The budget impact of introducing the OMNI® surgical system to a United States health plan for managing mild-to-moderate primary open-angle glaucoma.

OBJECTIVES: Minimally invasive glaucoma surgery devices fill an unmet need in the treatment paradigm between topical intraocular pressure medicines and more invasive filtration procedures. This study evaluated the adoption of The OMNI® Surgical System with or without cataract surgery in primary open-angle glaucoma patients. METHODS: A budget impact analysis estimated costs before and after adoption of OMNI® to a hypothetical US health plan with 1 million Medicare-covered lives over two years. Model input data were derived from published sources and development of the model included primary research with key opinion leaders and payers. The model compared total annual direct costs for OMNI® versus other treatment options (medications, other minimally invasive surgical procedures, selective laser trabeculoplasty) to calculate budget impact. A one-way sensitivity analysis was conducted to assess parameter uncertainty. RESULTS: Increased adoption of OMNI® resulted in budget neutrality over the two years with a decrease in total costs of $35,362. Per member per month incremental costs were $0.00 when used without cataract surgery and yielded cost savings of -$0.01 when used with cataract surgery. Sensitivity analysis confirmed model robustness and identified surgical center fee variability as a key driver of costs. CONCLUSION: OMNI® is budgetary efficient from a US payer perspective.

Understanding differences between what alternate propensity score methods estimate.

BACKGROUND: Many approaches to propensity score methods are used in the applied health economics and outcomes research literature. Often this creates confusion when different approaches produce different results for the same data. OBJECTIVE: To present a conceptual overview based on a potential outcomes framework to demonstrate how more than 1 mean treatment effect parameter can be estimated using the propensity score methods and how the selection of appropriate methods should align with the scientific questions. METHODS: We highlight that more than 1 mean treatment effect parameter can be estimated using the propensity score methods. Using the potential outcomes framework and alternate data-generating processes, we discuss under what assumptions different mean treatment effect parameter estimates are supposed to vary. We tie these discussions with propensity score methods to show that different approaches may estimate different parameters. We illustrate these methods using a case study of the comparative effectiveness of apixaban vs warfarin on the likelihood of stroke among patients with a prior diagnosis of atrial fibrillation. RESULTS: Different mean treatment effect parameters take on different values when treatment effects are heterogeneous. We show that traditional propensity score approaches, such as blocking, weighting, matching, or doubly robust, can estimate different mean treatment effect parameters. Therefore, they may not produce the same results even when applied to the same data using the same covariates. We found significant differences in our case study estimates of mean treatment effect parameters. Still, once a mean treatment effect parameter is targeted, estimates across different methods are not different. This highlights the importance of first selecting the target parameter for analysis by aligning the interpretation of the target parameter with the scientific questions and then selecting the specific method to estimate this target parameter. CONCLUSIONS: We present a conceptual overview of propensity score methods in health economics and outcomes research from a potential outcomes framework. We hope these discussions will help applied researchers choose appropriate propensity score approaches for their analysis. DISCLOSURES: Dr Unuigbe's time was supported through an unrestricted postdoctoral fellowship from Pfizer to the University of Washington, Seattle.

Clinical and Economic Outcomes Among Nonvalvular Atrial Fibrillation Patients With Coronary Artery Disease and/or Peripheral Artery Disease.

To address literature gaps on treatment with real-world evidence, this study compared effectiveness, safety, and cost outcomes in NVAF patients with coronary or peripheral artery disease (CAD, PAD) prescribed apixaban versus other oral anticoagulants. NVAF patients aged ≥65 years co-diagnosed with CAD/PAD initiating warfarin, apixaban, dabigatran, or rivaroxaban were selected from the US Medicare population (January 1, 2013 to September 30, 2015). Propensity score matching was used to match apixaban versus warfarin, dabigatran, and rivaroxaban cohorts. Cox models were used to evaluate the risk of stroke/systemic embolism (SE), major bleeding (MB), all-cause mortality, and a composite of stroke/myocardial infarction/all-cause mortality. Generalized linear and two-part models were used to compare stroke/SE, MB, and all-cause costs between cohorts. A total of 33,269 warfarin-apixaban, 9,335 dabigatran-apixaban, and 33,633 rivaroxaban-apixaban pairs were identified after matching. Compared with apixaban, stroke/SE risk was higher in warfarin (hazard ratio [HR]: 1.93; 95% confidence interval [CI]: 1.61 to 2.31), dabigatran (HR: 1.69; 95% CI: 1.18 to 2.43), and rivaroxaban (HR: 1.24; 95% CI: 1.01 to 1.51) patients. MB risk was higher in warfarin (HR: 1.67; 95% CI: 1.52 to 1.83), dabigatran (HR: 1.37; 95% CI: 1.13 to 1.68), and rivaroxaban (HR: 1.87; 95% CI: 1.71 to 2.05) patients vs apixaban. Stroke/SE- and MB-related medical costs per-patient per-month were higher in warfarin, dabigatran, and rivaroxaban patients versus apixaban. Total all-cause health care costs were higher in warfarin and rivaroxaban patients compared with apixaban patients. In conclusion, compared with apixaban, patients on dabigatran, rivaroxaban, or warfarin had a higher risk of stroke/SE, MB, and event-related costs.

