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PURPOSE: To show the impact of drug-drug interactions (DDIs) associated with co-administration of enzyme-inducing (EI) antiseizure medications and oral contraceptives (OCs) on the annual number of unintended pregnancies, their outcomes, and their associated costs in the United States (US). METHODS: A Microsoft Excel pregnancy-outcomes model was developed to determine the impact of DDIs in women who take an OC as well as an EI antiseizure medication known to lower the effectiveness of the OC in preventing pregnancy. The model compared the number of unintended pregnancies, the expected pregnancy outcomes, and associated costs in women taking an OC and an EI medication with a matched cohort of women who took an OC and an enzyme-neutral (EN) antiseizure medication that is known not to interact with OCs. The model perspectives were patients and third-party payers in the US. Unintended pregnancy rates, pregnancy outcomes, and cost inputs for the model were taken from published studies. RESULTS: The results of the analysis showed an estimated increase in the annual number of unintended pregnancies in the US of 503 (a change from 1151 to 1654), an increase of 44.7%, for the estimated 71,922 women currently taking an OC plus an EI medication in the US when compared with a matched cohort taking an OC plus an EN medication. This resulted in an estimated annual healthcare cost increase of $3 million, which is an increase of 5.5% in the annual costs for contraception and pregnancy care. A scenario analysis showed that the annual number of unintended pregnancies could be lower (575 vs 1654) for a matched cohort of women taking EI medications and using a copper intrauterine device, a highly effective and nonhormonal form of contraception, rather than an OC. CONCLUSIONS: Physicians treating women of reproductive age for epilepsy who wish to avoid pregnancy should consider the potential for DDIs that might result in unintended pregnancies. Thus, physicians should alert women using EI medications for epilepsy control to the increased potential for unintended pregnancies if they use OCs for contraception.
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Anticoncepcionais Orais , Preparações Farmacêuticas , Anticoncepção , Interações Medicamentosas , Feminino , Humanos , Gravidez , Resultado da Gravidez , Estados UnidosRESUMO
This study evaluated the patterns of care and health care resource use (HCRU) in patients with metastatic squamous cell carcinoma of the head and neck (SCCHN) who received ≥3 lines of systemic therapy in the United Kingdom (UK). Oncologists (n = 40) abstracted medical records for patients with metastatic SCCHN who initiated third-line systemic therapy during 1 January 2011-30 August 2014 (n = 220). Patient characteristics, treatment patterns and SCCHN-related HCRU were summarised descriptively for the metastatic period; exploratory multivariable regression analyses were conducted on select HCRU outcomes. At metastatic diagnosis, most patients had an Eastern Cooperative Oncology Group performance status (PS) of 0/1 (95%). For patients with PS 0/1, the most common first-line treatment was cisplatin+5-fluorouracil (5-FU); docetaxel was the most common second- and third-line treatment. For patients with PS ≥ 2, the most common first-, second-, and third-line treatments were carboplatin+5-FU, cetuximab, and methotrexate, respectively. Most patients received supportive care during (85%) and after (89%) therapy. This study provides useful information, prior to the availability of immunotherapy, on patient characteristics, treatment patterns, HCRU, and survival in a real-world UK population with metastatic SCCHN receiving ≥3 lines of systemic therapy. Patterns of care and HCRU varied among patients with metastatic SCCHN; specific systemic therapies varied by patient PS.
