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.

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.

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.

Adolescent girls' preferences for HPV vaccines: a discrete choice experiment.

PURPOSE: To measure adolescent girls' preferences over features of human papillomavirus (HPV) vaccines in order to provide quantitative estimates of the perceived benefits of vaccination and potential vaccine uptake. DESIGN/METHODOLOGY/APPROACH: A discrete choice experiment (DCE) survey was developed to measure adolescent girls' preferences over features of HPV vaccines. The survey was fielded to a U.S. sample of 307 girls aged 13-17 years who had not yet received an HPV vaccine in June 2008. FINDINGS: In a latent class logit model, two distinct groups were identified--one with strong preferences against vaccination which largely did not differentiate between vaccine features, and another that was receptive to vaccination and had well-defined preferences over vaccine features. Based on the mean estimates over the entire sample, we estimate that girls' valuation of bivalent and quadrivalent HPV vaccines ranged between $400 and $460 in 2008, measured as willingness-to-pay (WTP). The additional value of genital warts protection was $145, although cervical cancer efficacy was the most preferred feature. We estimate maximum uptake of 54-65%, close to the 53% reported for one dose in 2011 surveillance data, but higher than the 35% for three doses in surveillance data. RESEARCH LIMITATIONS/IMPLICATIONS: We conclude that adolescent girls do form clear opinions and some place significant value on HPV vaccination, making research on their preferences vital to understanding the determinants of HPV vaccine demand. ORIGINALITY/VALUE: DCE studies may be used to design more effective vaccine-promotion programs and for reassessing public health recommendations and guidelines as new vaccines are made available.

Parent attitudes about school-located influenza vaccination clinics.

The use of alternative venues beyond physician offices may help to increase rates of population influenza vaccination. Schools provide a logical setting for reaching children, but most school-located vaccination (SLV) efforts to date have been limited to local areas. The potential reach and acceptability of SLV at the national level is unknown in the United States. To address this gap, we conducted a nationally representative online survey of 1088 parents of school-aged children. We estimate rates of, and factors associated with, future hypothetical parental consent for children to participate in SLV for influenza. Based on logistic regression analysis, we estimate that 51% of parents would be willing to consent to SLV for influenza. Among those who would consent, SLV was reported as more convenient than the regular location (42.1% vs. 19.9%, P<0.001). However the regular location was preferred over SLV for the child's well-being in case of side effects (46.4% vs. 20.9%, P<0.001) and proper administration of the vaccine (31.0% vs. 21.0%, P<0.001). Parents with college degrees and whose child received the 2009-2010 seasonal or 2009 H1N1 influenza vaccination were more likely to consent, as were parents of uninsured children. Several measures of concern about vaccine safety were negatively associated with consent for SLV. Of those not against SLV, schools were preferred as more convenient to the regular location by college graduates, those whose child received the 2009-2010 seasonal or 2009 H1N1 influenza vaccination, and those with greater travel and clinic time. With an estimated one-half of U.S. parents willing to consent to SLV, this study shows the potential to use schools for large-scale influenza vaccination programs in the U.S.

Cost-effectiveness of using 2 vs 3 primary doses of 13-valent pneumococcal conjugate vaccine.

BACKGROUND AND OBJECTIVE: Although effective in preventing pneumococcal disease, 13-valent pneumococcal conjugate vaccine (PCV13) is the most expensive vaccine on the routinely recommended pediatric schedule in the United States. We examined the cost-effectiveness of switching from 4 total doses to 3 total doses by removing the third dose in the primary series in the United States. METHODS: We used a probabilistic model following a single birth cohort of 4.3 million to calculate societal cost savings and increased disease burden from removing the 6-month dose of PCV13. Based on modified estimates of 7-valent pneumococcal conjugate vaccine from randomized trials and observational studies, we assumed that vaccine effectiveness under the 2 schedules is identical for the first 6 months of life and largely similar after administration of the 12- to 15-month booster dose. RESULTS: Removing the third dose of PCV13 would annually save $500 million (in 2011$) but would also result in an estimated 2.5 additional deaths among inpatients with pneumonia or invasive pneumococcal disease. Such dose removal would also result in 261,000 estimated otitis media and 12,000 estimated pneumonia cases annually. These additional illnesses could be prevented through modest increases in coverage. Overall, societal savings per additional life-year lost would be ∼$6 million. When nonfatal outcomes are also considered, savings would range from $143,000 to $4 million per additional quality adjusted life-year lost, depending on the assumptions used for otitis media. CONCLUSIONS: Sizable societal cost savings and a moderate pneumococcal disease increase could be expected from removing the PCV13 primary series' third dose.

