MS Trust to Oppose NICE Plan to Reject Zinbryta as MS Therapy in Health System for England, Wales

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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MS treatments in UK

The Multiple Sclerosis (MS) Trust isĀ expressing its disappointment at the recent committee decision ofĀ theĀ National Institute for Health and Care ExcellenceĀ (NICE)Ā to not recommendĀ Zinbryta (daclizumab) be made available as a therapy to MSĀ patients using the public health system in England and Wales.

NICE’sĀ preliminary recommendationĀ 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)Ā and the drug’s benefits forĀ 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, onĀ 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,Ā and will respond.Ā Anyone who wants to comment on the NICE recommendations can do so until Oct. 21, using theĀ appraisal consultationĀ page on the agency’s website.

ā€œWe remain hopeful that NICE will reconsider its draft guidance, but it is very frustrating that, yet again, access to an effective new treatment will be further delayed by the NICE appraisal process,ā€ Amy Bowen,Ā director of Service Development at the MS Trust,Ā said in aĀ news release.

The NICE committee will meet again on Nov. 2 to consider further evidence from Biogen, as well asĀ 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 ā€“ weā€™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 antibodyĀ taken as a 150 mg subcutaneous injection once monthly, and being developed byĀ BiogenĀ andĀ AbbVie. It binds to the receptor subunit CD25 of interleukin-2 (IL-2), which is highly expressed in immune T-cells. TheseĀ immune cells are overly activeĀ in MS, and Zinbryta is thought toĀ deplete the activated T-cells andĀ 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 theseĀ patients in May.

Data from clinical trials, including the DECIDE (NCT01064401) and SELECT (NCT01051349) studies, have shown that ZinbrytaĀ can reduce relapse rates by approximately 50% in RRMS patients compared to placebo, and by 45% compared to beta interferon treatment.