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Antineoplásicos/uso terapêutico , Serviço Hospitalar de Oncologia/estatística & dados numéricos , Carcinoma de Células Escamosas de Cabeça e Pescoço/terapia , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Ambulatório Hospitalar/estatística & dados numéricos , Cuidados Paliativos/estatística & dados numéricos , Reino Unido , Adulto JovemRESUMO
European Society for Blood and Marrow Transplantation (EBMT) hematologic response categories comprehensively assess complement inhibitor responses in patients with paroxysmal nocturnal hemoglobinuria (PNH). Using data from the 16-week randomized controlled period of the phase 3 PEGASUS trial (N = 80), we estimated the treatment cost per responder by the EBMT response category for pegcetacoplan and eculizumab in adults with PNH and a suboptimal response to eculizumab. Average drug costs per responder, number needed to treat, and incremental drug costs per responder were estimated using dosages administered during the trial (base case). A US payer perspective (2020 US dollars) was used. Scenario analyses were conducted for various costs, dosages, treatment durations, patient populations, and settings. In total, 30 of 41 (73%) who switched to pegcetacoplan and 2 of 39 (5%) patients who continued eculizumab had a good, major, or complete response (good-to-complete responders) at Week 16. Average weekly drug costs per good-to-complete responder were USD 15,923 with pegcetacoplan and USD 216,100 with eculizumab; average weekly drug costs per patient were USD 11,651 and USD 11,082, respectively. Average drug costs per good-to-complete responder with pegcetacoplan were similar across complement inhibitor-naïve populations and were consistently lower than with eculizumab. Switching from eculizumab to pegcetacoplan allowed more patients with a suboptimal response to attain a good-to-complete response at lower costs. These results apply to patients with a suboptimal response to prior eculizumab treatment only.
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OBJECTIVES: The first 3-antigen hepatitis B vaccine was approved by the United States (US) Food and Drug Administration in November 2021 and was recommended by the Centers for Disease Control and Prevention in 2022. We estimated the cost-effectiveness of this 3-antigen vaccine (PreHevbrio™) relative to the single-antigen vaccine, Engerix-BTM, to prevent hepatitis B virus (HBV) infection among US adults. METHODS: A cost-effectiveness model was developed using a combined decision-tree and Markov structure to follow 100,000 adults over their remaining lifetimes after vaccination with either the 3-antigen or single-antigen vaccine. Outcomes from societal and healthcare sector perspectives were calculated for adults aged 18-44, 45-64, and ≥65 years; adults with diabetes; and adults with obesity. Seroprotection rates were obtained from the phase3, head-to-head PROTECT trial (NCT03393754). Incidence, vaccine costs, vaccine adherence rates, direct and indirect costs, utilities, transition probabilities, and mortality were obtained from published sources. Health outcomes and costs (2020USD) were discounted 3% annually and reported by vaccine and population. One-way sensitivity and scenario analyses were conducted. RESULTS: In the model, the 3-antigen vaccine led to fewer HBV infections, complications, and deaths compared with the single-antigen vaccine in all modeled populations due to higher rates and faster onset of seroprotection. Compared with the single-antigen vaccine, the 3-antigen vaccine had better health outcomes, more quality-adjusted life-years (QALYs), and lower costs in adults aged 18-64 years, adults with diabetes, and adults with obesity (dominant strategy). For adults aged ≥65 years, the 3-antigen vaccine was cost-effective compared with the single-antigen vaccine ($26,237/QALY gained) below common willingness-to-pay thresholds ($50,000-$100,000/QALY gained). In sensitivity analyses, results were sensitive to vaccine cost per dose, incidence, and age at vaccination. CONCLUSION: The recently approved 3-antigen vaccine is a cost-saving or cost-effective intervention for preventing HBV infection and addressing the long-standing burden of hepatitis B among US adults.
