Summary

Multiple sclerosis (MS) is a chronic, inflammatory disease affecting the central nervous system (CNS). The symptoms depend on the location of the lesions in the CNS. The prevalence rate for multiple sclerosis in Norway is among the highest reported worldwide. This disease, which usually starts around the age of 30 (range 20-40), most commonly has a relapsing-remitting course in about half the patients, followed by a secondary progressive phase. Most patients experience increasing disability involving motor, sensory, visual, and bowel and bladder systems. The medicines used today in patients with signs or symptoms of inflammation are disease-modifying drugs. In 2016 the NIPH conducted a Health Technology Assessment (HTA), including a network meta-analyses, on 11 different medicines

(https://nyemetoder.no/metoder/multippel-sklerose-ms-fullstendig-metodevurdering).

The present Health Technology Assessment (HTA) have added two new medicines for the indication and removed a group of medicines (interferons) due to low priority use. We also included one medicine without marketing authorisation, rituximab (a drug with marketing authorisation for rheumatoid arthritis, B cell non-Hodgins's lymphomas and a few types of cancer), which is used off-label in MS-patients. We aim at examining the relative effect, safety and cost-effectiveness of these medicines used for multiple sclerosis in Norway. The report will also assess the legal and ethical implications using rituximab off-label.