Following a full submission:
cladribine (Mavenclad®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.
SMC restriction:
- Patients with rapidly evolving severe relapsing-remitting MS: patients with two or more relapses in the prior year whether on treatment or not, and at least one T1 gadolinium-enhancing lesion.
- Patients with sub-optimal therapy relapsing-remitting MS: patients with one or more relapses in the previous year while on disease modifying therapy, and at least one T1 gadolinium-enhancing lesion or nine T2 lesions.
In a phase III study cladribine showed superiority over placebo in terms of annualised relapse rate in patients with high disease activity relapsing-remitting multiple sclerosis.
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Medicine details
- Medicine name:
- cladribine (Mavenclad)
- SMC ID:
- 1300/18
- Indication:
Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.
- Pharmaceutical company
- Merck
- BNF chapter
- Central nervous system
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 12 February 2018
MHRA issued a statement on the use of gadolinium-containing contrast agents in February 2018. As a result the sub-groups within the SMC advice for cladribine have been redefined as follows:
- Patients with rapidly evolving severe relapsing-remitting MS: patients with two or more relapses in the prior year whether on treatment or not, and at least one T1 gadolinium-enhancing lesion at baseline MRI or a significant increase in T2 lesion load compared with a previous MRI.
- Patients with sub-optimal therapy relapsing-remitting MS: patients with one or more relapses in the previous year while on disease modifying therapy, and MRI evidence of disease activity.