NICE Opposes Ponvory Being Added to NHS for England and Wales

The National Institute for Health and Care Excellence (NICE) will not recommend that Ponvory (ponesimod) be added to the National Health Service (NHS) of England and Wales for people with active, relapsing forms of multiple sclerosis (MS).

The provisional decision, made because Ponvory was not found to be sufficiently cost effective, means that the oral therapy will not be available at low or no cost to patients with clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS) through each country’s public health system.

Its follows a similar May decision by the regulatory agency regarding Zeposia (ozanimod), which also was not added to the NHS of those countries to treat adults with active RRMS.

NICE’s opinion came as a disappointment to the MS Society, which is planning to submit the views of patients and healthcare professionals to encourage the agency to reconsider.

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People who wish to share their experience with Ponvory and describe how the treatment would make a difference to people with relapsing MS can send their opinions by email to [email protected]. The deadline for submissions is Oct. 22.

“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,” Sarah Rawlings, PhD, director of Research and External Affairs at the MS Society, said in a press release.

“We will be urging NICE and the manufacturer [Janssen] to review the evidence and consider what’s best for people living with MS,” Rawlings said.

While NICE’s opinion applies to England and Wales only, the government of Northern Ireland usually follows NICE guidance after a review. A decision by the Scottish Medicines Consortium regarding Ponvory’s inclusion in Scotland’s public health system is expected next month.

“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,” Rawlings said. “Ponesimod would be the only oral first-line treatment for some people with relapsing MS.”

Ponvory is an oral modulator of the sphingosine-1-phosphate receptor 1. It works by trapping immune cells inside lymph nodes, so they cannot get into the central nervous system and cause damage to nerve cells.

The treatment has been approved by regulatory agencies in the U.S., European Union, and in the U.K. for people with active, relapsing forms of MS.

Approvals were based on findings from the OPTIMUM Phase 3 trial (NCT02425644), which compared the safety and efficacy of Ponvory to those of Aubagio (teriflunomide) — an approved oral first-line therapy for MS that also reduces the activity of the immune system, but through a different mechanism.

A total of 1,133 people with RRMS and active SPMS were included in OPTIMUM, and randomly assigned to treatment with either Ponvory or Aubagio as a daily tablet for 108 weeks (about two years).

Top-line results demonstrated that Ponvory significantly lowered the number of relapses each year by 30.5%, and reduced the number of brain lesions visible on an MRI scan by 56% compared with Aubagio. The treatment also prevented worsening fatigue and loss of brain volume.

However, no significant differences between the two treatments were found in terms of confirmed disability accumulation (CDA), likely due to the low number of patients in each arm experiencing CDA.

Because the effects of Ponvory on disability progression remain unclear, NICE did not consider the medication cost-effective for its inclusion and availability through the NHS — a publicly funded healthcare system, the MS Society reported.

This decision is not final, the group added, and NICE welcomes the views of the MS community.