A qualitative concept elicitation study to understand patient-reported symptoms and impacts of Neisseria gonorrhoeae infections in the United States.

BACKGROUND: Gonorrhea is the second most common bacterial sexually-transmitted infection in the United States (US), with rising rates. Emerging antimicrobial resistance threatens public health; and vaccines are in development. This study documents patient-reported gonorrhea symptoms and health-related quality of life (HRQoL) impact, in women who have sex with men (WSM), men who have sex with women (MSW) and men who have sex with men (MSM). METHODS: Semi-structured qualitative interviews were conducted (April 2021-March 2022) among US adults with recent (≤6 months) confirmed gonorrhea. Concept saturation was achieved, confirming adequate participant numbers to meet objectives. Elicited symptom and HRQoL impacts were used to develop a conceptual disease model. Common patient-reported outcome measure (PROM) items were compared to elicited concepts. RESULTS: 32 participants (15 WSM, 8 MSW and 9 MSM) were included. Eight were asymptomatic; six had repeat infections; five women and four men had complications (i.e., infertility or pelvic inflammatory disease [PID], and urethritis, respectively).The most frequently reported symptoms were vaginal discharge (n = 11/12), dysuria (n = 10/12), and abdominal/vaginal pain (n = 9/12) for symptomatic WSM; dysuria (n = 5/6) and penile discharge (n = 4/6) for symptomatic MSW; and throat, testicular or rectal pain (n = 4/6) for symptomatic MSM. All (symptomatic and asymptomatic) participants reported HRQoL impacts including negative emotional experiences (n = 31/32), and interference with sexual activity (n = 30/32), relationships (n = 24/32) and social life (n = 17/32). Concepts were poorly represented in existing PROMs. CONCLUSION: Participants reported a diverse range of symptoms and HRQoL impacts, to help inform the value of new treatment and prevention options. More research is needed to quantify patient burden and develop PROMs.

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).

Rule of Prevention: a potential framework to evaluate preventive interventions for rare diseases.

Background: The benefits of preventive interventions lack comprehensive evaluation in standard health technology assessments (HTA), particularly for rare and transmissible diseases. Objective: To identify possible considerations for future HTA using analogies between the treatment and prevention of rare diseases. Study design: An Expert panel meeting assessed whether one HTA assessment framework can be applied to assess both rare disease treatments and preventive interventions. Experts also evaluated the range of value elements currently included in HTAs and their applicability to rare, transmissible, and/or preventable diseases. Results: A broad range of value should be considered when assessing rare, transmissible disease prevention. Although standard HTA can be applied to transmissible diseases, the risk of local outbreaks and the need for large-scale prevention programs suggest a modified assessment framework, capable of incorporating prevention-specific value elements in HTAs. A 'Rule of Prevention' framework was proposed to allow broader value considerations anchored to severity, equity, and prevention benefits in decision-making for preventive interventions for rare transmissible diseases. Conclusion: The proposed prevention framework introduces an explicit initial approach to consistently assess rare transmissible diseases, and to incorporate the broader value of preventive interventions compared with treatment.

Burden of Pertussis in Adults Aged 50 Years and Older: A Retrospective Database Study in England.

