Interventions of interest:

  • inclisiran (Leqvio®, Novartis)
  • bempedoic acid (Nexletol®, Esperion Therapeutics)
  • bempedoic acid/ezetimibe (Nexlizet™, Esperion Therapeutics)

An independent appraisal committee voted that the evidence is not adequate to demonstrate a net health benefit of bempedoic acid over usual care for the entire population of eligible patients, but is adequate when focused on patients unable to take statins and patients with heterozygous familial hypercholesterolemia (HeFH). At current pricing the committee judged the long-term value for money as low to intermediate, with a 36% discount needed to reach ICER’s health-benefit price benchmark for the entire patient population.

For inclisiran, by a unanimous vote the evidence was judged adequate to demonstrate a net health benefit over usual care alone.  If priced at parity with current pricing for PCSK9 inhibitors, the committee voted that inclisiran would represent a low-to-intermediate long-term value for money. ICER’s recommended net price benchmark range for inclisiran is $3,600-$6,000 per year.

At the policy roundtable, experts emphasized the need to align pricing and access in order to reduce health inequities, streamline access to new therapies for patients in high-risk populations, and promote broader use of statins and ezetimibe as effective, low-cost treatment options.

Final Documents

ICER’s President, Steven D. Pearson, MD, MSc stated:

“The innovation in recent years that has produced new treatment options for patients with high cholesterol is impressive.  The unmet need and the potential impact on population health is substantial.  And yet, with the large number of patients who could benefit from these treatments, the potential price tag is impressive as well. That’s why it’s so important to provide a choice among multiple treatment options for patients with diverse needs, and to ensure that patients and the health system can afford these treatments.  We saw this opportunity squandered in the early years of PCSK9 inhibitors.  The only way we get this right for patients moving forward is to price new treatments to their demonstrated clinical value, and link that to responsible insurance coverage criteria that are based on evidence and informed by input from clinical experts and patients.” 

“Unfortunately, as the independent appraisal committee confirmed, current pricing for bempedoic acid is too high to get the ball rolling in the right direction.  We’ll have to wait to see what the price will be for inclisiran, but it would be a real loss for patients if at the outset of another round of new innovation drug makers set prices that send us right back into another grinding number of years in which access is limited while drug makers and insurers wrestle over what is viewed as an unreasonable price.  Patients deserve better.”

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