key: cord-0069601-vi9pbwao
authors: Santos, J
title: COVID-19 vaccination: what are the costs we should include?
date: 2021-10-20
journal: Eur J Public Health
DOI: 10.1093/eurpub/ckab164.201
sha: 40b8fbbeb93aa9faca0e86562c0f37223b4d0ba3
doc_id: 69601
cord_uid: vi9pbwao

As for previous communicable diseases, the vaccine against SARS-CoV-2 can be a truly “game-changing” factor to tackle the COVID-19 pandemic. A lot has been discussed about what is the less expensive vaccine and how health expenditures might be overrun with pandemic containment measures. There are interesting questions on cost estimation of this technology that should be discussed. The focus has been mainly on vaccine costs rather than on immunization delivery costs, which might also represent an important constraint. This includes human resources, equipment or maintenance which cannot be ignored. Such programs are highly dependent on labor supply, as well as on opportunity costs of reallocating an important share of health care workers for COVID-19 vaccination. On the other hand, costs regarding prevented health care use on COVID-19, from testing to intensive care unit, cannot be neglected, with associated opportunity costs as well. However, prevention of potentially needed measures such as lockdowns with effects in all spheres of society, such as economy and education, are of utmost relevance and are not commonly accounted for in health technology assessments. Furthermore, vaccines have important effects that are not commonly present in prescription drugs such as herd effect, protection against comorbidities or others to be explored in such a recent disease. Only a few efforts for COVID-19 vaccines' economic evaluations exist. However, at the same time, vaccines (and the rollout of vaccination programs) continue to be developed and improved. Therefore, such assessments will be important for studying boosters or revaccinations later on, but also for future pandemic preparedness. Moreover, such efforts on estimating vaccination cost-effectiveness, considering a wide range of costs, might be essential for sub-population prioritization.

Digital health is a strategic priority for the future of health in Europe. But development and deployment of digital solutions is not enough to guarantee a successful implementation. Public health services require a workforce that is ready to search and evaluate the best digital solutions for specific public health activities, such as epidemiological surveillance and health planning. Although there are some examples of digital health updated curricula in medical and public health schools, a coordinated and comprehensive approach should be proposed in Europe, including undergraduate, postgraduate and continuous education. Young professionals are certainly more digitally literate and should be involved in this discussion, but public health professionals from different ages and backgrounds should be considered. This presentation aims to promote discussion about digital public health education, identifying proposals for a renewed curriculum. During this discussion participants will be organized in small groups and will discuss proposals for a digital public health curricula, specifically tailored for three different target audiences: undergraduate medical students, public health students and public health professionals. This discussion will be guided by a facilitator and main conclusions will be considered for a concrete proposal prepared by the EUPHA Digital Health section. All participants will be offered the chance to be involved in following discussions. It is well known how vaccines typically require many years of research and testing before being on the market, but in 2020 the COVID-19 pandemic pushed scientists to embark on a race to produce safe and effective SARS-CoV-2 vaccines in record time. In such an emergency situation, striking the right balance between urgency and acceptable safety and efficacy evidence is challenging. Furthermore, other relevant issues need to be more comprehensively addressed, including cost-effectiveness of vaccination campaigns and real-world data on effectiveness and safety. Currently the European Medicines Agency (EMA) has approved for use four vaccines against COVID-19. Data on their efficacy and safety will continue to be collected beyond licensure and submitted to EMA, but the need for a more complete assessment, which includes contextual and societal considerations (e.g. impact on population health, population's demand, attitudes and behaviours, ethical considerations) and economic analysis, is unquestionable to support national decision-maker processes. In this kind of ''holistic'' approach, the Health Technology Assessment (HTA) could be the answer in order to support the allocation of resources into different COVID-19 vaccines and to make it possible a timely and equitable access to vaccination. As also stated in the HTAi Position Paper on ''HTA's Critical Role in the (Early) Assessment of (potential) Vaccines to prevent the spread of COVID-19 globally'', the following issues should be carefully tackled: 1) affordability, sustainability and distributional effects; 2) cost-effectiveness considerations; 3) fostering HTA collaborations; 4) need for early, adaptive and living HTA. Accounting for such issues is essential to ensure that HTA is successfully implemented in the field of COVID-19 vaccines, at the present time and in its future developments on a national and international scale. This workshop will discuss how HTA could help the EU-wide and national decision-making process about COVID-19 vaccines.

An adapted and living HTA framework considering the unique characteristics of COVID-19 vaccines could be an answer to current and future challenges in vaccination campaigns.

