Dr. Laura Prünte, Michael Barth, Nico Johannes Urban
(Meeting-Abstract; präsentiert auf der 28. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA), 11.–12.11.2021)
From vaccine approval to reimbursement: an analysis of discrepancies between label according to marketing authorization and indication for reimbursement listed in the Vaccination Policy (SI-RL) in Germany
The Robert Koch Institute (RKI) is part of the Federal Ministry of Health and the official institution in Germany in the field of disease surveillance and prevention. The Standing Commission on Vaccination (STIKO) is an independent panel of experts at the RKI and is responsible for developing recommendations for the use and analysis of licensed vaccines. The aim of this work was to record and analyze discrepancies between label (according to marketing authorization) and indication for reimbursement listed in the Vaccination Policy (SI-RL) according to § 20i Abs. 1 SGB V for vaccines that were approved after 01 April 2006 in Germany and recommended by the STIKO after November 2012. COVID-19 vaccines were not considered.
Materials and Methods
All vaccines approved in Germany and listed in the Vaccination Policy (SI-RL) were recorded. Duplicates, combined and imported vaccines were removed. The dates of decision on reimbursement of vaccines were recorded, the discrepancies between label of vaccines and reimbursement were rated, and the results of STIKO meetings since November 2012 were evaluated.
Out of a total of 440 identified vaccines, 7 vaccines remained after exclusion (IXIARO®, Bexsero, Trumenba®, Rotarix, RotaTeq®, Shingrix, Zostavax®). The period between approval and reimbursement ranged between “no delay” for Trumenba® and 136 months for IXIARO®, and 6 vaccines are reimbursed (IXIARO®: only reimbursed for stays abroad due special interest; Bexsero 6% of label population; Trumenba®: 7%; Rotarix: 100%; RotaTeq®: 100%, Shingrix: 59%).
25 STIKO-meetings were evaluated. The average time between first discussion and first STIKO assessment was 36 months (minimum 6 months for the measles/mumps/rubella/varicella (MMR-V) combination vaccine and maximum 86 months for varicella vaccine). HPV vaccine was discussed most often (26 times) and the measles/mumps/rubella/varicella combination vaccine was least discussed (once). The number of STIKO decisions were between 2 for the diphtheria/Haemophilus influenzae type B/hepatitis B/pertussis/poliomyelitis/tetanus combination vaccine, the MMR-V combination vaccine and the Japanese encephalitis and the meningococci (type B) vaccine and 7 for the influenza, pneumococcal and shingles vaccines.
Approval of a vaccine does not automatically result in guaranteed reimbursement for the label population; for the most part, reimbursement is provided for a subpopulation. STIKO recommendations are published according to STIKO priorities and the content and timing of STIKO recommendations are difficult to predict due to many possible influencing factors.