Repatha™ approved; joins Praluent® in the marketplace

The U.S. Food and Drug Administration (FDA) approved Repatha (evolocumab) from Amgen on August 27. In addition to diet and maximally tolerated statin therapy, Repatha is approved for the treatment of:

  • People with heterozygous familial hypercholesterolemia (HeFH),
  • People with homozygous familial hypercholesterolemia (HoFH), or
  • People with clinical atherosclerotic cardiovascular disease (ASCVD) such as heart attacks or strokes, who may require additional lowering of LDL (bad) cholesterol.1

For the majority of people struggling to lower high cholesterol, even for many of those who may be eligible for PCSK9 inhibitors, the best and more affordable therapy is still statin therapy. 

What’s the difference between Repatha and Praluent? Repatha and Praluent are both proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors that work to help the body clear LDL cholesterol from the blood. PCSK9 inhibitors are approved to treat people with familial hypercholesterolemia (FH), a rare genetic disorder where the body is unable to remove LDL cholesterol from the blood.

There are two types of FH: heterozygous (HeFH) and homozygous (HoFH), dependent on if the individual has one or two copies of the gene mutation. Repatha is approved to treat members with HeFH or HoFH. Praluent is approved to treat members with HeFH. Both drugs were approved to treat members with ASCVD.

How many people will use Repatha? 

  • Approximately one in 500 people has HeFH and one in a million has HoFH.2  A recent analysis of Prime members estimates 14,500 to 29,000 members aged 20-74 have HeFH, and seven to 46 members aged 20-74 have HoFH.3
  • When evaluating potential use of PCSK9 inhibitors for HeFH, HoFH, and high-risk secondary prevention of ASCVD, Prime estimates 395 per 100,000 commercially insured members may be eligible for treatment.3

How much will Repatha cost?

  • According to the manufacturer, the wholesale acquisition cost (WAC) price for Repatha will be $14,100 per year.4
  • The estimated impact of PCSK9 inhibitors as a category is $4.80 per member per month (PMPM) at one year post launch for commercially insured coverage without utilization management.3

Strategies to manage members with high cholesterol

Blue Cross and Prime actively work with employers to optimize statin therapy for members who may be eligible for PCSK9 inhibitors. While PCSK9 inhibitors may be an appropriate therapy for members with HeFH or HoFH, for the majority of members struggling to lower their high cholesterol, the best and more affordable therapy is treatment with statins.

Products and programs like GuidedHealth® work to address adherence issues. Encouraging 90-day fills of statins through PrimeMail® or the extended supply network (ESN) can also help improve adherence to therapy.

Strategies to manage PCSK9 inhibitors

Prime is prepared with a comprehensive drug cost management program: Cholesterol Best in Care™. Blue Cross and Prme work together to show employers how we can save them money -- helping the right people get the right drug, at the right cost. When PCSK9 inhibitors are necessary, we are ready to manage appropriate use of Repatha (and Praluent) and help control costs for clients.

  • Robust prior authorization to manage appropriate use
  • Dispensing and member support from Prime Specialty Pharmacy
  • Preferred product strategy (expected this fall)
  • Benefit design recommendations

Next story: Defining the new dynamics in health care: Read more.

1 U.S. Food and Drug Administration. Press release. “FDA approves Repatha to treat certain patients with high cholesterol.” August 27, 2015.

2 Cuchel M, Bruckert E, Ginsberg HN, et al. European Heart Journal July 22, 2014. DOI: http://dx.doi.org/10.1093/eurheartj/ehu274.

3 Prime internal analysis.

4 Amgen. Press release. “FDA approves Amgen’s new cholesterol-lowering medication Repatha (evolocumab).” August 27, 2015.

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