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Study: Two Out of Three Praluent, Repatha Prescriptions Went Unfilled

Researchers blame high out-of-pocket costs and insurance snags

In the first year that the costly cholesterol medications alirocumab and evolocumab were available, fewer than one in three adults who were prescribed one of the drugs actually received it. The reason? A combination of out-of-pocket costs and lack of insurance approval, according to a study published by JAMA Cardiology.

Since 2015, the proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen) have been approved for adults 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 utilization management processes, including prior authorization and patient therapy copays. To date, limited information is available on how these preauthorization 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 in Durham, North Carolina, 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% were women, 57% were 65 years or older, and 53% had governmental insurance.

Of the patients given a prescription, 20.8% received approval on the first day, and 47.2% ever received approval. Of those approved, 65.3% filled the prescription, resulting in 30.9% 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 versus commercial insurance, and those filled at a specialty versus retail pharmacy. Approval rates varied nearly threefold among the top 10 largest pharmacy benefit managers.

Not having a prescription filled by patients was most associated with copay costs, with prescription abandonment rates ranging from 7.5% for those with $0 copay to more than 75% for copays greater than $350.

Several limitations of the study are noted in the article.

Source: JAMA Network Journals; September 27, 2017.

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