The MS Trust is very disappointed that NICE is unable to recommend ocrelizumab as an NHS treatment for early primary progressive MS.
In the appraisal consultation document, NICE acknowledges that there are no disease modifying treatments approved for primary progressive MS (PPMS), and that clinical trials have shown that ocrelizumab can slow the worsening of disability in PPMS.
However, NICE considers that the benefits gained from ocrelizumab treatment do not represent value for money to the NHS, when compared to the cost of routine NHS treatment currently provided for PPMS. The manufacturer’s proposal to provide ocrelizumab to the NHS at a reduced price while a clinical trial is on-going has also been rejected.
The MS Trust is reviewing the appraisal documents from NICE and we will respond to the consultation process.
We are very disappointed by this initial decision, but not surprised; we knew this was going to be a tough fight and will continue to make the strongest possible case for NHS approval of ocrelizumab for primary progressive MS. People do everything they can to minimise the impact PPMS has on their lives, but they are all too aware that, at the moment, there is nothing that will slow down the progression of their disease.
We are pleased that NICE recognises the innovative nature of ocrelizumab and urge NICE, NHS England and the manufacturer to find a solution which enables those eligible to access this drug as soon as possible.
- Jo Sopala, Director of Development
We encourage people to add their own comments on this initial decision; you can do so via the NICE website by 5pm on 19 July 2018. The NICE appraisal committee will meet again on 2 August to review the comments received and further evidence from the manufacturer. NICE expects to publish its final decision for the NHS in October 2018.
Last week, in a reversal of an earlier decision, NICE announced that they approved ocrelizumab for relapsing remitting MS in England and Wales.
Ocrelizumab appraisals in Scotland
The SMC (Scottish Medicines Consortium) is currently reviewing ocrelizumab as a treatment for relapsing remitting MS by the NHS in Scotland. Their decision will be published on 9 July 2018.
The appraisal of ocrelizumab for PPMS is planned for later this year.
New clinical trial announced for ocrelizumab in primary progressive MS
ORATORIO-HAND is a new clinical trial to test the effect of ocrelizumab on hand and arm function in people with more advanced disability, including those who need a wheelchair. The study will recruit approximately 1000 participants with PPMS with an EDSS between 3 and 8 who will take either ocrelizumab or placebo.
The main measure of the study will be the nine-hole peg test, a measure of arm, wrist and hand function. Detailed planning for the study is still underway but it is anticipated that recruitment will begin at the end of 2018, with study centres worldwide, including the UK.
Press release with further details of this study.
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