Corrigendum to "Effectiveness and Safety of Oral Anticoagulants in Adults with Non-valvular Atrial Fibrillation Patients and Concomitant Coronary/Peripheral Artery Disease" American Journal of Medicine 131:09 (2018): 1074-1085.e4.

RESULTS: There were 33,269 apixaban-warfarin, 9,345 dabigatran-warfarin, and 42,156 rivaroxaban-warfarin matched pairs, with a median follow-up of 4-5 months. Compared with warfarin, apixaban was associated with lower rates of stroke/systemic embolism (hazard ratio [HR] 0.52; 95% confidence interval [95% CI], 0.43-0.62), major bleeding (HR 0.60; 95% CI, 0.55-0.66) and stroke/myocardial infarction/all-cause mortality (HR 0.70; 95%CI, 0.66-0.74); dabigatran was associated with lower rates of major bleeding (HR: 0.73; 95% CI, 0.62-0.85); dabigatran and rivaroxaban were associated with lower rates of stroke/myocardial infarction/all-cause mortality (HR 0.77; 95% CI, 0.69-0.86 and HR 0.81; 95% CI, 0.77-0.85, respectively). Rivaroxaban was associated with a lower rate of stroke/systemic embolism (HR 0.61; 95% CI, 0.53-0.71) and a higher rate of major bleeding (HR 1.10; 95%CI, 1.03-1.18) versus warfarin.

Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients.

Background and Purpose- This ARISTOPHANES study (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients) used multiple data sources to compare stroke/systemic embolism (SE) and major bleeding (MB) among a large number of nonvalvular atrial fibrillation patients on non-vitamin K antagonist oral anticoagulants (NOACs) or warfarin. Methods- A retrospective observational study of nonvalvular atrial fibrillation patients initiating apixaban, dabigatran, rivaroxaban, or warfarin from January 1, 2013, to September 30, 2015, was conducted pooling Centers for Medicare and Medicaid Services Medicare data and 4 US commercial claims databases. After 1:1 NOAC-warfarin and NOAC-NOAC propensity score matching in each database, the resulting patient records were pooled. Cox models were used to evaluate the risk of stroke/SE and MB across matched cohorts. Results- A total of 285 292 patients were included in the 6 matched cohorts: 57 929 apixaban-warfarin, 26 838 dabigatran-warfarin, 83 007 rivaroxaban-warfarin, 27 096 apixaban-dabigatran, 62 619 apixaban-rivaroxaban, and 27 538 dabigatran-rivaroxaban patient pairs. Apixaban (hazard ratio [HR], 0.61; 95% CI, 0.54-0.69), dabigatran (HR, 0.80; 95% CI, 0.68-0.94), and rivaroxaban (HR, 0.75; 95% CI, 0.69-0.82) were associated with lower rates of stroke/SE compared with warfarin. Apixaban (HR, 0.58; 95% CI, 0.54-0.62) and dabigatran (HR, 0.73; 95% CI, 0.66-0.81) had lower rates of MB, and rivaroxaban (HR, 1.07; 95% CI, 1.02-1.13) had a higher rate of MB compared with warfarin. Differences exist in rates of stroke/SE and MB across NOACs. Conclusions- In this largest observational study to date on NOACs and warfarin, the NOACs had lower rates of stroke/SE and variable comparative rates of MB versus warfarin. The findings from this study may help inform the discussion on benefit and risk in the shared decision-making process for stroke prevention between healthcare providers and nonvalvular atrial fibrillation patients. Clinical Trial Registration- URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT03087487.

