Ocrevus (ocrelizumab)

Licensing

The European Commission has granted marketing authorization for ocrelizumab (Ocrevus) for the treatment of both active relapsing MS and early active primary progressive multiple sclerosis. This follows a recommendation from the European Medicines Agency in November that a licence should be granted for:

• Active relapsing MS, meaning people who are having relapses or showing new lesions on MRI scans
• Early primary progressive MS,defined as people who have had symptoms of MS for 15 years or less, have an EDSS of 3.0 to 6.5 and evidence of MS activity on MRI scans​

Appraisal

NICE (May 2019) and SMC (January 2020) approved Ocrevus for people with primary progressive MS if they:

• have had symptoms of primary progressive MS for 15 years or less and
• are able to walk 20 metres or more, with or without walking aids (up to EDSS 6.5) and
• have evidence of MS activity on MRI scans

This reversed an earlier decision by NICE to reject Ocrevus for PPMS. The final publication of this decision was paused to allow time for further discussions to take place between NICE, NHS England and drug manufacturer Roche.

• MS Trust submission to the appraisal
• MS Trust response to initial decision

This decision applies initially to England and Scotland only.

Roche is working with the NHS in Wales and Northern Ireland to make Ocrevus available throughout the UK.

Research on Ocrevus for primary progressive MS:

• ORATORIO - Ocrevus compared to placebo

This phase III study recruited 732 participants with primary progressive MS and EDSS of 3 to 6.5 who took either Ocrevus or placebo by iv infusion every 6 months for more than 2 years.

The main measure of the study was the onset of disability progression. This was measured by the number of participants with an increased EDSS which was still evident 3 months later. The study also recorded the number of participants with an increased EDSS still evident after 6 months, walking speed over 25 feet and volume of brain and MS lesions.

Fewer people taking Ocrevus had an increase in disability, compared to placebo. An increase in disability which lasted 3 months was seen in 32.9% of those taking Ocrevus and 39.3% of those taking placebo. In addition, increased disability which lasted at least 6 months was seen in 29.6% taking Ocrevus and 35.7% taking placebo. Comparing the two groups, people taking Ocrevus were 24% less likely to have an increase in their disability than those taking placebo.

After 120 weeks of treatment, walking speed over 25 feet was 39% slower for Ocrevus compared to 55% slower for placebo. Brain lesion volume decreased by 3.4% with Ocrevus and increased by 7.4% with placebo. Loss of brain volume was 0.9% for Ocrevus and 1.09% for placebo.

Future research on Ocrevus for primary progressive MS:

• ORATORIO-HAND (O'HAND)- Ocrevus​ compared to placebo

This phase III study is designed to evaluate the effect of Ocrevus​ on hand and arm function in people with more advanced disability, including those who use a wheelchair. The study will recruit approximately 1000 participants with EDSS between 3 and 8 and includes eleven study centres in the UK. The main measure of the study will be the nine-hole peg test, a measure of arm, wrist and hand function. A secondary measure will be onset of disability progression, measured by the number of participants with an increased EDSS which persists for 3 months or longer.
Estimated completion date April 2028.
Further details of this study.

• Consonance - Ocrevus​

This study is recruiting 600 people with either secondary or primary progressive MS. All participants will take Ocrevus​ every 24 weeks for four years. Progression of disability will be assessed using a combination of measures.
Estimated completion date January 2024.
Further details of this study.