INTRODUCTION: Pertussis, a highly infectious respiratory disease caused by Bordetella pertussis, affects people of all ages. Older adults are particularly susceptible to its severe outcomes and complications. METHODS: In this retrospective cohort study, the incidence rate of pertussis among individuals aged ≥ 50 years was assessed during 2009-2018 using Clinical Practice Research Datalink and Hospital Episode Statistics databases, United Kingdom. Health care resource utilisation (HCRU) and direct medical costs (DMCs) were compared between patients with a pertussis diagnosis and propensity score-matched controls (matched on demographic and clinical variables). RESULTS: Among 5,222,860 individuals, 1638 had a pertussis diagnosis (incidence rate: 5.8 per 100,000 person-years; 95% confidence interval 5.5-6.0). Baseline (- 18 to - 6 months) HCRU and DMC were similar among 1480 pertussis patients and 1480 matched controls. However, there were increases in HCRU in the pertussis vs. matched cohort around the pertussis diagnosis (from months - 6 to - 1 to 5-11). The most notable increases (pertussis vs. controls) were in the rates of general practitioner (GP)/nurse visits (4.7-fold), clinical assessments (4.1-fold), and accident and emergency visits (3.0-fold) during the month before diagnosis and GP/nurse visits during the 2 months after diagnosis (2.5-fold) (all p < 0.001). DMCs were significantly higher in the pertussis cohort (p < 0.001). Total excess DMC in the pertussis cohort during months - 1 to + 11 was £318 per patient. CONCLUSION: A pertussis diagnosis among adults aged ≥ 50 years resulted in significant increases in HCRU and DMC across several months around diagnosis. These results highlight the need for increased awareness of pertussis infection among adults aged ≥ 50 years and suggest that pertussis booster doses among this population should be considered.

Range of invasive meningococcal disease sequelae and health economic application - a systematic and clinical review.

BACKGROUND: Invasive meningococcal disease (IMD) is uncommon, life-threatening, with many diverse sequelae. The aims were to: 1) comprehensively characterise the sequelae; 2) have a systematic application for sequelae impact in economic evaluation (EE). METHODS: Sequelae categorised as physical/neurological or psychological/behavioural were identified from a systematic review of IMD observational studies (OS) and EEs in high-income countries (published 2001-2020). A comprehensive map and EE-relevant list, respectively, included physical/neurological sequelae reported in ≥2OS and ≥ 2OS + 2EE (≥1OS and ≥ 1OS + 1EE for psychological/behavioural). Sequelae proportions were selected from the highest quality studies reporting most sequelae. Three medical experts independently evaluated the clinical impact of findings. RESULTS: Sixty-Six OS and 34 EE reported IMD sequelae. The comprehensive map included 44 sequelae (30 physical/neurological, 14 psychological/behavioural), of which 18 (14 physical/neurological and 4 psychological/behavioural) were EE-relevant. Experts validated the study and identified gaps due to limited evidence, underreporting of psychological/behavioural sequelae in survivors/their families, and occurrence of multiple sequelae in the acute phase and long-term. CONCLUSIONS: The considerable burden of IMD sequelae on survivors and their families is potentially underestimated in EE, due to underreporting and poorly-defined subtle sequelae. When assessing IMD burden and potential interventions e.g., vaccination, sequelae range and duration, underreporting, and indirect burden on dependents should be considered.

Burden of Pertussis in Individuals with a Diagnosis of Asthma: A Retrospective Database Study in England.

PURPOSE: The impact of pertussis in individuals with asthma is not fully understood. We estimated the incidence, health care resource utilization (HCRU), and direct medical costs (DMC) of pertussis in patients with asthma. PATIENTS AND METHODS: In this retrospective cohort study, the incidence rate of pertussis (identified using diagnostic codes) among individuals aged ≥50 years with an asthma diagnosis was assessed during 2009-2018 using Clinical Practice Research Datalink and Hospital Episode Statistics databases. HCRU and DMC were compared - between patients with diagnoses of asthma and pertussis (asthma+/pertussis+) and propensity score-matched patients with a diagnosis of asthma without pertussis (asthma+/pertussis-) - in the months around the pertussis diagnosis (-6 to +11). RESULTS: Among 687,105 individuals, 346 had a reported pertussis event (incidence rate: 9.6/100,000 person-years of follow-up; 95% confidence interval: 8.6-10.7). HCRU and DMC were assessed among 314 asthma+/pertussis+ patients and 1256 matched asthma+/pertussis- controls. Baseline HCRU was similar in both cohorts, but increases were observed in the asthma+/pertussis+ cohort from -6 to -1 month before to 2-5 months after diagnosis. Rates of accident and emergency visits, general practitioner (GP)/nurse visits, and GP prescriptions were 4.3-, 3.1-, and 1.3-fold, respectively, in the asthma+/pertussis+ vs asthma+/pertussis- cohorts during the month before diagnosis; GP/nurse visit rates were 2.0- and 1.2-fold during 0-2 and 2-5 months after diagnosis, respectively (all p<0.001). DMC was 1.9- and 1.6-fold during the month before and 2 months from diagnosis, respectively, in the asthma+/pertussis+ vs asthma+/pertussis- cohorts (both p<0.001). During months -1 to +11, DMC in the asthma+/pertussis+ cohort was £370 higher than in the asthma+/pertussis- controls. CONCLUSION: A pertussis diagnosis among adults aged ≥50 years with asthma resulted in significant increases in HCRU and DMC across several months around diagnosis, suggesting lengthy diagnosis times and highlighting the need for prevention strategies.

