–Public comment period open until April 2, 2018–
BOSTON, March 12, 2018– The Institute for Clinical and Economic Review (ICER) has posted two Draft Scoping Documents outlining planned reviews of 1) three antiandrogen therapies for certain types of high risk prostate cancer, and 2) two therapies for hereditary transthyretin-related (hATTR) amyloidosis. The scoping documents will be open to public comment for three weeks until April 2, 2018 at 5pm ET.
ICER’s report on treatments for high risk, non-metastatic, castration resistant prostate cancer is expected to include three antiandrogen therapies: enzalutamide (Xtandi®, Astellas and Pfizer), abiraterone acetate (Zytiga®, Janssen), and apalutamide (Erleada™, Janssen).
The review of therapies for hATTR amyloidosis is expected to include 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. Both therapies are currently under review by the FDA, with approval decisions expected in July and August of 2018, respectively.
Both reports will be subject to deliberation during a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees, in September of 2018.
The scoping documents were developed with input from key stakeholders, including clinical experts, patients, and patient advocacy groups, who provided important insights into living with these conditions and added context to the current treatment landscapes. ICER will continue to engage with patients, clinicians, drug manufacturers, and other stakeholders to assess appropriate outcomes and comparators for the review and to enrich the evidence available from clinical trials.
All interested stakeholders are encouraged to submit comments and suggested refinements to the scopes to ensure all perspectives are adequately considered.
Comments can be submitted by email to email@example.com and must be received by April 2nd at 5pm ET. All comments submitted must meet ICER’s formatting specifications.
ICER’s Patient Participation Guide and Manufacturer Engagement Guide provide additional guidance for submitting public comments, including suggestions for what types of information may be most useful.
In addition to comments on the scope, ICER also welcomes submissions from stakeholders on examples of low-value care practices within these clinical areas. These submissions will inform a report section focused on strategies to reduce waste and preserve resources for high-value, potentially higher cost treatments. More information is available in each of the scoping documents.
Following the public comment period, revised scoping documents will be posted in early April. ICER’s website provides additional information on the anticipated timelines for the reviews. Prostate Cancer | 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.