Draft Scoping Document for ICER Review of Drugs for Relapsing-Remitting Multiple Sclerosis

–Document will inform development of report for public deliberation by CTAF–

July 1, 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 relapsing-remitting multiple sclerosis (RRMS). Multiple sclerosis is a chronic, immune-mediated inflammatory demyelinating disease of the central nervous system that affects approximately 400,000 Americans.

The draft scoping document was developed with input from key stakeholders, including relevant patient organizations, clinical experts, and manufacturers of the drugs under study. The document will be open to public comment for two weeks, until Friday, July 15th at 5PM PT. The scoping document will inform the development of a report evaluating the comparative clinical effectiveness and value of drug therapies for RRMS. The drugs to be reviewed in the report include:

  • Platform agents: interferon beta-1a, peginterferon beta-1a, interferon beta-1b, glatiramer acetate
    • Stakeholders indicated greatest interest in a comparison of Avonex® (Biogen) and Rebif® (EMD Serono), two competing formulations of interferon beta-1a. As a result, ICER will perform a detailed comparison of the two agents and will summarize the existing literature on other platform agents.
  • Oral agents:
    • Dimethyl fumarate (Tecfidera®, Biogen)
    • Fingolimod (Gilenya®, Novartis),
    • Teriflunomide (Aubagio®, Sanofi-Genzyme)
  • Other injectable or infused MS agents:
    • Alemtuzumab (Lemtrada®, Sanofi-Genzyme)
    • Daclizumab (ZinbrytaTM, Biogen/AbbVie)
    • Natalizumab (Tysabri®, Biogen)
    • Ocrelizumab (OcrevusTM, Roche/Genentech)
    • Rituximab (Rituxan®, Roche/Genentech)

In initial discussions held to inform the draft scoping document, patient organizations and clinical experts provided feedback on the outcomes of greatest importance to patients, and identified important considerations such as many MS patients’ preference for oral agents over injectable or infused drugs. ICER will continue to engage with patient groups and clinicians to enrich the available data from clinical trials.

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 RRMS will serve as the basis for deliberation and discussion at a public meeting of the California Technology Assessment Forum (CTAF), a core program of ICER, in February 2017.

CTAF 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.

Previously, ICER’s scoping documents were open to comment for one week. Now there will be a two-week period for providing public comment.

All interested stakeholders, including patients, providers, payers, and manufacturers, are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. All comments must be received by Friday, July 15th at 5:00PM PT. Comments can be submitted by email to publiccomments@icer-review.org. 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 22, 2016. The revised scope will guide development of a Draft Evidence Report, scheduled to be posted on or about November 22, 2016. Once posted, the Draft Evidence Report will be open to a three-week public comment period, during which time we again invite all interested stakeholders to provide comments, suggestions, and refinements to the report.

During the February 2017 CTAF public meeting, the Panel will vote on key questions raised in the report, and a policy roundtable of patient, clinical, payer, and policy experts in the field of MS 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 February meeting, are included below and available on ICER’s website:

July 1st-July 15th: Public Comment Period on Draft Scoping Document

July 22nd: Final scoping document posted

November 22nd: Initial Draft Evidence Report and Draft Voting Questions Posted

November 22nd– December 14th: Public Comment Period on Draft Evidence Report and Draft Voting Questions

January 19th: Evidence Report Posted

February 2017: Public Meeting of the Midwest CEPAC

Late February 2017: Final Report and Meeting Summary Posted

 

Meeting Details:

Date: February 2017

Location: TBD, Bay Area, California

Additional details will be posted to the ICER website as they become available.