Evaluating Vaccination Programs That Prevent Diseases With Potentially Catastrophic Health Outcomes: How Can We Capture the Value of Risk Reduction?

In the last 5 years, guidelines have been developed for performing cost-effectiveness analyses (CEAs) for the economic evaluation of vaccination programs against infectious diseases. However, these cost-effectiveness guidelines do not provide specific guidance for including the value of reducing the risk of rare but potentially catastrophic health outcomes, such as mortality or long-term sequelae. Alternative economic evaluation methods, including extended CEA, the impact inventory, cost-benefit analyses, willingness to pay or the value of a statistical life, to capture the value of this risk reduction could provide more complete estimates of the value of vaccination programs for diseases with potentially catastrophic health and nonhealth outcomes. In this commentary, using invasive meningococcal disease as an example, we describe these alternative approaches along with examples to illustrate how the benefits of vaccination in reducing risk of catastrophic health outcomes can be valued. These benefits are not usually captured in CEAs that only include population benefits estimated as the quality-adjusted life-years gained and reduced costs from avoided cases.

Cost-Effectiveness of 4CMenB Infant Vaccination in England: A Comprehensive Valuation Considering the Broad Impact of Serogroup B Invasive Meningococcal Disease.

OBJECTIVES: This cost-effectiveness analysis (CEA) of 4CMenB infant vaccination in England comprehensively considers the broad burden of serogroup B invasive meningococcal disease (MenB IMD), which has not been considered, or was only partially considered in previous CEAs. METHODS: A review of previous MenB vaccination CEAs was conducted to identify aspects considered in the evaluation of costs and health outcomes of the disease burden of MenB IMD. To inform the model structure and comprehensive analysis, the aspects were grouped into 5 categories. A stepwise analysis was conducted to analyze the impact of each category, and the more comprehensive consideration of disease burden, on the incremental cost-effectiveness ratio (ICER). RESULTS: MenB IMD incidence decreased by 46.0% in infants and children 0-4 years old within 5 years after introduction of the program. Stepwise inclusion of the 5 disease burden categories to a conventional narrow CEA setting reduced the ICER from £360 595 to £18 645-that is, considering the impact of all 5 categories, 4CMenB infant vaccination is cost-effective at a threshold of £20 000 per QALY gained. CONCLUSIONS: When considering comprehensively the MenB IMD burden, 4CMenB infant vaccination can be cost-effective, a finding contrary to previous CEAs. This analysis allows policy decision-makers globally to infer the impact of current disease burden considerations on the cost-effectiveness and the comprehensive assessment necessary for MenB IMD. Although this comprehensive CEA can help inform decision making today, it may be limited in capturing the full disease burden and complex interactions of health and economics of MenB IMD.

A DELPHI study on aspects of study design to overcome knowledge gaps on the burden of disease caused by serogroup B invasive meningococcal disease.

BACKGROUND: Value assessment of vaccination programs against serogroup B invasive meningococcal disease (IMD) is on the agenda of public health authorities. Current evidence on the burden due to IMD is unfit for pinning down the nature and magnitude of the full social and economic costs of IMD for two reasons. First, the concepts and components that need to be studied are not agreed, and second, measures of the concepts that have been studied are weak and inconsistent. Thus, the economic evaluation of the available serogroup B meningococcal (MenB) vaccines is difficult. The aims of this DELPHI study are to: (1) agree on the concepts and components determining the burden of MenB diseases that need to be studied; and (2) seek consensus on appropriate methods and study designs to measure quality of life (QoL) associated with MenB induced long-term sequelae in future studies. METHODS: We designed a DELPHI questionnaire based on the findings of a recent systematic review on the QoL associated with IMD-induced long-term sequelae, and iteratively interviewed a panel of international experts, including physicians, health economists, and patient representatives. Experts were provided with a controlled feedback based on the results of the previous round. RESULTS: Experts reached consensus on all questions after two DELPHI rounds. Major gaps in the literature relate (i) to the classification of sequelae, which allows differentiation of severity levels, (ii) to the choice of QoL measures, and (iii) to appropriate data sources to examine long-term changes and deficits in patients' QoL. CONCLUSIONS: Better conceptualisation of the structure of IMD-specific sequelae and of how their diverse forms of severity might impact the QoL of survivors of IMD as well as their family network and care-providers is needed to generate relevant, reliable and generalisable data on QoL in the future. The results of this DELPHI panel provide useful guidance on how to choose the study design, target population and appropriate QoL measures for future research and hence, help promote the appropriateness and consistency in study methodology and sample characteristics.

