GVS assessment of ozanimod (Zeposia®) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS)

The National Health Care Institute has completed its assessment whether ozanimod (Zeposia®) for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease, as defined by clinical characteristics or characteristics visible on imaging, can be included in the Medication Reimbursement System (GVS). The National Health Care Institute's advice is to include ozanimod (Zeposia®) on List 1A of the GVS in cluster 0N07XXCO V.

Registered indication

Ozanimod (Zeposia®) is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease, as defined by clinical characteristics or characteristics visible on imaging.

Ozanimod is available as hard capsules. Each hard capsule contains 0.23 mg, 0.46 mg or 0.92 mg ozanimod and the recommended maintenance dose is 0.92 mg once a day.

Interchangeability

Based on the criteria for interchangeability, it can be concluded that ozanimod (Zeposia®) is interchangeable with the other medicinal products in the GVS cluster 0N07XXCO V, which includes: dimethyl fumarate and teriflunomide.

The National Health Care Institute's advice

The National Health Care Institute advices the Minister of Medical Care to include ozanimod (Zeposia®) in cluster 0N07XXCO V on List 1A of the GVS. 0.92 mg/day can be applied as the standard dose.

This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.