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Diabetes Mellitus , Hepatite B , Adulto , Humanos , Estados Unidos/epidemiologia , Análise Custo-Benefício , Hepatite B/epidemiologia , Hepatite B/prevenção & controle , Vacinação , Vírus da Hepatite B , Vacinas contra Hepatite B , Anos de Vida Ajustados por Qualidade de VidaRESUMO
INTRODUCTION: Nonpharmaceutical interventions (NPI) and ring vaccination (i.e., vaccination that primarily targets contacts and contacts of contacts of Ebola cases) are currently used to reduce the spread of Ebola during outbreaks. Because these measures are typically initiated after an outbreak is declared, they are limited by real-time implementation challenges. Preventive vaccination may provide a complementary option to help protect communities against unpredictable outbreaks. This study aimed to assess the impact of preventive vaccination strategies when implemented in conjunction with NPI and ring vaccination. METHODS: A spatial-explicit, individual-based model (IBM) that accounts for heterogeneity of human contact, human movement, and timing of interventions was built to represent Ebola transmission in the Democratic Republic of the Congo. Simulated preventive vaccination strategies targeted healthcare workers (HCW), frontline workers (FW), and the general population (GP) with varying levels of coverage (lower coverage: 30% of HCW/FW, 5% of GP; higher coverage: 60% of HCW/FW, 10% of GP) and efficacy (lower efficacy: 60%; higher efficacy: 90%). RESULTS: The IBM estimated that the addition of preventive vaccination for HCW reduced cases, hospitalizations, and deaths by â¼11 % to â¼25 % compared with NPI + ring vaccination alone. Including HCW and FW in the preventive vaccination campaign yielded â¼14 % to â¼38 % improvements in epidemic outcomes. Further including the GP yielded the greatest improvements, with â¼21 % to â¼52 % reductions in epidemic outcomes compared with NPI + ring vaccination alone. In a scenario without ring vaccination, preventive vaccination reduced cases, hospitalizations, and deaths by â¼28 % to â¼59 % compared with NPI alone. In all scenarios, preventive vaccination reduced Ebola transmission particularly during the initial phases of the epidemic, resulting in flatter epidemic curves. CONCLUSIONS: The IBM showed that preventive vaccination may reduce Ebola cases, hospitalizations, and deaths, thus safeguarding the healthcare system and providing more time to implement additional interventions during an outbreak.
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Ebolavirus , Epidemias , Doença pelo Vírus Ebola , Humanos , Doença pelo Vírus Ebola/epidemiologia , Doença pelo Vírus Ebola/prevenção & controle , Surtos de Doenças/prevenção & controle , Vacinação/métodos , Programas de Imunização , República Democrática do Congo/epidemiologiaRESUMO
BACKGROUND: This study aims to evaluate the epidemiological impact and return on investment of the pediatric immunization program (PIP) in Poland from the healthcare-sector and societal perspectives. RESEARCH DESIGN AND METHODS: A health-economic model was developed focusing on the nine vaccines, targeting 11 pathogens, recommended by the public health authorities for children aged 0-6 years in Poland. The 2019 birth cohort (388,178) was followed over their lifetime, with the model estimating discounted health outcomes, life-years gained, quality-adjusted life-years, and direct and indirect costs with and without the PIP based on current and pre-vaccine - era disease incidence estimates, respectively. RESULTS: Across 11 targeted pathogens, the Polish PIP prevented more than 452,300 cases of disease, 1,600 deaths, 37,900 life-years lost, and 38,800 quality-adjusted life-years lost. The PIP was associated with vaccination costs of 54 million. Pediatric immunization averted 65 million from a healthcare-sector perspective (benefit-cost ratio [BCR], 2.2) and averted 358 million from a societal perspective (BCR, 7.6). The BCRs from both perspectives remained >1.0 in scenario analyses. CONCLUSIONS: The Polish PIP, which has not previously been systematically assessed, brings large-scale prevention of disease-related morbidity, premature mortality, and associated costs. This analysis highlights the value of continued investment in pediatric immunization in Poland.
