Factors associated with the pricing of childhood vaccines in the U.S. public sector.

Vaccine purchase cost has grown substantially over the last few decades. A closer look at vaccine prices reveals that not all vaccines shared the same increasing pattern. Various factors, such as vaccine attributes, competition, and supply shortages, could relate to price changes. In this study, we examined whether a variety of factors influenced the prices of noninfluenza childhood vaccines purchased in the public sector from 1996 to 2014. The association differed among price-capped vaccines and combination vaccines. There was an increasing time trend in real prices for non-price-capped vaccines, which was mostly offset by the effect of market longevity. The effect of competition in lowering prices was more pronounced among non-price-capped vaccines when manufacturer and vaccine component fixed effects were excluded. Supply shortage, manufacturer name change, and number of vaccine doses in series showed no effect. The results may help policy makers better understand price behaviors and make more informed decisions in vaccine planning and financing.

Costs of school-located influenza vaccination clinics in Maine during the 2009-2010 H1N1 pandemic.

This study retrospectively estimated costs for a convenience sample of school-located vaccination (SLV) clinics conducted in Maine during the 2009-2010 influenza season. Surveys were developed to capture the cost of labor including unpaid volunteers as well as supplies and materials used in SLV clinics. Six nurses from different school districts completed a clinic day survey on staff time; four of the six also provided data for materials and supplies. For all clinics, average per-dose labor cost was estimated at $5.95. Average per-dose material cost, excluding vaccine, was $5.76. From the four complete clinic survey responses, total per-dose cost was estimated to be an average of $13.51 (range = $4.91-$32.39). Use of donated materials and uncompensated volunteer staff could substantially reduce per-dose cost. Average per-dose cost could also be lowered by increasing the number of doses administered in a clinic.

Coordination costs for school-located influenza vaccination clinics, Maine, 2009 H1N1 pandemic.

School nurses played a key role in Maine's school-located influenza vaccination (SLV) clinics during the 2009-2010 pandemic season. The objective of this study was to determine, from the school district perspective, the labor hours and costs associated with outside-clinic coordination activities (OCA). The authors defined OCA as labor hours spent by staff outside of clinic operations. The authors surveyed a convenience sample of 10 school nurses from nine school districts. Eight nurses responded to the survey, representing seven districts, 45 schools and 84 SLV clinics that provided a total of 22,596 vaccine doses (H1N1 and seasonal combined) to children and adolescents. The mean total OCA time per clinic was 69 hours: out of total hours, 22 (36%) were spent outside regular clinic operation time. The authors estimated the mean cost of OCA to be $15.36 per dose. Survey respondents reported that costs would be lower during non-pandemic seasons and as schools become more proficient at planning clinics.

Valuing health across the lifespan: health state preferences for seasonal influenza illnesses in patients of different ages.

OBJECTIVE: This study sought to measure whether public values for health states vary with the age of the affected individual. METHODS: Health state preferences were measured via a 15-minute survey administered through the Internet in December 2007 using a probability sample of the adult population of the United States (N = 1012). Respondents were asked to value hypothetical descriptions of seasonal influenza illness (uncomplicated influenza illness, hospitalization) and possible vaccine-related adverse events (anaphylaxis, Guillain-Barré syndrome) using time trade-off or willingness-to-pay questions. Respondents were randomized to four different ages for an affected hypothetical individual: 1-year-old, 8-year-old, 35-year-old, 85-year-old. All other aspects of the health state description were held constant. Summary statistics for each health state and age were calculated. The Kruskal-Wallis test was used to measure differences in responses across ages of affected individuals in the hypothetical scenarios. Regression analyses were used to evaluate the effect of age on time trade-off or willingness-to-pay amounts controlling for respondent characteristics. RESULTS: Median values for time trade-off and willingness-to-pay were highest for young children. This pattern was generally consistent across responses and type of valuation. CONCLUSIONS: Approaches that assume health state values do not differ with the age of a patient may bias economic analyses that use these values. If patient age is likely to affect health state valuations, then age should be included as an attribute in the valuation exercise.

A tool for the economic analysis of mass prophylaxis operations with an application to H1N1 influenza vaccination clinics.

