GVS advice concerning siponimod (Mayzent®) for the treatment of secondary progressive multiple sclerosis
The National Health Care Institute has completed its assessment whether siponimod (Mayzent®) is interchangeable with a product that is included in the Medicine Reimbursement System (GVS). Based on the criteria for interchangeability, it can be concluded that siponimod (Mayzent®) is interchangeable with the second-line MS products in the GVS cluster 0L01BBCO V: fingolimod and cladribine. The National Health Care Institute's advice is to include siponimod (Mayzent®) in List 1A in cluster 0L01BBCO V with a standard dose of 2 mg. We also recommend the inclusion of siponimod (Mayzent®) on List 2 of the Health Insurance Regulation (Rzv) and imposing the conditions stated below.
Registered indication
Siponimod (Mayzent®) is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity.
Review of interchangeability
Based on the criteria for interchangeability, it can be concluded that siponimod (Mayzent®) is interchangeable with the second-line MS products in the GVS cluster 0L01BBCO V: fingolimod and cladribine.
The National Health Care Institute's advice
The National Health Care Institute recommends that siponimod (Mayzent®) be included in List 1A in cluster 0L01BBCO V with a standard dose of 2 mg. The National Health Care Institute also recommends the inclusion of siponimod (Mayzent®) on List 2 of the Health Insurance Regulation (Rzv) and imposing the conditions stated below.
Condition siponimod
Only for an insured person aged 18 years or older with active secondary progressive multiple sclerosis (SPMS) evidenced by relapses or imaging features of inflammatory activity and who has not responded to treatment with at least one disease-modifying medicinal product registered for the treatment of MS.
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.