Pregnancy dose Tdap and postpartum cocooning to prevent infant pertussis: a decision analysis.

BACKGROUND: Infants <2 months of age are at highest risk of pertussis morbidity and mortality. Until recently, the US Advisory Committee on Immunization Practices (ACIP) recommended protecting young infants by "cocooning" or vaccination of postpartum mothers and other close contacts with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, adsorbed (Tdap) booster vaccine. ACIP recommends pregnancy vaccination as a preferred and safe alternative to postpartum vaccination. The ACIP cocooning recommendation has not changed. METHODS: We used a cohort model reflecting US 2009 births and the diphtheria-tetanus-acellular pertussis schedule to simulate a decision and cost-effectiveness analysis of Tdap vaccination during pregnancy compared with postpartum vaccination with or without vaccination of other close contacts (ie, cocooning). We analyzed infant pertussis cases, hospitalizations, and deaths, as well as direct disease, indirect, and public health costs for infants in the first year of life. All costs were updated to 2011 US dollars. RESULTS: Pregnancy vaccination could reduce annual infant pertussis incidence by more than postpartum vaccination, reducing cases by 33% versus 20%, hospitalizations by 38% versus 19%, and deaths by 49% versus 16%. Additional cocooning doses in a father and 1 grandparent could avert an additional 16% of cases but at higher cost. The cost per quality-adjusted life-year saved for pregnancy vaccination was substantially less than postpartum vaccination ($414 523 vs $1 172 825). CONCLUSIONS: Tdap vaccination during pregnancy could avert more infant cases and deaths at lower cost than postpartum vaccination, even when postpartum vaccination is combined with additional cocooning doses. Pregnancy dose vaccination is the preferred alternative to postpartum vaccination for preventing infant pertussis.

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.

Financial barriers to the adoption of combination vaccines by pediatricians.

OBJECTIVES: To describe the prevalence of combination vaccine use and the associated financial barriers faced by pediatric practices, and to identify determinants of adoption of combination vaccines. DESIGN: Mailed national survey. SETTING: Pediatric practices during the period from August through October 2008. PARTICIPANTS: Pediatricians randomly selected from the American Medical Association Masterfile. MAIN OUTCOME MEASURE: Use of 1 of 2 infant combination vaccines (the diphtheria and tetanus toxoids and acellular pertussis, hepatitis B virus, and inactivated poliovirus [DTaP-HepB-IPV] vaccine or the DTaP, IPV, and Haemophilus influenzae type b [DTaP-IPV/Hib] vaccine). RESULTS: We received 629 responses (response rate, 67%). Four hundred ninety-two pediatricians (78%) reported using 1 or both of the infant combination vaccines of interest (ie, the DTaP-HepB-IPV or DTaP-IPV/Hib vaccine). More than half of the respondents said their practice did not receive adequate reimbursement for the purchase and administration of vaccines in general. More than one-fifth reported not using 1 or more of the combination vaccines because of inadequate reimbursement for the cost of vaccine doses (23% of respondents) and/or vaccine administration (20% of respondents). The infant combination vaccines studied were less likely to be used by smaller practices, by those with a lower proportion of publicly insured patients, and by those with less inclusive state vaccine financing policies. CONCLUSIONS: One in 5 pediatricians reported that inadequate reimbursement prevented their using 1 or more combination vaccines. Practice size as well as the proportion of children whose vaccinations are paid for by public funds appear to be important determinants of the adoption of combination vaccines.

Mothers' preferences and willingness to pay for vaccinating daughters against human papillomavirus.