This article uses the 2009 H1N1 influenza vaccination program experience to introduce a cost analysis approach that may be relevant for planning mass prophylaxis operations, such as vaccination clinics at public health centers, work sites, schools, or pharmacy-based clinics. These costs are important for planning mass influenza vaccination activities and are relevant for all public health emergency preparedness scenarios requiring countermeasure dispensing. We demonstrate how costs vary depending on accounting perspective, staffing composition, and other factors. We also describe a mass vaccination clinic budgeting tool that clinic managers may use to estimate clinic costs and to examine how costs vary depending on the availability of volunteers or donated supplies and on the number of patients vaccinated per hour. Results from pilot tests with school-based H1N1 influenza vaccination clinic managers are described. The tool can also contribute to planning efforts for universal seasonal influenza vaccination.

Evaluation of non-continuous temperature monitoring practices for vaccine storage units: A Monte Carlo simulation study.

Objectives: Evaluate different non-continuous temperature monitoring practices for detection of out-of-range temperatures (above or below the recommended temperature range of 2-8°C for refrigeration units), which are called excursions, within vaccine storage units. Methods: Simulations based on temperature data collected by 243 digital data loggers operated in vaccine storage units at health care providers who participated in a CDC-sponsored continuous temperature monitoring pilot project, from 2012 to 2015. In the primary analysis, we evaluate: (1) twice-daily current temperature readings without minimum and maximum readings (min/max), (2) twice-daily current temperature readings with once-daily min/max, and (3) twice-daily current temperature readings with twice-daily min/max. Results: Recording current temperature twice-daily without min/max resulted in the detection of 4.8-6.4% of the total number of temperature excursions. When min/max readings were introduced, the percentage of detected temperature excursions increased to 27.8-96.6% with once-daily min/max and to 34.8-96.7% with twice-daily min/max. Conclusions: Including min/max readings improves the ability of a temperature monitoring practice to detect temperature excursions. No combination of the non-continuous temperature monitoring practices were able to consistently detect all simulated temperature excursions.

Evaluating Partial Series Childhood Vaccination Services in a Mobile Clinic Setting.

This study aims to evaluate the cost-benefit of vaccination services, mostly partial series administration, provided by a mobile clinic program (MCP) in Houston for children of transient and low-income families. The study included 469 patients who visited the mobile clinics on regular service days in 2 study periods in 2014 and 836 patients who attended vaccination events in the summer of 2014. The benefit of partial series vaccination was estimated based on vaccine efficacy/effectiveness data. Our conservative cost-benefit estimates show that, compared with office-based settings, every dollar spent on vaccination by the MCP would result in $0.9 societal cost averted as an incremental benefit in regular service days and $3.7 during vaccination-only events. To further improve the cost-benefit of vaccination services in the MCP, decision-makers and stakeholders may consider improving work efficiency during regular service days or hosting more vaccination events.

Use of a choice survey to identify adult, adolescent and parent preferences for vaccination in the United States.

BACKGROUND: Adult and adolescent vaccination rates are far below coverage targets in the United States. Our objective was to identify the most influential factors related to vaccine uptake among adults, adolescents, and parents of adolescents (parents) in the United States. METHODS: We used a fractional factorial design to create a binary choice survey to evaluate preferences for vaccination. The national survey was fielded to a sample of adults, adolescents ages 13-17 years, and parents, using a national probability-based online research panel in November 2015. Respondents were presented with 5 profiles of a hypothetical vaccine and asked in a series of questions whether they would accept each vaccine. We analyzed the binary choice data using logistic regression in STATA v13 (College Station, TX) to calculate the odds that a participant would choose to accept the vaccine. RESULTS: We received completed responses from 334 (51%) of 652 adults, 316 (21%) of 1516 adolescents, and 339 (33%) of 1030 parents. Respondents were generally representative of the U.S. POPULATION: Vaccine effectiveness was the most influential factor in the choice to vaccinate for all groups. Other most influential factors were primary care provider (PCP) recommendation and the out-of-pocket cost of the vaccine. Other factors such as risk of illness, risk of vaccine side effects, vaccination location, and time for vaccination were not important in the decision to get vaccinated. CONCLUSIONS: Adults, adolescents, and parents are most sensitive to vaccine effectiveness, PCP recommendation, and out-of-pocket cost for vaccination in their decision to get vaccinated. Strong PCP recommendations that focus on vaccine effectiveness and health care policies that minimize out-of-pocket costs for vaccinations may increase vaccine uptake by adults and adolescents.

