GVS advice PCV15 (Vaxneuvance®) to prevent severe progression of pneumococcal disease in people in medical high-risk groups
The National Health Care Institute has assessed whether the 15-valent pneumococcal polysaccharide conjugate vaccine (PCV15, Vaxneuvance®) can be included in the Medicine Reimbursement System (GVS). This medicinal product can be used to prevent pneumonia and invasive disease caused by S. pneumoniae in people who fall into medical high-risk groups. The National Health Care Institute advises the Minister for Health, Welfare and Sport (VWS) to include PCV15 on List 1A of the GVS under certain conditions.
Condition for which the medicinal product can be applied
PCV15 (Vaxneuvance®) can be used for the prevention of pneumonia and invasive disease caused by S. pneumoniae in people who fall into medical high-risk groups. PCV15 is a 15-valent pneumococcal conjugate vaccine directed against 15 different types of Streptococcus pneumoniae. These are bacteria that can cause pneumococcal disease. Pneumococcal disease can lead to life-threatening complications such as meningitis, blood poisoning (sepsis) and severe pneumonia.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport to place 15-valent pneumococcal polysaccharide conjugate vaccine (PCV15, Vaxneuvance®) on List 1A of the Health Insurance Regulation (Rzv) in a newly formed cluster with the 13-valent pneumococcal polysaccharide conjugate vaccine (Prevenar13®). The standard dose of PCV15 and of PCV13 can be determined for both at a single dose (0.5ml). We also recommend that the existing List 2 condition applicable to pneumococcal vaccines also be applied to PCV15.
Medicine Reimbursement System (GVS)
PCV15 is an extramural drug. Extramural drugs are medicinal products for home use, available at the pharmacy on prescription from a physician. They will only be reimbursed from the basic health care package if they are listed in the GVS. The amount of the reimbursement depends on the list the product is on. Interchangeable medicinal products are clustered in List 1A. These may be subject to a reimbursement limit. Unique medicinal products are listed in List 1B. There is no reimbursement limit for these products. Additional conditions may apply for reimbursement. In that case, a medicinal product is also listed on List 2.
The Scientific Advisory Board (WAR) advises the National Health Care Institute on the assessment. Based on the assessment, the National Health Care Institute sends an advisory report to the Minister of Health, Welfare and Sport. The Minister makes the final decision whether or not to reimburse the medication from the basic health care package.