NICE has recommended the use of Mavenclad for highly active relapsing multiple sclerosis in adults only if the patient have two relapses in the previous year and one T1 gadolinium-enhancing lesion at baseline MRI or a significant increase in T2‑lesion load.
The committee has agreed that the oral dosage form has an advantage as it will be less disruptive. Patient experts mentioned that the many of the available treatments require hospital appointments, resulting in disruption of patient’s lives.
The committee has considered alemtuzumab and natalizumab as appropriate comparators for severely active disease; alemtuzumab and fingolimod for sub-optimally treated disease.
The effectiveness of Mavenclad was studies in CLARITY trial. The trial included 1,326 people with active relapsing–remitting multiple sclerosis, 433 people had cladribine and 437 people had placebo. The results showed that cladribine reduced relapses and delayed disability progression compared with placebo. Disability progression had no significant impact.
NICE was satisfied with the model submitted by the company. NICE agreed that compared to fingolimod and natalizumab, cladribine was cheaper and effective.
The list price is £2,047.24 per 10 mg tablet.