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New HTA Decisions in England
December 2019
Drug name
MAVENCLAD® (cladribine)
Merck Serono
Decision date
Therapeutic area
Neurological conditions
Therapeutic sub area
Multiple sclerosis
Recommended with restrictions
Cladribine is recommended as an option for treating highly active multiple sclerosis in adults.
Decision Detail
Cladribine is recommended only if the person has: 1) rapidly evolving severe relapsing–remitting multiple sclerosis, that is with at least: 2 relapses in the previous year, and 1 T1 gadolinium-enhancing lesion at baseline MRI or a significant increase in T2‑lesion load compared with a previous MRI, or; 2) relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity.
Clinical trial evidence was provided by the CLARITY trial, a randomised double-blind study of 1,326 people with active relapsing–remitting multiple sclerosis, which compared two different doses of cladribine with placebo. Results show that cladribine reduces relapses and slow the progression of disability compared with placebo for people with relapsing–remitting multiple sclerosis. The effectiveness of cladribine for treating rapidly evolving severe or suboptimally treated relapsing–remitting multiple sclerosis is uncertain, but it is likely to be more effective than placebo. Based on indirect analyses, the committee concluded that, although the meta-regression did provide estimates for effect sizes adjusted for baseline risk, the evidence from the meta-regression was insufficient to show that cladribine had substantially different effectiveness to alemtuzumab, fingolimod and natalizumab. After combining the ERG's assumptions, cladribine remained more effective and cheaper than fingolimod and natalizumab in the relevant subgroups. Cladribine was less effective and cheaper than alemtuzumab in the combined scenario analysis in both the rapidly evolving severe and suboptimal treatment subgroups. This resulted in incremental cost-effectiveness ratios (ICERs) of £219,549 gained per QALY lost and £372,802 gained per QALY lost respectively. The committee concluded that cladribine was a cost-effective use of NHS resources for rapidly evolving severe relapsing–remitting multiple sclerosis and suboptimally treated relapsing–remitting multiple sclerosis (that is, disease that has responded inadequately to disease-modifying therapy). However, the committee understood from the experts that it was not the number of, but the increase in, MRI lesions that is important to measure response to treatment.