– Public comment period open now until January 24th; Requests to make oral comment during public meeting also being accepted –
BOSTON, December 19, 2017– The Institute for Clinical and Economic Review(ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of tisagenlecleucel (KymriahTM, Novartis) and axicabtagene ciloleucel (YescartaTM, Kite Pharma/Gilead). The draft report, along with draft voting questions, will be open to public comment for four weeks. Findings contained in this report are preliminary and subject to change based on public comment and further analysis of the evidence.
Both drugs are chimeric antigen receptor T-cell (CAR-T) therapies and were approved earlier this year as potentially curative treatments for certain cancers. Tisagenlecleucel was approved for patients under age 25 with B-cell precursor acute lymphoblastic leukemia, and is also part of an ongoing study of adults with diffuse large B-cell lymphoma. Axicabtagene ciloleucel is indicated for adults with relapsed or refractory large B-cell non-Hodgkin’s lymphoma.
ICER is committed to engaging with all stakeholders in a thorough and transparent manner. Prior to conducting this review, ICER spoke with key patient groups and clinical experts, and accepted public comments on a Draft Scoping Document. The current draft report incorporates input received from patients, clinicians, and other stakeholders during each of these opportunities for engagement.
Submit a Public Comment: The Draft Evidence Report and Draft Voting Questions are now open to public comment until January 24, 2018 at 5 PM ET. All stakeholders are invited to submit formal comments by email to email@example.com.
Guidelines for submitting public comments, including formatting specifications, are available on ICER’s website. ICER’s Manufacturer Engagement Guide and Patient Participation Guide provides additional detail on what types of information may be most informative to the report. ICER will review all comments and incorporate any necessary changes in the Evidence Report and Revised Voting Questions that will be posted on or about February 15, 2018. All public comments and ICER’s response to comments will be posted publicly along with the Evidence Report.
Register for the Public Meeting: The Evidence Report will be the subject of a public meeting of the California Technology Assessment Forum (CTAF) on March 2, 2018 in Oakland, CA. During the meeting, the independent council will vote on key questions raised in the report, and an expert policy roundtable will discuss recommendations to apply the evidence to policy and practice.
Register to Make an Oral Comment: During the public meeting, there will be a limited amount of time available for interested stakeholders to make an oral comment on the report. Requests to submit oral comments must be emailed to firstname.lastname@example.org by 5 PM ET on January 24th. Please note that individuals who wish to deliver oral comments must separately register to attend the meeting. For more information about registering for oral comment, please visit our website.
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.