Cost-effectiveness analysis of 20-valent pneumococcal conjugate vaccine for routine pediatric vaccination programs in Japan.

BACKGROUND: The Japanese National Immunization Program currently includes the pediatric 13 valent pneumococcal conjugate vaccine (PCV13) to prevent pneumococcal infections. We aimed to evaluate the cost-effectiveness of 20-valent PCV (PCV20) as a pediatric vaccine versus PCV13. METHODS: A decision-analytic Markov model was used to estimate expected costs, quality-adjusted life-years (QALYs), and prevented cases and deaths caused by invasive pneumococcal disease, pneumonia, and acute otitis media over a ten-year time horizon from the societal and healthcare payer perspectives. RESULTS: PCV20 was dominant, i.e. less costly and more effective, over PCV13 (gained 294,599 QALYs and reduced Japanese yen [JPY] 352.6 billion [2.6 billion United States dollars, USD] from the societal perspective and JPY 178.9 billion [USD 1.4 billion] from the payer perspective). Sensitivity and scenario analyses validated the robustness of the base scenario results. When comparing PCV20 with PCV13, the threshold analysis revealed an incremental cost-effectiveness ratio that was within the threshold value (JPY 5 million/QALY) at a maximum acquisition cost of JPY 74,033 [USD 563] (societal perspective) and JPY 67,758 [USD 515] (payer perspective). CONCLUSIONS: As a pediatric vaccine, PCV20 was dominant over PCV13 regardless of the study perspective.

Single Visit Evaluation and Tympanostomy Tube Placement for the Treatment of Acute Otitis Media in Children.

OBJECTIVE: To review our experiences with development of a single visit surgery (SVS) program for children with recurrent acute otitis media (AOM) undergoing tympanostomy tube (TT) placement the same day as their otolaryngology surgical consultation. STUDY DESIGN: Retrospective cohort analysis. METHODS: Retrospective series of patients participating in SVS from inception March 1, 2014 to April 30, 2020 were analyzed, with attention to factors associated with increasing interest and participation in SVS and parent experiences/satisfaction. RESULTS: A total of 224 children had TT placed through SVS for AOM management. The average age of patients was 18.1 months (standard deviation 7.8 months), and 130 (58.0%) were male. The median interval between initial contact to schedule SVS, and the SVS date was 15 days (interquartile range 9-23 days). When analyzing year-over-year volumes from inception of SVS, notable increases were seen in 2016 and 2017 after a radio advertisement was played locally. A marked increase in volume was noted after implementation of a Decision Tree Scheduling (DTS) algorithm for children with recurrent AOM. Sixty-six (28.8%) procedures were performed after institution of DTS. A parent survey demonstrated high levels of satisfaction with the SVS experience. Estimations of savings to families in terms of time away from work demonstrated potential for indirect healthcare benefits. CONCLUSIONS: SVS for TT placement was a successful, alternative model of care for management of children with AOM. Marketing strategies regarding SVS, and the inclusion of SVS pathway in DTS platforms increased rates of interest and choice of this option. Parents of children undergoing TT through SVS were satisfied with the overall experience. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2823-2829, 2021.

Comparative study of endoscopic and microscopic tympanoplasty performed by a single experienced surgeon.

PURPOSE: The use of endoscopes in otologic procedures has been increasing worldwide. This study aimed to compare the efficacy of microscopic tympanoplasty (MT) and endoscopic tympanoplasty (ET) for tympanic membrane and middle ear surgery. MATERIALS AND METHODS: We retrospectively analyzed 81 patients who underwent MT (n = 44) and ET (n = 37) for chronic otitis media with tympanic membrane perforation performed by a single surgeon between January 2013 and September 2019. The hearing outcomes, graft success rate, complications, operation time and hospital stay, and cost-effectiveness were recorded and compared between groups. Hearing outcomes were determined by pure tone audiometry. Cost-effectiveness was determined by the operation cost and total cost. RESULTS: There was no significant difference between the MT and ET groups regarding demographic characteristics, with the exception of the male:female ratio. There was no significant difference in the pre- and postoperative air conduction, bone conduction thresholds, and air-bone gap values between the two groups, but a significant audiologic improvement was observed in both groups (p < 0.05). In terms of recurrence of tympanic membrane perforation, postoperative otorrhea, and discomfort symptoms, there was no significant difference between groups (p > 0.05). The operation time and hospital stay were shorter in the ET group than in the MT group (p < 0.05). There were no significant differences in operation cost between the two groups (p > 0.05), but the total cost was significantly lower in the ET group than the MT group (p < 0.05). CONCLUSION: ET is as safe and medically efficacious as conventional MT, shortens the operation time and hospital stay, and is cost-effective.

