The first PCSK9 inhibitor approval: 5 lessons

With FDA’s approval of Praluent (alirocumab) injection, the first in a new class of injectable cholesterol-lowering drugs called PCSK9 inhibitors, comes the need for a utilization management approach.

To guide its utilization management approach of these new drugs, Prime Therapeutics LLC (Prime) analyzed its claims data and confirmed current statin treatments were not being used or adhered to as guidelines recommend. Adherence to statins is a long-standing national problem which is well studied and documented. Not surprisingly, Prime’s analysis validates there is a significant opportunity to optimize statin use even for members who may be eligible for PCSK9s.

Related:5 things to know about cholesterol-lowering PCSK9 inhibitors

Prime analyzed more than 3 million members who were commercially insured and enrolled in benefits through a Prime client continuously for 4 years through 2014. Of those, 1.8% had established cardiovascular disease. And of these members:

• Only 1 in 5 were using a high-dose statin and were taking it regularly in 2014, which is the recommendation of the American College of Cardiology and the American Heart Association. This means 80% of people with established cardiovascular disease significantly underuse statins.

• 27% had no statin claim in 2014

• Of those without a statin claim or not adherent, only 1 in 4 had tried a second statin during the 4 years

• 45% either had no statin claim or were not adherent to their prescribed statin therapy

“How formularies are structured, and the utilization management strategies implemented for formulary drugs, will need to be carefully reviewed so the appropriate high-risk patients are prescribed PCSK9s,” said David Lassen, chief clinical officer at Prime. “Because PCSK9s have not been proven to prevent heart attacks, and their long-term safety has not yet been established, we recommend payers optimize statin therapy prior to the initiation of PCSK9s.”

 

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