– Report expected to include review of Ingrezza™, recently approved, and Austedo™, currently under FDA review; ICER’s Open Input period now open until May 12, 2017-
Boston, Mass., April 21, 2017 – The Institute for Clinical and Economic Review (ICER) will develop a report assessing the comparative clinical effectiveness and value of drugs to treat tardive dyskinesia, a condition characterized by involuntary movements that is associated, in many cases, with long-term use of antipsychotic medications. ICER’s report is expected to review evidence on valbenazine (Ingrezza™, Neurocrine Biosciences), the first drug approved for tardive dyskinesia, along with deutetrabenazine (Austedo™, Teva Pharmaceuticals), a drug currently approved for use in Huntington’s disease and under review by the Food and Drug Administration (FDA) for tardive dyskinesia. An approval decision for deutetrabenazine in this indication is expected by August 30, 2017. The report is also likely to include tetrabenazine (Xenazine®, Lundbeck), a drug approved for treatment of involuntary movements associated with Huntington’s disease, but also used in patients with tardive dyskinesia. This preliminary list of drugs is tentative and subject to change as the scope of the review develops.
An “Open Input” period begins today, and comments on the topic will be accepted from all interested stakeholders until May 12, 2017 at 5 PM ET. The Open Input period is intended to allow stakeholders to share key information relevant to the development of the 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 further explanation of the types of information that may be most helpful to development of the report, visit ICER’s website. ICER’s Manufacturer Engagement Guide and ICER’s Patient Participation Guide and Patient Guide to Open Input provide additional information for manufacturers and patient groups. 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 May 12, 2017 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 May 8, 2017 and will be open to public comment for three weeks.
The report will be the subject of a December 2017 meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). During the meeting, the independent panel will deliberate and vote on the comparative clinical effectiveness, benefits or disadvantages, and contextual considerations of the drugs. The panel will discuss the implications of the votes for policy and practice with a roundtable including clinical experts and patients to provide guidance to patients, clinicians, insurers, and policymakers in making informed, evidence-based decisions related to use of the drugs.
The key dates for ICER’s review of treatments for tardive dyskinesia are included below:
- Open Input Period: April 21, 2017- May 12, 2017
- Draft Scoping Document Posted: May 8, 2017
- Public Comment: May 8 – May 26, 2017
- Revised Scoping Document Posted: June 9, 2017
- Draft Evidence Report Posted: October 2, 2017
- Public Comment: October 2 – October 30, 2017
- Evidence Report Posted: November 21, 2017
- Public Meeting: December 5, 2017
- Final Report Posted: December 21, 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.