Title: Diroximel fumarate for treating relapsing-remitting multiple sclerosis [ID1673]
Funder: Department of Health and Social Care

Abstract: Multiple sclerosis is a chronic neurological condition which affects the brain, optic nerves, and spinal cord. It often results in progressive neurological impairment and severe disability. Multiple sclerosis has an unpredictable course which varies in severity and rate of progression. Symptoms can include pain, disturbance to muscle tone including weakness or spasticity, chronic fatigue, unsteady gait, speech problems, incontinence, visual disturbance and cognitive impairment. Relapsing–remitting multiple sclerosis is the most common clinical form of multiple sclerosis. It is characterised by periods of remission (in which people may have fewer symptoms, or they may be relatively stable) followed by relapses (which may or may not result in residual disability). Relapsing–remitting multiple sclerosis can progress to secondary progressive multiple sclerosis, which is characterised by more persistent or gradually increasing disability; some people with secondary progressive disease continue to have relapses._x000D_ _x000D_ Approximately 131,000 people in the UK have multiple sclerosis, and about 7,000 people are diagnosed each year.[1] Approximately 85% of people are diagnosed with relapsing–remitting multiple sclerosis and around 50% of those people transition to secondary progressive multiple sclerosis within 20 years of diagnosis.[2] A small number of people are diagnosed with secondary progressive multiple sclerosis without a previous diagnosis of relapsing–remitting multiple sclerosis._x000D_ _x000D_ Current pharmacological management of relapsing–remitting multiple sclerosis includes disease-modifying agents to reduce the frequency and severity of relapses and the rate of disease progression._x000D_ _x000D_ NICE recommends the following treatment options for relapsing–remitting multiple sclerosis:_x000D_ _x000D_ • peginterferon beta-1a for relapsing–remitting multiple sclerosis (NICE TA624)_x000D_ _x000D_ • cladribine tablets for highly active multiple sclerosis only if the person has rapidly evolving severe relapsing–remitting disease or disease that has responded inadequately to treatment with disease-modifying therapy (NICE TA616)_x000D_ _x000D_ • ocrelizumab for active relapsing–remitting multiple sclerosis only if alemtuzumab is contraindicated or otherwise unsuitable (NICE TA533)_x000D_ _x000D_ • interferon beta-1a and glatiramer acetate for relapsing–remitting multiple sclerosis and interferon beta-1b for relapsing–remitting multiple sclerosis with 2 or more relapses within the last 2 years (NICE TA527)_x000D_ _x000D_ • teriflunomide and dimethyl fumarate for active relapsing–remitting multiple sclerosis, only if people do not have highly active or rapidly evolving severe relapsing–remitting multiple sclerosis (NICE TA303 and TA320 respectively)_x000D_ _x000D_ • alemtuzumab for highly active relapsing–remitting multiple sclerosis despite treatment with at least 1 disease-modifying therapy, or for rapidly evolving severe relapsing–remitting multiple sclerosis (NICE TA312)._x000D_ _x000D_ • fingolimod for highly active relapsing–remitting multiple sclerosis in adults who have an unchanged or increased relapse rate or ongoing severe relapses compared with the previous year despite treatment with beta interferon (NICE TA254)_x000D_ _x000D_ • natalizumab for rapidly-evolving severe relapsing–remitting multiple sclerosis (NICE TA127)._x000D_ _x000D_ References_x000D_ 1. Public Health England (2020) Multiple sclerosis: prevalence, incidence and smoking status - data briefing. Accessed July 2020._x000D_ 2. Multiple Sclerosis Trust (2017) Secondary progressive multiple sclerosis. Accessed May 2020.

Lay abstract: To appraise the clinical and cost effectiveness of diroximel fumarate within its marketing authorisation for relapsing–remitting multiple sclerosis.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: NEUROLOGICAL