GVS assessment of a 4 component meningococcal B vaccine (Bexsero®)
The National Health Care Institute has completed its assessment whether the product 4 component meningococcal B vaccine (4CMenB) (Bexsero®) is interchangeable with another product that is included in the Medication Reimbursement System (GVS). None of the medicinal products included in the Medicine Reimbursement System are interchangeable with 4CMenB (Bexsero®). Based on this criterion, 4CMenB (Bexsero®) cannot be placed on List 1A. The National Health Care Institute advises the Minister for Medical Care to include 4CMenB (Bexsero®) on List 1B and List 2 of the GVS and that the conditions stated below be imposed.
Registered indication
Bexsero® is indicated for the active immunisation of patients aged 2 months and above against invasive meningococcal disease caused by Neisseria meningitidis group B.
Therapeutic value
The National Health Care Institute has concluded that the 4CMenB vaccine for the active immunisation of patients with complement deficiency or hyposplenia/asplenia (functional) against invasive meningococcal disease caused by Neisseria meningitidis group B has added value compared to non-vaccination.
The National Health Care Institute's advice
The National Health Care Institute recommends that 4CMenB (Bexsero®) for the active immunisation of patients with complement deficiency (congenital or acquired through use of the medicinal product eculizumab) or hyposplenia/asplenia (functional) against invasive meningococcal disease caused by Neisseria meningitidis group B be included in List 1B and List 2 of the Health Insurance Regulation and that the conditions stated below be imposed.
Condition for 4 component meningococcal B vaccine (Bexsero®)
Insured individuals aged 2 months and above with:
- a congenital complement deficiency;
- an indication for use of the medicinal product eculizumab;
- hyposplenia/asplenia (functional), who run a high risk of invasive meningococcal disease.
Preceding current assessment
In 2018, at the request of the State Secretary of Health, Welfare and Sport, the National Health Care Institute assessed the effectiveness and cost-effectiveness of Bexsero® for vaccination of the general population against invasive meningococcal disease caused by Neisseria meningitidis group B. As this concerned a reimbursement application for vaccination of the general population, the National Health Care Institute was unable to issue a ruling concerning the inclusion of Bexsero® in the Medicine Reimbursement System.