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.”

NEXT: Five take-aways from the study

Lassen offered these 5 take-aways from the study:

• 80% of people with established cardiovascular disease significantly underuse statins--the best and most affordable therapy to lower bad cholesterol levels. Adherence to statins is a long-standing national problem.

• There is significant opportunity to optimize statin use, even for members who may be eligible for PCSK9s.

• PCSK9s may be an appropriate solution for those with a rare genetic condition who are unable to lower their LDL cholesterol levels, but adherence to statin treatments should be evaluated first.

• Optimize statin therapy prior to the initiation of PCSK9s is the right thing to do clinically for members and the responsible thing to do as the total cost of care is being managed.

• When new drugs come to market, especially high-cost specialty drugs without long-term safety data, it's important that the healthcare industry evaluates the clinical merit, long-term safety profile and cost of the drug as part of the overall drug management strategy.

Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

Related:Move over Sovaldi: Could PCSK9 inhibitors be a bigger cost challenge?

Prime Therapeutics advises many members may achieve health goals and save money by optimizing cholesterol-lowering statins before trying PCSK9s. Prime previously forecasted that PCSK9 drugs could be priced between $7,000 and $12,000 per year and could cost the US health system $23.3 billion per year if broadly used by as many as 2.3 million Americans. If used by only 40% of the more than 600,000 Americans with a rare genetic condition leading to abnormally high cholesterol levels for which statins aren’t always effective, they could still add an additional $2.1 billion per year in new costs. The actual cost of Praluent is $14,600 per year, so costs will be approximately 50% higher than initial forecasts.