NHS patients to get easier access to MS pill after NICE rethink – – pharmaphorum

Patients in England are to get easier access to Merck KGaAs multiple sclerosis drug Mavenclad after NICE dropped requirements for a special MRI scan before prescription.

NICE is currently very quiet as like all government bodies it is unable to make public announcements during the purdah period before the December 12 general election.

But German Merck said that NICE had issued update guidance on Mavenclad (cladribine tablets) following a fast-tracked guidance update.

The change follows concerns raised by the Accelerated Access Collaborative (AAC), which aims to fast-track novel medicines to NHS patients, and NHS England.

Following the representations that previous guidance was restricting access, gadolinium-based MRI scanning is no longer required prior to prescribing the tablets for highly active MS.

The changes are effective immediately, although the guidance will be updated within 30 days.

The AAC is a cross government-industry collaboration working to make the UK one of the most pro-innovation healthcare systems in the world.

The AAC had already tagged Mavenclad as a rapid uptake product, as it had the potential to improve the lives of 500,000 people and save the NHS up to 30 million.

NICE had first backed Mavenclad in guidance as long ago as November 2017, but uptake and access in first line use had been restricted because of the scanning requirement.

Belinda Byrne, Mercks UK & Ireland medical director, said: Since the positive NICE recommendation for cladribine tablets in November 2017, uptake and access for first line use has been restricted due to the requirement for a gadolinium-enhanced MRI.

As well as historical safety concerns about gadolinium, the areas of enhancement are transient and if the lesion is no longer visible then the patient is ineligible for treatment.

Mavenclad provides a short-course oral treatment for adults with highly active relapsing MS, that can help reduce relapses for up to four years with a maximum of 20 days oral treatment, taken in the first and second year.

Following completion of treatment in the first two years, no additional treatment is required in years three and four.

Mavenclad competes against other oral MS drugs such as Biogens Tecfidera (dimethyl fumarate), and a range of other injected drugs.

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NHS patients to get easier access to MS pill after NICE rethink - - pharmaphorum