The first and only licensed disease-modifying treatment ocrelizumab, for people with early Primary-Progressive Multiple Sclerosis PPMS will not be made available on the NHS. In clinical trials ocrelizumab has shown it could delay the need for a wheelchair by seven years in people with early PPMS.
Ocrelizumab is licensed for both relapsing-remitting multiple sclerosis (RRMS) and PPMS in over 65 countries globally, with over 50,000 people having been treated with this first-in-class treatment. PPMS affects around 10-15,000 people in the UK and people with this highly disabling form of MS often end up in a wheelchair.
The Department of Health does not allow medicines to have different confidential prices for different indications which meant NICE could not consider the indication-specific price offered by Roche. Failure to resolve this technicality between NHS England and NICE means that people with PPMS are denied access to the only effective treatment available for their condition.
In the Phase III clinical trial ORATORIO, ocrelizumab was shown to slow disability progression and reduce signs of disease activity in the brain (MRI lesions) in people with PPMS, compared with placebo, with a median follow-up of three years.
Richard Erwin, General Manager, Roche UK said, “This is devastating news for people with PPMS. The committee has recognised ocrelizumab as an innovative treatment that provides a step change in the treatment of PPMS with a substantial effect on the lives of patients and their families. We ask that NICE are given the flexibility to consider an indication-specific price for ocrelizumab in PPMS.”
Jo Sopala, Director of Health Professional Programmes, MS Trust said, “There are currently no approved treatments for PPMS and people with this form of MS experience disability significantly quicker than those with other forms. The lack of treatments that can modify their disease often forces them to rely on wheelchairs and mobility aids sooner, impacting on their independence. They are the forgotten people with MS and it is critical that NICE overturn the decision for ocrelizumab as soon as possible.”
Professor Gavin Giovannoni, Consultant Neurologist at Barts and the London School of Medicine and Dentistry said, “As doctors, we are left feeling powerless when we deliver the devastating diagnosis of PPMS to people because we know there is currently no disease-modifying treatment available to help them. It is even more frustrating that an effective treatment that can help slow the disease has been developed and made available across the globe yet people in England and Wales will continue to suffer disability worsening because of an archaic and inflexible medicine assessment system.”