The next step in the approval process is for the European Commission to grant a licence for cladribine, taking into consideration the EMA's recommendation. Cladribine will then have to be appraised by NICE and the SMC to determine availability in the UK.
In anticipation of the granting of a licence, NICE have already started the appraisal process and a decision is expected to be published in February 2018. The MS Trust is contributing to the appraisal. If NICE approves the use of cladribine, it could be available on the NHS from June 2018.
In 2011, an application for a licence was turned down due to concerns about a higher risk of cancer in people taking cladribine in clinical trials. Further analysis of clinical trial data and comparison with data from trials of other disease modifying drugs suggests that there is not an increased risk of cancer in people taking cladribine.
Cladribine is taken as a pill in two treatment courses, twelve months apart:
- in the first course you take cladribine pills for five consecutive days in the first month and for five consecutive days in the second month
- the second course is taken 12 months later; you take cladribine pills for five consecutive days in the first month and for five consecutive days in the second month
In large clinical trials, cladribine reduced the risk of relapses by 58% compared to placebo. Cladribine also significantly reduced the risk of increased disability which persisted for 3 or 6 months.
The main side effects reported in clinical trials include reduced white blood cell counts which in most cases was mild or moderate but was considered more severe in about 25% of those taking cladribine, and infections, including herpes zoster(shingles).