Multiple Sclerosis: Drug Evaluators Seek Comments

DECEMBER 16, 2016
Rachel Lutz
Got an opinion on which multiple sclerosis drugs work best?

The Institute for Clinical and Economic Review (ICER) is looking for comment on its report on the comparative clinical effectiveness and value of disease modifying therapies for relapsing remitting and primary progressive multiple sclerosis.

ICER, a non-profit research institute that reviews the efficacy of drugs, is also welcoming draft voting questions until December 21 at 5 pm Eastern time.
 
In statement, ICER explained that they are “committed to engaging with all stakeholders in a thorough and transparent manner,” and said that before releasing the Draft Evidence Report, ICER spoke with key stakeholders such as patient groups, clinical experts, and drug manufacturers to include and engage them in the process. 

Of 16 disease modifying therapies under review, only one does currently not have U.S. Food and Drug Administration approval, though it is expected to be granted by the end of the year (ocrelizumab), and one other drug is approved for other conditions and is used off label for multiple sclerosis (rituximab). The subcutaneous injection drugs included in the ICER review are: interferon B-1a (Avenoex/Biogen), interferon B-1b (Betaseron/Bayer), interferon B-1b (Extavia/Novartis), glatirameracetate 20 mg (Copaxone/Teva), glatirameracetate 40 mg (Copaxone/Teva), glatirameracetate 20 mg (Glatopa/Sandoz), interferon B-1a (Rebif/ EMD Serono), peginterferon B-1a (Plegridy/ Biogen) and daclizumab (Zinbryta/ Biogen and AbbVie). The review also includes three oral drugs (fingolimod [Gilenya, Novartis], teriflunomide [Aubagio, Sanofi Genzyme], and dimethyl fumarate [Tacfidera, Biogen]) in addition to four intravenous infusions: natalizumab (Tysabri/ Biogen), alemtuzumab (Lemtrada/ Sanofi Genzyme), ocrelizumab (Ocrevus,/Genentech), and rituximab (Rituxan/ Genentech). 
 
In the report, ICER explained that through discussions with advocacy organizations, they learned that while some patients have strong preferences for oral medications over injectables – this could be potentially due to their dislike of needles, injection site reactions, and the difficulty of storing medications that require refrigeration.

However, ICER added, some patients are equally comfortable with medications. The advocacy groups also highlighted that patients sometimes have a low tolerance for risk and tend not to choose DMTs with known, potentially severe side effects. 
 
The Evidence Report will be presented at a public meeting of the California Technology Assessment Forum (CTAF) on February 16, 2017 in Oakland, California.

The CTAF will vote on questions raised in the report at the meeting and a panel of experts will host a roundtable discussion surrounding recommendations to apply the evidence to new policy and practice guidelines. At this meeting, there will be an allotment of time for stakeholders to make oral comments on the report – requests for oral comment are also being accepted until December 21 at 5 pm. 

Their report draft, titled, “Disease Modifying Therapies for Relapsing Remitting and Primary Progressive Multiple Sclerosis: Effectiveness and Value,” is available for review online.
 


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