Public health management of invasive meningococcal disease in Baden-Wuerttemberg, Germany, 2012: adherence to guidance and estimation of resources required as determined in a survey of local health authorities.

BACKGROUND: Invasive meningococcal disease (IMD) incidence in Germany is low, but management of contacts to prevent subsequent cases still requires resources. Local public health authorities (LHA) advise antibiotic post-exposure prophylaxis (PEP) and vaccination to close contacts as defined in national guidance. We aimed to audit implementation of recommendations for IMD public health management in the state of Baden-Wuerttemberg, Germany, and to estimate associated costs. METHODS: We surveyed all 38 LHAs in Baden-Wuerttemberg to evaluate knowledge of national guidance and implementation of IMD contact management using standardized questionnaires. For IMD cases notified in 2012, we requested numbers of household and other contacts ascertained, including advice given regarding PEP and post-exposure vaccination, plus staff time required for their management. We estimated costs for advised antibiotics, LHA staff time and visits to emergency departments according to published sources. The cost of preventing a subsequent case was estimated based on the number of household contacts that received PEP per IMD case and on the previous finding that ~284 household contacts must receive PEP to prevent one subsequent IMD case. RESULTS: Although LHAs were familiar with national recommendations, they did not advise PEP to 4% of household contacts, while 72% and 100% of school and health provider contacts, respectively, were advised PEP. Only 25% of household contacts of a case with a vaccine-preventable serogroup were advised post-exposure vaccination. A mean of 11.0 contacts/IMD case (range 0-51), of which 3.6 were household contacts, were recommended PEP. Per IMD case, mean costs for LHA staff were estimated at €440.86, for antibiotics at €219.14 and for emergency department visits to obtain PEP at €161.70 - a total of €821.17/IMD case. Preventing a subsequent IMD case would cost ~ €65,000. CONCLUSIONS: Our results provide insight into costs of IMD public health management in Germany. We identified marked underuse of post-exposure vaccination in household contacts and overuse of PEP in school and health care contacts. In view of an estimated 3-6 quality-adjusted life years lost per case of IMD, our estimated cost of €65,000 for preventing a subsequent case seems justifiable.

Estimating costs associated with a community outbreak of meningococcal disease in a colombian Caribbean city.

Meningococcal disease is a serious and potentially life-threatening infection that is caused by the bacterium Neisseria meningitidis (N. meningitidis), and it can cause meningitis, meningococcaemia outbreaks and epidemics. The disease is fatal in 9-12% of cases and with a death rate of up to 40% among patients with meningococcaemia. The objective of this study was to estimate the costs of a meningococcal outbreak that occurred in a Caribbean city of Colombia. We contacted experts involved in the outbreak and asked them specific questions about the diagnosis and treatment for meningococcal cases during the outbreak. Estimates of costs of the outbreak were also based on extensive review of medical records available during the outbreak. The costs associated with the outbreak were divided into the cost of the disease response phase and the cost of the disease surveillance phase. The costs associated with the outbreak control and surveillance were expressed in US$ (2011) as cost per 1,000 inhabitants. The average age of patients was 4.6 years (SD 3.5); 50% of the cases died; 50% of the cases were reported to have meningitis (3/6); 33% were diagnosed with meningococcaemia and myocarditis (2/6); 50% of the cases had bacteraemia (3/6); 66% of the cases had a culture specimen positive for Neisseria meningitidis; 5 of the 6 cases had RT-PCR positive for N. meningitidis. All N. meningitidis were serogroup B; 50 doses of ceftriaxone were administered as prophylaxis. Vaccine was not available at the time. The costs associated with control of the outbreak were estimated at US$ 0.8 per 1,000 inhabitants, disease surveillance at US$ 4.1 per 1,000 inhabitants, and healthcare costs at US$ 5.1 per 1,000 inhabitants. The costs associated with meningococcal outbreaks are substantial, and the outbreaks should be prevented. The mass chemoprophylaxis implemented helped control the outbreak.

