NICE draft guidance recommends siponimod for secondary progressive MS

NICE draft guidance recommends siponimod for secondary progressive multiple sclerosis

NICE has issued draft guidance which now recommends siponimod (also called Mayzent) for treating secondary progressive multiple sclerosis (MS). The drug, made by Novartis, could benefit an estimated 11,000 people in England living with secondary progressive MS.

Taken orally, siponimod is licensed to treat secondary progressive MS in adults with evidence of active disease (where people have relapses or features of inflammatory activity that show up on imaging).

Clinical trial results show that siponimod reduces the number of relapses and slows disability progression compared with placebo.

In response to consultation on the initial draft guidance, the company provided updated cost-effectiveness analyses that matched the committee’s preferred assumptions. These included comparing siponimod with best supportive care and assuming that there is a reduction in the treatment effect of siponimod over time. As a result, when taking into consideration the confidential commercial arrangement agreed with NHS England and NHS Improvement for siponimod, the independent appraisal committee was satisfied that siponimod was likely to represent a cost-effective use of NHS resources.

Siponimod costs £1,643.72 per pack of 28 tablets at its list price. The company has agreed a confidential commercial arrangement with NHS England and NHS Improvement which will make siponimod available at a discounted price.

Secondary progressive MS comes after relapsing remitting MS for many people. With this type of MS a person’s disability gets steadily worse and they’re less likely to have relapses (when symptoms get worse but then get better). People can have secondary progressive disease that is ‘active’, which means they have relapses or features of inflammatory activity that show up on imaging.

Registered stakeholders, including the company and organisations representing healthcare professionals and people with MS, now have the opportunity to appeal against the draft guidance. If no appeals are received NICE expects to publish final guidance next month.

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, said: “We know there are currently few, if any treatments available for people with this form of MS, and that siponimod is a promising drug that has the potential to address this unmet clinical need. We are, therefore, pleased that the company has been able to address the issues identified by the committee in our earlier draft guidance so that people with this condition now have a further treatment option.”

John Stewart, NHS Director of Specialised Commissioning, said: “At the same time as NHS staff came together to fight a pandemic and treat over 110,000 severely ill hospitalised people for Covid-19, they also continued providing around the clock care for people with long-term conditions like multiple sclerosis, and this new deal provides patients with treatment hope for the first time in a decade.

“The NHS, in collaboration with NICE and working closely with Novartis, has secured another landmark deal which will help up to 11,000 people with secondary progressive multiple sclerosis lead healthier and better-quality lives.”