The National Institute for Health and Care Excellence (NICE), the health authority for England and Wales, has decided not to recommend Zinbryta (daclizumab) be made available to multiple sclerosis (MS) patients through the country’s health service. The decision came in a first stage of the drug’s review process, and NICE is welcoming feedback from patient groups, healthcare professionals, and others.
In making this initial decision, NICE reported that issues linked to the clinical and cost-effectiveness models presented by Zinbryta’s developer, Biogen, presented a high degree of uncertainty. Biogen has been asked to submit further evidence.
“The committee concluded that daclizumab was not cost effective for patients without more active disease … [and] that it had not been presented with robust evidence that daclizumab was cost effective for people with more active disease … Because the committee considered the analyses to be highly uncertain or not relevant to the NHS [National Health System], it invited the company to submit revised analyses,” NICE concluded in its report.
Zinbryta was approved by the European Medicines Agency (EMA), the regulatory agency for the E.U., as a treatment for adults with relapsing MS (RMS) in July, Biogen and AbbVie announced at the time. Zinbryta is an antibody that has been used for a number of years as a post-operative treatment for patients receiving kidney transplants to help prevent rejection of the donated organ. The drug binds to a molecule called CD25 on the surface of activated immune cells and reduces their number, including immune cells responsible for the damage to the myelin sheaths in MS. For MS patients, the medication is a self-administered, once monthly subcutaneous injection.
Those wishing to comment can do so through the appraisal consultation page on NICE’s website.
The efficacy and safety of Zinbryta was established in a series of clinical trials, including the Phase 3 DECIDE (NCT01064401) study and the Phase 2b SELECT (NCT01051349), the MS Society of the U.K. noted in a press release, adding that it intended to oppose NICE’s “negative decision.”
“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,” Emma Gray, U.K. MS Society’s interim assistant director of research, said in the release. “There are more than 100,000 people living with MS in the UK. It’s an unpredictable and challenging condition to live with, but access to the right treatment and care can make a huge difference. As part of our Treat Me Right Campaign we’re calling for approved medicines, including daclizumab, to be made available on the NHS so that people have a wide range of choices.”
The decision applies to England and Wales, and the Department of Health in Northern Ireland is expected to make a decision shortly. Usually, that agency’s decisions are based on those made by NICE, the MS Society reported. Likewise, a decision is pending in Scotland, where appraisals are led by the Scottish Medicines Consortium (SMC).
The MS Society also welcomes opinions from MS patients involved in the Phase 3 and Phase 2b trials mentioned above. Those wishing to support this society’s submission are asked to email [email protected]. Others are also invited to contact the society, using that email address, to find out more about getting involved.
Zinbryta was approved as a RMS treatment by the U.S. Food and Drug Administration in May 2016.