Economics of an adolescent meningococcal conjugate vaccination catch-up campaign in the United States.

BACKGROUND: In June 2005, the Advisory Committee on Immunization Practices recommended the newly licensed quadrivalent meningococcal conjugate vaccine for routine use among all US children aged 11 years. A 1-time catch-up vaccination campaign for children and adolescents aged 11-17 years, followed by routine annual immunization of each child aged 11 years, could generate immediate herd immunity benefits. The objective of our study was to analyze the cost-effectiveness of a catch-up vaccination campaign with quadrivalent meningococcal conjugate vaccine for children and adolescents aged 11-17 years. METHODS: We built a probabilistic model of disease burden and economic impacts for a 10-year period with and without a program of adolescent catch-up meningococcal vaccination, followed by 9 years of routine immunization of children aged 11 years. We used US age- and serogroup-specific surveillance data on incidence and mortality. Assumptions related to the impact of herd immunity were drawn from experience with routine meningococcal vaccination in the United Kingdom. We estimated costs per case, deaths prevented, life-years saved, and quality-adjusted life-years saved. RESULTS: With herd immunity, the catch-up and routine vaccination program for adolescents would prevent 8251 cases of meningococcal disease in a 10-year period (a 48% decrease). Excluding program costs, this catch-up and routine vaccination program would save US$551 million in direct costs and $920 million in indirect costs, including costs associated with permanent disability and premature death. At $83 per vaccinee, the catch-up vaccination would cost society approximately $223,000 per case averted, approximately $2.6 million per death prevented, approximately $127,000 per life-year saved, and approximately $88,000 per quality-adjusted life-year saved. Targeting counties with a high incidence of disease decreased the cost per life-year saved by two-thirds. CONCLUSIONS: Although costly, catch-up and routine vaccination of adolescents can have a substantial impact on meningococcal disease burden. Because of herd immunity, catch-up and routine vaccination cost per life-year saved could be up to one-third less than that previously assessed for routine vaccination of children aged 11 years.

Non-traditional settings for influenza vaccination of adults: costs and cost effectiveness.

OBJECTIVE: Influenza vaccination rates remain far below national goals in the US. Expanding influenza vaccination in non-traditional settings such as worksites and pharmacies may be a way to enhance vaccination coverage for adults, but scant data exist on the cost effectiveness of this strategy. The aims of this study were to (i) describe the costs of vaccination in non-traditional settings such as pharmacies and mass vaccination clinics; and (ii) evaluate the projected health benefits, costs and cost effectiveness of delivering influenza vaccination to adults of varying ages and risk groups in non-traditional settings compared with scheduled doctor's office visits. All analyses are from the US societal perspective. METHODS: We evaluated the costs of influenza vaccination in non-traditional settings via detailed telephone interviews with representatives of organizations that conduct mass vaccination clinics and pharmacies that use pharmacists to deliver vaccinations. Next, we constructed a decision tree to compare the projected health benefits and costs of influenza vaccination delivered via non-traditional settings or during scheduled doctor's office visits with no vaccination. The target population was stratified by age (18-49, 50-64 and >or=65 years) and risk status (high or low risk for influenza-related complications). Probabilities and costs (direct and opportunity) for uncomplicated influenza illness, outpatient visits, hospitalizations, deaths, vaccination and vaccine adverse events were derived from primary data and from published and unpublished sources. RESULTS: The mean cost (year 2004 values) of vaccination was lower in mass vaccination (dollars US 17.04) and pharmacy (dollars US 11.57) settings than in scheduled doctor's office visits (dollars US 28.67). Vaccination in non-traditional settings was projected to be cost saving for healthy adults aged >or=50 years, and for high-risk adults of all ages. For healthy adults aged 18-49 years, preventing an episode of influenza would cost dollars US 90 if vaccination were delivered via the pharmacy setting, dollars US 210 via the mass vaccination setting and dollars US 870 via a scheduled doctor's office visit. Results were sensitive to assumptions on the incidence of influenza illness, the costs of vaccination (including recipient time costs) and vaccine effectiveness. CONCLUSION: Using non-traditional settings to deliver routine influenza vaccination to adults is likely to be cost saving for healthy adults aged 50-64 years and relatively cost effective for healthy adults aged 18-49 years when preferences for averted morbidity are included.

