High Cholesterol

Midwest CEPAC

ICER plans to assess the comparative clinical effectiveness and value of inclisiran (Novartis) and bempedoic acid (NexletolTM, 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.

Date of Review: February 2021

Interventions of interest:

  • inclisiran (Novartis)
  • bempedoic acid (NexletolTM, Esperion Therapeutics, Inc.)
  • bempedoic acid/ezetimibe (Nexlizet™, Esperion Therapeutics, Inc.)

For questions or additional information, please contact Maggie O’Grady at mogrady@icer-review.org.

ASSOCIATED MEETING & MATERIALS

Midwest CEPAC
February 5, 2021 9:30 am - 4pm CT

TBD

Key Dates

Associated Materials

06/12/2020 – 06/30/2020

07/06/2020

07/06/2020

07/06/2020 – 07/24/2020

08/03/2020

08/17/2020

09/24/2020
Model Analysis Plan

11/12/2020
Draft Evidence Report

11/12/2020
Draft Voting Questions

11/12/2020 – 12/11/2020
Public Comments

01/22/2021
Revised Voting Questions

01/22/2021
Evidence Report

01/22/2021
Response to Public Comments

02/05/2021
Meeting Agenda

02/05/2021
Evidence Presentation

02/26/2021
Final Evidence Report and Meeting Summary

02/26/2021
Report-at-a-Glance

02/26/2021
Final Policy Recommendations


ASSOCIATED MEETING & MATERIALS

New England CEPAC
October 27, 2015 10am-4pm

Joseph B. Martin Conference Center at Harvard Medical School

77 Avenue Louis Pasteur

Boston, MA 02115

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.

Download ICER's New Evidence Update on Evolocumab here.

Key Dates

Associated Materials

07/07/2015

09/08/2015

09/08/2015

09/08/2015 – 09/22/2015

Public comments received on the Draft Evidence Report.


10/06/2015

10/06/2015

10/06/2015

ICER’s response to public comments received on the draft evidence report.


10/21/2015

Research protocol posted to Open Science Framework: https://osf.io/7awvd/


10/27/2015

10/27/2015

11/25/2015

11/25/2015
Action Guide For Clinicians, Payers, and Policymakers

11/25/2015
Action Guide For Patients

11/25/2015

08/16/2016

09/11/2017

03/10/2018

02/15/2019