Update: ICER’s report on abuse-deterrent opioids will now be the subject of a New England CEPAC meeting scheduled for July 20, 2017. The timeline has been revised accordingly. For the current timeline and meeting details, please see the meeting page.
August 17, 2016 – The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of abuse-deterrent opioids for pain management. The report will form the basis of a March 2017 meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC).
Deaths related to opioid use disorder continue to be a primary public health concern. In an effort to help curb the epidemic, drug manufacturers are developing abuse-deterrent opioids for patients in need of opioid pain medication. To date, the Food and Drug Administration has approved a number of abuse-deterrent opioids and is expected to make approval decisions on several new formulations this fall. ICER’s report will review several of these new and emerging medications with the goal of providing clarity on how effectively these drugs work to reduce misuse of opioids and its many consequences, including overdose and opioid-related death.
A three-week “Open Input” period begins today, and comments on the topic will be accepted from any and all interested stakeholders. The Open Input period is intended to allow stakeholders to share key information relevant to the development of ICER’s scope and evidence report. During this time, ICER will also contact key patient groups and clinical experts to gain further insights.
For more information about the Open Input period, including a further explanation of the types of information that may be most helpful to development of the report, visit ICER’s website. There are no page limits to Open Input submissions, and input received will be incorporated throughout report development. All input can be emailed to email@example.com and must be received by 5PM ET on Wednesday, September 7th in order to be considered.
A Draft Scoping Document, which will provide more detail on ICER’s proposed scope for the review, will be available on or about September 8, 2016.
During the March 2017 meeting of the New England CEPAC, the independent Council will deliberate and vote on the comparative clinical effectiveness and value of the treatments included in this review. The Council will discuss the implications of the votes for policy and practice with a roundtable of experts in the field to provide guidance to patients, clinicians, insurers, and policymakers confronted with decisions on use of abuse-deterrent opioids.
Key dates for the development of the report, including formal opportunities for stakeholder engagement, are as follows:
- Topic announcement: August 17, 2016
- Open Input Period: August 17, 2016-September 7, 2016
- Draft Scoping Document posted: September 8, 2016
- Public comment on Draft Scoping Document: September 8, 2016- September 28, 2016
- Final Scoping Document posted: October 6, 2016
- Draft Evidence Report and Draft Voting Questions Posted: January 25, 2017
- Public Comment on Draft Evidence Report and Draft Voting Questions: January 25, 2017-February 22, 2017
- Evidence Report and Revised Voting Questions Posted: March 9, 2017
- Public Meeting of the New England CEPAC: March 23, 2017
- Final Report Posted: March 30, 2017
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.