The National Institute for Health and Care Excellence (NICE) has made a provisional decision not to recommend ponesimod be made available on the NHS in England and Wales. This is the first stage of its approval process as an MS treatment.
What is ponesimod (ponvory)?
Ponesimod (brand name Ponvory) is a tablet taken daily. Like fingolimod (brand name Gilenya), it's thought to act by trapping certain immune cells (called lymphocytes) in the body’s lymph nodes.
Ponesimod has been shown in Phase III clinical trials to be more effective at reducing the relapse rate in relapsing MS and fatigue-related symptoms compared to teriflunomide (brand name Aubagio). In August 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) granted a UK licence to ponesimod for the treatment of people with active relapsing forms of MS. ‘Active’ means you’re having relapses or MRI scans of your brain or spinal cord show new or growing lesions.
However, following review, NICE found that the treatment was not cost effective enough to be recommended for use on the NHS. NICE considered that ponesimod’s effect on disability progression is unclear.
People with MS could benefit from more oral treatments
Dr Sarah Rawlings, Director of Research and External Affairs at the MS Society, says:
“It's disappointing to see ponesimod not recommended at this stage, not least because it is the second rejection of a new oral treatment option for MS in just five months.
“MS is painful relentless and disabling, but access to the right treatment can make a massive difference. Despite the range of treatments for relapsing MS, oral options are still limited in number, and people could benefit from a further treatment option. Ponesimod would be the only oral first-line treatment for some people with relapsing MS.
“We will be urging NICE and the manufacturer to review the evidence and consider what’s best for people living with MS.”
Where does this decision apply?
This decision applies to England and Wales only.
NICE decisions are checked by the Government in Northern Ireland but are usually adopted.
In Scotland, separate appraisals are carried out by the Scottish Medicines Consortium (SMC), and a decision on ponesimod is expected in November 2021
NICE rethink its decision
While the initial decision is disappointing, it's not final at this stage. NICE has reversed its initial view before based on further evidence and/or price negotiations between the pharmaceutical company and NHS.
NICE is now welcoming feedback on its initial decision from patient groups, health care professionals and others.
We’ll be submitting our views and encouraging NICE to rethink its decision. Tell us why you think ponesimod, a tablet-based treatment, would make a difference to people with relapsing MS.
Please email [email protected] with your thoughts or experience by 22 October 2021.