The Institute for Clinical and Economic Review (ICER) is seeking public comment on its review of 3 calcitonin gene-related peptide (CGRP) inhibitors for prevention of migraine, as well as an update to its 2016 report on treatments for plaque psoriasis.
The draft scoping documents will be open to public comment until December 22, at 5 pm ET. For more information about submitting comments, visit ICER’s website
ICER will review the comparative clinical effectiveness and value of 3 CGRP inhibitors currently under FDA review. Approval decisions are expected throughout mid- to late-2018 regarding:
- Erenumab (Amgen/Novartis)
- Fremanezumab (Teva)
- Galcanezumab (Eli Lilly)
The second document outlined ICER's update to a 2016 report on treatments for plaque psoriasis.
The plaque psoriasis report update will incorporate data that has emerged since ICER's initial review. It will also include the 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 3 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.
All interested stakeholders are encouraged to submit comments and suggested refinements to the scopes to ensure all perspectives are adequately considered, and must be received by December 22 at 5 pm ET.
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, the revised scoping documents will be posted on or about January 9, 2018.
Last month, ICER announced
the receipt of a 3-year grant, totaling $13.9 million, from the Laura and John Arnold Foundation (LJAF). ICER, a Boston-based, nonprofit drug-pricing watchdog, plans to use the funding in support of its ongoing efforts to change the ways in which new prescription drugs are evaluated and priced.
ICER performs analyses on the effectiveness and costs of medical tests, treatments, and delivery systems; develops reports assessing the value of key new drugs; and creates initiatives that use evidence to drive changes to both practice and policy.