October 30, 2017
2 min read

Many patients denied approval for PCSK9 inhibitor therapy

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Less than 50% of patients who apply for PSCK9 inhibitors get payer approval despite having recommended indications, according to a study published in Circulation.

PCSK9 inhibitors alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen) reduce LDL levels by 60% and may decrease major adverse CV events in people with familial hypercholesterolemia or clinical atherosclerotic CVD, according to Gregory P. Hess, MD, MSc, senior fellow of health economics at the University of Pennsylvania, and colleagues.

“However, alirocumab and evolocumab are significantly more expensive than other lipid-lowering therapies with an average cost of $14,300 per year,” they wrote. “These costs pose a significant challenge to health care payers, especially in light of the uncertain long-term clinical effectiveness of these drugs.”

Hess and colleagues reviewed pharmacy claims and electronic health records for 9,357 patients prescribed PCSK9 inhibitors between July 2015 and August 2016 to determine rates of therapy approval. The study cohort included 451 individual health plans from 49 states and the District of Columbia.

Sixty percent of participants had a history of atherosclerotic CVD, yet only 47% (n = 4,397) were approved for PCSK9 inhibitor therapy. Of those approved, 64.7% fulfilled their prescription.

The mean patient responsibility was $202.87 for those approved for PCSK9 inhibitor therapy who accepted their prescriptions, vs. $478.83 for patients who abandoned their prescriptions despite approval.

Medicare had the highest approval rate (60.9%) compared with commercial third-party payers (24.4%) and Medicaid (31.2%).

Age older than 65 years (OR = 1.2; 95% CI, 1.05-1.38), history of atherosclerotic CVD (OR = 1.22; 95% CI, 1.1-1.36), prescription by a cardiologist or nonprimary care provider (OR = 1.61; 95% CI, 1.42-1.81), longer statin duration (OR = 1.2; 95% CI, 1.01-1.42) and noncommercial payers (OR = 12.32; 95% CI, 7.09-21.39) were all significantly associated with therapy approval. LDL was not associated with increased approval rates, even when levels were greater than 330 mg/dL.

“Whether or not we can agree on the cost-effectiveness of these drugs, I believe most would agree that one’s access to medications should be driven primarily by the strength of the indications for the prescription as opposed to what drug plan you happen to carry,” Robert W. Yeh, MD, MSc, director of the Smith Center for Outcomes Research in Cardiology at Beth Israel Deaconess Medical Center in Boston, said in a press release. “Better education for providers prescribing these medications and more uniform guidelines by insurers about what will and will not be covered are necessary to reduce the amount of administrative waste that is created to reject prescriptions for new medications.” by Cassie Homer

Disclosures: Hess and Yeh report no relevant financial disclosures. One author reports he receives consultant fees from Amarin Corp.