— Proposed updates reflect experience with current framework, benchmarking with other HTA groups, and external stakeholder input —

— Proposals are open to public comment until June 30 —

BOSTON, June 5, 2023 – The Institute for Clinical and Economic Review (ICER) proposed a set of changes to its methods and processes for conducting value assessments, beginning in 2024.  These proposals are based on ICER’s experience in methods development for health technology assessment (HTA) reports in the US, benchmarking with HTA agencies around the world, and input from stakeholders across the US health system. ICER is accepting public comment on these proposals through June 30, 2023.

Areas with proposed changes include:

  • Clinical trial diversity ratings and other methods adaptations related to health equity.
  • Cost-effectiveness scenarios related to potential effects of Medicare drug price negotiation.
  • New methods to ensure that cost-effectiveness analyses done according to a modified societal perspective have “non-zero” inputs for impacts on productivity for the patient and caregivers, even when direct data are lacking.

“Since our inception, ICER has strived to combine state-of-the-art academic methods with active engagement of all stakeholders in the US health system,” said Steven D. Pearson, MD, MSc, President of ICER. “We need to stay willing to change. We need to listen constantly to those engaged in our reviews and to explore ways to change our methods to keep evolving and improving. We look forward to formal public input on these draft proposals for the next iteration of our value assessment framework.”

Submit a Public Comment

All comments should be submitted via email to publiccomments@icer.org by Friday, June 30, 2023 at 5pm ET in the following format:

  • 5 pages maximum (excluding references and an appendix that may only contain data tables and figures from published evidence or grey literature, but not additional commentary)
  • Times New Roman, 12-point font size
  • Word document (no PDFs)

After reviewing all public comments, ICER will reflect further and make any final changes before releasing the updated Value Assessment Framework on or about September 25, 2023.

Register for our Public Webinar

On September 28, 2023, ICER will host a webinar to explain the rationale for the finalized framework updates. Register here to attend the virtual webinar.

The full timeline for updating our Value Assessment Framework is available here.

About ICER

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.