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1.
Hum Vaccin Immunother ; 20(1): 2358566, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38847198

ABSTRACT

A maternal vaccine and long-acting monoclonal antibody (mAb) were recently approved to protect infants against respiratory syncytial virus (RSV). We identified subgroups of pregnant people with different preferences for RSV preventives and respondent characteristics associated with subgroup membership. An online survey, including a discrete choice experiment (DCE), was conducted among US pregnant people. RSV preventive attributes included effectiveness, duration of protection during RSV season, injection recipient/timing, preventive type (vaccine or mAb), and type of visit required to receive injection. In DCE choice tasks, pregnant people selected between two hypothetical preventive profiles with varying attribute-levels and a no-preventive option. Logistic regression, including latent class analysis (LCA), was used to analyze the data. Of 992 pregnant people (mean age: 30.0 years), 60.3% were expecting their second/later birth. LCA identified three preference subgroups: 'Effectiveness' (preventive choice mostly driven by increases in effectiveness; 51.4% class membership probability), 'Season' (preventive choice mostly driven by improvement in duration of protection during the RSV season; 39.2% class membership probability), and 'No Preventive' (frequently chose no-preventive option; 9.4% class membership probability). 'Effectiveness' and 'Season' preferred maternal vaccine over mAb; mAb was preferred by 'No Preventive.' Perceiving RSV as serious for infants, higher health literacy, and lower household income were associated with 'Effectiveness.' Perceiving RSV as serious for pregnant people was associated with 'Season.' Perceiving RSV to not be serious for pregnant people and not being employed were associated with 'No Preventive.' Subgroups of pregnant people vary in preferences for RSV preventives. Most pregnant people preferred a maternal vaccine, although some may be more willing to accept alternative preventive options.


Subject(s)
Latent Class Analysis , Respiratory Syncytial Virus Infections , Respiratory Syncytial Virus Vaccines , Respiratory Syncytial Virus, Human , Humans , Female , Pregnancy , Respiratory Syncytial Virus Infections/prevention & control , United States , Adult , Respiratory Syncytial Virus Vaccines/immunology , Respiratory Syncytial Virus Vaccines/administration & dosage , Young Adult , Respiratory Syncytial Virus, Human/immunology , Infant , Surveys and Questionnaires , Patient Preference/statistics & numerical data , Vaccination/statistics & numerical data , Pregnant Women/psychology , Antibodies, Monoclonal/therapeutic use , Adolescent
2.
Infect Dis Ther ; 13(7): 1665-1682, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38834858

ABSTRACT

INTRODUCTION: Respiratory syncytial virus (RSV) is one of the major causes of respiratory tract infections among children. Until recently, the monoclonal antibody palivizumab was the only RSV prophylaxis available in Japan. In 2024, the bivalent RSV prefusion F protein-based (RSVpreF) vaccine was approved for the prevention of RSV infection in infants by active immunization of pregnant women. In this study, we assessed the cost-effectiveness of a combined strategy of RSVpreF vaccine and palivizumab in Japanese setting. METHODS: Using a Markov model, we evaluated prevented cases and deaths of medically attended RSV infections from birth to age 11 months for each of the three healthcare settings: inpatient (hospitalization), emergency department visits, and outpatient visits. Incremental cost-effectiveness ratios (ICERs) were calculated from economic outcomes (intervention costs, medication costs, and productivity losses) and quality-adjusted life years (QALYs). Further, we calculated the maximum price of RSVpreF vaccine within which the program would be cost-effective. RESULTS: In comparison with the current prophylaxis (palivizumab alone), a combined prophylaxis of year-round RSVpreF vaccination of pregnant women and palivizumab prescription for premature infants born in < 32 weeks gestational age (wGA) and all infants with high risk prevented 14,382 medically attended cases of RSV (hospitalization, 7490 cases; emergency department, 2239 cases; outpatient, 4653 cases) and 7 deaths, respectively. From a healthcare payer perspective, when the price of RSVpreF vaccine was equal to or less than ¥23,948 (US $182), a combination prophylaxis was cost-effective under the ICER threshold of ¥5 million per QALY. The other combination prophylaxis of year-round RSVpreF vaccination and palivizumab prescription of premature born in < 32 wGA regardless of risk in infants was a dominant strategy (more effective and less costly). CONCLUSION: A combined prophylaxis of year-round RSVpreF vaccine and palivizumab could be a cost-effective strategy to protect neonates throughout the infant stage (< 1 years old) in Japan.