Real-world comparison of bleeding risks among non-valvular atrial fibrillation patients prescribed apixaban, dabigatran, or rivaroxaban.

Limited real-world data are available regarding the comparative safety of non-vitamin K antagonist oral anticoagulants (NOACs). The objective of this retrospective claims observational cohort study was to compare the risk of bleeding among non-valvular atrial fibrillation (NVAF) patients prescribed apixaban, dabigatran, or rivaroxaban. NVAF patients aged ≥18 years with a 1-year baseline period were included if they were new initiators of NOACs or switched from warfarin to a NOAC. Cox proportional hazards modelling was used to estimate the adjusted hazard ratios of any bleeding, clinically relevant non-major (CRNM) bleeding, and major inpatient bleeding within 6 months of treatment initiation for rivaroxaban and dabigatran compared to apixaban. Among 60,227 eligible patients, 8,785 were prescribed apixaban, 20,963 dabigatran, and 30,529 rivaroxaban. Compared to dabigatran or rivaroxaban patients, apixaban patients were more likely to have greater proportions of baseline comorbidities and higher CHA2DS2-VASc and HAS-BLED scores. After adjusting for baseline clinical and demographic characteristics, patients prescribed rivaroxaban were more likely to experience any bleeding (HR: 1.35, 95% confidence interval [CI]: 1.26-1.45), CRNM bleeding (HR: 1.38, 95% CI: 1.27-1.49), and major inpatient bleeding (HR: 1.43, 95% CI: 1.17-1.74), compared to patients prescribed apixaban. Dabigatran patients had similar bleeding risks as apixaban patients. In conclusion, NVAF patients treated with rivaroxaban appeared to have an increased risk of any bleeding, CRNM bleeding, and major inpatient bleeding, compared to apixaban patients. There was no significant difference in any bleeding, CRNM bleeding, or inpatient major bleeding risks between patients treated with dabigatran and apixaban.

Effectiveness and Safety of Anticoagulants in Adults with Non-valvular Atrial Fibrillation and Concomitant Coronary/Peripheral Artery Disease.

BACKGROUND: Direct oral anticoagulants (DOAC) are at least non-inferior to warfarin in efficacy and safety among patients with nonvalvular atrial fibrillation. Limited evidence is available regarding outcomes for nonvalvular atrial fibrillation patients with coronary/peripheral artery disease. METHODS: Non-valvular atrial fibrillation patients aged ≥65 years diagnosed with coronary/peripheral artery disease in the US Medicare population, newly initiating DOACs (apixaban, rivaroxaban, dabigatran) or warfarin were selected from January 1, 2013 to September 30, 2015. Propensity score matching was used to compare DOACs vs warfarin. Cox proportional hazards models were used to estimate the risk of stroke/systemic embolism, major bleeding, and composite of stroke/myocardial infarction/all-cause mortality. RESULTS: There were 15,527 apixaban-warfarin, 6,962 dabigatran-warfarin, and 25,903 rivaroxaban-warfarin-matched pairs, with a mean follow-up of 5-6 months. Compared with warfarin, apixaban was associated with lower rates of stroke/systemic embolism (hazard ratio [HR] 0.48; 95% confidence interval [CI], 0.37-0.62), major bleeding (HR 0.66; 95% CI, 0.58-0.75), and stroke/myocardial infarction/all-cause mortality (HR 0.63; 95% CI, 0.58-0.69); dabigatran and rivaroxaban were associated with lower rates of stroke/myocardial infarction/all-cause mortality (HR 0.79; 95% CI, 0.70-0.90 and HR 0.87; 95% CI, 0.81-0.92, respectively). Rivaroxaban was associated with a lower rate of stroke/systemic embolism (HR 0.72; 95% CI, 0.60-0.89) and a higher rate of major bleeding (HR 1.14; 95% CI, 1.05-1.23) vs warfarin. CONCLUSIONS: All DOACs were associated with lower stroke/myocardial infarction/all-cause mortality rates compared with warfarin; differences were observed in rates of stroke/systemic embolism and major bleeding. Findings from this observational analysis provide important insights about oral anticoagulation therapy among non-valvular atrial fibrillation patients with coronary/peripheral artery disease and may help physicians in the decision-making process when treating this high-risk group of patients.

Discontinuation risk comparison among 'real-world' newly anticoagulated atrial fibrillation patients: Apixaban, warfarin, dabigatran, or rivaroxaban.