Lifecycle model-based evaluation of infant 4CMenB vaccination in the UK.

OBJECTIVES: Invasive meningococcal disease, an uncommon but severe disease, imposes catastrophic health and economic burdens. Cost-utility analysis (CUA) assumes separability in lifetime health and economic variables and cannot capture the full value of preventing such burdens. We overcome these limitations with a retrospective societal perspective cost-benefit analysis (CBA) of meningococcal serogroup B vaccination (4CMenB) of one infant cohort in the United Kingdom using a health-augmented lifecycle model (HALM) incorporating health's interactions with consumption, earnings, non-market time and financial risk. METHODS: We used a static Markov model of vaccination's health impact and an HALM to estimate the private willingness to pay (PWTP) for the intrinsic and instrumental value of health under perfect capital markets, financial risk protection in the absence of insurance against permanent disability, parental spillovers, and acute phase disability. We estimated social WTP (SWTP) incorporating social severity preferences. We estimated rates of return that inform health payer reimbursement decisions, finance ministry budgeting decisions, and legislature taxation decisions. An expert Advisory Board investigated the validity of applying the HALM to infant 4CMenB. RESULTS: The PWTP for a 2 + 1 vaccination schedule is £395, comprising £166 of disability insurance value, £79 of positive parental spillover value, £28 in the value of averting acute phase disability, and £122 in residual intrinsic and instrumental value of health. SWTP is £969. CONCLUSIONS: HALM-based CBA provides an empirically richer, more utility-theoretically grounded approach to vaccine evaluation than CUA, demonstrating good value for money for legislatures (based on private values) and for all decision-makers (based on social values).

Economic evaluation on meningococcal vaccination strategies among children under nine years of age in Zhejiang province, China.

Meningococcal vaccination in Chinese national immunization program (NIP) includes polysaccharide vaccine against Neisseria meningitidis serogroup A (MPV-A) and polysaccharide vaccine against Neisseria meningitidis serogroup A and C(MPV-AC). This study aimed to assess the cost-effectiveness of an alternative strategy using polysaccharide conjugate vaccine against Neisseria meningitidis serogroup A,C,W,Y(MCV-ACWY) and polysaccharide vaccine against Neisseria meningitidis serogroup A,C,W,Y(MPV-ACWY). From a societal perspective, we constructed a decision tree-Markov model to simulate the economic and health consequences of meningococcal disease in a 2023 birth cohort with the current meningococcal vaccination strategy and the alternative. Parameters of epidemiology, vaccine efficacy, cost, and utility were extracted from database and previous literatures. The sensitivity analysis was implemented to evaluate the robustness of the model. Compared to the current practice, the alternative strategy could avoid 513 meningococcal disease cases, 53 sequelae and 47 deaths. The ICER was estimated at $16899.81 /QALY, under the threshold of one time of the GDP per capita of Zhejiang province in 2023. The incidence of meningococcemia, the incidence of meningococcal meningitis, the case fatality of meningococcemia, the vaccine efficacy of MCV-ACWY and the price of MCV-ACWY would influence the cost-effectiveness of the meningococcal vaccination strategies. At the threshold, the probability of cost-effectiveness was 14.76% for the current strategy and 55.98% for the alternative strategy, respectively. The current meningococcal vaccination strategy had effectively prevented meningococcal disease at a low cost, but with limited serogroup coverage. Strategy using MCV-ACWY and MPV-ACWY could increase health benefits at a substantial cost at a cost-effective manner.

Cost impact of complications in meningococcal disease: evidence from a United States managed care population.