Public Health Impact and Cost-Effectiveness Analysis of Routine Infant 4CMenB Vaccination in Germany to Prevent Serogroup B Invasive Meningococcal Disease.

INTRODUCTION: Invasive meningococcal disease (IMD) is an uncommon, severe, life-threatening disease primarily affecting infants, with potential lifelong sequelae. Neisseria meningitidis (Nm) serogroup B (MenB) causes most IMD cases in Germany, many of which can be prevented with four-component MenB (4CMenB) vaccination. The potential public health and economic impact of introducing routine 4CMenB infant vaccination in Germany was assessed. METHODS: A dynamic transmission-based cost-effectiveness model adapted for Germany assessed the impact of infant 4CMenB universal mass vaccination (UMV) versus no vaccination. The model included the latest real-world evidence on vaccine effectiveness, the comprehensive burden of disease on patients (sequelae) and their family (quality of life impact), comprehensive German IMD costs, and vaccination uptake assumptions. RESULTS: The largest public health impact was predicted in children: a rapid decline, 5 years after UMV implementation, of 39.9% (34.7%) for MenB (all IMD) cases aged 0-4 years and 42.4% (36.8%) in infants. Over lifetime (100-year time horizon), 4CMenB could prevent 3154 MenB (3303 all IMD) cases, 291 MenB (304 all IMD) deaths and 1370 MenB (1435 all IMD) long-term sequelae. 4CMenB saved 25,878 quality-adjusted life-years (QALYs), at a cost of €188,762 per QALY gained in the base case (societal perspective including lost productivity). Scenarios including potential Nm carriage protection (enabling herd protection) or societal preferences for the prevention of severe diseases led to more cost-effective results, while a scenario excluding IMD impact beyond the patient with increased discounting of vaccination health benefits produced less cost-effective results. CONCLUSIONS: MenB IMD is a vaccine-preventable disease. This analysis for Germany can inform decision-makers on the potential impact of introducing infant 4CMenB UMV. The program is predicted to rapidly produce health benefits (reduction in child cases, deaths and sequelae) at a cost per QALY to society of around €190,000 (base case), decreasing to around €78,000 when considering societal preferences and IMD underreporting.

Invasive meningococcal disease (IMD) is an uncommon but severe infection, usually presenting as meningitis and/or sepsis, caused by the bacteria Neisseria meningitidis. Most cases occur in infants, young children and adolescents. Patients who survive the disease can develop lifelong sequelae, such as physical, neurological and psychological/behavioural problems that impact their quality of life and that of their family/caregivers. This disease can be prevented by vaccination. The use of the four-component meningococcal serogroup B vaccine (4CMenB) in countries like Germany can prevent the most common form of this disease, IMD caused by serogroup B. This study assessed the public health and economic impact of infant vaccination in Germany with 4CMenB. For this, the authors used an economic model that measured the lifetime impact of the disease on patients but also on their families. The model predicted that after 5 years of vaccination, the number of cases and deaths in infants and young children aged 0­4 years would rapidly decrease by almost 40%. Over a long-term horizon of 100 years, this number was predicted to remain stable. Due to the reduced number of cases, vaccination would also result in fewer deaths and patients with sequelae, as well as cost savings for the healthcare system and society due to the reduced loss of productivity. In conclusion, in Germany, IMD caused by serogroup B is preventable through vaccination, and the 4CMenB vaccine in German infants is predicted to rapidly reduce the disease burden, save lives and prevent healthcare costs.