Discontinuation of oral anticoagulants may expose non-valvular atrial fibrillation (NVAF) patients to an increased risk of stroke. This study describes the real-world discontinuation rates and compared the risk of drug discontinuation among NVAF patients initiating apixaban, warfarin, dabigatran, or rivaroxaban. This retrospective cohort study evaluated newly-anticoagulated NVAF patients in the MarketScan® data population from 01/01/2012 through 12/31/2014. Discontinuation was defined as a lack of subsequent prescription of the index drug within 30 days after the last supply day of the last prescription. A Cox model was used to estimate the hazard ratio (HR) of discontinuation, adjusted for age, sex, and comorbidities. Among 45,361 eligible NVAF patients, 15,461 (34.1%) initiated warfarin; 7,438 (16.4%) apixaban; 4,661 (10.3%) dabigatran; and 17,801 (39.2%) initiated rivaroxaban treatment. Compared to warfarin, patients who initiated dabigatran (adjusted HR [aHR]: 0.84, 95% confidence interval [CI]: 0.80-0.87, P<0.001), rivaroxaban (aHR: 0.70, 95% CI: 0.68-0.73, P<0.001), or apixaban (aHR: 0.57, 95% CI: 0.55-0.60, P<0.001) were 16%, 30%, and 43% less likely to discontinue treatment, respectively. When compared to apixaban, patients who initiated dabigatran (aHR: 1.46, 95% CI: 1.38-1.54, P<0.001) or rivaroxaban (aHR: 1.23, 95% CI: 1.17-1.28, P<0.001) were more likely to discontinue treatment. Among newly-anticoagulated NVAF patients in the real-world setting, initiation on rivaroxaban, dabigatran, or apixaban was associated with a significantly lower risk of discontinuation compared to warfarin. When compared to apixaban, patients who initiated treatment with warfarin, dabigatran, or rivaroxaban were more likely to discontinue treatment.

Incidence and Burden of Pertussis Among Infants Less Than 1 Year of Age.

BACKGROUND: Infant-specific pertussis data, especially among neonates, are limited and variable. This study (NCT01890850) provides overall and age-specific pertussis incidence and associated health care utilization and costs among commercially insured infants in the US. METHODS: Nearly 1.2 million infants born from 2005 to 2010 with commercial health plan coverage were followed during their first 12 months of life. Pertussis cases were identified from medical claims (International Classification of Diseases, 9th revision, Clinical Modification code: 033.0, 033.9, 484.3), and incidence rates were calculated. Each pertussis case was then matched to 10 comparators, so pertussis-related health care utilization and costs before and after the index date could be assessed. RESULTS: The overall pertussis incidence rate among infants <12 months of age was 117.7/100,000 person-years; infants 3 months of age had the highest incidence rate (247.7/100,000 person-years). Infants diagnosed with pertussis were significantly more likely to have prior diagnoses of upper respiratory infection, cough and wheezing-related illnesses than comparators (P < 0.001). Pertussis cases were more likely to be hospitalized within 14 days after the index date (31.8% vs. 0.5%; P < 0.001) and their adjusted health care costs during follow-up were 2.82 times higher than comparators (P < 0.001; 95% confidence interval: 2.08-3.81). The incremental cost of pertussis during the 12-month follow-up period averaged $8271 (P < 0.001). The average incremental cost varied substantially by age, ranging from $18,781 (P < 0.001) to $3772 (P = 0.02) among infants 1 month and 7-12 months of age, respectively. CONCLUSIONS: The health burden of pertussis, particularly in the youngest infants, remains substantial, highlighting the need to intensify efforts to protect this most vulnerable population.

Major bleeding risk among non-valvular atrial fibrillation patients initiated on apixaban, dabigatran, rivaroxaban or warfarin: a "real-world" observational study in the United States.