OBJECTIVES: To compare health care utilization and associated costs among patients with and without invasive meningococcal disease (IMD)-related sequelae. METHODS: A retrospective analysis of an administrative claims database from 1998-2009 was performed. Patients with an IMD-related inpatient admission and continuous health plan enrollment selected and categorized by presence (complicated-IMD) or absence (uncomplicated-IMD) IMD-related sequelae during the follow-up year. Differences in the follow-up year healthcare utilization and costs between the two groups tested using univariate and multivariable analyses. RESULTS: We identified 173 patients; 41% had at least one diagnosis claim for IMD-related sequelae. Significantly higher predicted total health care costs for complicated-IMD cases (mean: $72,101), compared with uncomplicated cases (mean: $41,883; P < 0.001). CONCLUSIONS: We observed significantly higher health care costs among complicated-IMD cases, compared with uncomplicated cases. The substantially higher costs observed among patients with IMD-related sequelae warrant inclusion of these costs in studies conducting economic evaluations of meningococcal vaccination programs.

[Hospital admissions for meningococcal infections in Madrid, Spain (1997-2005)]. / Ingresos hospitalarios por infecciones meningocócicas en la Comunidad de Madrid (1997-2005).

BACKGROUND AND OBJECTIVES: Neisseria meningitidis infection causes an important morbidity and mortality in Spain. Our study aims to estimate the burden of hospital admissions for meningococcal infection in Spain during a nine-year period (1997-2005) by analyzing the Spanish hospital surveillance system. METHODS: An epidemiological retrospective study was conducted. Data were obtained from the national surveillance system for hospital data (Conjunto Mínimo Básico de Datos) maintained by the Ministry of Health. Information about hospitalizations, age, length of stay in hospital, mortality and cost per patient was obtained. RESULTS: There were 1137 hospital discharges for meningococcal disease (International Classification of Diseases 9th Clinical Modification: ICD 9 CM code 036 in any listed diagnosis) during the study period. Annual incidence was 2.41 cases per 100,000 individuals. Mortality rate and case-fatality rate were 0.19 cases per 100,000 population and 7.7%, respectively. The average length of hospitalization was 12 days. The youngest age group showed the highest hospitalizations incidence (24.42 hospitalizations per 100,000 population in those under 4 years of age) but the case-fatality rate was higher in the oldest group (11% in patients over 30 years). These hospitalizations imply an annual cost of 592,980 euro to the Madrid Health System. CONCLUSIONS: Our study shows that meningococcal infection is still an important cause of hospital admissions and mortality in Madrid, resulting in a high cost to the Health Care System.

Clinical and economic burden of invasive meningococcal disease: Evidence from a large German claims database.

BACKGROUND: Limited data is available to describe clinical characteristics, long-term outcomes, healthcare resource use and the attributable costs of invasive meningococcal disease (IMD) in Germany. We aimed to examine demographic and clinical characteristics as well as healthcare resource use and related costs. METHODS: We conducted a retrospective cohort study based on the InGef database in patients with IMD between 2009 and 2015. Cases were identified based on hospital main discharge diagnoses of IMD. Demographics, clinical characteristics, 30-day and 1-year mortality as well as IMD-related complications and sequelae in IMD cases were examined. In addition, short and long-term costs and healthcare resource use in IMD cases were analyzed and compared to an age- and sex-matched control group without IMD. RESULTS: The study population comprised 164 IMD cases between 2009 and 2015. The mean length of the IMD-related hospitalization was 13 days and 38% of all cases presented with meningitis only, 35% with sepsis only, 16% with both and 11% with other IMD. The 30-day and one-year mortality were 4.3% and 5.5%, respectively. Approximately 13% of IMD cases had documented IMD-related complications at hospital discharge and 24% suffered from sequelae during follow-up. The IMD-related hospitalization was associated with mean costs of € 9,620 (standard deviation: € 22,197). The difference of mean costs between IMD cases and matched non-IMD controls were € 267 in the first month and € 1,161 from one month to one year after discharged from IMD-related hospitalization. During the later follow-up period, the mean overall costs and costs associated with individual healthcare sectors were also higher for IMD cases without reaching statistical significance. CONCLUSIONS: IMD resulted in severe complications and sequelae and was associated with extensive costs and increased healthcare resource use in Germany, especially in the first year after IMD diagnosis and due the IMD-related hospitalization.

