–Document will inform development of report for public deliberation by the New England CEPAC–
June 24, 2016- The Institute for Clinical and Economic Review (ICER) has posted a draft scoping document that will inform a report on drug therapies for treatment of plaque psoriasis. The document will be open to public comment for one week, until July 1, 2016 at 5:00PM EST.
The draft scoping document was developed with input from key stakeholders, including relevant patient organizations, clinical experts, and manufacturers of the drugs under study. It will form the foundation for development of a report evaluating the comparative clinical effectiveness and value of drug therapies for plaque psoriasis. The drugs to be reviewed in the report include:
- Adalimumab (Humira®, AbbVie)
- Etanercept (Enbrel®, Amgen, Inc.)
- Infliximab (Remicade®, Janssen)
Anti IL-17A agents:
- Secukinumab (Cosentyx®, Novartis)
- Ixekizumab (Taltz®, Eli Lilly and Co.)
- Brodalumab (Valeant Pharmaceuticals and AstraZeneca)
Anti IL-12/13 agent:
- Ustekinumab (Stelara®, Janssen)
- Apremilast (Otezla®, Celgene)
While a number of the drugs to be reviewed also have an indication for psoriatic arthritis, we have chosen to focus only on plaque psoriasis for this review. Plaque psoriasis and psoriatic arthritis are distinct conditions with distinctly different clinical and patient-reported outcomes. ICER may consider reviewing treatments for psoriatic arthritis separately in a future report.
Each ICER report includes a full analysis of how well the drugs work (comparative effectiveness), and the value the treatments represent to patients and the health care system (cost-effectiveness and the potential budget impact). The reports support the goal of getting excellent drugs to market quickly and at a price that is affordable to patients and the health system, without hindering the development of new and effective drugs.
A version of the report assessing treatments for psoriasis will serve as the basis for deliberation and discussion at a meeting of the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) on November 18, 2016.
The New England CEPAC is a core program of ICER. New England CEPAC is an independent, regional body of practicing physicians, methodological experts, and leaders in patient advocacy and engagement that provide objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions.
The scoping document will be open to public comment for a period of one week, during which time we invite all interested stakeholders, including patients, providers, payers, and manufacturers, to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. All comments must be received by Friday, July 1st at 5:00PM EST. Comments can be submitted by email to email@example.com. More information about submitting a public comment, including formatting specifications, is available in our Public Comment Guide.
Following the public comment period, a revised scoping document will be posted on or about July 8, 2016. The revised scope will guide development of a Draft Evidence Report, scheduled to be posted on or about September 29, 2016. Once posted, the Draft Evidence Report will be open to a two-week public comment period, during which time we again invite all interested stakeholders to provide comments, suggestions, and refinements to the report.
During the November 18, 2016 New England CEPAC public meeting, the independent Council will vote on key questions raised in the report, and a policy roundtable of experts in the field of psoriasis will discuss recommendations for how best to apply the evidence to policy and practice.
Additional key dates for the draft report, as well as further information about the November meeting, are included below and available on ICER’s website:
June 24th: Draft scoping document posted
June 24th-July 1st: Public Comment Period on Draft Scoping Document
July 8th: Final scoping document posted
September 29th: Initial Draft Evidence Report and Draft Voting Questions Posted
September 29th – October 13th: Public Comment Period on Draft Evidence Report and Draft Voting Questions
October 28th: Evidence Report Posted
November 18th: Public Meeting of the Midwest CEPAC
On or about November 29th: Final Report Posted
Date: November 18, 2016
Location: Boston, MA
Additional details will be posted to the ICER website as they become available.