, however, the requirements for access to such new treatments are restrictive, then such a promising scenario is unlikely. 37 Indeed, some have suggested that despite their established clinical value, perceived costs and budgetary concerns relating to the use of PCSK9 inhibitors in the target patient groups have led to lower than expected uptake of these treatments. 38 This is a simplistic approach, however, which does not integrate possible rebates and discounts that may be offered by the manufacturers (It is noteworthy that, in the US, both manufacturers of PCSK9 inhibitors have lowered their price recently by 60%); indeed, recent developments suggest that the budget impact of such treatments is lower than anticipated, 39 especially when weighed against the burden of cardiovascular complications.…”

The patient journey with proprotein convertase subtilisin/kexin type 9 inhibitors in community practice

“…Furthermore, only half of PCSK9 inhibitor prescriptions received payer approval, and up to a one-third of approved prescriptions were never filled. The reasons for these low rates are due in part to insurance barriers, 3 which lead to high rates of payer rejections and increased out-of-pocket expenses for patients. 4 To date, there is limited information on patients' experiences when trying to obtain, fill, and use PCSK9 inhibitor therapy in community practice.…”