— Both reports will be subject of September Midwest CEPAC meeting; Open Input now being accepted until March 7, 2018 —
BOSTON, February 16, 2018 – The Institute for Clinical and Economic Review (ICER) will assess the comparative clinical effectiveness and value of therapies for high-risk prostate cancer and hereditary amyloidosis 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 September of 2018.
The review of prostate cancer treatments is expected to assess the clinical effectiveness and value of three anti-androgen drugs: enzalutamide (Xtandi®, Astellas and Medivation), approved by the FDA in 2012, abiraterone acetate (Zytiga®, Janssen), approved in 2011, and apalutamide (Erleada™, Janssen), just approved earlier this week.
The second report is expected to review two new therapies for the treatment of hereditary transthyretin-related (hATTR) amyloidosis, a rare genetic condition characterized by nerve, heart, and eye damage that is currently treated through supportive measures alone. FDA approval decisions for inotersen (Ionis Pharmaceuticals, Inc.), an antisense oligonucleotide that interferes with transthyretin production in the liver, and patisiran (Alnylam Pharmaceuticals), which inhibits transthyretin through an RNA interference pathway; approvals are expected in July and August of 2018, respectively.
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 March 7, 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 firstname.lastname@example.org and must be received by 5 PM ET on March 7, 2018 to be considered.
During the Midwest CEPAC meeting in September, 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 in March of 2018 and 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 prostate cancer and amyloidosis.
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.