NICE reverses decision on medication for relapsing multiple sclerosis
The current topic of discussion regarding NICE is how its recent changes will impact patient access to medicine but, away from the headlines, the body continues to perform its role of determining which medicines will be available to patients. In this case, it has approved Biogen's Zinbryta for patients suffering from relapsing remitting multiple sclerosis, though with the caveat of there being particular circumstances dependent for its use.
This means that patients will eligible if they have failed to respond to first-line, disease-modifying therapy or have rapidly evolving severe multiple sclerosis. The approval comes a full year after the FDA had given its nod for the same indication of the drug, coming as a reversal on a decision last September to reject the drug.
Zinbryta is a human monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25). CD25 is expressed at high levels on T-cells that become activated in people with MS. The treatment is self-administered once every month by patients. It will be used as treatment in those who are unsuitable or unresponsive to alemtuzumab.
“We are pleased that NICE has reversed its earlier decision and has now approved Zinbryta as a treatment for relapsing remitting MS in England and Wales. It further expands the range of disease modifying drugs by offering a different dosing schedule, a different mode of action and a different profile of benefits and risks compared to existing disease modifying drugs,” commented Pam Macfarlane, Chief Executive Officer of the MS Trust, on the decision.
The drug was found, in clinical trials, to reduce the number of relapses by 50% compared to the use of a placebo.