Associated factors, health-related quality of life, and reported costs of chronic otitis media in adults at two otologic referral centers in a middle-income country.

BACKGROUND: Despite the high prevalence of chronic otitis media (COM) in low to middle-income countries, there are few studies regarding its associated factors, health-related quality of life, and treatment costs. This study aimed to identify associated factors of COM, assess its impact on the quality of life as well as estimate the patients' reported costs of COM treatment in Colombia. METHODS: Cross-sectional study. Two otology-referral centers in Bogotá (Colombia) were included. Questionnaires focusing on sociodemographic and clinical associated factors, quality of life, and patients' reported costs were administered to 200 adults with COM diagnosis and 144 control adults. Otoscopic evaluation and audiometric data were collected. RESULTS: The mean age was 42.2 years (SD: 14.44). The median length of COM was 26.13 years (SD: 17.06), and 79.5% of the COM patients reported otorrhea during childhood (P-value: 0.01). The most frequently reported allergic disease among our study population was allergic rhinitis (26.5%). COM was less frequent in patients with a medium-high socioeconomic status (PR: 0.54; 95% CI: 0.39-0.72), and more frequent in patients who reported increased ear discharge due to upper respiratory tract infections (PR: 1.69; 95% CI: 1.68-1.70). The global score of the "Chronic Suppurative Otitis Media Questionnaire-12" showed a difference of 9 points between patients with active and inactive COM (P < 0.001). Patients spent between 12.07% to 60.37% of their household income on expenses related to COM. CONCLUSIONS: Associated factors found in this study are consistent with previous reports. COM has a significant financial impact and affects patients' quality of life. Worldwide research addressing these issues in poor-resource countries is scarce, further studies are needed.

Perioperative cost evaluation of canal wall down mastoidectomy.

INTRODUCTION: To evaluate perioperative costs of canal wall-down (CWD) mastoidectomy as an initial surgery compared to revision surgery following initial canal wall-up (CWU) mastoidectomy. METHODS: This study is a retrospective chart review of adult patients who underwent CWD mastoidectomy for chronic otitis media with or without cholesteatoma at a tertiary referral center. Patients were divided into groups that had previous CWU surgery and were undergoing revision CWD and those that were having an initial CWD mastoidectomy. Cost variables including previous surgeries, imaging costs, audiometric testing, and post-operative visits were compared between the two groups using t-test analysis. RESULTS: There was no significant difference with regards to the cost of post-operative visits, peri-operative imaging, or revision surgeries between the two groups. Hearing outcomes based on mean speech reception threshold (SRT) were not statistically different between the two groups (p = 0.087). There was a significant difference in total cost with the revision group having a higher mean cost by $6967.84, most of which was accounted for by the difference in the cost of the previous surgeries of $6488.53. CONCLUSIONS: The revision CWD surgery group had increased total cost that could be attributed to the cost of previous surgery. Increased peri-operative cost was not noted with the initial CWD surgery group for any individual variables examined. Initial CWD mastoidectomy should be considered in the proper patient population to help decrease healthcare costs.

Respiratory Syncytial Virus-associated Acute Otitis Media in Infants and Children.

