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Mavenclad (cladribine) approved for use by the NHS in England and Wales

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Mavenclad (cladribine) has been approved as a treatment for people with highly active relapsing MS on the NHS in England and Wales.

The National Institute for Health and Care Excellence (NICE) has recommended that cladribine can be prescribed only if you have:

  • rapidly evolving severe relapsing remitting MS (at least two relapses in previous year and one gadolinium-enhancing lesion on an MRI scan), or
  • relapsing remitting MS that has responded inadequately to treatment with another disease modifying drug (one relapse in previous year and MRI evidence of disease activity).

The NHS in England are expected to provide funding for cladribine within three months of its approval, and the NHS in Wales must provide funding for the drug within two months.

Cladribine is currently being appraised by the Scottish Medicines Consortium (SMC) and we are contributing to the appraisal. The drug needs to be appraised by the regulatory body in Northern Ireland before it becomes available to people with MS in this area.

About cladribine

Cladribine is a disease modifying drug for people with relapsing remitting MS. It works by reducing the number of white blood cells, known as lymphocytes, which cause the nerve damage associated with MS. The drug is therefore able to slow down or stop the immune attack and reduce the damage to the brain and spinal cord.

In a phase III study, cladribine reduced relapses by 58% compared to placebo and also reduced the risk of disability progression. Side effects included lymphopenia (low levels of white blood cells) and shingles.

The drug is taken orally in two treatment courses, twelve months apart:

  • Year one – In the first course, cladribine pills are taken for four or five days consecutively at the beginning of the first month and then four or five days consecutively at the beginning of the second month.
  • Year two – The second course is taken 12 months later and follows the same pattern.

In the clinical trial no further treatment was required for years three and four.