3.
Infect Dis Ther ; 13(6): 1315-1331, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38733493

ABSTRACT

INTRODUCTION: Respiratory syncytial virus (RSV) is the leading cause of acute lower respiratory infections (ALRI) in children under one year of age. In high-income countries, RSV infections cause a significant overload of care every winter, imposing a significant burden to the healthcare system, which has made the development of prevention strategies a major global health priority. In this context, a new bivalent RSV prefusion F protein-based vaccine (RSVpreF) has recently been approved. The objective of this study was to evaluate the cost-effectiveness of vaccinating pregnant women with the RSVpreF vaccine to prevent RSV in infants from the Spanish National Healthcare System (NHS) perspective. METHODS: A hypothetical cohort framework and a Markov-type process were used to estimate clinical outcomes, costs, quality-adjusted life years (QALY) and cost-per-QALY gained (willingness-to-pay threshold: €25,000/QALY) for newborn infants born to RSV-vaccinated versus unvaccinated mothers over an RSV season. The base case analysis was performed from the NHS perspective including direct costs (€2023) and applying a discount of 3% to future costs and outcomes. To evaluate the robustness of the model, several scenarios, and deterministic and probabilistic analyses were carried out. All the parameters and assumptions were validated by a panel of experts. RESULTS: The results of the study showed that year-round maternal vaccination program with 70% coverage is a dominant option compared to no intervention, resulting in direct cost savings of €1.8 million each year, with an increase of 551 QALYs. Maternal vaccination could prevent 38% of hospital admissions, 23% of emergency room visits, 19% of primary care visits, and 34% of deaths due to RSV. All scenario analyses showed consistent results, and according to the probabilistic sensitivity analysis (PSA), the probability of maternal vaccination being cost-effective versus no intervention was 99%. CONCLUSIONS: From the Spanish NHS perspective, maternal vaccination with bivalent RSVpreF is a dominant alternative compared with a non-prevention strategy.

4.
Vaccines (Basel) ; 12(5)2024 May 20.
Article in English | MEDLINE | ID: mdl-38793811

ABSTRACT

We assessed the impact of respiratory syncytial virus (RSV) preventive characteristics on the intentions of pregnant people and healthcare providers (HCPs) to protect infants with a maternal vaccine or monoclonal antibodies (mAbs). Pregnant people and HCPs who treated pregnant people and/or infants were recruited via convenience sample from a general research panel to complete a cross-sectional, web-based survey, including a discrete choice experiment (DCE) wherein respondents chose between hypothetical RSV preventive profiles varying on five attributes (effectiveness, preventive type [maternal vaccine vs. mAb], injection recipient/timing, type of medical visit required to receive the injection, and duration of protection during RSV season) and a no-preventive option. A best-worst scaling (BWS) exercise was included to explore the impact of additional attributes on preventive preferences. Data were collected between October and November 2022. Attribute-level preference weights and relative importance (RI) were estimated. Overall, 992 pregnant people and 310 HCPs participated. A preventive (vs. none) was chosen 89.2% (pregnant people) and 96.0% (HCPs) of the time (DCE). Effectiveness was most important to preventive choice for pregnant people (RI = 48.0%) and HCPs (RI = 41.7%); all else equal, pregnant people (RI = 5.5%) and HCPs (RI = 7.2%) preferred the maternal vaccine over mAbs, although preventive type had limited influence on choice. Longer protection, protection starting at birth or the beginning of RSV season, and use for both pre-term and full-term babies were ranked highest in importance (BWS). Pregnant people and HCPs strongly preferred a preventive to protect infants against RSV (vs. none), underscoring the need to incorporate RSV preventives into routine care.

5.
Vaccine ; 41(51): 7632-7640, 2023 Dec 12.
Article in English | MEDLINE | ID: mdl-37993354

ABSTRACT

BACKGROUND: Assessment of maternal vaccine coverage is important for understanding and quantifying the impact of currently recommended vaccines as well as modeling the potential impact of future vaccines. However, existing data lack detail regarding uptake according to week of gestational age (wGA). Such granularity is valuable for more accurate estimation of vaccine impact. OBJECTIVE: To summarize contemporary maternal Tdap vaccination uptake, overall, yearly, and by wGA, and maternal influenza vaccination uptake, overall, by influenza observation year, immunization month, and delivery month, in the US. METHODS: Female patients 18-49 years of age with a pregnancy resulting in a live born infant (i.e., delivery) between 2017 and 2021 were selected from the Optum electronic health records (EHRs) database. Recently published gestational age algorithms were utilized to estimate wGA. RESULTS: Of 1,021,260 deliveries among 886,660 women between 2017-2021, 55.1% had Tdap vaccination during pregnancy; vaccine coverage varied slightly by year (2017: 56.6%; 2018: 55.2%; 2019: 55.2%; 2020: 54.7%; 2021: 52.1%). Most (64.4%) maternal Tdap vaccinations occurred 27-32 wGA; 79.5% occurred during the entire 10-week recommended vaccination window (27-36 wGA). In the evaluation of influenza vaccination uptake (n=798,113 deliveries; 714,841 women), 33.5% of deliveries had influenza vaccination during influenza observation years 2017-2021, most (73.0%) of which occurred during influenza peak activity months (October-January) with approximately one-quarter (27.0%) of vaccinations having occurred during the off-peak months, mostly in September. CONCLUSIONS: In this large contemporary analysis of EHR data, uptake of Tdap vaccination during pregnancy was consistent with previously published estimates; notably, most vaccination occurred early in the recommended 27-36 wGA window. Maternal influenza vaccination uptake largely correlated with peak influenza activity months and not gestational age. These study findings may have important implications for estimating the potential uptake and impact of future maternal vaccines.


Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines , Influenza Vaccines , Influenza, Human , Respiratory Syncytial Virus Vaccines , Whooping Cough , Pregnancy , Infant , Female , Humans , United States , Influenza, Human/prevention & control , Vaccination , Bacterial Vaccines , Whooping Cough/prevention & control
6.
Am Health Drug Benefits ; 8(2): 83-92, 2015 Apr.
Article in English | MEDLINE | ID: mdl-26005515

ABSTRACT

BACKGROUND: Pregnancy is associated with a significant cost for employers providing health insurance benefits to their employees. The latest study on the topic was published in 2002, estimating the unintended pregnancy rate for women covered by employer-sponsored insurance benefits to be approximately 29%. OBJECTIVES: The primary objective of this study was to update the cost of unintended pregnancy to employer-sponsored health insurance plans with current data. The secondary objective was to develop a regression model to identify the factors and associated magnitude that contribute to unintended pregnancies in the employee benefits population. METHODS: We developed stepwise multinomial logistic regression models using data from a national survey on maternal attitudes about pregnancy before and shortly after giving birth. The survey was conducted by the Centers for Disease Control and Prevention through mail and via telephone interviews between 2009 and 2011 of women who had had a live birth. The regression models were then applied to a large commercial health claims database from the Truven Health MarketScan to retrospectively assign the probability of pregnancy intention to each delivery. RESULTS: Based on the MarketScan database, we estimate that among employer-sponsored health insurance plans, 28.8% of pregnancies are unintended, which is consistent with national findings of 29% in a survey by the Centers for Disease Control and Prevention. These unintended pregnancies account for 27.4% of the annual delivery costs to employers in the United States, or approximately 1% of the typical employer's health benefits spending for 1 year. Using these findings, we present a regression model that employers could apply to their claims data to identify the risk for unintended pregnancies in their health insurance population. CONCLUSION: The availability of coverage for contraception without employee cost-sharing, as was required by the Affordable Care Act in 2012, combined with the ability to identify women who are at high risk for an unintended pregnancy, can help employers address the costs of unintended pregnancies in their employee benefits population. This can also help to bring contraception efforts into the mainstream of other preventive and wellness programs, such as smoking cessation, obesity management, and diabetes control programs.

7.
Pediatr Blood Cancer ; 44(5): 500-7, 2005 May.
Article in English | MEDLINE | ID: mdl-15602707

ABSTRACT

BACKGROUND: We hypothesized that child cognitive disability would be a significant risk factor for non-adherence with home deferoxamine (DFO) administration and that a factor that would contribute to improved adherence would be sharing of responsibilities for chelation between parents and patients. We explored the influences on adherence of behavioral and psychological adjustment; family stress; perceived convenience of and satisfaction with the DFO regimen; and parent and patient knowledge about DFO. PROCEDURE: Fifteen pediatric patients with sickle cell disease (SCD) who had evidence of excessive iron stores, and their parents, were interviewed about adherence and responsibility for chelation therapy. A neuropsychological assessment battery was administered to the patients. Family stress, the child's emotional and behavioral status, knowledge about chelation and iron overload were explored. Adherence was rated objectively using pharmacy refill patterns and observable signs of chelation. RESULTS: Sharing of responsibilities for chelation between parents and children was related to better adherence while neuropsychological status bore a complex relation to adherence. Of the exploratory variables, low family stress were related to better adherence while satisfaction with the home care regimen and convenience ratings were not useful in predicting adherence. No one element of adherence, even objective measures, was capable of classifying adherence, while a multifactorial scheme categorizing adherent, partially adherent and non-adherent groups demonstrated good face validity. CONCLUSIONS: Supporting developmentally appropriate sharing of responsibilities for self-care is critical, taking patient neurocognitive status into consideration. Clinicians should evaluate adherence using a multifactorial model that highlights the most salient targets for intervention.


