Original Title: Natalizumab subkutant til behandling av relapserende remitterende multippel sklerose: forenklet metodevurdering – helseøkonomisk evaluering

Authors' objectives: The Norwegian Institute of Public Health (NIPH) have conducted a rapid health technology assessment (HTA) of the subcutaneous (SC.) administration of natalizumab for treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) on behalf of the Commissioning Forum. The evaluation was performed based on the decision model in the full HTA, previously published of NIPH, of the drugs for the treatment of RRMS. The model was further updated based on the data for natalizumab SC.

Authors' results and conclusions: Natalizumab S.C. is a new route of administration of natalizumab. The results from a phase II-study showed that the effect (annual at-tack rate and new MRI lesions) of natalizumab SC. is comparable to natalizumab intravenously (IV.). We evaluated the health benefit and resource use of natalizumab SC. compared to rituximab, the most cost-effective treatment, and cladribine which is also used to treat highly active RRMS. The results of our analyses showed that: A reduction of approximately xxxx in drug costs for natalizumab SC. results in that the treatment costs NOK xxxxxxxx per quality-adjusted life-year (QALY) gained compared with rituximab, given the same health benefit as natalizumab IV. Given the same health benefit as natalizumab IV., natalizumab SC. is marginally more effective (0.017 QALYs) than rituximab. A price offer of xxxxxxxx (incl. VAT) per 300 mg natalizumab SC. gives an additional cost of approximately NOK xxxxxxxx per QALY compared with rituximab. A reduction of approximately xxxx in drug costs for natalizumab SC. results in that the treatment costs NOK xxxxxxxx per QALY compared with cladribine, given the same health benefit as natalizumab IV. Given the same health benefit as natalizumab IV., natalizumab SC. is more effective (0.238 QALYs) than cladribine. A price offer of NOK xxxxxxxx (incl. VAT) per 300 mg natalizumab SC. gives an additional cost of approximately xxxxxxxx per QALY compared with cladribine. Relapsing-remitting multiple sclerosis is a very severe disease that can cause serious disability and a loss of healthy life-years. Due to clauses of confidentiality, numbers are hidden (xxxxxx).

Project Status: Completed

Year Published: 2021

URL for published report: https://www.fhi.no/en/publ/2021/Natalizumab-subcutaneous-treatment-RRMS/

English language abstract: An English language summary is available

Publication Type: Other

Country: Norway

Organisation Name: Norwegian Institute of Public Health

Contact Address: P.O. Box 222 Skoyen, N-0123, Oslo