What is Ocrevus?
Ocrevus (also known as ocrelizumab) slows the worsening of disability in early, inflammatory primary progressive MS (PPMS). In a large clinical trial, fewer people with PPMS taking Ocrevus had an increase in disability; people taking Ocrevus were 24% less likely to have an increase in their disability than those taking placebo. In more real-life terms, this is equivalent to potentially delaying the need for a wheelchair by seven years for people with early, inflammatory PPMS.
You take Ocrevus as an intravenous infusion (drip). The first dose is given as two separate infusions, two weeks apart. After that, you have one infusion every six months. The most common side effects include infusion-related reactions such as headache, rashes, fever and nausea. Other side effects include infections such as coughs, colds, chest infections and herpes virus infections (such as cold sores or shingles).
Ocrevus works by targeting and killing a type of white blood cell called a B cell. B cells are involved in the MS immune attack which damages the myelin coating around nerve cells in the brain and spinal cord. Reducing the number of B cells leads to less inflammation and less damage to myelin. Ocrevus has been approved as an NHS treatment for relapsing remitting MS since 2018.
What’s the background? How come Ocrevus was rejected and then approved?
Last year, NICE completed a review of Ocrevus for PPMS and, using the price already agreed for RRMS, concluded that the benefits gained did not represent value for money to the NHS. Drug manufacturer Roche proposed a reduced price for Ocrevus for PPMS but this was initially rejected. Following pressure from the whole MS community, NICE put the decision to reject Ocrevus on hold to allow time for more talks between NICE, NHS England and Roche. As a result, an agreement was reached to provide Ocrevus at a lower price for PPMS, bringing it within the range that NICE considers cost effective.
Why is this such a landmark decision?
Ocrevus is the first drug which has been shown to reduce disability in clinical trials of progressive MS and is the first drug to be approved for NHS treatment of primary progressive MS. The introduction of a treatment for PPMS may also generate a greater focus on services for progressive MS and a more proactive approach to managing PPMS which could ultimately benefit a much wider group of people with PPMS than just those who are eligible for Ocrevus.
What about Wales, Northern Ireland and Scotland?
The decision by NICE applies to England. In January 2020, the Scottish Medicines Consortium (SMS) approved Ocrevus as a treatment on the NHS in Scotland. Roche is working with the NHS in Wales and Northern Ireland to make Ocrevus available throughout the UK. We’ll keep you updated as soon as we have further news.
I have primary progressive MS, how do I know if I will be eligible?
You may be eligible for Ocrevus if you have early, inflammatory PPMS. Early is defined by how long you have had PPMS and how it has affected you. You may be eligible if it is 15 years or less since your first symptoms of PPMS and if you are able to walk at least 20 metres, with or without walking aids (equivalent to EDSS 6.5). Inflammatory means that MRI scans show signs of MS activity which appears as new or enlarging lesions when two MRI scans are compared. You’ll probably know if you meet the early criteria, but it’s less likely that you’ll know if your MS is inflammatory because, once diagnosed, MRI scans are not routinely carried out for people with PPMS. There are no age restrictions on starting Ocrevus.
We don’t know exactly how many people will meet these criteria but at a rough estimate it is thought to be around a quarter (25%) of the 10,000 people with PPMS in the UK.
How will I be able to access Ocrevus?
In principle, NHS services have three months to prepare before they start offering the treatment to people with PPMS. But in practice it may take longer. The first step is to contact your MS team and ask how they will be assessing people with PPMS for starting treatment with Ocrevus. If you have an annual appointment with your neurologist, this would be a good opportunity to ask for more information. If you are no longer in contact with a neurologist, you should ask your GP to refer you to the nearest MS team. You can find your nearest MS team on the MS Trust website - the map of MS services shows hospitals with MS services. Alternatively, call our Enquiry Service on 0800 032 3839 or email email@example.com
Are there any other drugs for progressive MS?
At the moment, Ocrevus is the only treatment licensed and approved for NHS use which can modify the course of progressive MS. A wide range of drug treatments and other therapies can help to manage the symptoms of progressive MS; following a balanced diet and staying as active as possible can also help you remain as healthy as possible. A number of drugs are currently in the pipeline for progressive MS:
Ocrevus for more advanced PPMS
ORATORIO-HAND is a new clinical trial designed to test Ocrevus in people with more advanced disability including those who need to use a wheelchair and are up to 65 years old. The study will focus on hand and arm function, an aspect of MS which has been overlooked in previous clinical trials but is vital for maintaining independence. Detailed planning for the study is still underway but it is anticipated that recruitment will start later this year, with study centres worldwide, including the UK.
Siponimod for SPMS
In a large clinical trial, siponimod reduced worsening of disability by 21% compared to placebo. Siponimod is now being assessed for licensing by the European Medicines Agency; if successful it will then be reviewed by NICE.
Simvastatin for SPMS
Results from a small clinical trial showed that simvastatin, widely used to reduce blood levels of cholesterol, reduced the loss of brain volume compared to placebo. The effect of simvastatin on disability worsening is now being evaluated in a large study which is currently recruiting participants from around the UK. For more information and to register interest in taking part, visit ms-stat2.info.
Biotin for PPMS and SPMS
A highly concentrated formulation of biotin is being tested for an improvement in disability in people with PPMS and SPMS. The study is fully recruited and expected to finish later this year.
Ibudilast for PPMS and SPMS
Ibudilast is used in Japan and Korea to treat asthma and some complications of strokes. Laboratory studies suggested that it might have a neuroprotective effect, reducing nerve and myelin damage. In small, early clinical trials in progressive MS, it reduced the loss of brain volume and slowed down worsening of disability. Further analysis suggested that it was most effective for people with SPMS who are not having relapses but this will need to be confirmed in larger clinical trials.
So, what exactly does the drug development process involve?
The development of new drugs is a long and difficult process. Fewer than one or two compounds in 10,000 tested actually make it through to being licensed treatments with many being rejected on safety, efficacy or quality grounds. On average it will take 10-15 years for a new compound to get from the test-tube into the medicine cabinet. It is important to remember that not all the treatments currently being developed or tested will receive a licence or be approved for use in the NHS.