NICE approves ocrelizumab for early primary progressive MS
We expect NICE to issue final guidance on its prescription in mid-June. NHS England then has 90 days to make treatment available. The drug should be available to people living in England by September 2019.
Ocrelizumab is already available on the NHS as a treatment for people with relapsing remitting MS.
How did we get here?
In September 2018, NICE initially decided not to approve ocrelizumab for use on the NHS for early primary progressive MS, as it was considered too expensive for its benefits.
In response, we launched a campaign calling on NICE, NHS England and the drug manufacturer Roche, to find a deal to allow access to the drug on the NHS.
21,000 of you signed our petition, calling for a deal to be found. And thousands of you called on your MP to urge NICE, NHS England and Roche to find a way forward.
Today’s announcement means the first disease modifying treatment (DMT) for early primary progressive MS will be available on the NHS in England in a few months’ time.
Who will be able to access ocrelizumab?
Ocrelizumab has been approved for people living with early primary progressive MS. Early primary progressive MS is defined by:
- MRI scans that identify inflammation or new or enlarging lesions - doctors will sometimes refer to this as ‘active’ disease
- evidence of level of disability or an ‘EDSS’ score of more than 5.0 and living with primary progressive MS for less than 15 years or
- an EDSS score of 5.0 or less and living with primary progressive MS for less than 10 years.
There’s no age limit on accessing ocrelizumab for primary progressive MS.
Defining early primary progressive MS depends on the person's level of disability which is assessed using the Expanded Disability Status Scale (EDSS). EDSS is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. Scoring is based on an examination by a neurologist.Find out more about the EDSS scale
What about Scotland, Wales and Northern Ireland?
NICE is the body responsible for approving medicines for use in the NHS in England so the announcement applies only to England. However, we’re hopeful that we’ll see access to ocrelizumab for people with early primary progressive MS across the UK this year.
While not legally binding, NICE’s rulings act as an instruction to Welsh and Northern Ireland authorities to consider the drug for use in the NHS in their respective nations. The next step will be for governments in both nations to consider the ruling, including whether and how to implement it.
Roche have said they’ll be submitting ocrelizumab for primary progressive MS to the Scottish equivalent to NICE, the Scottish Medicines Consortium, in the near future. The drug company has said they're hopeful ocrelizumab will be available to people in Scotland with early, inflammatory PPMS in late 2019 or early 2020.
We’ll continue to work across all nations to ensure ocrelizumab is made available to all those across the UK who could benefit.
A landmark moment for the MS community
Genevieve Edwards, Director of External Affairs at the MS Society, said: “This is a landmark moment and an incredible victory for the more than 21,000 of us who helped overturn this result. We now want to see everyone who could benefit from ocrelizumab being able to access it, with increased support for MS services to make sure this happens.
“Right now however there isn’t enough evidence to show ocrelizumab can work for everyone, and we know the restrictions will be a massive blow for those who still don’t have any options. We’re driving research to find more and better treatments, and calling for drug trials to more fully address the needs of everyone with MS, until the day we are able to stop it in its tracks.”