Preferences for health economics presentations among vaccine policymakers and researchers.

PURPOSE: Measure the preferences of decision makers and researchers associated with the Advisory Committee on Immunization Practices (ACIP) regarding the recommended format for presenting health economics studies to the ACIP. METHODS: We conducted key informant interviews and an online survey of current ACIP work group members, and current and previous ACIP voting members, liaison representatives, and ex-officio members to understand preferences for health economics presentations. These preferences included the presentation of results and sensitivity analyses, the role of health economics studies in decision making, and strategies to improve guidelines for presenting health economics studies. Best-worst scaling was used to measure the relative value of seven attributes of health economics presentations in vaccine decision making. RESULTS: The best-worst scaling survey had a response rate of 51% (n = 93). Results showed that summary results were the most important attribute for decision making (mean importance score: 0.69) and intermediate outcomes and disaggregated results were least important (mean importance score: -0.71). Respondents without previous health economics experience assigned sensitivity analysis lower importance and relationship of the results to other studies higher importance than the experienced group (sensitivity analysis scores: -0.15 vs. 0.15 respectively; relationship of the results: 0.13 vs. -0.12 respectively). Key informant interviews identified areas for improvement to include additional information on the quality of the analysis and increased role for liaisons familiar with health economics. CONCLUSION: Additional specificity in health economics presentations could allow for more effective presentations of evidence for vaccine decision making.

Gaps in vaccine financing for underinsured children in the United States.

CONTEXT: The number of new vaccines recommended for children and adolescents has nearly doubled during the past 5 years, and the cost of fully vaccinating a child has increased dramatically in the past decade. Anecdotal reports from state policy makers and clinicians suggest that new gaps have arisen in financial coverage of vaccines for children who are underinsured (ie, have private insurance that does not cover all recommended vaccines). In 2000, approximately 14% of children were underinsured for vaccines in the United States. OBJECTIVES: To describe variation among states in the provision of new vaccines to underinsured children and to identify barriers to state purchase and distribution of new vaccines. DESIGN, SETTING, AND PARTICIPANTS: A 2-phase mixed-methods study of state immunization program managers in the United States. The first phase included 1-hour qualitative telephone interviews conducted from November to December 2005 with 9 program managers chosen to represent different state vaccine financing policies. The second phase incorporated findings from phase 1 to develop a national telephone and paper-based survey of state immunization program managers that was conducted from January to June 2006. MAIN OUTCOME MEASURES: Percentage of states in which underinsured children are unable to receive publicly purchased vaccines in the private or public sectors. RESULTS: Immunization program managers from 48 states (96%) participated in the study. Underinsured children were not eligible to receive publicly purchased meningococcal conjugate or pneumococcal conjugate vaccines in the private sector in 70% and 50% of states, respectively, or in the public sector in 40% and 17% of states, respectively. Due to limited financing for new vaccines, 10 states changed their policies for provision of publicly purchased vaccines between 2004 and early 2006 to restrict access to selected new vaccines for underinsured children. The most commonly cited barriers to implementation in underinsured children were lack of sufficient federal and state funding to purchase vaccines. CONCLUSIONS: The current vaccine financing system has resulted in gaps for underinsured children in the United States, many of whom are now unable to receive publicly purchased vaccines in either the private or public sectors. Additional strategies are needed to ensure financial coverage for all vaccines, particularly new vaccines, among this vulnerable population.

School-Based Influenza Vaccination: Health and Economic Impact of Maine's 2009 Influenza Vaccination Program.