Despite recent declines in the incidence of acute otitis media (AOM), more than 5 million cases and 5-6 million primary AOM visits still occur in young children in the United States, resulting in $4.4 billion direct medical costs annually. Our aims in this review are to describe the role of respiratory syncytial virus (RSV) in the etiology of AOM, discuss the prospect of prevention of RSV-associated AOM through immunization, and suggest future research strategies to assess the impact of immunization on RSV-associated AOM.

The economic benefits of increasing breastfeeding rates in Spain.

BACKGROUND: Interventions aimed at promoting breastfeeding rates are among the most effective possible health policies available, with an estimated return of US$35 per dollar invested. Indeed, some authors found that a 10% increase in exclusive breastfeeding rates in the first two years of life led to a reduction in treatment costs of US$312 million in the US, US$7.8 million in the UK, US$30 million in China, and US$1.8 million in Brazil. Among high-income countries, Spain stands out for its low breastfeeding rate. METHODS: We calculated the savings that the Spanish National Health System would have benefited from had breastfeeding rates been higher in Spain, both from the time of hospital discharge and at 6 months postpartum. We followed the methods used in similar studies carried out in the US, Italy, Australia, the Netherlands, and the UK, to conservatively estimate these potential savings by considering only the lower thresholds in all our estimates. Here we approximated the benefits of having increased exclusive breastfeeding rates based on the lower incidence of infantile pathologies among exclusively breastfed infants. Robust evidence indicates that among breastfed infants there is a lower prevalence of otitis media, gastroenteritis, respiratory infections, and necrotising enterocolitis. We obtained the estimated monetary cost of these diseases by combining their prevalences with data about their economic costs for diagnosis-related groups. RESULTS: The estimated effects we calculated imply that the Spanish National Health System could have saved more than €5.6 million for every percentage point increase in exclusive breastfeeding rates in Spain during 2014. CONCLUSIONS: Breastfeeding is essential both for the health of mothers and the health and development of newborns but is rarely considered as an economic issue and remains economically invisible. In addition to the improved wellbeing of mothers and their infants, breastfeeding can positively impact society as a whole and should therefore be better defined in public policies. Thus, strategies aimed at increasing exclusive breastfeeding rates would likely contribute to lowering the fiscal burden of the Spanish National Health System. Moreover, the magnitude of these potential benefits suggests that such policies would likely be socially cost-effective.

Management of infective complications of otitis media in resource-constrained settings.

PURPOSE OF REVIEW: Complications of otitis media are a cause of significant morbidity and mortality, compounded in resource-constrained settings in which human and physical resources to manage disease are suboptimal. Here, we examine the current best evidence to devise a protocol for management, in particular exploring the opportunity for conservative or nonspecialist management. RECENT FINDINGS: Reviews of the literature suggest that intratemporal and extracranial infections can be managed with antibiotics in the first instance, with aspiration or incision and drainage of abscess. Failure to respond necessitates mastoidectomy, which need not be extensive, and can be performed with hammer and gouge. Suspected or possible intracranial extension requires referral for computed tomography (CT) imaging. Intracranial infection can in some instances be managed with antibiotics, but large or persistent intracranial abscess, or the presence of cholesteatoma requires management in a centre for specialist surgery. SUMMARY: Many complications of otitis media could be managed by nonspecialists in appropriately equipped local or regional health facilities, and supported by appropriate training. However, regional centres with CT imaging and specialist surgery are required for assessment and treatment of cases that are suspected of having complex or advanced disease, or that fail to respond to initial treatment. Those involved in planning healthcare provision should look to develop infrastructure to support such management.

