2 Information about cladribine

Marketing authorisation indication

2.1 Cladribine tablets (Mavenclad, Merck Serono) are 'indicated for the treatment of adult patients with highly active relapsing multiple sclerosis as defined by clinical or imaging features'.

Dosage in the marketing authorisation

2.2 In the summary of product characteristics, the recommended cumulative dose is 3.5 mg/kg body weight over 2 years, taken as 1 treatment course of 1.75 mg/kg per year. Each treatment course consists of 2 treatment weeks, 1 at the beginning of the first month and 1 at the beginning of the second month of the respective treatment year. Each treatment week consists of 4 days or 5 days on which a patient takes 10 mg or 20 mg (1 or 2 tablets) as a single daily dose, depending on body weight. After completing the 2 treatment courses, no further cladribine treatment is needed in years 3 and 4.

Price

2.3 The list price is £2,047.24 per 10 mg tablet (excluding VAT, BNF online, November 2019). Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)