Health impact and cost-effectiveness of introducing the vaccine (Bexsero) against MenB disease into the Brazilian immunization programme.

Invasive meningococcal disease (IMD) is associated with a high mortality and severe sequelae. The aim of the present study was to evaluate the potential cost-effectiveness of the Bexsero vaccine in Brazil. We used a cohort model to compare routine vaccination against MenB disease with no vaccination. Epidemiological and cost estimates were obtained from the Brazilian Health Information System. The cost per disability-adjusted life year (DALY) averted and incremental cost-effectiveness ratio (ICER) was estimated assuming a 3-dose vaccination schedule, at R$90 (£ 20.50) per vaccine dose, 82.0% vaccine efficacy against MenB disease and a vaccine uptake of 90.0%. We estimated that 1,527 MenB cases would be prevented and 78 deaths averted. This strategy would cost R$ 762,381, 000 (£ 174,059,503) with a R$ 4,364,280 (£ 996,410) reduction in disease treatment costs. However, at an ICER of 372,256 (£ 84,990) per DALY averted, a vaccination programme is unlikely to be cost-effective.

Lifetime costs of invasive meningococcal disease: A Markov model approach.

INTRODUCTION: Invasive meningococcal disease (IMD) is an uncommon but life-threatening infectious disease associated with high sequelae rates in young children and an increased risk of mortality in adolescents and young adults. Funding decisions to reject inclusion of new meningococcal serogroup B vaccines on national immunisation schedules have been criticised by IMD patients, their families, paediatricians and charity organisations. We aim to estimate the lifetime costs of IMD with the best available evidence to inform cost-effectiveness analyses. METHODS: A Markov model was developed taking healthcare system and societal perspectives. A range of data including age-specific mortality rates, and probabilities of IMD-related sequelae were derived from a systematic review and meta-analysis. All currencies were inflated to year 2017 prices by using consumer price indexes in local countries and converted to US dollars by applying purchasing power parities conversion rates. Expert panels were used to inform the model development process including key structural choices and model validations. RESULTS: The estimated lifetime societal cost is US$319,896.74 per IMD case including the direct healthcare cost of US$65,035.49. Using a discount rate of 5%, the costs are US$54,278.51 and US$13,968.40 respectively. Chronic renal failure and limb amputation result in the highest direct healthcare costs per patient. Patients aged < 5 years incur the higher healthcare expenditure compared with other age groups. The costing results are sensitive to the discount rate, disease incidence, acute admission costs, and sequelae rates and costs of brain injuries and epilepsy. CONCLUSIONS: IMD can result in substantial costs to the healthcare system and society. Understanding the costs of care can assist decision-making bodies in evaluating cost-effectiveness of new vaccine programs.

Epidemiological burden of meningococcal disease in Latin America: A systematic literature review.

OBJECTIVE: To evaluate the epidemiological profile of invasive meningococcal disease (IMD), meningococcal meningitis, and Neisseria meningitidis carriers in Latin America. METHODS: A systematic review was conducted to identify and analyze studies published in 2008-2018. Incidence rates, case fatality rates (CFRs), and the relative distribution of cases per serogroup by country were assessed. RESULTS: Meningococcal surveillance in Latin America differs among countries, and most systems are based on passive sentinel surveillance. Thirty-nine studies were selected. In 2006, the incidence rate of IMD per 100 000 inhabitants was highest in Brazil (1.9), followed by Uruguay (1.3), Chile (0.8), Argentina (0.7), Colombia and Venezuela (0.3 each), and Mexico (0.06). Brazil reported the highest CFR (20%), followed by Uruguay (15%), Chile (11%), and Venezuela and Argentina (10% each). In 2012, the CFR in Chile increased to approximately 27%. The most frequent serogroups among IMD cases were C in Brazil (2007-2010) and Mexico (2005-2016), W in Chile (2012-2018), and B in Argentina (2012-2015). However, the true burden of IMD in Latin America is probably underestimated due to underreporting of cases. CONCLUSIONS: Improvements in IMD notification, IMD registration, national surveillance programs (including active surveillance systems), diagnostic tools, and characterization of isolates may better elucidate the true epidemiological burden of IMD in Latin America.