Costs of acute otitis media in children in a city of the Colombian Caribbean coast. / Costos de la otitis media aguda en niños de una ciudad de la costa caribe colombiana

INTRODUCTION: Acute otitis media is the main cause of consultation, antibiotic use, and ambulatory surgery in developed countries; besides, it is associated with an important economic burden. However, non-medical indirect costs of acute otitis media, which are relevant in this pathology, have been underestimated. OBJECTIVE: To estimate the costs of acute otitis media in pediatric patients in Cartagena, Colombia. MATERIALS AND METHODS: We conducted a prospective study of micro-costing between 2014 and 2015. The direct and indirect costs of acute otitis media were determined through forms applied to parents or caregivers. Loss of productivity was estimated based on the monthly legal minimum wage of 2014 (COP $616.000) (USD $308). RESULTS: A total of 62 episodes of acute otitis media occurred. The total economic costs attributed per episode was COP $358,954 (standard deviation: SD ± COP $254,903, i.e., USD $179). The total economic burden was COP $22,503,141 (USD $11,250), the indirect costs per episode were COP $101,402 (USD $51), and the average care time spent by parents was 3.7 days. CONCLUSION: The estimated costs of acute otitis media in this study were lower than the costs estimated in a review of high-income countries and similar to those of low-income countries such as Nigeria. Information on total costs (direct and indirect) of acute otitis media is necessary for public health decision-making and for full cost-effectiveness assessments.

Introducción. La otitis media aguda es la principal causa de consultas médicas, de uso de antibióticos y de cirugías ambulatorias en los países desarrollados. Está asociada con una significativa carga económica, pero sus costos indirectos no médicos, los cuales son relevantes en esta enfermedad, se han subestimado. Objetivo. Estimar los costos de la otitis media aguda en pacientes pediátricos en Cartagena, Colombia. Materiales y métodos: Se hizo un estudio prospectivo de microcosteo entre el 2014 y el 2015. Se determinaron los costos directos e indirectos de la otitis media aguda mediante encuestas a los padres o cuidadores. La pérdida de productividad se estimó con base en el salario mínimo legal vigente mensual del 2014 (COP $616.000) (USD $308). Resultados. Se presentaron 62 episodios de otitis media aguda. Los costos económicos totales por episodio fueron de COP $358.954 (desviación estándar, DE: ± $254.903) (USD $179). La carga económica total fue de COP $22'503.141 (USD $11.250), los costos indirectos por episodio fueron de COP $101.402 (USD $51) y el tiempo promedio empleado por los padres en el cuidado fue de 3,7 días. Conclusiones. Los costos estimados de la otitis media aguda en el presente estudio fueron menores a los estimados en países con ingresos altos y similares a los de países con ingresos bajos como Nigeria, según una revisión bibliográfica. La información sobre los costos totales directos e indirectos de la otitis es necesaria para la adopción de decisiones en salud pública y para hacer evaluaciones económicas completas de costo-efectividad.

Costs of acute otitis media in children in a city of the Colombian Caribbean coast / Costos de la otitis media aguda en niños de una ciudad de la costa caribe colombiana

Abstract Introduction: Acute otitis media is the main cause of consultation, antibiotic use, and ambulatory surgery in developed countries; besides, it is associated with an important economic burden. However, non-medical indirect costs of acute otitis media, which are relevant in this pathology, have been underestimated. Objective: To estimate the costs of acute otitis media in pediatric patients in Cartagena, Colombia. Materials and methods: We conducted a prospective study of micro-costing between 2014 and 2015. The direct and indirect costs of acute otitis media were determined through forms applied to parents or caregivers. Loss of productivity was estimated based on the monthly legal minimum wage of 2014 (COP $616.000) (USD $308). Results: A total of 62 episodes of acute otitis media occurred. The total economic costs attributed per episode was COP $358,954 (standard deviation: SD ± COP $254,903, i.e., USD $179). The total economic burden was COP $22,503,141 (USD $11,250), the indirect costs per episode were COP $101,402 (USD $51), and the average care time spent by parents was 3.7 days. Conclusion: The estimated costs of acute otitis media in this study were lower than the costs estimated in a review of high-income countries and similar to those of low-income countries such as Nigeria. Information on total costs (direct and indirect) of acute otitis media is necessary for public health decision-making and for full cost-effectiveness assessments.

