Updated guidance eases Mavenclad MRI requirements in England

England’s National Institute for Health and Care Excellence (NICE) has updated its guidance on the use of Mavenclad (cladribine) in people with aggressive relapsing-remitting multiple sclerosis (RRMS) in ways that should help eligible patients be able to access the medication sooner.

The new guidelines have less stringent MRI criteria for defining quickly progressing and severe RRMS. A single MRI scan showing disease activity is now sufficient.

The changes — called for by the clinical MS community — are thought to better reflect clinical practice and will avoid the need for multiple MRI scans that can delay a person’s ability to start treatment.

“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,” Stuart Hill, PhD, Merck’s medical director for the U.K. and Ireland, said in a press release emailed to Multiple Sclerosis News Today. Merck is Mavenclad’s developer. “This decision will enable … patients to get onto treatment quicker, which is critical as we know this can result in better outcomes for patients.”

NICE is a public body that offers best-practice recommendations for medical care in England and Wales. Its guidelines inform which medications will be covered under England’s public health insurance program, the National Health Services, and who will be eligible for coverage.

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Label recently expanded

Mavenclad is a short-course oral treatment that works to lower the number of immune cells that contribute to inflammatory damage in MS. It is given in two courses over two years. Each course involves a pair of two-week treatment cycles, spaced about a month apart, initiated at the beginning of each treatment year.

The therapy was initially approved in the U.K. for patients with relapsing MS and highly active disease, defined by clinical or imaging features. The label was expanded early this year to include patients with active disease.

The original NICE guidelines recommended Mavenclad be covered for patients with rapidly evolving and severe RRMS (RES-RRMS). This was defined as having two or more relapses in the previous year and at least one active inflammatory lesion in an initial (baseline) MRI scan, or a significant increase in overall lesion load between a baseline MRI scan and a comparator one taken later on.

The updated guidelines indicate that a baseline MRI scan showing evidence of disease activity is sufficient for RES-RRMS patients to be recommended for treatment. The change, issued May 21, became effective immediately.

The original guidelines also recommend Mavenclad for RRMS patients who had responded inadequately to other disease-modifying therapies, defined as one relapse in the last year and MRI evidence of disease activity. That guidance has not changed.

The decision was in response to requests from the MS clinical community in the U.K., who believed that the existing requirements were too restrictive and prevented patients from getting started on treatment.

“The broadening of the NICE RES-RRMS criteria for cladribine tablets has been requested by the MS clinical community for some time,” said Wallace Brownlee, PhD, a neurologist and clinical lead for the Multiple Sclerosis Service at the National Hospital for Neurology and Neurosurgery in England.

“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,” Brownlee added.