The U.S. Food and Drug Administration (FDA) approved Praluent™ (alirocumab) on July 24, the first of two cholesterol-lowering drugs in a new class of drugs known as PCSK9 inhibitors. In addition to diet and maximally tolerated statin therapy, Praluent is approved for use in:
- People with heterozygous familial hypercholesterolemia (HeFH), a rare genetic condition that results in extremely high LDL (bad) cholesterol or
- People with a history of clinical atherosclerotic cardiovascular disease (ASCVD) such as heart attacks or strokes, who require additional lowering of LDL cholesterol.1
At the same time, a new Prime study shows that 80 percent of people at high risk for cardiovascular disease significantly underuse statins.2 PCSK9 inhibitors may be an appropriate therapy for members with HeFH. But for the majority of people struggling to lower high cholesterol, the best and more affordable therapy is still statin therapy.
Blue Cross and Prime estimates 395 per 100,000 commercially insured members and 1,500 per 100,000 Medicare Part D members may be eligible for treatment under FDA labeling.3 Two drugs, Praluent and Repatha™ (evolocumab), fit this category of Proprotein Convertase Subtilisin/Kexin type 9. Repatha is expected to be approved in late August.
Before Praluent’s approval, Prime had estimated the cost impacts based on an anticipated cost of $10,000. But Praluent is now priced at $14,600 -- approximately 50% more than the original estimate.4 (Visit Prime's Drug Cost Calculator to estimate cost for your population.)
For the majority of people struggling to lower high cholesterol, the best and more affordable therapy is still statin therapy.
Use of current statin treatments
Prime studied recent claims data and found that only 1 in 5 members at risk for cardiovascular disease were using a high dose statin and were taking it regularly.2 This is the recommendation of the American College of Cardiology and the American Heart Association. In other words, 80 percent of people who are at high-risk for cardiovascular disease significantly underuse statins. In addition, Prime found that of those members without a statin claim or who were not adherent, only one in four members had tried a second statin over the previous four years.2
Blue Cross and Prime believe there is a significant opportunity to optimize statin use, even for members who may be eligible for PCSK9s inhibitors.
- PCSK9s inhibitors may be an appropriate therapy for members with HeFH. But for the majority of members struggling to lower high cholesterol, the best and more affordable therapy is statin therapy.
- Programs like GuidedHealth® work to address adherence issues. Encouraging 90-day fills of statins through PrimeMail® or the extended supply network (ESN), when available, can also help improve adherence to therapy.
- For those members where PCSK9s are necessary, we are ready to manage appropriate use of Praluent and help control costs for clients. A utilization management program is available.
- Prime Therapeutics Specialty Pharmacy™ has access to Praluent and care management programs are in place to provide support to members.
- U.S. Food and Drug Administration. Press release. “FDA approves Praluent to treat certain patients with high cholesterol.” July 24, 2015.
- “Statin Therapy, Intensity, Adherence and Number of Distinct Statins Tried Among Commercially Insured Adults with Atherosclerotic Cardiovascular Disease Continuously Enrolled Before and After 2013 ACC/AHA Cholesterol Guideline” K. L. Bowen, P. P. Gleason. Prime Therapeutics, Eagan, MN, United States. Accessed at: https://cdn.app.compendium.com/uploads/user/220a4eb2-dd7f-4520-ab96-7cfb9e87326b/8e648f20-2a6c-4610-9b15-849b37ce4f51/File/94496934b40d4b33b9ca7b0ec9bff872/abstract_statin_therapy_ascvd_before_after_2013_cholesterol_guidelines.pdf
- Prime internal analysis, 2015.
- Regeneron Pharmaceuticals, Inc. Press release. “Regeneron and Sanofi announce FDA approval of Praluent (alirocumab) injection, the first PCSK9 inhibitor in the U.S., for the treatment of high LDL cholesterol in adult patients.” July 24, 2015.