— Report will be subject of a Midwest CEPAC meeting in February 2021; Open Input now being accepted until June 30, 2020 —
BOSTON, June 12, 2020 – The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of inclisiran (Novartis) and bempedoic acid (Nexletol™, Esperion Therapeutics, Inc.) for treatment of high cholesterol in the setting of heterozygous familial hypercholesterolemia or secondary prevention of ASCVD. Inclisiran is currently undergoing FDA review, with an anticipated decision expected at the end of this year. Bempedoic acid received FDA approval in February 2020.
ICER’s Evidence Report on high cholesterol will be reviewed during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) in February 2021.
ICER’s website provides timelines of key posting dates and public comment periods for this assessment. An Open Input period begins today and is intended to allow stakeholders to share key information relevant to the development of the evidence report. Comments will be accepted from all interested stakeholders until June 30, 2020 at 5 p.m. ET. During this time, ICER will also contact key patient groups and clinical experts to gain further insights on the patient perspective and clinical context of treating high cholesterol.
For more information about the Open Input period, visit ICER’s website. ICER’s Manufacturer Engagement Guide, Patient Participation Guide, and Patient Guide to Open Input provide additional information for manufacturers and patient groups, including an explanation of what types of information may be most informative. Patients may submit their input via ICER’s patient input questionnaire and other stakeholders can submit input to email@example.com. Input must be received by 5 p.m. ET on June 30, 2020 to be considered. There are no page limits to Open Input submissions, and input received will be incorporated throughout report development.
A draft scoping document, which will provide more detail on ICER’s planned analysis, will be available on July 6, 2020. That document will be open to public comment for three weeks.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care.