Evaluating the Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine Compared to High-Dose Trivalent and Other Egg-Based Influenza Vaccines among Older Adults in the US during the 2017-2018 Influenza Season

The influenza-related disease burden is highest among the elderly. We evaluated the relative vaccine effectiveness (rVE) of adjuvanted trivalent influenza vaccine (aTIV) compared to other egg-based influenza vaccines (high-dose trivalent (TIV-HD), quadrivalent (QIVe-SD), and standard-dose trivalent (TIVe-SD)) against influenza-related and cardio-respiratory events among subjects aged >= 65 years for the 2017-2018 influenza season. This retrospective cohort analysis used prescription claims, professional fee claims, and hospital charge master data. Influenza-related hospitalizations/ER visits and office visits and cardio-respiratory events were assessed post-vaccination. Inverse probability of treatment weighting (IPTW) and Poisson regression were used to evaluate the adjusted rVE of aTIV compared to other vaccines. In an economic analysis, annualized follow-up costs were compared between aTIV and TIV-HD. The study was composed of 234,313 aTIV, 1,269,855 TIV-HD, 212,287 QIVe-SD, and 106,491 TIVe-SD recipients. aTIV was more effective in reducing influenza-related office visits and other respiratory-related hospitalizations/ER visits compared to the other vaccines. For influenza-related hospitalizations/ER visits, aTIV was associated with a significantly higher rVE compared to QIVe-SD and TIVe-SD and was comparable to TIV-HD. aTIV was also associated with a significantly higher rVE compared to TIVe-SD against hospitalizations/ER visits related to pneumonia and asthma/COPD/bronchial events. aTIV and TIV-HD were associated with comparable annualized all-cause and influenza-related costs. Adjusted analyses demonstrated a significant benefit of aTIV against influenza- and respiratory-related events compared to the other egg-based vaccines

A retrospective cohort study assessing relative effectiveness of adjuvanted versus high-dose trivalent influenza vaccines among older adults in the United States during the 2018-19 influenza season

Purpose: To evaluate the relative vaccine effectiveness (rVE) against influenza-related hospitalizations/ emergency room (ER) visits, influenza-related office visits, and cardio-respiratory disease (CRD)-related hospitalizations/ER visits and compare all-cause and influenza-related costs associated with two vaccines specifically indicated for older adults (>= 65 years), adjuvanted (aTIV) and high-dose trivalent influenza vaccine (TIV-HD), for the 2018-19 influenza season. Methods: A retrospective analysis of older adults was conducted using claims and hospital data in the United States. For clinical evaluations, adjusted analyses were conducted following inverse probability of treatment weighting (IPTW) to control for selection bias. Poisson regression was used to estimate the adjusted rVE against influenza-related hospitalizations/ER visits, influenza-related office visits, and any CRD-related hospitalizations/ER visits. For the economic evaluation, treatment selection bias was adjusted through 1:1 propensity score matching (PSM). All-cause and influenza-related costs associated with hospitalizations/ER, physician office and pharmacy visits were adjusted using generalized estimating equation (GEE) models. Results: After IPTW and Poisson regression, aTIV (n = 561,315) was slightly more effective in reducing influenza-related office visits compared to TIV-HD (n = 1,672,779) (6.6%; 95% CI: 2.8-10.3%). aTIV was statistically comparable to TIV-HD (2.0%; 95% CI: -3.7%-7.3%) in preventing influenza-related hospitalizations/ER visits but more effective in reducing hospitalizations/ER visits for any CRD (2.6%; 95% CI: 2.0-3.2%). In the PSM-adjusted cohorts (n = 561,243 pairs), following GEE adjustments, predicted mean annualized all-cause and influenza-related total costs per patient were statistically similar between aTIV and TIV-HD (US$9676 vs. US$9625 and US$18.74 vs. US$17.28, respectively; both p > 0.05). Finally, influenza-related pharmacy costs were slightly lower for aTIV as compared to TIV-HD ($1.75 vs$1.85; p = 65 were comparable between aTIV and TIV-HD. aTIV was slightly more effective in preventing influenza-related office visits and any CRD event as compared to TIV-HD in this population. (C) 2021 The Authors. Published by Elsevier Ltd

Clinical and Economic Outcomes Associated with Cell-Based Quadrivalent Influenza Vaccine vs. Standard-Dose Egg-Based Quadrivalent Influenza Vaccines during the 2018-19 Influenza Season in the United States