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Saúde Pública , Vacinas , Criança , Humanos , Polônia/epidemiologia , Programas de Imunização , Vacinação , Análise Custo-BenefícioRESUMO
INTRODUCTION: Decisions about prevention of and response to Ebola outbreaks require an understanding of the macroeconomic implications of these interventions. Prophylactic vaccines hold promise to mitigate the negative economic impacts of infectious disease outbreaks. The objective of this study was to evaluate the relationship between outbreak size and economic impact among countries with recorded Ebola outbreaks and to quantify the hypothetical benefits of prophylactic Ebola vaccination interventions in these outbreaks. METHODS: The synthetic control method was used to estimate the causal impacts of Ebola outbreaks on per capita gross domestic product (GDP) of five countries in sub-Saharan Africa that have previously experienced Ebola outbreaks between 2000 and 2016, where no vaccines were deployed. Using illustrative assumptions about vaccine coverage, efficacy, and protective immunity, the potential economic benefits of prophylactic Ebola vaccination were estimated using the number of cases in an outbreak as a key indicator. RESULTS: The impact of Ebola outbreaks on the macroeconomy of the selected countries led to a decline in GDP of up to 36%, which was greatest in the third year after the onset of each outbreak and increased exponentially with the size of outbreak (i.e., number of reported cases). Over three years, the aggregate loss estimated for Sierra Leone from its 2014-2016 outbreak is estimated at 16.1 billion International$. Prophylactic vaccination could have prevented up to 89% of an outbreak's negative impact on GDP, reducing the outbreak's impact to as little as 1.6% of GDP lost. CONCLUSION: This study supports the case that macroeconomic returns are associated with prophylactic Ebola vaccination. Our findings support recommendations for prophylactic Ebola vaccination as a core component of prevention and response measures for global health security.
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Doença pelo Vírus Ebola , Humanos , Doença pelo Vírus Ebola/epidemiologia , Produto Interno Bruto , Surtos de Doenças/prevenção & controle , Serra Leoa/epidemiologia , Vacinação/métodosRESUMO
Objective: We evaluated the public health impact and return on investment of Belgium's pediatric immunization program (PIP) from both healthcare-sector and societal perspectives. Methods: We developed a decision analytic model for 6 vaccines routinely administered in Belgium for children aged 0-10 years: DTaP-IPV-HepB-Hib, DTaP-IPV, MMR, PCV, rotavirus, and meningococcal type C. We used separate decision trees to model each of the 11 vaccine-preventable pathogens: diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, measles, mumps, rubella, Streptococcus pneumoniae, rotavirus, and meningococcal type C; hepatitis B was excluded because of surveillance limitations. The 2018 birth cohort was followed over its lifetime. The model projected and compared health outcomes and costs with and without immunization (based on vaccine-era and pre-vaccine era disease incidence estimates, respectively), assuming that observed reductions in disease incidence were fully attributable to vaccination. For the societal perspective, the model included productivity loss costs associated with immunization and disease in addition to direct medical costs. The model estimated discounted cases averted, disease-related deaths averted, life-years gained, quality-adjusted life-years gained, costs (2020 euros), and an overall benefit-cost ratio. Scenario analyses considered alternate assumptions for key model inputs. Results: Across all 11 pathogens, we estimated that the PIP prevented 226,000 cases of infections and 200 deaths, as well as the loss of 7,000 life-years and 8,000 quality-adjusted life-years over the lifetime of a birth cohort of 118,000 children. The PIP was associated with discounted vaccination costs of 91 million from the healthcare-sector perspective and 122 million from the societal perspective. However, vaccination costs were more than fully offset by disease-related costs averted, with the latter amounting to a discounted 126 million and 390 million from the healthcare-sector and societal perspectives, respectively. As a result, pediatric immunization was associated with overall discounted savings of 35 million and 268 million from the healthcare-sector and societal perspectives, respectively; every 1 invested in childhood immunization resulted in approximately 1.4 in disease-related cost savings to the health system and 3.2 in cost savings from a societal perspective for Belgium's PIP. Estimates of the value of the PIP were most sensitive to changes in input assumptions for disease incidence, productivity losses due to disease-related mortality, and direct medical disease costs. Conclusion: Belgium's PIP, which previously had not been systematically assessed, provides large-scale prevention of disease-related morbidity and premature mortality, and is associated with net savings to health system and society. Continued investment in the PIP is warranted to sustain its positive public health and financial impact.