BACKGROUND: Limited data are available about the real-world safety of non-vitamin K antagonist oral anticoagulants (NOACs). OBJECTIVES: To compare the major bleeding risk among newly anticoagulated non-valvular atrial fibrillation (NVAF) patients initiating apixaban, warfarin, dabigatran or rivaroxaban in the United States. METHODS AND RESULTS: A retrospective cohort study was conducted to compare the major bleeding risk among newly anticoagulated NVAF patients initiating warfarin, apixaban, dabigatran or rivaroxaban. The study used the Truven MarketScan(®) Commercial & Medicare supplemental US database from 1 January 2013 through 31 December 2013. Major bleeding was defined as bleeding requiring hospitalisation. Cox model estimated hazard ratios (HRs) of major bleeding were adjusted for age, gender, baseline comorbidities and co-medications. Among 29 338 newly anticoagulated NVAF patients, 2402 (8.19%) were on apixaban; 4173 (14.22%) on dabigatran; 10 050 (34.26%) on rivaroxaban; and 12 713 (43.33%) on warfarin. After adjusting for baseline characteristics, initiation on warfarin [adjusted HR (aHR): 1.93, 95% confidence interval (CI): 1.12-3.33, P=.018] or rivaroxaban (aHR: 2.19, 95% CI: 1.26-3.79, P=.005) had significantly greater risk of major bleeding vs apixaban. Dabigatran initiation (aHR: 1.71, 95% CI: 0.94-3.10, P=.079) had a non-significant major bleeding risk vs apixaban. When compared with warfarin, apixaban (aHR: 0.52, 95% CI: 0.30-0.89, P=.018) had significantly lower major bleeding risk. Patients initiating rivaroxaban (aHR: 1.13, 95% CI: 0.91-1.41, P=.262) or dabigatran (aHR: 0.88, 95% CI: 0.64-1.21, P=.446) had a non-significant major bleeding risk vs warfarin. CONCLUSION: Among newly anticoagulated NVAF patients in the real-world setting, initiation with rivaroxaban or warfarin was associated with a significantly greater risk of major bleeding compared with initiation on apixaban. When compared with warfarin, initiation with apixaban was associated with significantly lower risk of major bleeding. Additional observational studies are required to confirm these findings.

Vaccine Timeliness: A Cost Analysis of the Potential Implications of Delayed Pertussis Vaccination in the US.

BACKGROUND: Pertussis infection remains an important public health problem, particularly in infants. Despite high coverage, pertussis vaccination delays can leave infants at a vulnerable age with less protection than anticipated. METHODS: Current diphtheria-tetanus-pertussis (DTaP) vaccination timeliness for the first 3 doses in the US was estimated using National Immunization Survey data. A Markov model estimated the potential impact on outcomes and costs of a hypothetical situation of vaccination at exactly 60, 120 and 180 days, compared with current timeliness. Incidence and unit cost data came from published sources. Age-specific incidence (for month of life) of pertussis and the associated probabilities of hospitalization and death for the US, during 2000-2007, were taken from a recently published US DTaP vaccination cost-effectiveness study. The cost analysis was conducted from the healthcare system's perspective over a 1-year time horizon. A regression analysis was conducted to explore the factors associated with vaccination delay. RESULTS: Current DTaP vaccination was estimated to be delayed by 16, 27 and 44 days, for the first, second and third doses, respectively, relative to vaccination at exactly 60, 120 and 180 days. The model estimated that vaccination at exactly age 60, 120 and 180 days could prevent approximately 278 pertussis cases, 103 hospitalizations and 1 death in infants aged <1 year in the US, gaining approximately 38 quality-adjusted life years and saving approximately $1.03 million in healthcare costs. CONCLUSIONS: Timely administration of infant pertussis vaccine doses could potentially reduce subsequent pertussis cases, hospitalizations, deaths and medical costs in infants aged <1 year in the US.

The estimated incidence of pertussis in people aged 50 years old in the United States, 2006-2010.

BACKGROUND: Pertussis is believed to be widely underreported and under-recognized, particularly among adults. The aim of this study was to estimate the incidence of private practitioner-attended cough illness that could be attributed to Bordetella pertussis in adults aged ≥50 years in the US. METHODS: Multiple linear regressions were employed to estimate the overall incidence of pertussis. Data were extracted from IMS' private practice database of longitudinal, patient-level claims and IMS' commercial laboratory database during 4/1/2006-12/31/2010. Patients were ≥50 years old and had ≥1 ICD-9-CM claim for cough illness relating to pertussis, cough, or acute bronchitis. Pertussis positive laboratory tests, seasonal and secular variables were used for estimating the B. pertussis attributable fraction of cough illness. RESULTS: During the study period, there were 20.7 million cases of cough illness among people aged 50-64 and 27.5 million cases among those ≥65; of which the model attributed 2.5 and 1.7 %, respectively, to B. pertussis. The estimated incidences of cough illness attributed to B. pertussis during the study period were on average 202 and 257/100,000 among people aged 50-64 and ≥65 years, respectively, and increased over the years in both age groups. Depending on the year, estimated pertussis incidences were 42 to 105 times higher than medically attended ones in the same database. CONCLUSIONS: These findings indicate that the B. pertussis disease incidence in adults aged ≥50 years is significantly higher than generally estimated. Additional research regarding pertussis reporting and diagnosis in the adult populations is needed to validate these findings.

