-Report expected to review evidence on deutetrabenazine (AustedoTM), tetrabenazine (Xenazine®), and valbenazine (IngrezzaTM); Scoping Document will be open for public comment until May 26th at 5pm ET-
Boston, Mass., May 8, 2017– The Institute for Clinical and Economic Review (ICER) has posted a Draft Scoping Document for an upcoming report assessing the comparative clinical effectiveness and value of drugs for treatment of tardive dyskinesia, a condition characterized by involuntary body movements often associated with long-term use of certain antipsychotic medications. ICER’s report is expected to review evidence on three drug treatments. Valbenazine (IngrezzaTM, Neurocrine Biosciences), was recently approved by the FDA as the first drug with a specific indication for tardive dyskinesia; deutetrabenazine (AustedoTM, Teva Pharmaceuticals) is approved for use in Huntington’s disease and is currently under review for a tardive dyskinesia indication, while tetrabenazine (Xenazine®, Lundbeck) is approved for use in Huntington’s disease and is often used in tardive dyskinesia, though it is not formally indicated for such use. The Draft Scoping Document will be open to public comment for three weeks until May 26, 2017 at 5pm ET.
The document was developed with input from key stakeholders, including relevant patient organizations and clinical experts, who provided important insights into the context of treatment decisions and the day-to-day experience of individuals with tardive dyskinesia. For example, patients described the dual stigma faced in social settings and in the workplace associated with managing serious mental illness and tardive dyskinesia, and highlighted the physical and emotional impact on overall quality of life. ICER will continue to engage with patient groups, clinicians, drug manufacturers, and other stakeholders to identify appropriate outcomes and comparators and to enrich the evidence available from clinical trials with contextual information.
All interested stakeholders, including patients, providers, manufacturers, and payers, are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. All comments must be received by May 26, 2017 at 5pm ET. Comments can be submitted by email to email@example.com. More information about submitting a public comment, including formatting specifications, is available on ICER’s website. Specific guidance for patient groups is available in ICER’s Patient Participation Guide, and for manufacturers in ICER’s Manufacturer Engagement Guide. Following the public comment period, a revised scoping document will be posted on or about June 9, 2017.
The New England Comparative Effectiveness Public Advisory Council (New England CEPAC) will evaluate the report assessing treatments for tardive dyskinesia at a public meeting on December 5, 2017. The New England CEPAC is an independent, regional body of practicing physicians, methodological experts, and leaders in patient advocacy and engagement that provides objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions.
During the December 2017 public meeting, the Council will vote on key questions raised in the report, and a policy roundtable of patient, clinical, payer, and policy experts will discuss recommendations for how best to apply the evidence to policy and practice.