In the Journals

Prior authorization requirements substantial for PCSK9 inhibitors

PCSK9 inhibitors required more prior authorization requirements compared with other drugs for cardiometabolic disease, according to an analysis published in Circulation: Cardiovascular Quality and Outcomes.

“Our findings raise the question of whether [prior authorization]-related challenges are limiting access to PCSK9is for the most appropriate patients, particularly because individuals with FH — who are likely to have more clear-cut eligibility for PCSK9is — were subject to the same extensive [prior authorization] requirements as were patients with ASCVD,” Jalpa A. Doshi, PhD, associate professor of medicine in the division of general internal medicine, director of the economic evaluations unit in the Center for Evidence-Based Practice, director of value-based insurance design initiatives in the Center for Health Incentives, senior fellow at the Leonard Davis Institute of Health Economics and fellow at the Institute on Aging at University of Pennsylvania, and colleagues wrote.

Prior authorization data

Researchers analyzed data on formulary coverage and prior authorizations from 2016. The data represented 100% of people (275.3 million Americans) who had prescription coverage from 3,872 plans from health insurance exchanges, commercial insurance, Medicare and Medicaid. Information including coverage, administrative prior authorization criteria and both clinical and diagnostic prior authorization criteria were reviewed.

The two PCSK9 inhibitors analyzed were alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen). Ezetimibe (Zetia, Merck) and liraglutide (Victoza, Novo Nordisk) were also included in the analysis as comparators.

Between 82% and 97% of patients required prior authorizations from their insurance companies for PCSK9 inhibitors. A visit to a specialist was necessary for prior authorizations in one-third of patients with commercial insurance and fewer than three-quarters of patients with Medicare.

Patients with familial hypercholesterolemia (FH) needed to undergo genetic testing for insurance plans that required documentation to confirm their diagnosis.

Before receiving approval for PCSK9 inhibitors, most patients had to try multiple lipid-lowering drugs, and requirements on combinations of lipid-lowering medications and dosages were inconsistent.

More requirements on forms

Prior authorization forms for PCSK9 inhibitors had three to 11 times more fields compared with those for comparator drugs across payer segments. Patients seeking authorization for a PCSK9 inhibitor were also more likely to have to submit medical records for approval.

“It remains to be seen how payers will respond to accumulating evidence on PCSK9is from cardiovascular outcomes trials and cost-effectiveness studies,” Doshi and colleagues wrote. “In addition, some states have passed legislation requiring standardized [prior authorization] forms across drug classes, which may also influence [prior authorization] policies for PCSK9is in the future. Further research is needed to understand how [prior authorization] requirements impact prescribing and initiation of PCSK9is and how this affects cardiovascular outcomes in this patient population.”

In a related editorial, Cynthia A. Jackevicius, BScPhm, PharmD, MSc, professor of pharmacy practice and administration at Western University of Health Sciences College of Pharmacy in Pomona, California, wrote: “This challenging situation gives us the opportunity to redouble our efforts on improving our prescribing of established effective oral lipid-lowering therapies while ... advocating for an evidence-based, yet practical [prior authorization] process, greater transparency in the pricing of pharmaceuticals as well as incentives to explore drug policy that aims to improve access to effective therapies that are also affordable.” – by Darlene Dobkowski

Disclosures: The study was supported by Regeneron and Sanofi. Doshi reports she served as a consultant for Sanofi, received research funding from Biogen, Janssen, PhRMA, Pfizer and Sanofi and her spouse holds stock in Merck and Pfizer. Jackevicius reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.

PCSK9 inhibitors required more prior authorization requirements compared with other drugs for cardiometabolic disease, according to an analysis published in Circulation: Cardiovascular Quality and Outcomes.

“Our findings raise the question of whether [prior authorization]-related challenges are limiting access to PCSK9is for the most appropriate patients, particularly because individuals with FH — who are likely to have more clear-cut eligibility for PCSK9is — were subject to the same extensive [prior authorization] requirements as were patients with ASCVD,” Jalpa A. Doshi, PhD, associate professor of medicine in the division of general internal medicine, director of the economic evaluations unit in the Center for Evidence-Based Practice, director of value-based insurance design initiatives in the Center for Health Incentives, senior fellow at the Leonard Davis Institute of Health Economics and fellow at the Institute on Aging at University of Pennsylvania, and colleagues wrote.

Prior authorization data

Researchers analyzed data on formulary coverage and prior authorizations from 2016. The data represented 100% of people (275.3 million Americans) who had prescription coverage from 3,872 plans from health insurance exchanges, commercial insurance, Medicare and Medicaid. Information including coverage, administrative prior authorization criteria and both clinical and diagnostic prior authorization criteria were reviewed.

The two PCSK9 inhibitors analyzed were alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen). Ezetimibe (Zetia, Merck) and liraglutide (Victoza, Novo Nordisk) were also included in the analysis as comparators.

Between 82% and 97% of patients required prior authorizations from their insurance companies for PCSK9 inhibitors. A visit to a specialist was necessary for prior authorizations in one-third of patients with commercial insurance and fewer than three-quarters of patients with Medicare.

Patients with familial hypercholesterolemia (FH) needed to undergo genetic testing for insurance plans that required documentation to confirm their diagnosis.

Before receiving approval for PCSK9 inhibitors, most patients had to try multiple lipid-lowering drugs, and requirements on combinations of lipid-lowering medications and dosages were inconsistent.

More requirements on forms

Prior authorization forms for PCSK9 inhibitors had three to 11 times more fields compared with those for comparator drugs across payer segments. Patients seeking authorization for a PCSK9 inhibitor were also more likely to have to submit medical records for approval.

“It remains to be seen how payers will respond to accumulating evidence on PCSK9is from cardiovascular outcomes trials and cost-effectiveness studies,” Doshi and colleagues wrote. “In addition, some states have passed legislation requiring standardized [prior authorization] forms across drug classes, which may also influence [prior authorization] policies for PCSK9is in the future. Further research is needed to understand how [prior authorization] requirements impact prescribing and initiation of PCSK9is and how this affects cardiovascular outcomes in this patient population.”

In a related editorial, Cynthia A. Jackevicius, BScPhm, PharmD, MSc, professor of pharmacy practice and administration at Western University of Health Sciences College of Pharmacy in Pomona, California, wrote: “This challenging situation gives us the opportunity to redouble our efforts on improving our prescribing of established effective oral lipid-lowering therapies while ... advocating for an evidence-based, yet practical [prior authorization] process, greater transparency in the pricing of pharmaceuticals as well as incentives to explore drug policy that aims to improve access to effective therapies that are also affordable.” – by Darlene Dobkowski

Disclosures: The study was supported by Regeneron and Sanofi. Doshi reports she served as a consultant for Sanofi, received research funding from Biogen, Janssen, PhRMA, Pfizer and Sanofi and her spouse holds stock in Merck and Pfizer. Jackevicius reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.