Burden of Pertussis in COPD: A Retrospective Database Study in England.

Chronic obstructive pulmonary disease (COPD) may increase the risk and severity of pertussis infection. Health care resource utilization (HCRU) and direct medical costs (DMC) of treating pertussis among patients with COPD are unknown. Reported incidence of pertussis among individuals aged ≥ 50 years with COPD was assessed in Clinical Practice Research Datalink and Hospital Episode Statistics databases during 2009-2018 using a retrospective cohort design. HCRU and DMC from the National Health Service perspective were compared between patients with COPD and pertussis and propensity score-matched patients with COPD without pertussis. Seventy-eight new pertussis events were identified among 387 086 patients with COPD aged ≥ 50 years (incidence rate: 4.73; 95% confidence interval 3.74-5.91 per 100 000 person-years). HCRU and DMC were assessed among 67 patients with COPD and pertussis and 267 matched controls. During the month before the pertussis diagnosis, the rates of general practitioner (GP)/nurse visits (4289 vs. 1774 per 100 patient-years) and accident and emergency visits (182 vs. 18 per 100 patient-years) were higher in the pertussis cohort; GP/nurse visits (2935 vs. 1705 per 100 patient-years) were also higher during the following 2 months (all p < 0.001). During the month before the pertussis diagnosis, annualized per-patient total DMC were £2012 higher in the pertussis cohort (£3729 vs. £1717; p < 0.001); during the following 2 months, they were £2407 higher (£5498 vs. £3091; p < 0.001). In conclusion, a pertussis episode among individuals with COPD resulted in significant increases in HCRU and DMC around the pertussis event.

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.

Modelling the impact of 4CMenB and MenACWY meningococcal combined vaccination strategies including potential 4CMenB cross-protection: An application to England.

Invasive meningococcal disease (IMD), an uncommon but severe disease, affects mainly infants, young children and adolescents. Meningococcal B (4CMenB) and ACWY (MenACWY) vaccines targeting IMD-causing serogroups B and A, C, W and Y, respectively are available for these mostly-affected age-groups. The objective was to assess the impact of 4CMenB and/or MenACWY vaccination strategies on IMD in England, considering MenACWY carriage protection and potential cross-protection of 4CMenB against non-B serogroups. A novel dynamic transmission model was developed, accounting for vaccine characteristics, with separate variables for meningococcal carriage and IMD for three groups: B; ACWY; and 'Other' mostly non-pathogenic serogroups. A dynamic force of infection is assumed for each group. The model analysis uses data from England before 2015 (when 4CMenB and MenACWY were introduced), and accounts for existing MenC vaccination impact. Compared with no vaccination, the smallest decrease in IMD cases is observed for MenACWY strategies (toddler and/or adolescent). 4CMenB (infant or infant/adolescent), alone or with MenACWY, always results in the most rapid and steep decline in IMD cases. Combined strategies with adolescent 4CMenB result in the largest decrease in IMD cases, whereas adding MenACWY for toddlers has a minor impact. With potential 4CMenB cross-protection, 4CMenB infant strategy has a notable impact on reduction of MenW and MenY IMD cases in strategies where MenACWY toddler and/or adolescent vaccination is absent. This novel model allows for analysis of combined 4CMenB and MenACWY strategies including potential 4CMenB cross-protection. In settings comparable to England, a comprehensive meningococcal vaccination programme should include infant 4CMenB as essential building block. Decisions to include MenACWY toddler programmes should consider herd effects of MenACWY adolescent programmes and 4CMenB potential cross-protection effects. Extending 4CMenB infant and MenACWY adolescent programmes with a 4CMenB adolescent programme allows for the largest overall reduction in IMD cases.

Cost-Effectiveness Comparison of Pneumococcal Conjugate Vaccines in Turkish Children.

