Eligible patients with multiple sclerosis should be able to get routine access to Biogen’s Zinbryta on the NHS in the next few months following a green light from cost regulators.
The National Institute for Health and Care Excellence (NICE) has published a final appraisal determination recomending the drug for the treatment of adult patients living with relapsing-remitting multiple sclerosis (RRMS).
However, it has stipulated that, in order to access NHS funding, the patient must have active RRMS that has previously been treated with disease-modifying therapy or rapidly evolving severe RRMS, and treatment with alemtuzumab is contraindicated or otherwise unsuitable.
Also, the advice is contingent on the continued provision of the patient access scheme, which provides a simple discount to the list price of the drug, with the discount applied at the point of purchase or invoice.
Zinbryta (daclizumab), a human monoclonal antibody that modulates interleukin-2 signalling to reduce central nervous system pathology, and the occurrence of relapses and disability progression, was cleared in Europe in July last year.
Its approval was centred on data from two clinical trials showing that once-monthly subcutaneous administration of Zinbryta was linked with a statistically-significant reduction in the annual relapse rate of MS.
In the DECIDE trial, this reduction was 45 percent compared with Avonex, while in the SELECT study it was 54 percent versus placebo.
On the safety side, more serious skin reactions and raised liver enzyme levels were reported in patients taking the drug.