— Public Comments on Draft Protocol Will Be Accepted Through February 13, 2019 —

BOSTON, January 17, 2019 – The Institute for Clinical and Economic Review (ICER) today posted a draft protocol describing a new annual analysis an ICER “Unsupported Price Increase” (UPI) report that will analyze significant prescription drug increases and determine whether or not new clinical evidence exists that could be used to support those increases. Public comment is being sought to inform a final version of the analytic protocol. Once finalized, the protocol will guide the development of the first of these annual reports, currently scheduled for October 2019.

“Drug prices are often increased substantially over time in the US, and questions are frequently raised regarding whether these price increases are justified,” noted David Rind, MD, ICER’s Chief Medical Officer. “By identifying drugs with substantial price increases despite no new evidence of added benefit, we hope to make an important first step in providing policymakers with information they can use to advance the public debate on drug price increases.”

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 has developed a draft protocol for how it will conduct its UPI assessments. ICER proposes that its 2019 report will focus on up to 13 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.

A public comment period is now open for the draft protocol, and ICER will consider all feedback when finalizing its methodology for this initiative. Comments can be submitted by email to publiccomments@icer.org and must be received by 5 p.m. ET on February 13, 2019.

ICER anticipates publishing the final draft of its first UPI report in October. 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.