The Multiple Sclerosis (MS) Trust is expressing its disappointment at the recent committee decision of the National Institute for Health and Care Excellence (NICE) to not recommend Zinbryta (daclizumab) be made available as a therapy to MS patients using the public health system in England and Wales.
NICE’s preliminary recommendation was based on a review of available data on the clinical and cost effectiveness of Zinbryta, including evidence on the nature of relapsing-remitting MS (RRMS) and the drug’s benefits for people with the condition. It also took into account the effective use of resources in the National Health System (NHS).
In its report, the appraisal committee stated that “Daclizumab is not recommended within its marketing authorization for treating relapsing forms of multiple sclerosis in adults.”
More specifically, it expressed concerns regarding the analysis submitted by Biogen, Zinbryta’s manufacturer, on the cost effectiveness of the treatment compared with other disease-modifying therapies.
The MS Trust, an organization that helps MS patients and supports MS specialist services in the U.K., is now reviewing the NICE document, and will respond. Anyone who wants to comment on the NICE recommendations can do so until Oct. 21, using the appraisal consultation page on the agency’s website.
“We remain hopeful that NICE will reconsider its draft guidance, but it is very frustrating that, yet again, access to an effective new treatment will be further delayed by the NICE appraisal process,” Amy Bowen, director of Service Development at the MS Trust, said in a news release.
The NICE committee will meet again on Nov. 2 to consider further evidence from Biogen, as well as comments received from patients, healthcare professionals, and others. The committee will then prepare a final appraisal determination (FAD). Subject to any appeals, the FAD may be used to guide a NICE decision regarding Zinbryta’s availability through the NHS in England and Wales. NICE expects to publish its final guidance in 2017.
“It’s disappointing to see daclizumab not recommended at this stage but we will be urging NICE to overturn its decision – we’ve seen this happen before with other MS treatments,” the MS Society in the U.K. announced in a separate release.
Zinbryta is a humanized monoclonal antibody taken as a 150 mg subcutaneous injection once monthly, and being developed by Biogen and AbbVie. It binds to the receptor subunit CD25 of interleukin-2 (IL-2), which is highly expressed in immune T-cells. These immune cells are overly active in MS, and Zinbryta is thought to deplete the activated T-cells and increase other cells that regulate the immune response (namely NK cells).
Zinbryta was approved by the European Medicines Agency (EMA), the regulatory agency for the E.U., as a treatment for adults with relapsing MS in July, and approved by the U.S. Food and Drug Administration (FDA) for these patients in May.
Data from clinical trials, including the DECIDE (NCT01064401) and SELECT (NCT01051349) studies, have shown that Zinbryta can reduce relapse rates by approximately 50% in RRMS patients compared to placebo, and by 45% compared to beta interferon treatment.