Review of Health Technology Assessment (HTA) and Recommendations for the Introduction of Higher-Valency Pneumococcal Conjugated Vaccine (PCV) in 4 European Countries, The United-Kingdom (UK), and The United-States (US)

OBJECTIVES: To understand how National Immunisation Technical Advisory Groups (NITAGs) and HTA agencies evaluated higher-valency PCVs in children, elderly, and at-risk populations, by summarising evidence considered and identifying key drivers/barriers for recommendations.

METHODS: A narrative review was conducted on NITAGs and HTA agencies’ websites of France, Germany, Spain, the Netherlands, the UK, and the US. Records including recommendations coupled with justifications, published between 2009 and 2022, were included. Populations targeted, vaccines assessed, criteria for decision-making, evidence reviewed and final decisions were extracted.

RESULTS: Overall, 27 records were identified including 10 assessments for children, 11 for elderly, and 19 for at-risk groups. For children, 8 and 7 records assessed PCV13 and PCV10, respectively. For elderly and at-risk groups, all records assessed PCV13 except one on PCV15 and PCV20 in both populations and one on PCV10 in at-risk children. Burden of disease, immunogenicity, and efficacy data (n=26) were the most reported criteria, followed by the impact of current vaccination programmes (n=22), safety data (n=21), and economic evaluations (n=18).

All countries issued positive recommendations for replacing PCV7 by higher-valency PCVs in childhood vaccination programmes, driven by their broader serotype coverage and acceptable vaccine profiles. For the elderly, the US issued positive recommendations for the routine use of PCVs. Whereas, for the other countries, the major barrier was the important herd effect from the childhood vaccination programmes making PCV13 use likely not cost-effective in the elderly. For at-least high-risk groups, all countries recommended the use of PCVs in series with polysaccharide vaccine (or PCV20 as stand-alone in the US), driven by the high burden in this population and expected benefits of PCVs over polysaccharide vaccine.

CONCLUSIONS: This research provides an overview of data used in decision-making for higher-valency PCV recommendations and will be of interest to anticipate the evolution of recommendations with next generation of PCVs.