-Report will be subject of November New England CEPAC meeting; Open Input now being accepted until April 24, 2018 –
BOSTON, April 5, 2018 – The Institute for Clinical and Economic Review (ICER) today announced plans to develop a report assessing the comparative clinical effectiveness and value of several new options for medication-assisted treatment (MAT) of opioid use disorder. The report will be the subject of a public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) in November of 2018.
ICER’s upcoming review will assess the effectiveness and value of a recently-approved monthly buprenorphine injection (Sublocade™, Indivior), a buprenorphine implant (Probuphine®, Braeburn/Titan), and an investigational buprenorphine extended release injection (CAM2038, Braeburn) currently under review by the FDA, as compared to medications commonly used in MAT such as methadone, buprenorphine/naloxone sublingual film (Suboxone®, Indivior), and injectable naltrexone (Vivitrol®, Alkermes). This list is tentative and subject to change.
ICER previously reviewed treatment strategies for opioid use disorder in a 2014 report.
An Open Input period begins today and is intended to allow stakeholders to share key information relevant to the development of the evidence report. Comments will be accepted from all interested stakeholders until 5 PM ET on April 24, 2018. During this time ICER will also contact key patient groups and clinical experts to gain further insights on the patient perspective and clinical context of these therapies.
ICER’s Manufacturer Engagement Guide, Patient Participation Guide, and Patient Guide to Open Input provide additional information for manufacturers and patient groups, including an explanation of what types of information may be most informative.
There are no page limits to Open Input submissions, and input received will be incorporated throughout report development. All input can be emailed to publiccomments@icer.org and must be received by 5 PM ET on April 24, 2018 to be considered.
During the New England CEPAC meeting in November, the independent evidence appraisal committee will deliberate and vote on evidence presented in ICER’s report.
A draft scoping document will be available on approximately April 26th and will provide more detail on ICER’s planned analyses. The document will be open to public comment for three weeks.
ICER’s website provides a timeline of key posting dates and public comment periods for the review.
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.