Cardiovascular disease (CVD) is the most common cause of death in the United States and approximately one third of American adults have CVD. Low density lipoprotein cholesterol (LDL) is a major modifiable risk factor for myocardial infarction, stroke, and death from cardiovascular disease. The use of statins to decrease LDL has contributed to the marked decline in death from CVD since 1950, but some patients are not able to tolerate statins and others have inadequate reductions in LDL. In June 2015, the FDA advisory panel voted to recommend approval of two human monoclonal antibodies that target proprotein convertase subtilisin/kexin type 9 (PCSK9) in the blood and markedly reduce LDL cholesterol levels.

Based on the results of the ODYSSEY Outcomes trial, ICER has calculated two updated value-based price benchmarks, net of rebates and discounts, for alirocumab in patients with a recent acute coronary event: $2,300-$3,400 per year if used to treat all patients who meet trial eligibility criteria, and $4,500-$8,000 per year if used to treat higher-risk patients with LDL cholesterol ≥ 100 mg/dL despite intensive statin therapy.

Interventions of Interest:

  • alirocumab (Praluent®, Regeneron/Sanofi)
  • evolocumab (Repatha®, Amgen)

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Final Documents

Below you will find the final documents from the assessment review process:

2019 Evidence Update: ICER published this Final New Evidence Update for alirocumab (Praluent®, Regeneron/Sanofi), an injectable PCSK9 inhibitor used for the treatment of high cholesterol in certain patient populations. This New Evidence Update is based on further analysis of results from the ODYSSEY Outcomes trial, which have now undergone peer review and were published in the New England Journal of Medicine on November 7, 2018.

“These new data demonstrate that alirocumab not only lowers levels of bad cholesterol but can also reduce deaths among a patient population with a recent history of an acute coronary event. Patients in the trial whose cholesterol levels remained high despite intensive use of statin drugs had the most benefit from treatment, and we have performed a separate analysis of a value-based price benchmark for this patient subset. We commend the Regeneron and Sanofi team for seeking an independent assessment of the new data and an updated cost-effectiveness evaluation to inform future negotiations with payers on a fair, value-based price. Insurers and health systems may need to consider how to manage short-term affordability constraints given the large number of patients eligible for treatment. Nonetheless, we believe that responsible pricing aligned with value will generate reciprocal action from payers to ensure appropriate access for patients today while sustaining broader affordability for patients and the health system in the long term.”