OBJECTIVE: To estimate the societal economic and health impacts of Maine's school-based influenza vaccination (SIV) program during the 2009 A(H1N1) influenza pandemic. DATA SOURCES: Primary and secondary data covering the 2008-09 and 2009-10 influenza seasons. STUDY DESIGN: We estimated weekly monovalent influenza vaccine uptake in Maine and 15 other states, using difference-in-difference-in-differences analysis to assess the program's impact on immunization among six age groups. We also developed a health and economic Markov microsimulation model and conducted Monte Carlo sensitivity analysis. DATA COLLECTION: We used national survey data to estimate the impact of the SIV program on vaccine coverage. We used primary data and published studies to develop the microsimulation model. PRINCIPAL FINDINGS: The program was associated with higher immunization among children and lower immunization among adults aged 18-49 years and 65 and older. The program prevented 4,600 influenza infections and generated $4.9 million in net economic benefits. Cost savings from lower adult vaccination accounted for 54 percent of the economic gain. Economic benefits were positive in 98 percent of Monte Carlo simulations. CONCLUSIONS: SIV may be a cost-beneficial approach to increase immunization during pandemics, but programs should be designed to prevent lower immunization among nontargeted groups.

Trends in childhood vaccine purchase costs in the US public sector: 1996-2014.

While vaccination remains as one of the most cost-effective preventive strategies, the cost of fully immunizing a child has grown considerably over the last few decades. This study examines trends in non-influenza childhood vaccine purchase costs in the public sector from 1996 to 2014. Non-influenza vaccine purchase cost per child for children aged 0 through 18years was calculated based on public-sector purchase prices. Purchase cost changes were then decomposed into changes attributable to recommendation updates and changes attributable to price variation. The study analyzed the growth rate of combination vaccine prices separately and compared these prices with the sum of prices of component vaccines. It is found that the average annual growth rate of non-influenza vaccine purchase cost per child during 1996-2014 was 12.6%. The growth rate attributable to price changes was 1.0% on average. Combination vaccine prices showed greater variation. The study concludes that vaccine price variation was one but a minor reason for purchase cost changes. Recommendation updates, particularly the introduction of new vaccines, played a much larger role in raising the purchase costs. If the 12.6% annual growth rate found during 1996-2014 in the study continues to apply, the purchase costs of childhood vaccines may more than double by 2020.

Hitting the Optimal Vaccination Percentage and the Risks of Error: Why to Miss Right.

OBJECTIVE: To determine the optimal level of vaccination coverage defined as the level that minimizes total costs and explore how economic results change with marginal changes to this level of coverage. METHODS: A susceptible-infected-recovered-vaccinated model designed to represent theoretical infectious diseases was created to simulate disease spread. Parameter inputs were defined to include ranges that could represent a variety of possible vaccine-preventable conditions. Costs included vaccine costs and disease costs. Health benefits were quantified as monetized quality adjusted life years lost from disease. Primary outcomes were the number of infected people and the total costs of vaccination. Optimization methods were used to determine population vaccination coverage that achieved a minimum cost given disease and vaccine characteristics. Sensitivity analyses explored the effects of changes in reproductive rates, costs and vaccine efficacies on primary outcomes. Further analysis examined the additional cost incurred if the optimal coverage levels were not achieved. RESULTS: Results indicate that the relationship between vaccine and disease cost is the main driver of the optimal vaccination level. Under a wide range of assumptions, vaccination beyond the optimal level is less expensive compared to vaccination below the optimal level. This observation did not hold when the cost of the vaccine cost becomes approximately equal to the cost of disease. DISCUSSION AND CONCLUSION: These results suggest that vaccination below the optimal level of coverage is more costly than vaccinating beyond the optimal level. This work helps provide information for assessing the impact of changes in vaccination coverage at a societal level.

Impact and cost-effectiveness of a second tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine dose to prevent pertussis in the United States.

