NICE says initial 'no' to ocrelizumab for relapsing MS
Ocrelizumab is an intravenous infusion taken every six months. It was licensed to treat both people with relapsing and early primary progressive MS by the European Medicines Agency (EMA) in January this year.
What's NICE's decision based on?
NICE said the evidence submitted by the pharmaceutical company Roche is not enough to show it's more clinically and cost effective than other treatment options for relapsing MS.
Ocrelizumab has been shown to be safe and highly effective for relapsing MS. But without NICE approval it will be difficult for people who could benefit to access it.
Decision not set in stone
Genevieve Edwards, our Director of External Affairs, said: “Naturally we’re very disappointed by the NICE guidance. But the decision isn't set in stone, and we’ll be speaking to NICE and the drug manufacturers to make sure we get the right outcome for everyone living with MS.
"Over 100,000 people have MS in the UK, and we’re working hard to make sure they can all access more and better treatments. We’ve been here before and turned it around."
What does this mean for primary progressive MS?
The review of ocrelizumab for primary progressive MS is happening separately and hasn't reached this stage yet.
Genevieve says “For us and thousands of others, ocrelizumab also offers immense hope in progressive MS. We’re yet to know what NICE recommends here, and will be continuing our efforts to make sure everyone who could benefit can access the drug. There are still people with MS who don’t have any options for treatment, and addressing this is our absolute priority.”
Where would this decision apply?
This decision applies to England and Wales only.
The Department of Health in Northern Ireland is expected to make a decision on ocrelizumab for relapsing MS soon. Its decisions are usually based on those made by NICE. The Scottish Medicines Consortium (SMC) are currently carrying out a separate appraisal for people in Scotland.
Speaking up for MS
While the initial decision is concerning, it's important we're clear that it's not final at this stage. NICE has reversed its initial view before, based on more evidence and/or price negotiations between the pharmaceutical company and NHS England.
They're now welcoming feedback and we’ll be speaking up for MS and encouraging them to rethink. The pharmaceutical company, Roche, will also submit more evidence.
We'll keep you updated on the next steps.