ICER Publishes Revised Protocol for Assessing Unsupported Price Increases for Prescription Drugs

— Through April 19, ICER is accepting Public Input on which additional price increases should be included in the 2019 assessment —

BOSTON, March 15, 2019 – The Institute for Clinical and Economic Review (ICER) today posted its revised protocol for conducting a new annual analysis to determine whether or not significant prescription drug price increases have been accompanied by new clinical evidence that could potentially support those increases. ICER’s first “Unsupported Price Increase” report is scheduled to be released on October 8, 2019.

With guidance from a multi-stakeholder advisory group — comprising representatives from patient advocacy groups, pharmaceutical companies, and payers representing both Medicaid and the private market — ICER developed a draft protocol for how it will conduct its UPI assessments. This draft was published on January 17, 2019. Based on stakeholder feedback offered during the public comment period, ICER has revised this protocol and will now begin the its initial UPI assessment.

ICER’s 2019 report will focus on at least 10 prescription drugs that experienced the most significant US price increases over the past 24 months, based primarily on which net price increases resulted in the largest overall budget impact for the US health system. ICER will review changes in the evidence base for each of these drugs and assess whether or not new clinical data exists that could suggest that the drugs could be significantly more beneficial for patients than what was previously understood.

ICER is now accepting Public Input, including recommendations for up to three additional drugs that may not qualify for the initial top 10 list but still meet some of the following criteria:

  • Drugs with extremely high price increases that do not have substantial budget impact at the national level;
  • Drugs used by millions of Americans with price increases that fell just below two times the medical care CPI;
  • Drugs whose price increases have important affordability implications for individual patients even if not for the health system; and/or
  • Drugs whose price increases raise concerns about the fairness of the price increases.

Comments can be submitted by email to publiccomments@icer-review.org and must be received by 5 p.m. ET on April 19, 2019.

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.