There are several challenges in current and future HTA of COVID-19 vaccines, namely the evaluation of their broad economic impacts, their effectiveness and safety and organization issues. 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 redesigned 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 countryspecific 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.

Joã o Vasco Santos J Santos 1,2,3

As for previous communicable diseases, the vaccine against SARS-CoV-2 can be a truly ''game-changing'' factor to tackle the COVID-19 pandemic. A lot has been discussed about what is the less expensive vaccine and how health expenditures might be overrun with pandemic containment measures. There are interesting questions on cost estimation of this technology that should be discussed. The focus has been mainly on vaccine costs rather than on immunization delivery costs, which might also represent an important constraint. This includes human resources, equipment or maintenance which cannot be ignored. Such programs are highly dependent on labor supply, as well as on opportunity costs of reallocating an important share of health care workers for COVID-19 vaccination. On the other hand, costs regarding prevented health care use on COVID-19, from testing to intensive care unit, cannot be neglected, with associated opportunity costs as well. However, prevention of potentially needed measures such as lockdowns with effects in all spheres of society, such as economy and education, are of utmost relevance and are not commonly accounted for in health technology assessments. Furthermore, vaccines have important effects that are not commonly present in prescription drugs such as herd effect, protection against comorbidities or others to be explored in such a recent disease. Only a few efforts for COVID-19 vaccines' economic evaluations exist. However, at the same time, vaccines (and the rollout of vaccination programs) continue to be developed and improved. Therefore, such assessments will be important for studying boosters or revaccinations later on, but also for future pandemic preparedness. Moreover, such efforts on estimating vaccination cost-effectiveness, considering a wide range of costs, might be essential for sub-population prioritization.

The role of HTA in COVID-19 vaccination campaign: the Italian experience Chiara Cadeddu C Cadeddu 1 , W Ricciardi 1 1 Section of Hygiene, University Department of Life Sciences, Università Cattolica del Sacro Cuore, Rome, Italy Contact: chiara.cadeddu@unicatt.it Issue/problem: Italy was one of the four European countries that started to join forces to accelerate access and distribution of a muchneeded vaccine against COVID-19. When the first vaccine was approved, a National Strategic Plan for COVID-19 vaccination, examining the most relevant domains for Health Technology Assessment (HTA), has just been issued in Italy. Description of the problem: Considering the possible provision of COVID-19 vaccines in the short time, in Autumn 2020 the necessity for a comprehensive assessment came up. In Italy HTA has been identified as the method for assessing the broad value of existing and new vaccines by the last two National Immunization Plans. However, the pandemic highlighted the need for a quick introduction and distribution of COVID-19 vaccines. A multidisciplinary Steering Group was therefore appointed by the Ministry of Health, in order to define vaccination strategies, organizational models, economic aspects, communication and social issues.

Taking into account plans already released by other countries, a National Strategic Plan for COVID-19 vaccination was issued in December 2020. Main topics covered were: epidemiology and priority groups to be immunized, logistic and organization, efficacy and safety monitoring, economic and burden of disease assessments, communication. The application of these recommendations has finally proven to be difficult, because of vaccines procurement delays, suspected adverse events, inequalities in the different Regional settings.

Given the concerns and difficulties faced by Italy and other European countries in the appraisal and management of COVID-19 vaccines, a HTA adapted framework could be an option for guiding the definition of National Strategic Plans. This could offer a common structured approach, make decision-making process more transparent, and be significant for a timely, convenient, and affordable access to new vaccines against SARS-CoV-2. Resilient health systems should be able to both respond to sudden shocks and adapt to structural changes. Structural fragilities in the health systems of EU countries were present before the COVID-19 pandemic and the crisis has just exacerbated these weaknesses, along with creating acute response capacity shortages. It became clear that health systems were largely unprepared for a shock of this magnitude. In order to be better prepared and able to respond more effectively towards the next health emergency, it is important to have robust tools and methods to measure the level of resilience in health systems. The workshop will present a new concept to carry out resilience testing of health systems against potential future shocks and adverse scenarios based on the opinion of the European Commission's Expert Panel on effective ways of investing in health. This will be followed by a discussion with experts on the practical development and implementation of this methodology. Format of the workshop:

Pitch on the resilience testing concept by a member of the Expert Panel on effective ways of investing in health (10 minutes) Responses by experts from three EU Member States and discussion (40 minutes) Concluding remarks by the OECD and the Observatory on Health Systems and Policies (10 minutes)

Getting real with future shocks: How to test health system resilience? Organised by: European Commission, HaDEA Chair persons: Massimo Fagnini (European Commission) Contact: massimo.fagnini@ec