Non-egg-based influenza vaccines eliminate the potential for egg-adapted mutations and potentially increase vaccine effectiveness. This retrospective study compared hospitalizations/emergency room (ER) visits and all-cause annualized healthcare costs among subjects aged 4-64 years who received cell-based quadrivalent (QIVc) or standard-dose egg-based quadrivalent (QIVe-SD) influenza vaccine during the 2018-19 influenza season. Administrative claims data (IQVIA PharMetrics(R) Plus, IQVIA, USA) were utilized to evaluate clinical and economic outcomes. Adjusted relative vaccine effectiveness (rVE) of QIVc vs. QIVe-SD among overall cohort, as well as for three subgroups (age 4-17 years, age 18-64 years, and high-risk) was evaluated using inverse probability of treatment weighting (IPTW) and Poisson regression models. Generalized estimating equation models among the propensity score matched sample were used to estimate annualized all-cause costs. A total of 669,030 recipients of QIVc and 3,062,797 of QIVe-SD were identified after IPTW adjustments. Among the overall cohort, QIVc had higher adjusted rVEs against hospitalizations/ER visits related to influenza, all-cause hospitalizations, and hospitalizations/ER visits associated with any respiratory event compared to QIVe-SD. The adjusted annualized all-cause total costs were higher for QIVe-SD compared to QIVc ((+$461); p < 0.05)

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

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

Rotavirus disease: quantification of the disease and its impact due to vaccination using electronic claims databases

Estimates of the clinical and financial burden of RV disease among children aged less than 5 years before and after the introduction of the vaccines stratified by various age groups, particularly during recent years’ RV seasons, are limited. Published studies to date using real-world practice data have included only the Rotateq vaccine, and have not included Medicaid low-income population1. Additionally, there is no published study that looked at the effectiveness of Rotarix in the US born infants. Hence this research addresses these limitations by quantifying the incidence and cost of Rotavirus (RV) and Acute Gastroenteritis (AGE) among children less than 5 years of age among commercial and Medicaid plans. Additionally the study also assessed the impact of incomplete and complete vaccination among those in commercial and Medicaid plans. Study population included beneficiaries who continuously received benefits for at least 6 months while aged <5 years were identified separately in commercial (2000-2010) and Medicaid (2002-2009) claims. Incidence of RV-coded encounters, diarrhea-coded but RV-attributable encounters, and first RV episodes were calculated, along with incremental cost of first RV episodes. Incidence rates among the post vaccination period reduced significantly compared to pre vaccination period for both RV coded and diarrhea coded, but RV attributable disease in both population. Incremental per-patient per-month cost of first RV episodes in Medicaid was $2,054 and$3608 in commercial. Forty two percent of children in the commercial population had completed vaccination by 2010, and 11.1% of Medicaid patient had completed vaccination by 2009. Both complete and incomplete vaccination confers protection against RV episodes among inpatient visits, outpatient visits and ER visits for both population. Additionally there is evidence of strong indirect protection among those unvaccinated groups.Ph. D.Includes bibliographical referencesby Girishanthy Krishnaraja

The economic burden of CIDP in the United States: A case-control study.

BACKGROUND:Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare neurological disorder of the peripheral nervous system. The economic burden of CIDP is not well understood. OBJECTIVES:To assess the economic and clinical burden of CIDP and to compare the incremental burden relative to a matched control group without CIDP. METHODS:This retrospective case-control analysis was conducted using data from the IQVIA Real-World Data Adjudicated Claims. Adults newly diagnosed with CIDP between 7/1/2010 and 6/30/2014 were identified and direct matched to controls without CIDP. Baseline characteristics were assessed and compared over a 6-month pre-index period. Healthcare resource use, costs and clinical characteristics were assessed and compared over a 2-year follow-up. Total cost differences over the 2-year follow-up were compared between matched cohorts using a generalized estimating equation model. RESULTS:The final sample comprised a total of 790 cases matched to 790 controls. Over the 2-year follow-up, cases more frequently experienced neuropathic pain, back pain and osteoarthritis and more commonly utilized opioids, anti-convulsants and anti-depressants. Compared to controls, more cases had ≥1 hospitalization (26.2% vs. 9.0%), and cases had a higher mean number of outpatient prescription fills (62.8 vs. 32.0) and physician office visits (34.7 vs. 13.0) (all p<0.0001). Cases had 7.5x higher mean total costs ($116,330 vs.$15,586, p<0.0001). Important cost drivers were costs for outpatient ancillary, radiology and HCPCS drugs (mean $76,366 vs.$4,292) and costs for inpatient care (mean $16,357 vs.$2,862) (both p<0.0001). Among cases, CIDP therapy (inclusive of both outpatient pharmacy and medical claims) accounted for 51.2% of mean total costs. After further adjusting for baseline clinical characteristics, cases were associated with a 6.1x increase in total costs compared to controls (p<0.0001). CONCLUSIONS:Our findings suggest a substantial clinical and economic burden among patients with CIDP relative to matched controls over a 2-year follow-up

