GVS advice on natalizumab SC (Tysabri®) for adult patients with highly active RRMS
The National Health Care Institute has completed its assessment whether natalizumab SC (Tysabri®) can be included in the Medicine Reimbursement System (GVS). Natalizumab SC (Tysabri®) is used for the treatment of adult patients with highly active RRMS. The National Health Care Institute advises the Minister to include natalizumab SC (Tysabri®) on List 1A of the Health Insurance Regulation (Rzv) in a new to be formed cluster with ofatumumab.
Registered indication
Natalizumab SC is available as a 150 mg solution for injection in a pre-filled syringe. It is indicated for the treatment of adult patients with highly active relapsingremitting multiple sclerosis (RRMS) for the following patient groups:
- Patients with highly active disease despite a full and adequate treatment with at least 1 diseasemodifying therapy (DMT). Or;
- Patients with rapidly evolving severe RRMS, defined by 2 or more disabling relapses in 1 year, and with 1 or more gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesions load as compared to a previous recent MRI.
The National Health Care Institute's advice
The National Health Care Institute advises the Minister to place natalizumab SC (Tysabri®) on List 1A of the Health Insurance Regulation (Rzv) in a new to be formed cluster with ofatumumab. The standard dose of natalizumab SC and that of ofatumumab can be set at 10.7 mg and 0.66 mg per day respectively.