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It makes you wonder WTF is going on. Make no mistake, it is certainly causing more than a little head scratching here.
Novartis’s Mayzent, otherwise known as the drug siponimod, the first ever oral disease modifying therapy for secondary progressive multiple sclerosis (SPMS) has hit the proverbial rocks as it tries to navigate its way to reach the safe haven called approval.
Of course, it’s not a shipwreck but the good ship Mayzent has hit some stormy waters.
It has been turned down, temporarily at least, as an MS treatment available through the UKs national health service in England and Wales, and t looks likely that Scotland and Northern Ireland will follow suit. The biggest ‘rock’ in question is the National Institute for Health and Care Excellence (NICE).
NICE is the body responsible for, among other things, issuing guidelines on the use of new medicines by the NHS in England and Wales. These are based on evaluations of efficacy, safety and cost-effectiveness.
The draft guidance that NICE has issued, for public consultation, says:
“Siponimod is licensed to treat this type of MS in adults with evidence of active disease, which means they have relapses or features of inflammatory activity that show up on an MRI scan.
“Interferon beta-1b is currently the only disease-modifying treatment available for people with active secondary progressive MS. However, few people take it because it can cause side effects such as flu-like symptoms.
NICE: Effectiveness ‘uncertain’
“Clinical trial results show that siponimod reduces the number of relapses and slows disability progression compared with placebo. However, because there is no evidence directly comparing siponimod with interferon beta-1b, it is uncertain how effective siponimod is compared with that treatment.
“The committee has requested further analyses to be included in the company’s economic model. These include comparing siponimod with best supportive care and assuming that there is a reduction in its treatment effect over time.” The full draft guidance can be found here.
In response, a statement from Novartis expressed the company’s disappointment but said: “If the initial decision from NICE remains unchanged patients will be denied access to the first licensed oral therapy for SPMS with active disease, leaving them without an effective, convenient treatment to manage their condition and help them maintain independence for longer.
“We are committed to continuing to work closely with NICE to address outstanding questions and data requirements in order to secure access as quickly as possible to siponimod for those patients in England and Wales that could benefit.”
The MS Society and MS Trust are united in calling for NICE to change its draft guidelines.
Denial would be devastating
Jonathan Blades, MS Society’s head of campaigns and external relations, said: “Siponimod is the first new treatment for secondary progressive MS in over a decade, and the only oral option. There’s just one alternative and it isn’t suitable for everyone. For those people, to be denied a way to manage their condition will be devastating.
“This decision could have a profoundly negative impact on thousands of lives. But NICE, together with the drug manufacturers and NHSE, have an opportunity to turn that around. We’re urging them to look again at the evidence and the reality of life with a gradually worsening disability, and do what’s right.”
And David Martin, chief executive, MS Trust said: “We are hugely disappointed by this initial decision. Time and time again, we hear from people with secondary progressive MS struggling at home, feeling like they have been forgotten. Just earlier this month, a new report has highlighted the significant gaps in support and services for people with SPMS. Not everybody will be eligible for siponimod, but we hope that the availability of a new treatment will lead to a renewed focus on the needs of all people with SPMS.”
The MS Trust added that it is reviewing NICE’s decision and will continue to make the strongest possible case for NHS approval.
What puzzles me is that Mayzent/Siponimod is widely endorsed. Approved in the USA, Canada, Australia, and by the European Medicines Agency, to name a few. In the UK, however, the NHS is being prevented from using it to treat people living with SPMS.0
It seems to me that NICE isn’t so nice.
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Please note that being born in the UK, all my posts, are written using British English spelling.
Centre not center (except in names, Centers of Disease Control) Colour not color Diarrhoea not diarrhea Haematology not hematology Haematopoietic not hematopoietic
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50shadesofsun.com is the personal website of Ian Franks. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. More recently, he was a freelance medical writer and editor for various health information sites. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.
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Note: Health-related information available on 50shadesofsun website is for your general knowledge only. It is not a substitute for medical advice or treatment for specific medical conditions. Ian is not a doctor, so cannot and does not give you medical advice. You should seek prompt medical care for any specific health issues. Also, consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely his own unless otherwise stated.