NICE have altered their prescription requirements for Mavenclad, oral cladribine tablets for highly active relapsing MS, after the Accelerated Access Collaborative (AAC) raised concerns about the level of uptake of the drug.
The AAC, which aims to fast-track novel medicines to NHS patients and NHS England, had marked Mavenclad as a rapid-uptake product, determining that it ‘had the potential to improve the lives of 500,000 people and save the NHS up to £30 million’. However, uptake of the drug in first-line use had been restricted by the guidance stipulating a gadolinium-enhanced MRI prior to prescription.
Regarding the need for the gadolinium-enhanced MRI, Belinda Byrne, Merk’s medical director for the UK and Ireland, noted ‘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. Once treatment in the first two years is completed, no additional treatment is required in years three and four.NICE issued updated guidance TA616 on 19th December, effective immediately.
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