1 Recommendations

1.1 Diroximel fumarate is recommended as an option for treating active relapsing–remitting multiple sclerosis (normally defined as 2 clinically significant relapses in the previous 2 years) in adults, only if:

  • they do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis and

  • the company provides diroximel fumarate according to the commercial arrangement.

1.2 If patients and their clinicians consider diroximel fumarate to be one of a range of suitable treatments (including dimethyl fumarate), choose the least expensive treatment, taking into account administration costs, dosage, price per dose and commercial arrangements.

1.3 These recommendations are not intended to affect treatment with diroximel fumarate that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

The summary of product characteristics states that diroximel fumarate is expected to be as clinically effective as dimethyl fumarate, which NICE already recommends for active relapsing–remitting multiple sclerosis. Clinical trial evidence suggests that diroximel fumarate causes fewer gastrointestinal side effects than dimethyl fumarate.

Comparing the costs of diroximel fumarate and dimethyl fumarate is appropriate because the 2 treatments work in the same way and are likely be used in the same population. The total costs associated with diroximel fumarate are similar to or lower than those associated with dimethyl fumarate. So, diroximel fumarate is recommended.

  • National Institute for Health and Care Excellence (NICE)