GVS assessment of 13-valent pneumococcal conjugate vaccine (Prevenar13®) for medical high-risk groups
The National Health Care Institute has completed its assessment whether 13-valent pneumococcal conjugate vaccine (PVC13; Prevenar13®) is interchangeable with a product that is included in the medication reimbursement system (GVS). The National Health Care Institute's advice is to remove PCV13 (Prevenar13®) from List 3B and include it in List 1B and List 2 of the GVS.
Registered indication
PCV13 is registered for the following indications:
- Active immunization for the prevention of invasive diseases, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents aged 6 weeks to 17 years.
- Active immunization for the prevention of invasive diseases and pneumonia caused by Streptococcus pneumoniae in adults aged 18 years and older.
The marketing authorisation holder has requested inclusion in List 1B of the Health Insurance Act for persons belonging to the medical risk groups for which the National Coordination Centre for Communicable Disease Control (LCI) of the National Institute for Public Health and the Environment (RIVM) in its recent guideline “Pneumococcal disease” (last update 2020; website in Dutch) recommends vaccination with PCV13 in sequential combination with the 23-valent polysaccharide vaccine (PPV23; Pneumovax®) and for which PPV23 is already included in the Medicine Reimbursement System (GVS).
Assessment
There is no medicinal product in the GVS that is interchangeable with PCV13 (Prevenar13®). Based on this, PCV13 (Prevenar13®) cannot be placed on List 1A. Next, the National Health Care Institute assessed whether PCV13 (Prevenar13®) is eligible for inclusion on List 1B.
The National Health Care Institute's advice
Based on the considerations mentioned in the report, the National Health Care Institute recommends removing PCV13 (Prevenar13®) from List 3B and including it for the active immunization for the prevention of pneumonia and invasive diseases caused by S. pneumoniae in medical high-risk groups in List 1B and List 2 of the Health Insurance Act. This means an adaptation of the current further condition regarding pneumococcal vaccine. Inclusion in List 1B will lead to additional costs.
Pneumococcal vaccine conditions (List 2)
only for insured persons:
- that fall into a medical high-risk group and have been designated in accordance with the (international) guidelines accepted in the Netherlands by the relevant professional groups.
- who, as a result of COVID-19, have been hospitalised, and
- whose thorax CT shows residual abnormalities (fibrosis, and/or bronchial disorders, and/or persistent infiltrative abnormalities/atelectasis), and
- who show abnormalities in lung function (FVC < 70% and/ or Z score < 2.00, or FEV1/FVC Z ratio score < -1.64 and FEV1 < 50% of predicted, or DLCOc < 60%).
This report is a summary of recommendations by the National Health Care Institute. The original text is in Dutch.