Resumen Introducción. La otitis media aguda es la principal causa de consultas médicas, de uso de antibióticos y de cirugías ambulatorias en los países desarrollados. Está asociada con una significativa carga económica, pero sus costos indirectos no médicos, los cuales son relevantes en esta enfermedad, se han subestimado. Objetivo. Estimar los costos de la otitis media aguda en pacientes pediátricos en Cartagena, Colombia. Materiales y métodos: Se hizo un estudio prospectivo de microcosteo entre el 2014 y el 2015. Se determinaron los costos directos e indirectos de la otitis media aguda mediante encuestas a los padres o cuidadores. La pérdida de productividad se estimó con base en el salario mínimo legal vigente mensual del 2014(COP$616.000) (USD$308). Resultados. Se presentaron 62 episodios de otitis media aguda. Los costos económicos totales por episodio fueron de COP $358.954 (desviación estándar, DE: ± $254.903) (USD $179). La carga económica total fue de COP $22'503.141 (USD $11.250), los costos indirectos por episodio fueron de COP $101.402 (USD $51) y el tiempo promedio empleado por los padres en el cuidado fue de 3,7 días. Conclusiones. Los costos estimados de la otitis media aguda en el presente estudio fueron menores a los estimados en países con ingresos altos y similares a los de países con ingresos bajos como Nigeria, según una revisión bibliográfica. La información sobre los costos totales directos e indirectos de la otitis es necesaria para la adopción de decisiones en salud pública y para hacer evaluaciones económicas completas de costo-efectividad.

Optimising pain management in children with acute otitis media through a primary care-based multifaceted educational intervention: study protocol for a cluster randomised controlled trial.

BACKGROUND: Whilst current guidelines highlight the importance of pain management for children with acute otitis media (AOM), there is evidence to suggest that this is not implemented in everyday practice. We have developed a primary care-based multifaceted educational intervention to optimise pain management in children with AOM, and we trial its clinical and cost effectiveness. METHODS: This cluster randomised controlled trial aims to recruit 250 children aged 6 months to 10 years presenting with AOM to general practitioners (GPs) in 30 primary care centres (PCCs) across the Netherlands. GPs in the PCCs allocated to the intervention group receive a blended GP educational programme (online and face-to-face training). The intervention asks GPs to proactively discuss pain management with parents using an information leaflet, and to prescribe paracetamol and ibuprofen according to current guidelines. GPs in both groups complete an online module illustrating various otoscopic images to standardise AOM diagnosis. GPs in the PCCs allocated to the control group do not receive any further training and provide 'care as usual'. During the 4-week follow-up, parents complete a symptom diary. The primary outcome is the difference in parent-reported mean earache scores over the first 3 days. Secondary outcomes include both number of days with earache and fever, GP re-consultations for AOM, antibiotic prescriptions, and costs. Analysis will be by intention-to-treat. DISCUSSION: The optimal use of analgesics through the multifaceted intervention may provide symptom relief and thereby reduce re-consultations and antibiotic prescriptions in children with AOM. TRIAL REGISTRATION: Netherlands Trial Register, NTR4920 . Registered on 19 December 2014.

Estimating the cost-effectiveness of an infant 13-valent pneumococcal conjugate vaccine national immunization program in China.

