Changing Vaccine Assessment Criteria and Focus Towards Prevention Strategies

ABSTRACT

Objectives: To understand changes to granting access to novel vaccines by NITAG and payers and how prevention has become a focus in many markets Methods: Secondary research by studying various NITAG documents and published articles followed by primary research with experts in EU4 and UK Results: For NITAG recommendations, disease burden, vaccine efficacy, vaccine safety, followed by Epidemiology and mathematical modelling are conducted by most Western countries. Published studies on efficacy, effectiveness and reactogenicity are considered as key reference. UK specifically takes into account health economic modelling outputs. Recommendations in other markets are also considered in making local decisions. For vaccine funding payers consider the efficacy, durability and dosing regimen as key drivers, followed by aspects of strain coverage, formulation and storage. Platform were not considered by payers, while physicians considered it to be very important. For cost containment reasons, many NITAGs issue a recommendation for a narrow patient population Payers in all markets indicated that there is focus or prioritization of prevention strategies from ongoing COVID-19 pandemic and are likely to remain. UK for instance has increased its prevention budgets;however, this does not mean there is higher willingness to pay. In Germany there is no ring-fenced prevention specific budget. Conclusion(s) Severity of the disease is an important criterion in assessing the burden, an influential factor in vaccine decision making. In all countries in focus, Payers anticipate that the evaluation of new vaccines launched post-COVID-19 to be faster. Structural changes in Italy (restructure of AIFA and new NITAG) and UK (new public health agency), add to uncertainties on timelines. The length of the evaluation process will depends mainly on pre-work done with availability of local data on burden, epidemiology, and cost-effectiveness modelling.Copyright © 2023