NICE Expands Cladribine Access for MS Patients

The National Institute for Health and Care Excellence (NICE) has recommended c ladribine (Mavenclad, Merck Serono) for adults in England with relapsing-remitting multiple sclerosis (RRMS). This decision makes the NHS the first healthcare system in Europe to widely offer the at-home tablet for patients with active MS.

The final draft guidance means cladribine is an option for adults with active RRMS when high-efficacy disease-modifying therapies (DMTs) would be offered.

A Convenient Alternative to Existing Therapies

Cladribine requires just 20 days of dosing over 4 years, offering a more convenient option compared to many existing therapies that require frequent hospital infusions, self-injections, or extensive monitoring.

Patients can avoid lengthy travel to appointments, remain in work, and better plan for starting a family. “Patients planning a pregnancy can also safely conceive in years 3 and 4 of their treatment cycle because cladribine is administered in short courses over 2 years,” the regulator noted.

Laura Thomas, head of policy at the MS Society, welcomed the guidance. “Cladribine is self-administered, so this decision could particularly benefit people who’d struggle to go into hospital regularly, like younger working-age adults,” she said. “It will also benefit patients considering starting a family, as it’s safe to get pregnant 6 months after the final course of treatment – which is less restrictive than many other DMT options.” 

Proven Benefits in Reducing Relapses

Multiple sclerosis affects more than 150,000 people in the UK, with 85%-90% diagnosed with the relapsing form. Cladribine works by targeting T and B cells, which damage the myelin sheath in MS patients.

The treatment has already been recommended by NICE for highly active and rapidly evolving severe forms of MS. The new recommendation expands access to a much wider group of patients, with an estimated 2000 people expected to benefit over the next 3 years.

Clinical Trial Evidence

Clinical trial evidence shows that cladribine reduces relapses and delays disability progression compared with placebo. Indirect comparisons suggest that the relapse rate with cladribine is similar to that of ocrelizumab and ofatumumab, the most commonly prescribed treatments for active RRMS.

The CLARITY  trial, a randomised, double-blind study of 1326 patients with active and highly active RRMS, compared 3.5 mg/kg and 5.25 mg/kg doses of cladribine with placebo. The study found a 58% reduction in the average annual relapse rate. Nearly 80% of patients taking cladribine experienced no relapses. MRI scans also showed that patients receiving the treatment developed 7.5 times fewer new brain lesions compared with those given a placebo.

NICE highlighted that cladribine offers comparable clinical benefits to current treatments while significantly reducing hospital visits and clinical monitoring time.

Professor James Palmer, NHS medical director for specialised commissioning, said in a statement that the decision would “free up clinical time, helping clinicians see more patients and boosting NHS productivity”.

Dr Rob Hicks is a retired NHS doctor. A well-known TV and radio broadcaster, he has written three books and has regularly contributed to national newspapers, magazines, and online. He is based in the UK.