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.
Only for an insured person with highly active relapsing-remitting multiple sclerosis (RRMS):
- with highly active disease despite a full and adequate treatment with at least 1 diseasemodifying therapy (DMT).
- 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.