BACKGROUND: The 13-valent pneumococcal conjugate vaccine (PCV13) is used for universal infant vaccination in Turkey. OBJECTIVES: To assess the cost effectiveness of replacing PCV13 with pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). METHODS: A Markov cohort model with monthly cycles following 1 cohort of infants over a 10-year time horizon was used. Local input parameters were obtained from published sources and expert consultation whenever possible. The model was adapted to estimate the health benefits and economic impact of each vaccine on invasive pneumococcal disease, pneumonia, and acute otitis media (AOM). An annual discount rate of 3% was used for benefits and costs (2016 euros). RESULTS: Under base-case assumptions, vaccinating 1 birth cohort of 1 325 783 infants with PHiD-CV instead of PCV13 was predicted to have the same impact on meningitis and pneumonia, a similar impact on bacteremia (+30 cases), but greater reductions in AOM-related general practitioner visits (-34 955) and hospitalizations (-624). Assuming equal vaccine prices, PHiD-CV was predicted to be dominant over PCV13 (176 additional quality-adjusted life-years while saving €635 330 [discounted]). One-way sensitivity analysis indicated that varying the vaccine price differential had the largest effect on the incremental cost-effectiveness ratio, and then AOM parameters. Probabilistic sensitivity analysis predicted PHiD-CV to be dominant over PCV13 in 92.4% of simulations. CONCLUSIONS: Any difference in price between PHiD-CV and PCV13 is expected to be the key driver of vaccine choice for preventing childhood pneumococcal disease in Turkey. At price parity, PHiD-CV use is likely to be a dominant strategy over the use of PCV13.

The cost-of-illness for invasive meningococcal disease caused by serogroup B Neisseria meningitidis (MenB) in Germany.

INTRODUCTION: Invasive meningococcal disease (IMD) is a severe disease mainly affecting infants and young children. The most common serogroup causing IMD in Germany is the serogroup type B Neisseria meningitidis (MenB). The aim of the present study is to estimate the economic burden of MenB-related IMD in Germany. METHOD: A bottom-up, model-based costing approach has been used to calculate the diagnose- and age-specific yearly lifetime costs of a hypothetical cohort of MenB-related IMD cases. Direct costs contain the treatment cost for the acute phase of the disease, long-term sequelae, costs for rehabilitation, and public health response. Indirect costs are calculated for the human-capital approach and the friction-cost approach considering productivity losses of patients or parents for the acute phase and long-term sequelae. Publicly available databases from the Federal Statistical Office, the SOEP panel data set, literature, and expert opinion were used as data sources. All future costs beyond the reference year of 2015 were discounted at 3%. RESULTS: The total costs for the hypothetical cohort (343 patients) from a societal perspective are €19.6 million (€57,100/IMD case) using the friction-cost approach and €58.8 million (€171,000/IMD case) using the human-capital approach. Direct costs amount to €18.6 million or €54,300 €/case. Sequelae are responsible for 81% of the direct costs/case. DISCUSSION: The elevated costs/MenB-related IMD case reflect the severity of the disease. The total costs are sensitive to the productivity-loss estimation approach applied. MenB is an uncommon but severe disease; The costs/case reflect the severity of the disease and is within the same magnitude as for human papilloma virus infections. The available literature on sequelae is due to the uncommonness limited and heterogeneous.

Systematic Review of Invasive Meningococcal Disease: Sequelae and Quality of Life Impact on Patients and Their Caregivers.