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Programas de Imunização , Saúde Pública , Criança , Humanos , Bélgica/epidemiologia , Imunização , Análise Custo-BenefícioRESUMO
BACKGROUND: Respiratory syncytial virus (RSV) is an important cause of lower respiratory infections and hospitalizations among older adults. We aimed to estimate the potential clinical benefits and economic value of RSV vaccination of older adults in the United States (US). METHODS: We developed an economic model using a decision-tree framework to capture outcomes associated with RSV infections in US adults aged ≥ 60 years occurring during one RSV season for a hypothetical vaccine versus no vaccine. Two co-base-case epidemiology sources were selected from a targeted review of the US literature: a landmark study capturing all RSV infections and a contemporary study reporting medically attended RSV that also distinguishes mild from moderate-to-severe disease. Both base-case analyses used recent data on mortality risk in the year after RSV hospitalizations. Direct medical costs and quality-adjusted life-years (QALYs) lost per case were obtained from the literature and publicly available sources. Model outcomes included the population-level clinical and economic RSV disease burden among older adults, potential vaccine-avoidable disease burden, and the potential value-based price of a vaccine from a third-party payer perspective. RESULTS: Our two base-case analyses estimated that a vaccine with 50% efficacy and coverage matching that of influenza vaccination would prevent 43,700-81,500 RSV hospitalizations and 8,000-14,900 RSV-attributable deaths per RSV season, resulting in 1,800-3,900 fewer QALYs lost and avoiding $557-$1,024 million. Value-based prices for the co-base-case analyses were $152-$299 per vaccination at a willingness to pay of $100,000/QALY gained. Sensitivity analyses found that the economic value of vaccination was most sensitive to RSV incidence and increased posthospitalization mortality risks. CONCLUSIONS: Despite variability and gaps in the epidemiology literature, this study highlights the potential value of RSV vaccination for older adults in the US. Our analysis provides contemporary estimates of the population-level RSV disease burden and insights into the economic value drivers for RSV vaccination.
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Infecções por Vírus Respiratório Sincicial , Vacinas contra Vírus Sincicial Respiratório , Vírus Sincicial Respiratório Humano , Idoso , Análise Custo-Benefício , Humanos , Infecções por Vírus Respiratório Sincicial/epidemiologia , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Estados Unidos/epidemiologia , VacinaçãoRESUMO
BACKGROUND AND OBJECTIVES: Current routine immunizations for children aged ≤10 years in the United States in 2019 cover 14 vaccine-preventable diseases. We characterize the public-health impact of vaccination by providing updated estimates of disease incidence with and without universally recommended pediatric vaccines. METHODS: Prevaccine disease incidence was obtained from published data or calculated using annual case estimates from the prevaccine period and United States population estimates during the same period. Vaccine-era incidence was calculated as the average incidence over the most recent 5 years of available surveillance data or obtained from published estimates (if surveillance data were not available). We adjusted for underreporting and calculated the percent reduction in overall and age-specific incidence for each disease. We multiplied prevaccine and vaccine-era incidence rates by 2019 United States population estimates to calculate annual number of cases averted by vaccination. RESULTS: Routine immunization reduced the incidence of all targeted diseases, leading to reductions in incidence ranging from 17% (influenza) to 100% (diphtheria, Haemophilus influenzae type b, measles, mumps, polio, and rubella). For the 2019 United States population of 328 million people, these reductions equate to >24 million cases of vaccine-preventable disease averted. Vaccine-era disease incidence estimates remained highest for influenza (13 412 per 100 000) and Streptococcus pneumoniae-related acute otitis media (2756 per 100 000). CONCLUSIONS: Routine childhood immunization in the United States continues to yield considerable sustained reductions in incidence across all targeted diseases. Efforts to maintain and improve vaccination coverage are necessary to continue experiencing low incidence levels of vaccine-preventable diseases.
