The Evolving HTAi Statement on COVID-19 Vaccines

Abstract

Developments in COVID-19 have gone unprecedently fast, and HTAs have tried to keep pace, for example, in HTA-committees like the Joint Committee of Vaccination & Immunization. Necessarily, HTAs of COVID-19 related issues have been numerous and of a dynamic character to adequately cope with the rapidly changing landscape. HTAi drafted a statement on COVID-19 vaccines in the 2nd half of 2020 and an update in the 1st half of 2021. Here, we will address the role of real-world data (RWD) on effectiveness, safety and benefit/risk coming from the close monitoring programs around implementation in selected countries. Notably, an abundance of data came from Israel and the United Kingdom. Where the initial vaccination programs were designed based on clinical trials, HTA-committees continuously monitored observational data and dynamically re-designed the programs based on these. RWD have sometimes enhanced an increasing generic view on the vaccines, for example, concerning the use in older adults, as well as prioritizing specific ones for specific groups. RWD clearly show the effects of the vaccination programs on hospitalizations and deaths, in particular in those countries with an early kick-start of vaccination. Typically, cost-effectiveness analysis has so far not played any role in HTAs within crisis situations. We will address this in our presentation, illustrating potential value-for-money of the current vaccines in various country-specific settings looking at dynamic modelling and extensive data needs underlying economic assessments. Correspondingly, these models were initially populated with clinical trial data and are currently undergoing continuous updates as RWD come. Increasing interest in cost-effectiveness, dynamic pricing, tiered pricing in different parts of the world and enhanced competition will further shift attention to the economic aspects, further illustrating the dynamic character of HTAs in this field and HTAi's statement as an overall concept.