Cholesterol lowering medications PCSK9 inhibitors (PCSK9i), alirocumab and evolocumab, were approved in 2015. Their high cost however has led to strict prior authorisation practices and high copays, curtailing use of PSCK9i in clinical practice, according to a new study published by JAMA Cardiology.

PCSK9 inhibitors are typically prescribed by doctors for adult patients with persistently elevated low-density lipoprotein cholesterol (LDL-C) levels despite maximally tolerated statin therapy and those with familial high cholesterol. The retail cost for these PCSK9i can be as much as $14,000 per year, leading health insurers and pharmacy benefit managers to implement utilisation management processes including prior authorisation and patient therapy copays. To date, limited information is available on how these preauthorisation processes and copays jointly are associated with access to PCSK9i in community practice.

Using pharmacy transaction data, Ann Marie Navar, MD, PhD, of the Duke Clinical Research Institute, Durham, N.C., and colleagues evaluated 45,029 patients who were newly prescribed PCSK9i in the United States between August 2015 and July 2016. Of patients given a new PCSK9i prescription, 51 percent were women, 57 percent were 65 years or older, and 53 percent had governmental insurance.

In the first year of availability of PCSK9 inhibitors, researchers found that fewer than 1 in 3 adult patients initially prescribed one of these medications actually received it. Not having a prescription filled by patients was most associated with copay costs, with prescription abandonment rates ranging from 7.5 percent for those with $0 copay to more than 75 percent for copays greater than $350.

Other key findings of the study include:

- Of the patients given a prescription, 20.8 percent received approval on the first day, and 47.2 percent ever received approval.
- Of those patients approved, 65.3 percent filled the prescription, resulting in 30.9 percent of those prescribed PCSK9i ever receiving therapy.
- Patients who were older, male, and had atherosclerotic cardiovascular disease were more likely to be approved, but approval rates did not vary by patient LDL-C level nor statin use.
- Other factors associated with drug approval included having government vs. commercial insurance, and those filled at a specialty vs. retail pharmacy.
- Approval rates varied nearly threefold among the top 10 largest pharmacy benefit managers.

Source: JAMA Cardiology
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cholesterol drugs, PCSK9 inhibitors, alirocumab, evolocumab Cholesterol lowering medications PCSK9 inhibitors (PCSK9i), alirocumab and evolocumab, were approved in 2015. Their high cost however has led to strict prior authorisation practices and high copays, curtailing use of PSCK9i in clinical practice, accordin