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Influenza Humana , Doenças Preveníveis por Vacina , Vacinas , Criança , Humanos , Programas de Imunização , Esquemas de Imunização , Lactente , Estados Unidos/epidemiologia , Vacinação , Cobertura Vacinal , Doenças Preveníveis por Vacina/epidemiologia , Doenças Preveníveis por Vacina/prevenção & controleRESUMO
BACKGROUND AND OBJECTIVES: We evaluated the economic impact of routine childhood immunization in the United States, reflecting updated vaccine recommendations and recent data on epidemiology and coverage rates. METHODS: An economic model followed the 2017 US birth cohort from birth through death; impact was modeled via a decision tree for each of the vaccines recommended for children by the Advisory Committee on Immunization Practices as of 2017 (with annual influenza vaccine considered in scenario analysis). Using information on historic prevaccine and vaccine-era incidence and disease costs, we calculated disease cases, deaths, disease-related healthcare costs, and productivity losses without and with vaccination, as well as vaccination program costs. We estimated cases and deaths averted because of vaccination, life-years and quality-adjusted life-years gained because of vaccination, incremental costs (2019 US dollars), and the overall benefit-cost ratio (BCR) of routine childhood immunization from the societal and healthcare payer perspectives. RESULTS: Over the cohort's lifetime, routine childhood immunization prevented over 17 million cases of disease and 31 000 deaths; 853 000 life years and 892 000 quality-adjusted life-years were gained. Estimated vaccination costs ($8.5 billion) were fully offset by the $63.6 billion disease-related averted costs. Routine childhood immunization was associated with $55.1 billion (BCR of 7.5) and $13.7 billion (BCR of 2.8) in averted costs from a societal and healthcare payer perspective, respectively. CONCLUSIONS: In addition to preventing unnecessary morbidity and mortality, routine childhood immunization is cost-saving. Continued maintenance of high vaccination coverage is necessary to ensure sustained clinical and economic benefits of the vaccination program.
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Coorte de Nascimento , Vacinas contra Influenza , Criança , Análise Custo-Benefício , Humanos , Programas de Imunização , Vacinas contra Influenza/uso terapêutico , Estados Unidos , VacinaçãoRESUMO
OBJECTIVE: To estimate the cost-effectiveness of once-daily tenofovir/emtricitabine compared with twice-daily zidovudine/lamivudine and once-daily abacavir/lamivudine in treatment-naïve adults with HIV-1 infection in the United States. METHODS: A Markov model with four therapy lines and six health states based on CD4(+) cell-count ranges was developed to estimate lifetime costs and health outcomes. Efficacy data (virologic response and CD4(+) cell-count changes) for first-line therapy were from 144-week results of Study 934 comparing tenofovir/emtricitabine with zidovudine/lamivudine and 48-week results of Study CNA30024 comparing abacavir/lamivudine with zidovudine/lamivudine, all in combination with efavirenz. Data from Study CNA30024 for abacavir/lamivudine were adjusted to allow for an indirect comparison with tenofovir/emtricitabine. Subsequent therapy lines were based on likely baskets of antiretroviral therapy recommended by US treatment guidelines. Utility values, mortality rates, and costs (2009 US dollars) were obtained from published sources. Base-case results were tested in sensitivity and variability analyses. RESULTS: Average discounted results showed that individuals using tenofovir/emtricitabine were predicted to remain on first-line therapy for 7.7 years, accrue lifetime costs of $747,327, and experience 15.75 quality-adjusted life-years (QALYs), compared with 6.0 years, $777,090, and 15.68 QALYs for individuals using abacavir/lamivudine and 5.8 years, $778,287, and 15.44 QALYs for individuals using zidovudine/lamivudine. Tenofovir/emtricitabine was cost-effective compared with the other two first-line regimens in more than 75% of all probabilistic sensitivity analysis simulation runs for every willingness-to-pay threshold between $0 and $250,000 per QALY gained. Results were robust in variability and one-way sensitivity analyses. CONCLUSIONS: Tenofovir/emtricitabine was predicted to be more effective and cost-saving compared with abacavir/lamivudine and zidovudine/lamivudine in treatment-naïve adults with HIV-1 infection in the United States.