INTRODUCTION: The United States experienced a substantial increase in reported pertussis cases over the last decade. Since 2005, persons 11 years and older have been routinely recommended to receive a single dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine. The objective of this analysis was to evaluate the potential impact and cost-effectiveness of recommending a second dose of Tdap. METHODS: A static cohort model was used to calculate the epidemiologic and economic impact of adding a second dose of Tdap at age 16 or 21 years. Projected costs and outcomes were examined from a societal perspective over a 20-year period. Quality-adjusted Life Years (QALY) saved were calculated. RESULTS: Using baseline pertussis incidence from the National Notifiable Diseases Surveillance System, Tdap revaccination at either age 16 or 21 years would reduce outpatient visits by 433 (5%) and 285 (4%), and hospitalization cases by 7 (7%) and 5 (5%), respectively. The costs per QALY saved with a second dose of Tdap were approximately US $19.7 million (16 years) and $26.2 million (21 years). In sensitivity analyses, incidence most influenced the model; as incidence increased, the costs per QALY decreased. To a lesser degree, initial vaccine effectiveness and waning of effectiveness also affected cost outcomes. Multivariate sensitivity analyses showed that under a set of optimistic assumptions, the cost per QALY saved would be approximately $163,361 (16 years) and $204,556 (21 years). CONCLUSION: A second dose of Tdap resulted in a slight decrease in the number of cases and other outcomes, and that trend is more apparent when revaccinating at age 16 years than at age 21 years. Both revaccination strategies had high dollar per QALY saved even under optimistic assumptions in a multivariate sensitivity analysis.

Cost-effectiveness of seasonal inactivated influenza vaccination among pregnant women.

OBJECTIVE: To evaluate the cost-effectiveness of seasonal inactivated influenza vaccination among pregnant women using data from three recent influenza seasons in the United States. DESIGN, SETTING, AND PARTICIPANTS: We developed a decision-analytic model following a cohort of 5.2 million pregnant women and their infants aged <6 months to evaluate the cost-effectiveness of vaccinating women against seasonal influenza during pregnancy from a societal perspective. The main outcome measures were quality-adjusted life-year (QALY) gained and cost-effectiveness ratios. Data sources included surveillance data, epidemiological studies, and published vaccine cost data. Sensitivity analyses were also performed. All costs and outcomes were discounted at 3% annually. MAIN OUTCOME MEASURES: Total costs (direct and indirect), effects (QALY gains, averted case numbers), and incremental cost-effectiveness of seasonal inactivated influenza vaccination among pregnant women (cost per QALY gained). RESULTS: Using a recent benchmark of 52.2% vaccination coverage among pregnant women, we studied a hypothetical cohort of 2,753,015 vaccinated pregnant women. With an estimated vaccine effectiveness of 73% among pregnant women and 63% among infants <6 months, QALY gains for each season were 305 (2010-2011), 123 (2011-2012), and 610 (2012-2013). Compared with no vaccination, seasonal influenza vaccination during pregnancy was cost-saving when using data from the 2010-2011 and 2012-2013 influenza seasons. The cost-effectiveness ratio was greater than $100,000/QALY with the 2011-2012 influenza season data, when CDC reported a low attack rate compared to other recent seasons. CONCLUSIONS: Influenza vaccination for pregnant women can reduce morbidity from influenza in both pregnant women and their infants aged <6 months. Seasonal influenza vaccination during pregnancy is cost-saving during moderate to severe influenza seasons.

Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001.

OBJECTIVE: To evaluate the economic impact of the routine US childhood immunization schedule: diphtheria and tetanus toxoids and acellular pertussis; tetanus and diphtheria toxoids; Haemophilus influenzae type b conjugate; inactivated poliovirus; measles, mumps, and rubella; hepatitis B; and varicella vaccines. DESIGN: Decision tree-based analysis was conducted using population-based vaccination coverage, published vaccine efficacies, historical data on disease incidence before vaccination, and disease incidence reported for 1995-2001. Costs were estimated using the direct cost and societal (direct and indirect costs) perspectives. Program costs included vaccine, administration, vaccine-associated adverse events, and parent travel and time lost. All costs were inflated to 2001 US dollars, and all costs and benefits in the future were discounted at a 3% annual rate. PARTICIPANTS: A hypothetical 2001 US birth cohort of 3,803,295 infants was followed up from birth through death. MAIN OUTCOME MEASURES: Net present value (net savings) and benefit-cost ratios of routine immunization. RESULTS: Routine childhood immunization with the 7 vaccines was cost saving from the direct cost and societal perspectives, with net savings of 9.9 billion dollars and 43.3 billion dollars, respectively. Without routine vaccination, direct and societal costs of diphtheria, tetanus, pertussis, H influenzae type b, poliomyelitis, measles, mumps, rubella, congenital rubella syndrome, hepatitis B, and varicella would be 12.3 billion dollars and 46.6 billion dollars, respectively. Direct and societal costs for the vaccination program were an estimated 2.3 billion dollars and 2.8 billion dollars, respectively. Direct and societal benefit-cost ratios for routine childhood vaccination were 5.3 and 16.5, respectively. CONCLUSION: Regardless of the perspective, the current routine childhood immunization schedule results in substantial cost savings.