Cost Effectiveness of Meningococcal Serogroup B Vaccination in College-Aged Young Adults.

INTRODUCTION: Neisseria meningitidis serogroup B is the most common form of meningococcal infection in young adults in the U.S. Vaccines have recently become available, but it is not clear that the benefits outweigh the costs. The purpose of this study was to assess cost effectiveness and determine potentially favorable conditions for universal vaccination. METHODS: Costs and benefits of universal vaccination at college entry versus no universal vaccination with an outbreak response were estimated in 2018 in the context of a mid-sized U.S.-based 4-year college from both a health sector and a societal perspective. Probability, cost, and utility data were obtained from the published literature. Costs (2015 U.S.$) and benefits were discounted at 3%. One-way and multivariable probabilistic sensitivity analyses were performed including variations in the specific vaccine used. Further testing of the model's parameters at extremes was used to identify favorable conditions for universal vaccination. RESULTS: The incremental cost per quality-adjusted life year gained with universal vaccination was $13.9 million under the health sector perspective and $13.8 million under the societal perspective, each perspective was compared with a willingness-to-pay threshold of $150,000 per quality-adjusted life year. Multivariable probabilistic sensitivity analysis showed that universal vaccination was not the preferred strategy for <$15 million per quality-adjusted life year. Under an extremely favorable model, a universal vaccination strategy became cost effective for vaccine series costing <$65. CONCLUSIONS: This study demonstrates that universal vaccination at college entry is not cost effective. The rarity of N. meningitidis serogroup B contributes to the lack of cost effectiveness for universal vaccination.

Healthcare Resource Utilization and Cost of Invasive Meningococcal Disease in Ontario, Canada.

BACKGROUND: Invasive meningococcal disease (IMD) is associated with significant morbidity and mortality, thus remaining a concern for healthcare providers and the public. Evidence of the longitudinal burden of IMD and associated costs are scarce. Here we have evaluated the healthcare utilization and cost associated with hospitalized IMD cases in Ontario, Canada. METHODS: Observational cohort study utilizing the Ontario provincial claims databases, comprising: (1) individuals hospitalized with IMD between January 1995 and June 2012 and (2) age-, gender- and area-matched non-IMD controls (1:20 ratio). IMD cases were identified through diagnostic codes from hospitalization data and medical services claims. Costs are presented in Canadian dollars. RESULTS: Nine-hundred twelve IMD cases and 18,221 non-IMD controls were included. Over 5 years of follow-up, 27% of IMD cases (excluding initial hospitalization and 30-day acute phase) versus 15% of non-IMD controls (P < 0.001) were hospitalized. Compared with controls, IMD cases were more likely to receive alternative level of care (6.7% vs. 1.1%; P < 0.001) or visit the intensive care unit (49.2% vs. 2.4%; P < 0.001), and were associated with significantly higher mean hospitalization cost per case ($40,075 vs. $2827; P < 0.001). The hospitalization cost per case remained significantly higher when excluding the initial hospitalization and acute phase ($9867 vs. $3312; P < 0.001). The mean total cost per IMD case, including medications, hospitalization and medical services, was $45,768-$52,631 ($13,520-$23,789 excluding initial hospitalization and acute phase), for an overall cost (all cases during total follow-up) of $41,740,142-$47,999,289. CONCLUSIONS: In addition to its clinical burden, IMD is associated with significant economic burden to the public health system.

AMEND study protocol: a case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults.

