Formulary Exclusions and Prior Authorization Requirements Continue to Limit Patient Access to PCSK9is

Published Mar 4, 2020

New Research Examines Low Insurer Approval Rates for Alirocumab and Evolocumab Prescriptions

Value in HealthLawrenceville, NJ, USA—March 4, 2020—Value in Health, the official journal of ISPOR—the professional society for health economics and outcomes research, announced today the publication of new research showing that insurer approval rates for PCSK9i prescriptions remain low. Those who gain access to the medications appear to be largely determined by plan-level policies such as lack of formulary coverage. The report, “Trends and Factors Associated With Insurer Approval of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Prescriptions,” was published in the February 2020 issue of Value in Health.

Two proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9is), alirocumab and evolocumab, were approved by the US Food and Drug Administration (FDA) in 2015 for adults with familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol. With both PCSK9is entering the market at initial list prices of approximately $14,000 per year, insurers instituted various strategies including formulary exclusions and prior authorization requirements to manage utilization and spending on these agents.

To date, studies of insurer approval rates and examination of specific payer policies for PCSK9is have occurred separately. The authors of this new study sought to weave together these 2 lines of inquiry using a unique data set that allowed additional visibility into the relationship between payer prior authorization policies and prescription approval.

Index prescription approval rates for PCSK9i prescriptions ranged from 13% to 23% in the first 4 quarters of the study period, in keeping with the low rates reported in previous studies conducted in the year immediately after the drugs’ FDA approval. Quarterly trends revealed that an initial increase in approval rates over the first 3 quarters after the PCSK9is came on the market was followed by a gradual plateauing of approval rates over the following 18 months. Moreover, findings documented a rise in rejections related to prior authorization criteria across the study period; as time went on, nearly half of the patients in the study received an initial rejection because of prior authorization criteria. Specifically, requiring physicians to address more than 5 prior authorization criteria resulted in lower odds of approval for the index prescription and within 90 days. By the end of the study period, only 2 in 5 patients were receiving approval for any PCSK9i prescription within 30 days, and nearly a quarter of patients were still receiving initial rejections because of lack of coverage.

“This study is the first to examine longer-term trends in US insurer approvals of PCSK9i prescriptions and provides new information on how reasons for rejection changed over a 27-month period,” said author Jalpa A. Doshi, PhD, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. “Our use of a unique data source that enabled linkage of claims data for PCSK9is with policy information from a wide range of insurers allowed us to conduct a detailed examination of a patient’s PCSK9i prescription approval status in the context of their specific insurance plan’s formulary and prior authorization policies for the first time in the published literature. Our findings suggest that there are ongoing challenges in patient access to these therapies. Despite the fact that many patients do ultimately receive approval, there has not been a marked improvement in access to these therapies overall. Plan-level policies such as lack of formulary coverage and a higher number of prior authorization policy criteria for PCSK9is appear to play a dominant role in who obtains access.”



ISPOR, the professional society for health economics and outcomes research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2018 impact factor score is 5.037. Value in Health is ranked 5th of 98 journals in healthcare sciences and services, 4th of 81 journals in health policy and services, and 11th of 363 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.
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