— Final assessment to be published on November 16; through May 10, ICER is accepting Public Input on drugs of concern that should be considered in addition to those identified through the Protocol’s selection criteria —

BOSTON, April 12, 2021 – The Institute for Clinical and Economic Review (ICER) today posted a Protocol outlining how we will conduct our next analysis of “Unsupported Price Increases” (UPI) among prescription drugs within the US market. This initiative will examine the most significant drug-price increases that occurred in 2020 and determine whether new clinical evidence exists that could be used to support those increases.

Previously, ICER has published UPI reports for increases that occurred during the two-year period of 2017-2018, and for 2019.

Based on input from a multi-stakeholder advisory group — spanning patient advocates, life sciences companies, public and private payers, and health economists — this updated Protocol further hones how price increases shall be identified, how manufacturers can engage with ICER throughout the process, and how the clinical evidence will be assessed.

Public Input

To supplement the drug-price increases identified through the Protocol’s selection criteria, ICER is seeking up to three Public Input suggestions for additional price increases of concern that may also warrant an evidence review. Such suggestions may include:

  • Drugs with extremely high price increases that do not have substantial budget impact at the national level;
  • Drugs used by large numbers of Americans with list-price increases that did not quite exceed 2% above medical CPI;
  • Drugs whose price increases have important affordability implications for individual patients even if not for the health care system;
  • Drugs whose price increases raise concerns about the fairness of the price increases;
  • Drugs with net-price increases that are found to be unreliable in available data sources but whose list-price increases suggest review could be appropriate; or
  • Drugs with large increases in budget impact due to increases in net price even in the absence of increases in list price.

Those additional suggestions of concerning price increases can be emailed to publiccomments@icer.org by 5 p.m. ET on May 10, 2021.

The complete timeline for this initiative 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.

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. For more information about ICER, please visit ICER’s website.