Stroke associated with discontinuation of warfarin therapy for atrial fibrillation.

OBJECTIVE: The objective of this study was to determine the association between warfarin discontinuation and stroke among patients with nonvalvular atrial fibrillation (NVAF). RESEARCH DESIGN AND METHODS: This was a retrospective, observational study of adult NVAF patients (≥ 18 years) who were on warfarin in the Truven MarketScan commercial claims and encounters and Medicare supplemental and coordination of benefits databases (1 January 2008 to 30 June 2012). Warfarin discontinuation was defined as a gap of ≥ 45 days in warfarin prescription within 1 year after initiation. Patients who did and did not discontinue warfarin were matched at a 1:1 ratio using a propensity score method. Matched patients were followed for up to 1 year to determine risks of ischemic stroke, transient ischemic attack (TIA), and hemorrhagic stroke. A multivariate Cox proportional hazards model was used to further adjust for the effects of potential confounders. RESULTS: A total of 27,000 patients were included. Patients who discontinued warfarin had higher rates of ischemic stroke compared to persistent patients (1.0 vs. 0.5 per 100 patient years, P < 0.01), but similar rates of TIA (1.2 vs. 0.9 per 100 patient years, respectively; P = 0.07) and hemorrhagic stroke (0.3 vs. 0.2 per 100 patient years, P = 0.31). After adjustment for potential confounders, warfarin discontinuation was significantly associated with increased risk of ischemic stroke (hazard ratio [HR]: 2.04; 95% confidence interval [CI]: 1.47-2.84), TIA (HR: 1.36; 95% CI: 1.04-1.78), and ischemic stroke or TIA (HR: 1.50; 95% CI: 1.20-1.87). CONCLUSIONS: Warfarin discontinuation is associated with increased risk of ischemic stroke and TIA. Health care providers may need to take a more active role in the management of warfarin discontinuation and clinical outcomes, e.g., by considering newer anticoagulants with favorable risk-benefit profiles. Key limitations of the study include unavailability of important clinical factors and measures in claims data.

Mixing of diphtheria, tetanus, and acellular pertussis (DTaP) vaccines in a population of children in managed care.

The Advisory Committee on Immunization Practices recommends administering diphtheria, tetanus and acellular pertussis (DTaP) vaccines to children at 2, 4, 6, 15-18 months, and 4-6 y of age; preferably with the same-brand vaccine for the whole series. We estimated age-appropriate DTaP dose completion and the proportion of children receiving a "mixed" DTaP vaccination series (ie, including DTaP vaccines from ≥ 2 brands) across the 3 milestones. Commercially-insured children born between 01/01/2003 and 04/30/2011 were identified from United States health insurance claims data and assigned to ≥ 1 of 3 study cohorts based on the duration of continuous health plan enrollment: 1) birth to <8 months; 2) birth to <20 months; 3) birth to <7 years. Dose completion and brand mixing of the first 3, first 4 or all 5 doses were measured in the respective cohorts. Administered DTaP vaccinations were identified in claims data and classified by brand (based on vaccine components and manufacturer). The analysis included children who received ≥ 2 DTaP vaccinations and had known brand information for all doses. Age-appropriate dose completion was 77% with 3 doses (<8 months cohort), 71% with 4 doses (<20 months cohort), and 85% with 5 doses (<7 years cohort). Mixed DTaP series were received by 4.7% (95% confidence interval [CI]: 4.6%-4.7%) in the <8 months cohort, 29.0% (95% CI: 28.6%-29.4%) in the <20 months cohort, and 39.0% (95% CI: 34.5, 43.6) in the <7 years cohort. DTaP mixing was just 4.7% for the first 3 doses but subsequently increased with the number of administered doses.

Impact of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine use in wound management on health care costs and pertussis cases.

