Merck MS tablet set for wider use by NHS in England

Thousands more patients with multiple sclerosis in England will soon be able to access Merck KGaA's take-at-home tablet Mavenclad, reducing their need for clinic visits.

New guidance (PDF) from health technology assessment (HTA) agency NICE means that Mavenclad (cladribine) will soon be an option for people with active relapsing-remitting MS who are having relapses or new disease activity visible on MRI scans.

The drug has been an option for people with more severe, highly active forms of the disease – who have two or more relapses per year – since 2019.

In December, NICE said it was minded not to recommend the broader label, but has now changed its stance after a campaign by patient organisations, including the MS Society.

The new decision means that patients with less severe symptoms will have an oral alternative to current injected or infused MS medications – such as Roche's Ocrevus (ocrelizumab) and Novartis' Kesimpta (ofatumumab) – which require regular trips to hospital for dosing and monitoring.

In contrast, Mavenclad needs to be dosed just 20 times in the first two years of a four-year treatment cycle. The tablets are taken for a maximum of 10 days in the first and second years, with no treatment needed in the subsequent two years.

The intermittent treatment is also a big advance in treatment for MS patients hoping to have children because, while Mavenclad is contraindicated in pregnancy, they should be able to safely conceive in the third and fourth years of the treatment cycle.

NICE's decision follows the decision by the MHRA to approve Mavenclad for active relapsing-remitting MS last year, becoming the first medicines regulator in Europe to extend the drug's label.

It is estimated that more than 150,000 people in the UK live with MS, with around 85% having the relapsing-remitting form at first diagnosis, and NICE reckons about 2,000 patients could be offered the treatment over the first three years.

"Cladribine is self-administered, so this decision could particularly benefit people who'd struggle to go into hospital regularly, like younger working-age adults," said the MS Society's head of policy, Laura Thomas.

"It will also benefit patients considering starting a family, as it's safe to get pregnant six months after the final course of treatment," she added. "We're so glad more people with MS will now be able to choose an effective treatment which suits their lifestyle."

The list price of Mavenclad is around £2,050 per 10mg tablet, although, Merck is providing it to the NHS in England at a confidential discount. The new guidance is due to be finalised in April, with access in Wales and Northern Ireland typically decided shortly afterwards. Scotland, meanwhile, is still carrying out its appraisal of the wider use.

The drug is one of Merck's top sellers, with sales rising 12% last year to reach €1.1 billion.

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