Costs, Health Insurers Hinder Patient’s Access to Cholesterol-Lowering Drugs

A study was released from Duke Clinical Research Institute, finding that many prescriptions for a class of drugs proclaiming to be game changers for high cholesterol are going unfilled due to high out-of-pocket costs and challenges from pharmacy benefit managers.

The study was published online in JAMA Cardiology and found that fewer than one-third of patients prescribed a PCSK9 inhibitor, injectable drugs designed to lower cholesterol levels, actually got the drug.

Researchers found the two main factors in limited access were lack of insurance approval for the prescriptions and high copays. Less than 50% of patients prescribed a PCSK9 inhibitor received approval from their insurer.

Even after approval, one in three patients did not fill their prescription. A quarter of patients had copays over $300 per month for therapies that cost about $14,000 a year.

The net result was that just 31% of patients who were initially prescribed a PCSK9 inhibitor ever actually received the therapy, the researchers found. About 35% of patients who received approval never picked up the medication, which was almost entirely due to high out-of-pocket costs. In example, over 90% of approved patients who had no copay filled their prescription, but if the copay exceeded $300, only about 20% filled the prescription.

The drugs include evolocumab (brand name Repatha, manufactured by the study’s funder, Amgen, Inc.) and alirocumab (brand name Praluent). Both therapies were approved by the FDA in 2015 for people with familial hyperlipidemia (a form of very high cholesterol that runs in families) and those with established heart disease who have high cholesterol despite traditional statin therapy.

For more information, visit the Duke Clinical Research Institute.