The United Kingdom’s National Institute for Health and Care Excellence (NICE) has cleared its initial doubts and now recommends Zinbryta (daclizumab) to treat relapsing multiple sclerosis (MS) in England and Wales.
NICE had initially rejected Zinbryta after a first stage of the drug’s review process, due to some issues linked to the clinical and cost-effectiveness models presented by Zinbryta’s U.S. developer, Biogen. Those issues, the agency said, had raised a high degree of uncertainty.
At the time, the London-based MS Society campaigned for the drug’s approval and welcomed opinions from MS patients involved in the Phase 3 (NCT01064401) and Phase 2b (NCT01051349) trials that established Zinbryta’s effectiveness and safety, as well as the opinions of all those wishing to support the submission.
Those efforts paid off, and now a new treatment for relapsing MS will be available for people who are unable or unwilling to take Lemtrada (alemtuzumab) in England and Wales. In coming months, NICE will make a decision for Scotland and Northern Ireland as well.
The recommendation is still subject to appeal, but barring any delays it should be available on the National Health Service (NHS) within three months — meaning that Zinbryta will be available to anyone in the public healthcare system.
Zinbryta, a once-a-month injection, is an antibody that is already used following kidney transplants to help prevent rejection. The drug binds to a molecule called CD25 on the surface of activated immune cells, including those that damage the myelin sheaths in MS.
NICE recommends Zinbryta for patients who have active relapsing MS and who have been treated with other disease-modifying treatments— as well as for those with rapidly evolving severe MS, which is defined by at least two relapses in the previous year with magnetic resonance imaging scans showing new lesions.
“This is great news for people with relapsing MS,” Michelle Mitchell, chief executive of the MS Society, said in a press release. “This is an effective medicine and the first that people can take by self-injecting once a month. It also offers more choice to people who are currently unwilling or unable to take other MS drugs. We look forward to seeing it become widely available on the NHS in England and Wales.”
This is the first time the NHS has made a disease-modifying therapy available since 2014, meaning there are now 12 available drugs for people with relapsing MS.