– Both reports will be subject of Midwest CEPAC meeting in May 2019 –
– Open Input now being accepted until October 30, 2018 –
BOSTON, October 10, 2018 – The Institute for Clinical and Economic Review (ICER) will assess the comparative clinical effectiveness and value of new therapies for secondary progressive multiple sclerosis (SPMS) and treatment-resistant depression in upcoming reports. Both reports are set to be reviewed during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) in May of 2019.
The SPMS review is expected to assess the clinical effectiveness and value of siponimod (Novartis), which is currently undergoing FDA review with an approval decision expected in March 2019.
The treatment-resistant depression review is expected to assess the clinical effectiveness and value of esketamine (Janssen), which is currently undergoing FDA review with an approval decision expected in May 2019.
An Open Input period begins today and is intended to allow stakeholders to share key information relevant to the development of the evidence reports. Comments will be accepted from all interested stakeholders on either topic until October 30, 2018 at 5pm ET. 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 treatment for these conditions.
For more information about the Open Input period, visit ICER’s website. 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 email@example.com and must be received by 5 PM ET on October 30, 2018 to be considered.
During the Midwest CEPAC meeting in May 2019, the independent evidence appraisal committee will deliberate and vote on evidence presented in ICER’s reports.
Draft scoping documents for each review will be available on October 31, 2018*, and those will provide more detail on ICER’s planned analyses. The documents will be open to public comment for three weeks.
ICER’s website provides timelines of key posting dates and public comment periods for the reviews of treatments for SPMS and treatment-resistant depression.
*NOTE: The announcement was updated on October 29th to clarify that the draft scoping documents for each will review will be available on October 31, 2018.
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.