Effect of combination vaccines on completion and compliance of childhood vaccinations in the United States

Vaccination at age-appropriate intervals increases protection against morbidity and mortality; however, compliance rates among children remain low partly due to a complicated vaccination schedule. Use of combination vaccines reduces the number of injections per visit; however, there is limited evidence quantifying the effect of combination vaccines on vaccination rates. To examine how combination vaccines impact childhood completion (receipt of recommended doses) and compliance (receipt of age-appropriate vaccinations) rates, this study analyzed vaccination data from the 2012 National Immunization Survey (NIS), a nationally representative cross-sectional survey of caregivers of children aged 24 to 35 months in the United States. Vaccines were categorized as combination or single antigen. Vaccine completion was measured at ages 8, 18, and 24 months. Vaccine compliance and time undervaccinated were measured at 24 months. Children who received at least 1 combination vaccine (86%) had a higher completion rate (69%) and compliance with the full vaccine series (4:3:1:3:3:1:4 series) at 24 months (24%) than those who received only single-antigen vaccines (50% and 13%, respectively). Receipt of combination vaccine was associated with an increased likelihood of completing all recommended vaccinations at 24 months (odds ratio [OR] = 2.5; P < 0.001), receiving all vaccinations at age-appropriate times (OR = 2.2; P < 0.001), and less than 7 months undervaccinated (OR = 2.4; P < 0.001). Combination vaccines were associated with improved completion and compliance and should be encouraged among children who are undervaccinated or who received single-antigen vaccines only

Public Health Impact of Complete and Incomplete Rotavirus Vaccination among Commercially and Medicaid Insured Children in the United States.

BACKGROUND:This study (NCT01682005) aims to assess clinical and cost impacts of complete and incomplete rotavirus (RV) vaccination. METHODS:Beneficiaries who continuously received medical and pharmacy benefits since birth were identified separately in Truven Commercial Claims and Encounters (2000-2011) and Truven Medicaid Claims (2002-2010) and observed until the first of end of insurance eligibility or five years. Infants with ≥1 RV vaccine within the vaccination window (6 weeks-8 months) were divided into completely and incompletely vaccinated cohorts. Historically unvaccinated (before 2007) and contemporarily unvaccinated (2007 and after) cohorts included children without RV vaccine. Claims with International Classification of Disease 9th edition (ICD-9) codes for diarrhea and RV were identified. First RV episode incidence, RV-related and diarrhea-related healthcare resource utilization after 8 months old were calculated and compared across groups. Poisson regressions were used to generate incidence rates with 95% confidence intervals (CIs). Mean total, inpatient, outpatient and emergency room costs for first RV and diarrhea episodes were calculated; bootstrapping was used to construct 95% CIs to evaluate cost differences. RESULTS:1,069,485 Commercial and 515,557 Medicaid patients met inclusion criteria. Among commercially insured, RV incidence per 10,000 person-years was 3.3 (95% CI 2.8-3.9) for completely, 4.0 (95% CI 3.3-5.0) for incompletely vaccinated, and 20.9 (95% CI 19.5-22.4) for contemporarily and 40.3 (95% CI 38.6-42.1) for historically unvaccinated. Rates in Medicaid were 7.5 (95% CI 4.8-11.8) for completely, 9.0 (95% CI 6.5-12.3) for incompletely vaccinated, and 14.6 (95% CI 12.8-16.7) for contemporarily and 52.0 (95% CI 50.2-53.8) for historically unvaccinated. Mean cost for first RV episode per cohort member was $15.33 (95$12.99-$18.03) and$4.26 ($95$2.34-$6.35) lower for completely vaccinated versus contemporarily unvaccinated in Commercial and Medicaid, respectively. CONCLUSIONS:RV vaccination results in significant reduction in RV infection. There is evidence of indirect benefit to unvaccinated individuals