INTRODUCTION: Invasive meningococcal disease (IMD) primarily causes disease in young children and adolescents and can cause long-term disability. Many countries are considering implementation of meningococcal B and/or meningococcal ACWY vaccines to control meningococcal disease. Estimating the cost-effectiveness of meningococcal vaccine programme is hampered due to a lack of good quality costing and burden of disease data. This study aims to address this evidence gap by assessing the clinical, physical, neurocognitive, economic and societal impact of IMD on adolescents and young adults. METHODS AND ANALYSIS: A case-control study of 64 participants with confirmed IMD (15-24 years 11 months at time of disease) and 64 control participants (17-34 years 11 months) will be conducted in Australia from 2016 to 2020. All participants will undergo a neurocognitive assessment, full medical examination, pure tone audiometry assessment and complete quality of life and behavioural questionnaires. Meningococcal cases will be assessed 2-10 years posthospitalisation and a subset of cases will be interviewed to explore in depth their experiences of IMD and its impact on their life. Primary outcome measures include general intellectual functioning from the Wechsler Adult Intelligence Scale and overall quality of life from the Health Utilities Index. Secondary outcome measures include academic achievement, executive functioning, behaviour, hearing, psychological and physical functioning. Outcome measures will be compared between cases and controls using independent t-tests or ORs, or if any significant confounders are identified, adjusted analyses (analysis of covariance or adjusted ORs) will be conducted. Thematic analysis will be used to analyse transcribed interviews and a costing model will be used to project lifetime costs. ETHICS AND DISSEMINATION: The Adolescent MENingococcal Disease (AMEND) study has been approved by the Human Research Ethics Committee of the Women's and Children's Health Network (HREC/14/WCHN/024). The results will be disseminated via peer-reviewed publications, conference presentations, study participants, and meningococcal and meningitis foundations. TRIAL REGISTRATION NUMBER: NCT03798574.

Pros and cons of vaccination against serogroup B meningococcal disease. / Pros y contras de la vacunación frente a la enfermedad por meningococo B.

A vaccine has recently been approved in the EU against meningococcal serogroup B, the main cause of meningococcal disease. There is a fierce debate about the decision regarding a universal vaccination in infants older than 2 months, as recommended by the majority of scientific societies. In western Europe the only country to have included the universal vaccination is the United Kingdom, with a lower incidence of the disease than Ireland. Other countries have also adopted it, such as the Czech Republic, Cuba and certain regions of Italy. Numerous cost-effectiveness studies have been published regarding the vaccination with different assumptions, which have supported the decision not to implant the universal vaccination because it exceeds the will to pay for a health benefit. We discuss the pros and cons of the universal vaccination against meningococcal B, recommended by the Sociedad Española de Pediatría (Spanish Society of Paediatrics), which as yet has not been implemented.

Costs of Invasive Meningococcal Disease: A Global Systematic Review.

BACKGROUND: Invasive meningococcal disease remains a public health concern because of its rapid onset and significant risk of death and long-term disability. New meningococcal serogroup B and combination serogroup ACWY vaccines are being considered for publicly funded immunization programs in many countries. Contemporary costing data associated with invasive meningococcal disease are required to inform cost-effectiveness analyses. OBJECTIVE: The objective of this study was to estimate costs and resource utilization associated with acute infection and the long-term care of invasive meningococcal disease. DATA SOURCES AND METHODS: PubMed, EMBASE, The Cochrane Library, health economic databases, and electronically available conference abstracts were searched. Studies reporting any costs associated with acute infection and long-term sequelae of invasive meningococcal disease in English were included. All costs were converted into purchasing power parity-adjusted estimates [international dollars (I$)] using the Campbell and Cochrane Economics Methods Group and the Evidence for Policy and Practice Information and Coordinating Centre cost converter. RESULTS: Fourteen studies met our eligibility criteria and were included. The mean costs of acute admission ranged from I$1629 to I$50,796, with an incremental cost of I$16,378. The mean length of hospital stay was reported to be 6-18 days in multiple studies. The average costs reported for readmissions ranged from I$7905 to I$15,908. Key variables such as the presence of sequelae were associated with higher hospitalization costs and longer inpatient stay. No studies estimated direct non-healthcare costs and productivity loss. Ten studies reported only unadjusted mean values without using appropriate statistical methods for adjustment. CONCLUSIONS: Invasive meningococcal disease can result in substantial costs to healthcare systems. However, costing data on long-term follow-up and indirect costs used to populate health economic models are lacking.