How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, sex, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?

Cladribine for treating active relapsing multiple sclerosis

Open for comments Open until   Request commenting lead permission

We have updated this service so that members of the same organisation can now collaborate on a joint online response.

Read our blog to learn more.

1 Recommendations

1.1

Cladribine is not recommended, within its marketing authorisation, for treating relapsing forms of multiple sclerosis with active disease, as defined by clinical and imaging features, in adults.

1.2

This recommendation is not intended to affect treatment with cladribine that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

NICE has separately evaluated cladribine for highly active multiple sclerosis in NICE's technology appraisal guidance on cladribine for treating relapsing–remitting multiple sclerosis.

Why committee made these recommendations

This appraisal evaluates cladribine only for active relapsing–remitting multiple sclerosis. This does not include everyone it is licensed for.

Disease-modifying therapies for active relapsing–remitting multiple sclerosis include dimethyl fumarate, diroximel fumarate, ocrelizumab, ofatumumab and ponesimod. The aim of treatment is to reduce the number of relapses, slow the progression of disability, and maintain or improve quality of life.

Clinical trial evidence shows that cladribine reduces the number of relapses and increases the time until disability progresses compared with placebo. Indirect comparisons suggest that the relapse rate with cladribine is lower than with beta interferons, glatiramer acetate or teriflunomide, and similar to that with dimethyl fumarate, ocrelizumab, ofatumumab and ponesimod. But the results of the indirect comparisons are uncertain because different trial designs and approaches were used in the included trials.

There are uncertainties in the economic evidence because the data used to model expected relapses and disability progression may not represent what happens in NHS clinical practice. Because of these uncertainties, it is not possible to determine the most likely cost-effectiveness estimates for cladribine for active relapsing–remitting multiple sclerosis. So, it is not recommended.