–Documents open to public comment until December 22, 2017–
BOSTON, December 4, 2017– The Institute for Clinical and Economic Review (ICER) has posted two Draft Scoping Documents for public comment. One document outlines ICER’s review of the comparative clinical effectiveness and value of three calcitonin gene-related peptide (CGRP) inhibitors for prevention of migraine. The second outlines ICER’s update to a 2016 report on treatments for plaque psoriasis. The scoping documents will be open to public comment for three weeks until December 22, 2017 at 5pm ET.
ICER’s review of CGRP inhibitors for migraine will include erenumab (Amgen/Novartis), fremanezumab (Teva), and galcanezumab (Eli Lilly). Each of the three therapies is currently under FDA review, with approval decisions expected throughout mid-late 2018.
The plaque psoriasis report update will incorporate data that has emerged since ICER’s initial review. It will also include recently-approved guselkumab (Tremfya™, Johnson & Johnson), as well as tildrakizumab (Sun Pharma/Merck) and certolizumab pegol (Cimzia®, UCB), for which approval decisions are expected in March and May of 2018, respectively. Certolizumab pegol is currently approved for use in rheumatoid arthritis.
Both topics will be discussed at a future public meeting of one of ICER’s three independent evidence appraisal committees.
These scoping documents were developed with input from key stakeholders, including clinical experts, patients, and patient advocacy groups, who provided important insights into living with migraine and added context to the ways in which the plaque psoriasis treatment landscape has evolved since ICER’s initial report in 2016. ICER will continue to engage with patients, clinicians, drug manufacturers, and other stakeholders to assess appropriate outcomes and comparators for the reviews 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 firstname.lastname@example.org and must be received by December 22nd 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 new 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 on or about January 9, 2018.
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.