BACKGROUND: The burden of pneumococcal disease in China is high, and a 13-valent pneumococcal conjugate vaccine (PCV13) recently received regulatory approval and is available to Chinese infants. PCV13 protects against the most prevalent serotypes causing invasive pneumococcal disease (IPD) in China, but will not provide full societal benefits until made broadly available through a national immunization program (NIP). OBJECTIVE: To estimate clinical and economic benefits of introducing PCV13 into a NIP in China using local cost estimates and accounting for variability in vaccine uptake and indirect (herd protection) effects. METHODS: We developed a population model to estimate the effect of PCV13 introduction in China. Modeled health states included meningitis, bacteremia, pneumonia (PNE), acute otitis media, death and sequelae, and no disease. Direct healthcare costs and disease incidence data for IPD and PNE were derived from the China Health Insurance and Research Association database; all other parameters were derived from published literature. We estimated total disease cases and associated costs, quality-adjusted life years (QALYs), and deaths for three scenarios from a Chinese Payer Perspective: (1) direct effects only, (2) direct+indirect effects for IPD only, and (3) direct+indirect effects for IPD and inpatient PNE. RESULTS: Scenario (1) resulted in 370.3 thousand QALYs gained and 12.8 thousand deaths avoided versus no vaccination. In scenarios (2) and (3), the PCV13 NIP gained 383.2 thousand and 3,580 thousand QALYs, and avoided 13.1 thousand and 147.5 thousand deaths versus no vaccination, respectively. In all three scenarios, the vaccination cost was offset by cost reductions from prevented disease yielding net costs of ¥29,362.32 million, ¥29,334.29 million, and ¥13,524.72 million, respectively. All resulting incremental cost-effectiveness ratios fell below a 2x China GDP cost-effectiveness threshold across a range of potential vaccine prices. DISCUSSION: Initiation of a PCV13 NIP in China incurs large upfront costs but is good value for money, and is likely to prevent substantial cases of disease among children and non-vaccinated individuals.

Trends in healthcare utilization and costs associated with acute otitis media in the United States during 2008-2014.

BACKGROUND: Acute otitis media (AOM) is the most common cause of pediatric medical visits and antibiotic prescriptions worldwide, but its current impact on the US healthcare system is not clear. The aim of this study was to investigate changes in the incidence of AOM from 2008, just before 13-valent pneumococcal conjugate vaccine was introduced, to 2014 using US insurance records in the Truven MarketScan® database. The study also examined the costs associated with index AOM events during the two most recent years for which data were available (2013-2014). METHODS: AOM cases in the MarketScan database during 2008-2014 were identified using ICD9 diagnosis codes 381.xx and 382.xx. Incidence rates of healthcare utilization related to the index AOM episode were calculated using the annual number of enrolled person-years as the denominator and the number of individuals with AOM as the numerator. AOM-associated costs were calculated as the mean payment per episode during the 2 years from 2013 to 2014. RESULTS: The overall annual rate of AOM-related healthcare utilization was 60.5 per 1000 person-years and changed little from 2008 to 2014 (range, 58.4-62.6). Most of this was due to office/outpatient visits (55.7 [range, 52.0-58.8] per 1000 person-years). Emergency department/urgent care visits (4.7 [range 3.7-6.3] per 1000 person-years) and hospitalization (0.0 [range, 0.0-0.1] per 1000 person-years) contributed little. The rate of AOM-related healthcare utilization per 1000 person-years was highest in the youngest children and declined with age (474.3 for < 1 year, 503.9 for 1 year, 316.3 for 2-4 years, 94.9 for 5-17 years, 33.1 for 18-49 years, 28.6 for 50-64 years, 23.7 for 65-74 years, 20.2 for 75-84 years, and 16.1 for ≥85 years). The mean cost per AOM episode in 2013-2014 (95% confidence interval) was $199.0 (198.4-199.6) for office or outpatient visits, $329.6 (328.2-331.0) for emergency department/urgent care visits, and $1592.9 (1422.0-1763.8) for hospitalization. CONCLUSIONS: In the US, AOM-associated healthcare utilization and costs remain substantial. More effective preventive measures such as new vaccines are needed to reduce the burden of AOM.

Economic burden of pneumococcal infections in children under 5 years of age.

