Merck’s Mavenclad is being backed by the National Institute for Health and Clinical Excellence as an option for treating highly active multiple sclerosis in adults on the NHS.
In a Final Appraisal Determination, the cost watchdog is recommending routine funding for the drug if the patient rapidly evolving severe relapsing-remitting multiple sclerosis, that is, at least two relapses in the previous year and at least one T1 gadolinium-enhancing lesion at baseline MRI or relapsing-remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as one relapse in the previous year and MRI evidence of disease activity.
The decision comes just two months after the European Commission issued a green light for Mavenclad (cladribine), a selective immune reconstitution therapy (SIRT), on the back data showing that the pill cut the annualised relapse rate by 67 percent.
According to the firm, the drug is the first oral short-course treatment to provide efficacy across key measures of disease activity in adult patients with highly active RMS, including disability progression, annualised relapse rate and magnetic resonance imaging activity, and has the lowest treatment and monitoring burden of all available disease-modifying treatments (DMTs) for the condition.
"We are delighted NICE and the Appraisal Committee have reached this decision and consider this an important step in enabling rapid patient access to Mavenclad in England, Wales and Northern Ireland," said Simon Sturge, chief operating officer for the biopharma business of Merck. "The positive conclusion NICE has reached is testament to the value, cost-effectiveness and innovation Mavenclad brings to the multiple sclerosis treatment paradigm."