The Scottish Medicines Consortium (SMC) has issued final advice recommending restricted use of cladribine tablets (MAVENCLAD®) as an option for treating adults with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.
• 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.
The advice marks a step change in the treatment options available for patients in Scotland with highly active relapsing-remitting MS, as cladribine tablets are the first short-course oral therapy, with a maximum of 20 days’ tablets taken in the first two years of treatment, without the need for frequent monitoring.
In October 2017, NICE approved cladribine tablets for use in the NHS in England and Wales. Cladribine tablets are taken for a maximum of 10 days in the first year and a maximum of 10 days in the second year, with no additional treatment needed in years three and four. Patients can take cladribine tablets at home from the first dose as treatment does not require hospital administration. Monitoring is limited to the first two years only, meaning that cladribine tablets have the lowest administration and monitoring burden of the currently available high efficacy disease modifying therapies.
The guidance acknowledges that clinical experts consulted by SMC considered that cladribine [tablets] is an advancement due to its oral administration regimen and its favourable side-effect and withdrawal profile.