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Thursday, December 1, 2016
ICER Releases Draft Report on Disease-modifying Therapies for MS, Welcomes Comment
The Institute for Clinical and Economic Review (ICER) has released a Draft Evidence Report evaluating the comparative clinical effectiveness and value of disease-modifying therapies (DMTs) for patients with relapsing-remitting and primary-progressive forms of multiple sclerosis (MS).
Through Dec. 21, patients, the public, and other stakeholders can access the 82-page report and submit comments, ICER announced in a press release.
Sixteen DMTs are the focus of the ICER review. All of them, the institute notes, “have an FDA indication for RRMS [relapsing-remitting MS] with the exception of ocrelizumab, which the FDA is expected to approve in December 2016 for both RRMS and PPMS [ primary-progressive MS], and rituximab, which is approved for other conditions and is used off-label for RRMS and PPMS.”
DMTs aim to decrease the frequency of MS relapses and to prevent the disability that accumulates with disease progression by modulating the immune system.
In June, the FDA granted Priority Review designation to Ocrevus (ocrelizumab) for use in PPMS. Other agents have been studied for PPMS, with Rituxan (rituximab) being of particular interest to practitioners, patients, and insurers because its mechanism of action is similar to that of Ocrevus.
There is no definitive clinical guideline to help clinicians and patients with decisions about both initial therapy and choices for subsequent therapies following treatment failure, so the ICER Report may offer important treatment recommendations.
In its conclusion graph, the report states: “DMTs of interest in this evaluation uniformly and substantially improved health outcomes compared to best supportive care, but demonstrated mixed results compared to generic glatiramer acetate. … The notable exception to this finding was alemtuzumab [Lemtrada], which consistently demonstrated improved health outcomes and good value compared to both supportive care and generic glatiramer acetate 20 mg.”
ICER is a non-profit organization that evaluates evidence on the value of medical tests, treatments, and delivery systems in order to improve the U.S. healthcare system. In developing its report, ICER researchers consulted with clinical experts, patients, manufacturers and other stakeholders. In addition, ICER accepted public comments on a Draft Scoping Document prior to conducting the review.
The Draft Evidence Report, and its accompanying voting questions, are open for comments through 5 p.m. ET on Dec. 21. Comments should be submitted by email to firstname.lastname@example.org. More information can be found on the ICER website. All comments will be reviewed and posted, and any necessary changes will be then included in the evidence report.
The revised voting questions will be available from Jan. 27.
The Report will then be subjected to a public meeting of the California Technology Assessment Forum (CTAF), at which a panel will vote on key questions raised, and discussions will be held to make decisions concerning recommendations to be added to the report. That public meeting will take place in Oakland, California, on Feb. 16, 2017.
Daniela holds a PhD in Clinical Psychology from The University of Edinburgh, United Kingdom, a MSc in Health Psychology and a BSc in Clinical Psychology. Her work has been focused on vulnerability to psychopathology and early identification and intervention in psychosis.
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