Updated NICE guidance for MAVENCLAD

Updated NICE guidance for MAVENCLAD (cladribine tablets) reduces MRI requirements allowing more patients with Rapidly-Evolving Severe Relapsing-Remitting Multiple Sclerosis to benefit from quicker access

The National Institute for Health and Care Excellence (NICE) has updated their guidance for patients with Rapidly-Evolving Severe Relapsing-Remitting Multiple Sclerosis (RES-RRMS), including treatment naive patients, to initiate MAVENCLAD (cladribine tablets)

• The update considerably reduces the MRI requirements for patients with RES-RRMS, who now do not require a comparator MRI and only need baseline MRI activity to be eligible for MAVENCLAD
• This update follows requests from the MS clinical community to speed up access for patients to start treatment.

Merck, a leading science and technology company, has announced that the NICE guidance for MAVENCLAD (cladribine tablets) for patients with RES-RRMS has been updated to remove the requirement for a comparator MRI to initiate treatment.

Patients with RES-RRMS now only require baseline MRI activity to be eligible for MAVENCLAD, with no need for a second comparator MRI to show radiological activity.

Previously, NICE guidance required these patients to either have a T1 gadolinium-enhancing lesion at baseline MRI or a significant increase in T2 lesions load compared with a prior MRI.

This simplified access criteria for cladribine tablets follows requests from the MS clinical community to NICE to reassess the RES-RRMS criteria, which many felt was overly restrictive and placed a significant burden on NHS MRI resource.

“The broadening of the NICE RES-RRMS criteria for cladribine tablets has been requested by the MS clinical community for some time,” said Dr Wallace Brownlee, Clinical Lead for the Multiple Sclerosis Service at the National Hospital for Neurology and Neurosurgery. “By removing the requirement for this population to have a comparator MRI, more patients will be eligible for treatment with cladribine tablets and will be able to start treatment more quickly as they will not require an additional MRI scan.”

This was echoed by Merck’s Medical Director for the UK and Ireland, Dr Stuart Hill, who said “We welcome this change from NICE, as we know that many patients waiting for an MRI scan can experience anxiety and unnecessary delays before treatment can be initiated. This decision will enable RES-RMS patients to get onto treatment quicker, which is critical as we know this can result in better outcomes for patients.”

Cladribine tablets are the only short course oral treatment approved by NICE for adults with highly-active relapsing MS offered by NICE. They are taken through a maximum of 20 days’ oral treatment, with one course each given in the first and second years. Once treatment in the first two years is completed, no additional treatment is required for the next two years. NICE issued updated guidance TA616 on 21^st May which is effective immediately.