Boston, Mass., October 2, 2017– The Institute for Clinical and Economic Review(ICER) has released a Draft Evidence Report assessing the comparative clinical effectiveness and value of therapies to treat tardive dyskinesia, a movement disorder often associated with long-term use of antipsychotic medications. The report, along with draft voting questions, will be open to public comment for four weeks.
ICER’s report reviews evidence on three drug treatments. Valbenazine (Ingrezza™, Neurocrine Biosciences) and deutetrabenazine (Austedo®, Teva Pharmaceuticals) were both approved by the Food and Drug Administration earlier this year with an indication for tardive dyskinesia. Tetrabenazine (Xenazine®, Lundbeck and multiple generics) is approved for use in Huntington’s disease and is often used to treat tardive dyskinesia, though it is not formally approved for that indication.
ICER is committed to engaging with all stakeholders in a thorough and transparent manner. Before completing this Draft Evidence Report, ICER reached out to key stakeholders, including patient groups and clinical experts, to engage them in the process. ICER also accepted public comments on a Draft Scoping Document prior to conducting the review. The current draft report incorporates input received from patients, clinicians, and other stakeholders during each of these opportunities for engagement.
The Draft Evidence Report and Draft Voting Questions are now open to public comment until October 30, 2017 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 provide additional guidance. ICER will review all comments received and incorporate any necessary changes in the Evidence Report and Revised Voting Questions that will be posted on or about November 21, 2017. All comments and ICER’s response to comments will be posted publicly along with the Evidence Report.
The Evidence Report will be the subject of a public meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) on December 5, 2017 in Newton, MA. During the meeting, the independent panel 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.
During the public meeting, there will be a limited amount of time available for interested stakeholders to make an oral comment on the report. Beginning today, requests to provide oral comments are being accepted. All requests must be emailed to firstname.lastname@example.org by 5 PM ET on October 30th.
Please note that individuals who wish to deliver oral comments must separately register to attend the meeting using the link below. 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.