A meta-analysis of the dose-response relationship of inhaled corticosteroids in adolescents and adults with mild to moderate persistent asthma.

BACKGROUND: Although inhaled corticosteroids (ICS) are commonly used in the treatment of persistent asthma, the relationship between dose and clinical response remains unclear. OBJECTIVE: This study investigated whether ICS exhibit a dose-response relationship in the treatment of mild to moderate persistent asthma. METHODS: This was a meta-analysis of published randomized clinical trials concerning the relationship between ICS dose and response in asthma. Relevant studies were identified through a search of PubMed and MEDLINE for articles on asthma and ICS published between January 1996 and January 2001. The search was limited to publications classified as clinical trials that included the text words asthma and corticosteroids, glucocorticoids, beclomethasone, budesonide, fluticasone, flunisolide, mometasone, or triamcinolone acetonide. Five clinical measures were considered: morning peak expiratory flow rate (AM PEFR), evening PEFR (PM PEFR), forced expiratory volume in 1 second (FEV(1)), beta-agonist use, and asthma symptom score (severity of symptoms on a given day, as evaluated by patients). RESULTS: Forty-three studies were identified, of which 16 met the criteria for inclusion in the meta-analysis. These studies involved 4 agents: fluticasone propionate, triamcinolone acetonide, budesonide, and mometasone furoate. A statistically significant dose response in AM PEFR was observed with fluticasone propionate, triamcinolone acetonide, and budesonide (respective 95% CIs, 4.9 to 11.5, 4.7 to 18.0, and 5.8 to 24.9). A statistically significant dose response to fluticasone propionate and triamcinolone acetonide was also observed in PM PEFR (95% CIs, 2.0 to 8.7 and 2.4 to 13.7) and asthma symptom score (95% CI, -0.069 to -0.002 and -0.60 to -0.10). In terms of FEV(1), the dose response was statistically significant only with budesonide (95% CI, 0.025 to 0.17). Dose-response relationships were not disproportionately driven by the highest doses, and the greatest effects on response were seen at doses below or at the low end of the recommended range, suggesting that use of high doses of ICS may contribute only marginally to efficacy. CONCLUSIONS: Dose-response relationships were not uniformly observed with all drugs or for all measures of response. Use of higher doses of ICS in patients with mild to moderate persistent asthma does not appear to increase the efficacy of these drugs.

Willingness to pay for prevention and treatment of lymphatic filariasis in Leogane, Haiti.

BACKGROUND: Lymphatic filariasis (LF) affects more than 120 million people worldwide. Efforts to eliminate this disease require sustained community participation. This study explores community valuation of LF elimination efforts by estimating household and community willingness to pay (WTP) for the prevention of transmission and treatment of filarial lymphedema in the community of Leogane, Haiti. METHODS: A contingent valuation survey was used to assess individual WTP for specific prevention and treatment interventions. A 2-dimensional Monte Carlo simulation was developed to estimate confidence limits in mean WTP and to generate a distribution of WTP for the community, accounting for uncertainty in regression coefficients and variability within the population. RESULTS: Mean WTP was estimated to be $5.57/month/household (95% CL: $4.76, $6.72) to prevent disease transmission, and $491/yr (95% CL: $377, $662) for treatment of lymphedema for one person. Based on the estimated distributions, 7% and 39% of households were not willing to pay for prevention and treatment, respectively. CONCLUSIONS: These results suggest that the majority of the community places a positive value on both prevention and treatment of LF. Mean WTP provides a useful monetary estimate of overall societal benefit of LF prevention and treatment programs. However, for interventions which require broad and sustained community participation, the lower end of the distribution of WTP has additional implications. Cost recovery policies may result in inadequate participation and longer program duration.