INTRODUCTION: Invasive meningococcal disease (IMD, septicaemia and/or meningitis) has a severe acute and long-term burden: 5-10% of patients die within 48 h, and long-term sequelae have been reported in 10-20% of survivors. Health-related quality of life (HRQoL) is increasingly but inconsistently assessed. METHODS: A systematic literature review on Neisseria meningitidis IMD sequelae and HRQoL in survivors of all ages and their caregivers, including family, was conducted for high-income countries from 2001 to 2016 (in Medline and Embase, following Cochrane and PRISMA guidelines). RESULTS: A total of 31 studies, mostly of childhood IMD cases, were included. A broad range of physical, neurological and psychological IMD sequelae were identified. The literature has evolved, with more types of sequelae reported in more recent studies; however, meningococcal disease-specific and sequelae-specific HRQoL data are lacking, and existing studies used a wide variety of instruments. Physical sequelae included: amputations (up to 8% of children, 3% adolescents/adults) and skin scars (up to 55% of children, 18% adolescents, 2% adults). Neurologic sequelae included: hearing loss (up to 19% of infants, 13% children, 12% adolescents, 8% adults). Psychological sequelae included: anxiety, learning difficulties, emotional and behavioural difficulties. IMD negatively affects HRQoL in patients and also in their family and close caregiver network, both in the short- and long-term. Even IMD survivors without sequelae experienced an adverse impact on HRQoL after many years, affecting self-esteem, physical, mental and psychosocial health, and HRQoL was worse in those with cognitive and behavioural sequelae. CONCLUSION: A high proportion of IMD survivors are affected by a broad range of sequelae and reduced HRQoL that persists years after infection. Childhood IMD survivors had more sequelae and more severe sequelae compared with adult survivors. HRQoL was affected in patients and also in their families, caregivers and surrounding network over the long term. More research is needed to resolve data gaps and to standardise HRQoL assessment. FUNDING: GlaxoSmithKline Biologicals SA (Rixensart, Belgium).

Incidence and economic burden of acute otitis media in children aged up to 5years in three Middle Eastern countries and Pakistan: A multinational, retrospective, observational study.

Epidemiological data on acute otitis media (AOM), an infectious disease frequently affecting children, are lacking in some countries. This study was undertaken to assess the incidence of AOM in children ≤5years in Saudi Arabia, Oman, Pakistan, and Turkey, as well as the economic burden from a parent/caregiver perspective. Medical records of 4043 children (Saudi Arabia=1023, Oman=998, Pakistan=1022, Turkey=1000) were retrospectively reviewed and the incidence of AOM episodes calculated from suspected and confirmed cases. Using a standardized Health Economics Questionnaire, parents recorded resource use and expenses incurred per AOM episode [in local currency and converted to US dollars (USD)]. The overall incidence of AOM episodes per 1000 person-years was: Saudi Arabia, 207 [95% confidence interval (CI): 178-238]; Oman, 105 (95% CI: 85-127); Pakistan, 138 (95% CI: 116-163); and Turkey, 99 (95% CI: 79-123). The mean total out-of-pocket healthcare expense incurred by parents/caregivers per episode was: Saudi Arabia USD67.1 [standard deviation (SD)=93.0], Oman USD16.1 (SD=16.4), Pakistan USD22.1 (SD=20.5), and Turkey USD33.6 (SD=44.9). The incidence of AOM episodes varied across all four countries, probably due to different diagnostic and management practices. Nevertheless, our results confirm that AOM causes a substantial burden to public health, reinforcing the need for cost-effective prevention strategies.

Economic assessment of rotavirus vaccination in Saudi Arabia.

In the Kingdom of Saudi Arabia (KSA), rotavirus universal mass vaccination has been introduced in 2013, however, there is limited information available on the economic benefit and the epidemiological impact of the programme to date. We used a Markov cohort model to evaluate and compare the economic value of rotavirus vaccination with no vaccination in a birth cohort of 562,428 infants. This lifetime analysis considered the societal perspective. Model input was obtained through consensus of local experts after two rounds of evaluation of the proposed estimates. The primary outcome measure was to assess cost-effectiveness and to define the cost-neutrality level reached by comparing vaccination with no vaccination as a function of the price adjustment of the vaccination course. With an assumed vaccine coverage rate of 96%, the already started rotavirus vaccination is expected to reduce the overall burden of rotavirus gastroenteritis by 65% with model exercise, over lifetime. The maximum impact will be seen in rotavirus gastroenteritis-related hospitalizations (93%). Outpatient and emergency visits are shown to decline by 87% each while the occurrence of nosocomial infections, by 78%. Cost neutrality is reached if the vaccine price per course is less than SAR 178.20 at steady state. Rotavirus vaccination should be recommended in KSA given the important clinical impact the vaccine can have and the good value for money it can obtain.