The present study aimed to determine the cost of childhood pneumococcal infections under 5 years of age and to provide further data for future health economy studies. Electronic medical records of children diagnosed with meningitis caused by S. pneumoniae and all-cause pneumonia, and acute otitis media (AOM) between January 2013-April 2014 were retrospectively evaluated. Direct costs for the treatments of hospitalized patients (pneumonia and pneumococcal meningitis) including costs of healthcare services consisted of costs of hospital bed, examination, laboratory analyses, scanning methods, consultation, vascular access procedures, and infusion and intravenous treatments. Direct costs for patients (AOM) treated in outpatient setting included constant price paid for the examination and cost of prescribed antibiotics. Indirect costs included cost of work loss of parents and their transportation expenses. Data of 130 children with pneumococcal meningitis (n = 10), pneumonia (n = 53), and AOM (n = 67) were analyzed. The total median cost was €4,060.38 (direct cost: €3,346.38 and indirect cost: €829.18) for meningitis, €835.91 (direct cost: €480.66 and indirect cost: €330.09) for pneumonia, and €117.32 (direct cost: €17.59 and indirect cost: €99.73) for AOM. The medication cost (p = 0.047), indirect cost (p = 0.032), and total cost (p = 0.011) were significantly higher in pneumonia patients aged ≥36 months than those aged <36 months; however, direct cost of AOM were significantly higher in the patients aged <36 months (p = 0.049). Results of the present study revealed that the treatment cost was significantly enhanced for hospitalization and for advanced disease. Thus, preventive actions, mainly vaccination, should be conducted regularly.

Review of vaccine effectiveness assumptions used in economic evaluations of infant pneumococcal conjugate vaccine.

INTRODUCTION: Pneumococcal conjugate vaccines (PCVs) have provided a significant clinical and economic impact globally. The majority of countries which have implemented an infant PCV program have observed a substantial reduction in the burden of invasive pneumococcal disease (IPD), pneumococcal pneumonia, and acute otitis media (AOM) due to vaccine serotypes. After 17 years of use, many countries have evaluated and re-evaluated the value of their vaccine program using cost-effectiveness analyses; however, many of these analyses do not reflect the current body of evidence. AREAS COVERED: This literature review summarizes key assumptions used in cost-effectiveness analyses for PCVs and discusses whether these should be refined. EXPERT COMMENTARY: Many existing models continue to project cost-effectiveness of implementing a PCV program into a naïve population, despite sustained PCV use. Furthermore, many assumptions related to program effectiveness are based on evidence from controlled studies or extrapolated from vaccines that are no longer or were never used. Real world effectiveness data published from nearly 10 years of higher-valet vaccine use should be reflected in key assumptions that drive decision makers to choose one vaccine over another. As data continuously emerges, cost-effectiveness of programs should be evaluated in the context of the most current data.

Cost-effectiveness analysis of infant pneumococcal vaccination with PHiD-CV in Korea.

BACKGROUND: Streptococcus pneumoniae and non-typeable Haemophilus influenzae (NTHi) can cause invasive pneumococcal diseases (IPD), pneumonia, and acute otitis media (AOM). Both the 10-valent pneumococcal NTHi protein D conjugate vaccine (PHiD-CV) and the 13-valent pneumococcal conjugate vaccine (PCV-13) are included in the National Immunization Program for infants in Korea. This study aimed to evaluate the cost-effectiveness of the 3+1 schedule of PHiD-CV versus that of PCV-13 for National Immunization Program in Korea. METHODS: A published Markov model was adapted to evaluate the cost-effectiveness of vaccinating the 2012 birth cohort with PHiD-CV vs. PCV-13 from the Korean government perspective over 10 y. Best available published data were used for epidemiology, vaccine efficacy and disutilities. Data on incidence and direct medical costs were taken from the national insurance claims database. Sensitivity analyses were conducted to explore the robustness of the results. RESULTS: PHiD-CV was projected to prevent an additional 195,262 cases of pneumococcal diseases and NTHi-related diseases vs. PCV-13, with a substantially greater reduction in NTHi-related AOM and a comparable reduction in IPD and community-acquired pneumonia. Parity-priced PHiD-CV generated a health gain of about 844 quality-adjusted life years and a total cost-saving of approximately 4 million United States Dollars (USD) over 10 y. 93% of probabilistic simulations found PHiD-CV 3+1 to be the dominant vaccine option. CONCLUSION: Compared to PCV-13, PHiD-CV was projected to provide similar prevention against IPD and community-acquired pneumonia but would prevent more cases of AOM. Parity-priced PHiD-CV was anticipated to generate substantial cost-savings and health benefits vs. PCV-13 in Korea.