BACKGROUND: The Advisory Committee on Immunization Practices (ACIP) recommends the use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine for routine wound management in adolescents and adults who require a tetanus toxoid-containing vaccine who were vaccinated ≥ 5 years earlier with tetanus toxoid, reduced diphtheria toxoid (Td) vaccine, and who have not previously received Tdap. OBJECTIVE: To estimate the overall budget and health impact of vaccinating individuals presenting for wound management with Tdap instead of Td vaccine, the current standard of care in practices that do not use Tdap for purposes of wound management. METHODS: A decision-analytic economic model was developed to estimate the expected increase in direct medical costs and the expected number of cases of pertussis avoided associated with the use of Tdap instead of Td vaccine in the wound management setting. Patients eligible for Tdap were aged 10+ years and required a tetanus-containing vaccine. Age-specific wound incidence data and Td and Tdap vaccination rates were taken from the National Health Interview Survey and the National Immunization Survey for the most recent available year. Age-specific pertussis incidence used in this analysis (151 per 100,000 for adolescents, 366 per 100,000 for those aged 20-64 years, and 176 per 100,000 for those aged 65+ years) used reported incidence rates adjusted by a factor of 10 for adolescents and by a factor of 100 for adults, based on assumptions previously made by ACIP to account for underreporting. Vaccine wholesale acquisition costs without federal excise tax were assumed in the base case. Efficacy of vaccination with Tdap in preventing pertussis was based on clinical trial data. Possible herd immunity effects of vaccination were not included in the model. Costs associated with vaccination and treatment of pertussis cases were reported as total annual costs and per-member-per-month (PMPM) costs for hypothetical health plans and for the U.S. population. Aggregate and incremental costs and pertussis cases avoided were presented undiscounted (as recommended for budget-impact analyses) annually and cumulatively over a 3-year time horizon in 2012 U.S. dollars. Scenario analyses were conducted on key parameters, including wound incidence, pertussis incidence, vaccine efficacy and waning protection against pertussis, uptake rates for Tdap, and vaccine prices using alternative data sources or alternative clinically relevant assumptions. RESULTS: For a health plan with 1 million covered lives aged < 65 years, vaccination with Tdap instead of Td was estimated to cost an additional $132,364 ($0.01 PMPM) in the first year and an additional $368,640 ($0.01 PMPM) cumulatively over 3 years. For a health plan with 1 million covered lives aged 65+ years, vaccination with Tdap instead of Td was estimated to cost an additional $201,165 ($0.02 PMPM) in the first year and an additional $549,568 ($0.02 PMPM) cumulatively over 3 years. For the U.S. population aged 10+ years, vaccination with Tdap instead of Td was estimated to result in protection against pertussis for an additional 2.7 million patients with wounds annually and was estimated to cost an additional $121,101,671 to avoid 42,104 cases of pertussis over the 3-year time horizon. Results were sensitive to input parameter values, particularly parameters associated with the number of patients with wounds vaccinated with Tdap (range 2.7 to 5.1 million patients). However, for all of the alternative scenarios tested, the expected increase in PMPM costs ranged from < $0.01 to $0.03. CONCLUSIONS: Vaccination of adolescents and adults with Tdap for wound management may result in an increase in PMPM costs for health plans of < $0.01 to $0.03. Given the potential reduction in pertussis cases at the population level, vaccination with Tdap for routine wound management could be considered as another strategy to help address the pertussis public health concern in the United States.

Cost-effectiveness of Tdap vaccination of adults aged ≥65 years in the prevention of pertussis in the US: a dynamic model of disease transmission.

OBJECTIVES: In February 2012, the Advisory Committee on Immunization Practices (ACIP) advised that all adults aged ≥65 years receive a single dose of reduced-antigen-content tetanus, diphtheria, and acellular pertussis (Tdap), expanding on a 2010 recommendation for adults >65 that was limited to those with close contact with infants. We evaluated clinical and economic outcomes of adding Tdap booster of adults aged ≥65 to "baseline" practice [full-strength DTaP administered from 2 months to 4-6 years, and one dose of Tdap at 11-64 years replacing decennial Td booster], using a dynamic model. METHODS: We constructed a population-level disease transmission model to evaluate the cost-effectiveness of supplementing baseline practice by vaccinating 10% of eligible adults aged ≥65 with Tdap replacing the decennial Td booster. US population effects, including indirect benefits accrued by unvaccinated persons, were estimated during a 1-year period after disease incidence reached a new steady state, with consequences of deaths and long-term pertussis sequelae projected over remaining lifetimes. Model outputs include: cases by severity, encephalopathy, deaths, costs (of vaccination and pertussis care) and quality-adjusted life-years (QALYs) associated with each strategy. Results in terms of incremental cost/QALY gained are presented from payer and societal perspectives. Sensitivity analyses vary key parameters within plausible ranges. RESULTS: For the US population, the intervention is expected to prevent >97,000 cases (>4,000 severe and >5,000 among infants) of pertussis annually at steady state. Additional vaccination costs are $4.7 million. Net cost savings, including vaccination costs, are $47.7 million (societal perspective) and $44.8 million (payer perspective). From both perspectives, the intervention strategy is dominant (less costly, and more effective by >3,000 QALYs) versus baseline. Results are robust to sensitivity analyses and alternative scenarios. CONCLUSIONS: Immunization of eligible adults aged ≥65, consistent with the current ACIP recommendation, is cost saving from both payer and societal perspectives.