Subject(s)
Anemia, Sickle Cell/drug therapy , Anemia, Sickle Cell/psychology , Deferoxamine/therapeutic use , Patient Compliance , Adolescent , Anemia, Sickle Cell/complications , Caregivers/psychology , Chelation Therapy , Child , Child, Preschool , Cognition Disorders , Female , Home Care Services , Humans , Interviews as Topic , Iron Overload/drug therapy , Male , Parents , Patient Compliance/psychology , Patient Compliance/statistics & numerical data , Psychological Tests
8.
Med Care ; 42(5): 439-46, 2004 May.
Article in English | MEDLINE | ID: mdl-15083104

ABSTRACT

BACKGROUND: Despite continuing debate over a prescription drug benefit for the Medicare program, there has been relatively little research estimating the potential cost of providing such a benefit. OBJECTIVE: The objective of this study was to estimate the effect of prescription drug insurance on outpatient prescription drug expenditures among the elderly. RESEARCH DESIGN: We studied respondents aged > or =65 years to the 1997 Medical Expenditure Panel Survey, a representative survey of the U.S. noninstitutionalized population. Survey-weighted linear regression models were used to estimate the probability of any expenditures and total expenditures while controlling for sociodemographic characteristics, chronic conditions, and health status. MEASURES: We used prescription drug insurance status and outpatient prescription drug expenditures. RESULTS: An estimated 34 million elderly people filled 630 million prescriptions in 1997. Thirty-seven percent did not have prescription drug insurance. Total prescription drug expenditures exceeded $23 billion. Persons without prescription drug insurance spent slightly less than $7 billion; those with insurance spent more than $16 billion. After controlling for health status, comorbidity, and demographic characteristics, prescription drug insurance increased expenditures by $183 per person. The marginal increase in total expenditures of extending the average observed benefit to those currently uninsured is $2.3 billion (95% confidence interval, $1.2-3.5 billion). CONCLUSIONS: Proposals for a Medicare drug benefit provide high copayments to protect against insurance effects and to address uncertainty in cost estimates of the proposed benefit. By quantifying the insurance effect on expenditures among the elderly, the data reported here could reduce uncertainty in the budget estimation process.


Subject(s)
Drug Costs/statistics & numerical data , Drug Prescriptions/economics , Health Expenditures/statistics & numerical data , Insurance, Pharmaceutical Services/statistics & numerical data , Aged , Aged, 80 and over , Analysis of Variance , Chi-Square Distribution , Costs and Cost Analysis , Female , Humans , Linear Models , Male , Medicare/statistics & numerical data , United States
9.
J Allergy Clin Immunol ; 111(2): 296-300, 2003 Feb.
Article in English | MEDLINE | ID: mdl-12589348

ABSTRACT

BACKGROUND: Previous estimates of the cost of allergic rhinitis predate the substantial increase in the use of second-generation antihistamines and intranasal corticosteroids. OBJECTIVE: We sought to update estimates of the direct costs of allergic rhinitis in the United States and to estimate prescription medication expenditures by type of insurance coverage. METHODS: Data from the 1996 Medical Expenditure Panel Survey were used in a cross-sectional analysis of resource use and costs. RESULTS: Approximately 7.7% of the population are estimated to have had allergic rhinitis in 1996. The total direct medical cost of allergic rhinitis was estimated at $3.4 billion, with the majority attributable to prescription medications (46.6%) and outpatient visits (51.9%). Fifty-one percent of the prescription medication expenditures were for second-generation antihistamines, 25% for intranasal corticosteroids, and 5% for first-generation antihistamines. Fifty-eight percent of patients with allergic rhinitis received 1 or more prescription drugs for its treatment during the study year. Among these patients, mean prescription expenditures were $131 (95% CI, $119-$143), of which $50 (95% CI, $43-$56) were paid out of pocket. The mean prescription medication expenditure was $103 (95% CI, $70-$136) for persons with Medicaid, $155 (95% CI, $140-$169) for private insurance, $213 (95% CI, $0-$521) for other insurance, and $69 (95% CI, $57-$80) for no prescription drug insurance. CONCLUSION: The direct costs of allergic rhinitis have increased substantially since the introduction of second-generation antihistamines and intranasal corticosteroids, especially costs attributable to prescription medications. Individuals with no insurance coverage have higher total out-of-pocket prescription expenditures than those with coverage.


Subject(s)
Rhinitis, Allergic, Perennial/economics , Rhinitis, Allergic, Seasonal/economics , Ambulatory Care/economics , Costs and Cost Analysis , Cross-Sectional Studies , Data Collection , Drug Prescriptions/economics , Female , Humans , Insurance, Health , Male , Rhinitis, Allergic, Perennial/drug therapy , Rhinitis, Allergic, Seasonal/drug therapy , United States
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