A Moraxella catarrhalis vaccine to protect against otitis media and exacerbations of COPD: An update on current progress and challenges.

Moraxella catarrhalis is a major cause of morbidity and mortality worldwide, especially causing otitis media in young children and exacerbations of chronic obstructive pulmonary disease in adults. This pathogen uses several virulence mechanisms to colonize and survive in its host, including adherence and invasion of host cells, formation of polymicrobial biofilms with other bacterial pathogens, and production of ß-lactamase. Given the global impact of otitis media and COPD, an effective vaccine to prevent M. catarrhalis infection would have a huge impact on the quality of life in both patient populations by preventing disease, thus reducing morbidity and health care costs. A number of promising vaccine antigens have been identified for M. catarrhalis. The development of improved animal models of M. catarrhalis disease and identification of a correlate of protection are needed to accelerate vaccine development. This review will discuss the current state of M. catarrhalis vaccine development, and the challenges that must be addressed to succeed.

A Cost-Utility Analysis of 5 Strategies for the Management of Acute Otitis Media in Children.

OBJECTIVE: To assess whether antimicrobial therapy in young children with acute otitis media reduces time to resolution of symptoms, overall symptom burden, and persistence of otoscopic evidence of infection. We used a cost-utility model to evaluate whether immediate antimicrobial treatment seems to be worthwhile, and if so, which antimicrobial agent is most cost effective. STUDY DESIGN: We compared the cost per quality-adjusted life-day of 5 treatment regimens in children younger than 2 years of age with acute otitis media: immediate amoxicillin/clavulanate, immediate amoxicillin, immediate cefdinir, watchful waiting, and delayed prescription (DP) for antibiotic. RESULTS: The 5 treatment regimens, listed in order from least effective to most effective were DP, watchful waiting, immediate cefdinir, immediate amoxicillin, and immediate amoxicillin/clavulanate. Listed in order from least costly to most costly, the regimens were DP, immediate amoxicillin, watchful waiting, immediate amoxicillin/clavulanate, and immediate cefdinir. The incremental cost-utility ratio of immediate amoxicillin compared with DP was $101.07 per quality-adjusted life-day gained. The incremental cost-utility ratio of immediate amoxicillin/clavulanate compared with amoxicillin was $2331.28 per quality-adjusted life-day gained. CONCLUSIONS: In children younger than 2 years of age with acute otitis media and no recent antibiotic exposure, immediate amoxicillin seems to be the most cost-effective initial treatment.

Cost-Effectiveness of Watchful Waiting in Acute Otitis Media.

BACKGROUND: American Academy of Pediatrics guidelines for acute otitis media (AOM) allow for children meeting certain criteria to undergo watchful waiting (WW). The cost-effectiveness of this policy has not been evaluated in the United States. METHODS: A retrospective review of a random selection of 250 patients ≤18 years old with AOM in the emergency department of a tertiary care children's hospital was used to characterize current practice of AOM management. These data were incorporated into a decision-analytic cost-utility model comparing the cost-effectiveness of implementing WW to current practice. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed in 2015 USD per disability-adjusted life year (DALY) averted from a societal perspective. Multiple sensitivity analyses were conducted. RESULTS: From this cohort, chart review confirmed 247 actually had AOM on physical examination. Of these, 231 (93.5%) were prescribed antibiotics, 7 (2.8%) underwent WW, and 9 (3.6%) were sent home without an antibiotic prescription. When American Academy of Pediatrics criteria for WW were applied to this population, 104 patients (42.1%) met conditions for immediate antibiotic prescription, and 143 patients (57.9%) qualified for WW. In our modeled scenario, for every 1000 patients with AOM, implementing WW yielded 514 fewer immediate antibiotic prescriptions and 205 fewer antibiotic prescriptions used, averting 14.3 DALYs, and saving $5573. The preferability of WW over current practice proved highly robust to sensitivity analysis. CONCLUSIONS: WW for AOM management is cost-effective. Implementing WW may improve outcomes and reduce health care expenditures.

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.