Cost-effectiveness analysis of Tdap in the prevention of pertussis in the elderly.

OBJECTIVES: Health benefits and costs of combined reduced-antigen-content tetanus, diphtheria, and pertussis (Tdap) immunization among adults ≥65 years have not been evaluated. In February 2012, the Advisory Committee on Immunization Practices (ACIP) recommended expanding Tdap vaccination (one single dose) to include adults ≥65 years not previously vaccinated with Tdap. Our study estimated the health and economic outcomes of one-time replacement of the decennial tetanus and diphtheria (Td) booster with Tdap in the 10% of individuals aged 65 years assumed eligible each year compared with a baseline scenario of continued Td vaccination. METHODS: We constructed a model evaluating the cost-effectiveness of vaccinating a cohort of adults aged 65 with Tdap, by calculating pertussis cases averted due to direct vaccine effects only. Results are presented from societal and payer perspectives for a range of pertussis incidences (25-200 cases per 100,000), due to the uncertainty in estimating true annual incidence. Cases averted were accrued throughout the patient 's lifetime, and a probability tree used to estimate the clinical outcomes and costs (US$ 2010) for each case. Quality-adjusted life-years (QALYs) lost to acute disease were calculated by multiplying cases of mild/moderate/severe pertussis by the associated health-state disutility; QALY losses due to death and long-term sequelae were also considered. Incremental costs and QALYs were summed over the cohort to derive incremental cost-effectiveness ratios. Scenario analyses evaluated the effect of alternative plausible parameter estimates on results. RESULTS: At incidence levels of 25, 100, 200 cases/100,000, vaccinating adults aged 65 years costs an additional $336,000, $63,000 and $17,000/QALY gained, respectively. Vaccination has a cost-effectiveness ratio less than $50,000/QALY if pertussis incidence is >116 cases/100,000 from societal and payer perspectives. Results were robust to scenario analyses. CONCLUSIONS: Tdap immunization of adults aged 65 years according to current ACIP recommendations is a cost-effective health-care intervention at plausible incidence assumptions.

The socio-economic determinants of the health status of Roma in comparison with non-Roma in Bulgaria, Hungary and Romania.

BACKGROUNDS: Roma people from Central and Eastern Europe suffer some of the worst health conditions in the industrialized world. This article aims at identifying the determinants of health status among Roma in comparison with non-Roma in Bulgaria, Romania and Hungary. METHODS: Non-linear models were estimated for three different health indicators: self-reported health compared with the previous year, probability of reporting chronic conditions and feeling threatened by illness because of sanitary and hygienic circumstances. Ethnic origin differentiated by Roma, national population and other ethnic minorities is self-reported. The data used are from a unique data set provided by the United Nations Development Programme household survey on Roma and populations living in their close proximity for 2004. Sample sizes are 2536 for Bulgaria, 2640 for Hungary and 3292 for Romania. RESULTS: After controlling for demographic variables the Roma were significantly more likely to report worse health in any indicator than the non-Roma everywhere. However, after including socio-economic variables, Roma had a significantly higher probability of reporting chronic conditions only in Romania. For the probability of feeling threatened by illness because of unhygienic circumstances, being Roma was a main determinant in Hungary and Romania, but not in Bulgaria. The results for self-reported health were inconclusive. CONCLUSIONS: While these results in part support the development of health policies targeting Roma, the finding that poorly educated and less wealthy people, as well as other ethnic minorities also experience health inequalities suggests that broader multisectoral policies are needed in the countries studied.