Recommendations and Health Technology Assessment (HTA) landscape evaluation for pediatric pneumococcal conjugate vaccines (PCV) in Europe: A systematic literature review.

National Immunization Technical Advisory Groups (NITAGs) and Health Technology Assessment (HTA) agencies evaluate the value of vaccines and provide decision-making authorities with recommendations. The availability of information on disease-burden evidence considered or required for the assessment of vaccines included in national immunization programs (NIPs) is limited. The aim of this review is to summarize the epidemiologic and health economic (HE) evidence considered by NITAGs/HTA agencies when evaluating pediatric pneumococcal conjugate vaccine (PCV) NIPs. A systematic literature review of national recommendation reports for PCV NIPs in children in 31 European countries, published since 2001, was performed using NITAG/HTA agency websites, Google, MEDLINE, and EMBASE. The presence of epidemiological data was mapped, HE data was extracted, and findings were summarized. A total of 46 records for 19 countries were identified. Fifteen countries' records included a recommendation concerning implementation of PCV NIP, switching from one PCV to another or a change in vaccination schedule within an existing NIP. All of these included epidemiological invasive pneumococcal disease data, and to varying degree epidemiological data on acute otitis media and pneumonia. HE data was referenced in 13 countries' records, with 8 countries providing in-depth details on cost-effectiveness analyses. Pediatric PCV NIP recommendations were published by 61% of European countries, with varying degree of details and decision rationale. Some countries only publish the HE aspect of their rationale. The identified material can provide insight and support local policymakers and clinicians how data influenced the decision-making process in their countries.