Can Improved Statin Adherence Reduce Need for PCSK9 Inhibitors?

Study finds 80% of people with cardiovascular disease significantly underuse statins.

Following the approval of a new class of cholesterol-lowering drugs by the FDA, a new study finds that improved adherence to current traditional statin regimens may reduce the need for the new medications.

The Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors Praluent by Regeneron & Sanofi, which was approved last week by the FDA, and Repatha by Amgen, which is expected to be approved shortly by the FDA, carry a significantly higher cost than statins.

Praluent was announced to have a cost of $14,600 annually. With such a price point, if the drugs were to be broadly approved for the approximately 2.3 million people who could potentially use PCSK9 inhibitors, it could cost up to approximately $23.3 billion annually, according to pharmacy benefit manager Prime Therapeutics.

“PCSK9s may be an appropriate solution for our members with a rare genetic condition who are unable to lower their LDL cholesterol levels,” said David Lassen, chief clinical officer at Prime. “However, for the majority of others struggling to lower their bad cholesterol levels, the best and most affordable therapy is treatment with statins, which have a long track record of safety and effectiveness.”

A recent study by Prime analyzing claims data and statin usage found that adherence to statins is significantly low. Prime evaluated more than 3 million commercially insured members who enrolled in benefits through a Prime client continuously for 4 years through 2014.

Among these patients, 1.8% had established cardiovascular disease, but just 1 in 5 (20%) of these individuals were using a high dose statin and taking it regularly, as per American College of Cardiology and American Heart Association recommendations.

Furthermore, the study showed that 27% of these individuals had no statin claim last year. Among members without a statin claim or those who were not adherent, just 1 in 4 tried a second statin during the 4-year time period. Meanwhile, 45% of these patients either had no statin claim or were not adherent to the prescribed statin therapy last year.

“Because PCSK9s have not been proven to prevent heart attacks and their long term safety has not yet been established, we feel compelled to help our clients optimize statin therapy prior to the initiation of PCSK9s,” Lassen said. “We believe this is the right thing to do clinically for our members and the responsible thing to do as we manage the total cost of care.”

Prime estimates PCSK9 inhibitors could add between $0.93 and $6.71 per member per month (PMPM) to commercial insurance coverage costs and up to $15.66 PMPM to Medicare coverage costs depending on the conditions PCSK9 inhibitors are approved to treat. If the drugs were prescribed to 40% of approximately 600,000 Americans with abnormally high cholesterol levels that statins don’t reduce, it could add an additional $2.1 billion annually in new costs.

“At Prime, our goal is to help our members get the medicine they need to feel better and live well, while also helping keep prescriptions more affordable,” Lassen added. “Carefully reviewing prior statin use and then implementing utilization management strategies will be necessary so the appropriate high risk patients are prescribed PCSK9s. Doing so will help keep costs for all our members within reach.”