A choice-format, conjoint-analysis survey was developed and fielded to estimate how features of human papillomavirus (HPV) vaccines affect mothers' perceived benefit and stated vaccine uptake for daughters. Data were collected from a national sample of 307 U.S. mothers of girls aged 13-17 years who had not yet received an HPV vaccine. Preferences for four features of HPV vaccines were evaluated: protection against cervical cancer, protection against genital warts, duration of protection, and cost. We estimate that mean maximum willingness-to-pay (WTP)-an economic measure of the total benefits to consumers-for current HPV vaccine technology ranges between $560 and $660. All vaccine features were statistically significant determinants of WTP and uptake. Mothers were willing to pay $238 more for a vaccine that provides 90% protection for genital warts relative to a vaccine that provides no protection against warts. WTP for lifetime protection vs. 10 years protection was $245. Mothers strongly valued greater cervical cancer efficacy, with 100% protection against cervical cancers the most desired feature overall. Adding a second HPV vaccine choice to U.S. consumers' alternatives is predicted to increase stated uptake by 16%. Several features were significantly associated with stated choices and uptake: age of mother, race/ethnicity, household income, and concern about HPV risks. These findings provide new data on how HPV vaccines are viewed and valued by mothers, and how uptake may change in the context of evolving vaccine technology and as new data are reported on duration and efficacy.

MCV vaccination in the presence of vaccine-associated Guillain-Barré Syndrome risk: a decision analysis approach.

The study evaluates the benefits of meningococcal conjugate vaccine (MCV4) vaccination against the burden of vaccine-associated Guillain-Barré Syndrome (GBS) using simulation. An 11-year-old cohort was followed over an 8-year period in a simulation model Table 3 Figs. 1 and 2 to estimate health outcomes to assist decision makers in setting policy. Applying a 3% discount rate, MCV4 vaccination would save 2397 quality-adjusted life years (QALYs) while vaccine-attributable GBS could result in 5 QALYs lost. Based on the result, MCV4 vaccination is strongly favored despite possible vaccine-associated GBS risk.

Influenza vaccination coverage rate among high-risk children during the 2002-2003 influenza season.

BACKGROUND: Influenza vaccination is the primary method for preventing influenza and its complications. Characteristics of influenza vaccination coverage among high-risk children (HRC) during the 2002-2003 influenza season are described. METHODS: Children aged 1 to 17 years continuously enrolled in private health insurance plans during the 2002-2003 influenza season and entered in MarketScan paid claims databases were included. Children were partitioned into 2 groups: high-risk children and nonhigh-risk children (non-HRC) based on their diagnosis history since 1998. The influenza vaccination coverage rates of both groups during the 2002-2003 influenza season were assessed by demographic, child, and provider-related variables. RESULTS: The influenza vaccination coverage rate was 4.63% among all sampled children. Overall, influenza vaccination coverage rates were higher among HRC (11.74%) than non-HRC (3.31%). Among children ages 12 to 23 months, HRC had lower coverage than non-HRC, but, from age 2 years onward, HRC consistently had higher coverage than non-HRC. Influenza vaccination coverage varied by geographic area, with higher coverage among children living within metropolitan areas and in the Western and the Northeast regions of the United States. Children receiving vaccination under a comprehensive insurance plan had significantly lower coverage than children served by all other plan types. CONCLUSION: Influenza vaccination coverage during the 2002-2003 influenza season was very low among all children, leaving many children at risk for influenza and influenza-related complications. Coverage was influenced by child age, insurance plan type, and area of residence.

The impact of gaps in health insurance coverage on immunization status for young children.

OBJECTIVE: To examine the impact of full-year versus intermittent public and private health insurance coverage on the immunization status of children aged 19-35 months. DATA SOURCE: 2001 State and Local Area Integrated Telephone Survey's National Survey of Children with Special Health Care Needs (NS-CSHCN) and the 2000-2002 National Immunization Survey (NIS). STUDY DESIGN: Linked health insurance data from 2001 NS-CSHCN with verified immunization status from the 2000-2002 NIS for a nationally representative sample of 8,861 nonspecial health care needs children. Estimated adjusted rates of up-to-date (UTD) immunization status using multivariate logistic regressions for seven recommended immunizations and three series. PRINCIPAL FINDINGS: Children with public full-year coverage were significantly more likely to be UTD for two series of recommended vaccines, (4:3:1:3) and (4:3:1:3:3), compared with children with private full-year coverage. For three out of 10 immunizations and series tested, children with private part-year coverage were significantly less likely to be UTD than children with private full-year coverage. CONCLUSIONS: Our findings raise concerns about access to needed immunizations for children with gaps in private health insurance coverage and challenge the prevailing belief that private health insurance represents the gold standard with regard to UTD status for young children.

