Introduction
Methods
Meningococcal vaccines: an international comparison of decision-making processes, frameworks, and methodologies
Literature review: rapid evidence assessment
Literature search
Model type and assumptions
Country comparisons: methodology for health technology appraisal and decision-making
Country | Health technology appraisal method |
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Australia | Decisions to approve vaccine reimbursement rest with the Department of Health (DoH) within the federal government. The Pharmaceutical Benefits Advisory Committee (PBAC) provides guidance to the DoH regarding whether to include the vaccine in the Pharmaceutical Benefits Scheme or the National Immunisation Program. The Economic Sub-Committee of the PBAC is responsible for evaluating and interpreting economic analyses of health technologies; this guidance, combined with additional input from the Australian Technical Advisory Group on Immunisation and another independent group (frequently academic health economists) is used for comprehensive assessments of vaccine applications. Uncertainty surrounding economic evaluation outputs is acknowledged and clearly considered in final decision-making |
France | Vaccination policy in France is developed by the Ministry of Health based on recommendations from the Technical Vaccination Committee (CTV), an independent expert committee that devises immunization strategies and provides advice—including economic evaluations—on new vaccines. The CTV provides pharmacoepidemiologic evidence, disease modeling, and assessment of vaccination strategies during dossier evaluation. If deemed necessary by the CTV, vaccine cost, program cost, affordability, or financial sustainability may also be evaluated. After consideration of evidence from the CTV and the Commission for Transparency, which determines the impact of the vaccine on public health services, the final decision regarding integration into the national immunization schedule is made by the High Authority of Health |
Germany | In Germany, vaccination recommendations at a national level are made by the Standing Committee on Vaccination (STIKO). Based on the STIKO recommendations, the Federal Joint Committee (G-BA) decides whether a vaccine is included in the mandatory service of statutory health insurances. STIKO recommendations principally rest on a risk–benefit assessment that includes a number of criteria described in a standard operating procedure. The criteria list comprises, among others, efficacy, effectiveness, safety, number needed to vaccinate, and expected population-level effects. Economic analyses are not obligatory but may be considered when based on independently funded models. QALYs can be used as a summary measure of health outcome, although the STIKO and the G-BA have not set a cost-per-QALY threshold |
Italy | The recommendation of health technologies in Italy is conducted at the national level, but because of a highly decentralized national health service, decisions by the National Ministry of Health are nonbinding on local health authorities. The National Vaccine Prevention Plan issued by the Ministry of Health provides guidance and recommendations at the national level. However, decisions surrounding vaccine adoption may differ from region to region because some vaccines are mandatory at a national level and administration of others is determined within each region. Italian guidelines use cost-effectiveness analyses and QALYs as the foundation of economic evaluations |
Japan | Regulation of vaccines and other heath technologies requires coordination between the Japanese Ministry of Health, Labor, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency. In 2009, the Infectious Disease Sectional Committee made a recommendation to the government leading to inclusion of economic evaluations in decisions regarding vaccine adoption. The Health Science Council, also within the MHLW, is responsible for considering cost-effectiveness, but this evaluation is not required |
New Zealand | The Pharmaceutical Management Agency (PHARMAC) in New Zealand decides the public funding of pharmaceutical products, including vaccines. PHARMAC evaluates 4 parameters when assessing a product: need, health benefits, costs and savings, and suitability. In addition, the agency considers 3 levels of impact on society: personal, health sector, and wider society. Information also considered for vaccine efficacy modeling are degree and length of protection, age at administration, dosing schedule adherence, adverse reactions, possible loss of potency due to cold chain issues, and herd protection. The final decision for vaccine adoption rests with the Minister of Health based on the PHARMAC evaluation |
The Netherlands | The Dutch Ministry of Health decides whether to add a new vaccine to the national immunization plan and/or the “positive list” based on guidance from a Health Council subcommittee and the Drug committee, respectively. The Health Council subcommittee considers 2 assessments, the first by the National Institution for Public Health and Environment (RIVM), and the second, often by a university. One main criterion for evaluation are economic analyses. The Drug committee conducts 1 assessment, using materials submitted by the vaccine manufacturer, which must include a cost-effectiveness analysis. Recently, a new policy has been implemented to streamline the evaluation process to include only the RIVM and manufacturer-sponsored assessments. Vaccine evaluation is prioritized by the Ministry of Health, based mostly on severity and health burden of the disease in question, whereas evaluation by the Drug committee for inclusion in the positive list is not prioritized but initiated by the manufacturer. Recommendations of the Health Council subcommittee and Drug committee include information about the degree of uncertainty in the analyses and how this uncertainty may influence the robustness of the outcomes; a vaccine is not introduced if uncertainties are too influential or the severity is not considered high enough |
Expert interview results
Measuring disease burden
Consideration of vaccine benefits
Benefit | Description |
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Economic and financial | |
Labor force | Increased productivity and tax revenues |
Education | Increased school attendance leading to better education and greater potential productivity as an adult |
Medical care | Lower use of healthcare resources |
Outbreak control | Lower expenditure on outbreak response |
Indirect costs | Lower mortality associated with meningococcal disease (cause of death shifts to other diseases with different associated costs) |
Health | |
Herd effects | Reduction in disease incidence among unvaccinated individuals due to decreased transmission of the pathogen |
Comorbidities | Lower risk of developing secondary comorbidity associated with primary disease |
Nosocomial infections | Lower risk of acquiring additional infection while hospitalized for primary disease |
Antimicrobial resistance | Reduced incidence of resistant infections in the population due to reduced reliance on antibiotics |
Health systems | Less strain on health systems, increasing capacity to treat other conditions |
Societal | |
Family members/caregivers | Lower burden (financial, psychological) on those caring for survivors |
Leisure | Improved quality of leisure time due to better health |
Peace of mind | Less anxiety at the individual and societal level about contracting meningococcal disease |
Equity | Increased socioeconomic equity and increased access to preventive care for disadvantaged groups |
Political implications | Lower infant/child mortality is correlated with stable political systems |