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.

Out-of-pocket costs of childhood immunizations: a comparison by type of insurance plan.

BACKGROUND: The "Guide to Community Preventive Services" strongly recommends reducing out-of-pocket costs to increase vaccination rates among children. Nevertheless, out-of-pocket expenses are still incurred during the receipt of childhood vaccines, vaccine administration, and associated well-child visits. OBJECTIVE: Our goal was to estimate total and out-of-pocket costs of childhood immunization. METHODS: We used the 2003 benefit-plan data for all 1217 private and public health plans registered in Georgia and the 2003 Advisory Committee on Immunization Practices recommended vaccine schedule to calculate costs to vaccinate children aged 0 to 5 years in 2003 dollars. By applying published estimates of health insurance enrollment of Georgia children, we calculated the total and out-of-pocket costs per child according to insurance status and race/ethnicity. Immunization coverage according to payer type was based on National Immunization Survey data. RESULTS: Out-of-pocket costs ranged between $0 (Medicaid/Peachcare) and $652 (uninsured/Medicare). Most out-of-pocket costs were incurred during the first year of life. Up-to-date immunization status ranged from 63.7% for uninsured persons to 83.2% for privately insured persons. Up-to-date status was negatively correlated with out-of-pocket costs and the proportion of the population below 250% of the federal poverty level. CONCLUSIONS: For most Georgia families, out-of-pocket expenses for childhood immunizations were low, favoring compliance with the recommended immunization schedule. However, families least able to afford the expense faced disproportionately high out-of-pocket costs. Out-of-pocket costs were inversely correlated with immunization coverage levels. Uninsured children whose families lived below 250% of the federal poverty level experienced the lowest immunization coverage levels. Immunization coverage through the Vaccines for Children Program and Medicaid/State Children's Health Insurance Programs should be promoted to minimize or eliminate out-of-pocket costs related to childhood immunizations, especially among children of low-income families.

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.

The annual impact of seasonal influenza in the US: measuring disease burden and costs.

BACKGROUND: Despite preventive efforts, influenza epidemics are responsible for substantial morbidity and mortality every year in the United States (US). Vaccination strategies to reduce disease burden have been implemented. However, no previous studies have systematically estimated the annual economic burden of influenza epidemics, an estimate necessary to guide policy makers effectively. OBJECTIVE: We estimate age- and risk-specific disease burden, and medical and indirect costs attributable to annual influenza epidemics in the United States. METHODS: Using a probabilistic model and publicly available epidemiological data we estimated the number of influenza-attributable cases leading to outpatient visits, hospitalization, and mortality, as well as time lost from work absenteeism or premature death. With data from health insurance claims and projections of either earnings or statistical life values, we then estimated healthcare resource utilization associated with influenza cases as were their medical and productivity (indirect) costs in $2003. RESULTS: Based on 2003 US population, we estimated that annual influenza epidemics resulted in an average of 610,660 life-years lost (undiscounted), 3.1 million hospitalized days, and 31.4 million outpatient visits. Direct medical costs averaged $10.4 billion (95% confidence interval [C.I.], $4.1, $22.2) annually. Projected lost earnings due to illness and loss of life amounted to $16.3 billion (C.I., $8.7, $31.0) annually. The total economic burden of annual influenza epidemics using projected statistical life values amounted to $87.1 billion (C.I., $47.2, $149.5). CONCLUSIONS: These results highlight the enormous annual burden of influenza in the US. While hospitalization costs are important contributors, lost productivity from missed work days and lost lives comprise the bulk of the economic burden of influenza.