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Fármacos Anti-HIV/economia , Benzoxazinas/economia , Custos de Medicamentos , Infecções por HIV/economia , Avaliação de Processos e Resultados em Cuidados de Saúde/economia , Inibidores da Transcriptase Reversa/economia , Adenina/análogos & derivados , Adenina/economia , Adulto , Alcinos , Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Benzoxazinas/uso terapêutico , Contagem de Linfócito CD4 , Ensaios Clínicos como Assunto , Redução de Custos , Análise Custo-Benefício , Ciclopropanos , Desoxicitidina/análogos & derivados , Desoxicitidina/economia , Didesoxinucleosídeos/economia , Emtricitabina , Feminino , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/mortalidade , Pesquisa sobre Serviços de Saúde , Humanos , Lamivudina/economia , Masculino , Cadeias de Markov , Modelos Econômicos , Organofosfonatos/economia , Anos de Vida Ajustados por Qualidade de Vida , Inibidores da Transcriptase Reversa/uso terapêutico , Tenofovir , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia , Carga Viral , Zidovudina/economiaRESUMO
BACKGROUND: Ibalizumab-uiyk (ibalizumab) is a first-in-class, long-acting, postattachment HIV-1 inhibitor for adults with multidrug-resistant (MDR) HIV-1 infection. This analysis examines the cost-effectiveness and budget impact of ibalizumab treatment for this difficult-to-treat population in the United States. METHODS: A Markov model followed cohorts of adults with MDR HIV-1 infection through two final lines of antiretroviral therapy: ibalizumab + optimized background therapy (OBT) or OBT alone followed by nonsuppressive therapy. Model inputs were based on ibalizumab clinical trial data, market uptake projections, and published literature, with costs in 2019 dollars. The cost-effectiveness analysis assessed costs and health outcomes from a health care sector perspective for individuals receiving ibalizumab + OBT versus OBT alone over a lifetime time horizon. The budget-impact analysis estimated the impact on payer budgets of the introduction of ibalizumab over 3 years for a hypothetical commercial health plan. RESULTS: Compared with individuals receiving OBT alone, individuals receiving ibalizumab + OBT incurred higher costs but lived longer, healthier lives, with an incremental cost of $133,040 per QALY gained. For a hypothetical commercial health plan with 1 million members, the introduction of ibalizumab + OBT was estimated to increase budgets by $217,260, $385,245, and $560,310 ($0.018, $0.032, and $0.047 per member per month) in years 1, 2, and 3, respectively. These results were found to be robust in sensitivity and scenario analyses. CONCLUSIONS: Ibalizumab may represent a cost-effective and affordable option to improve health outcomes for individuals with MDR HIV-1 infection.
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Infecções por HIV , HIV-1 , Adulto , Anticorpos Monoclonais , Análise Custo-Benefício , Infecções por HIV/tratamento farmacológico , Humanos , Estados UnidosRESUMO
OBJECTIVE: This exploratory study estimates the economic value of the current vaccination program and increased coverage against four preventable diseases in older adults in the United States (US). METHODS: A population-based, age-structured economic model was used to conduct a cost-benefit analysis of vaccination against influenza, pertussis, herpes zoster, and pneumococcal disease among US adults aged 50 years and older, accounting for aging of the population. The model used separate decision trees for each disease to project the discounted number of vaccinated individuals, number of disease cases, and direct medical and indirect costs (2018 US$) over a 30-year period. Benefit-cost ratios (BCRs) and net present values were calculated for two primary analyses comparing current vaccination coverage versus no vaccination and comparing increased coverage versus current coverage. Key parameter values were varied in deterministic sensitivity analyses. RESULTS: Current adult vaccination coverage (vs. no vaccination) is estimated to result in nearly 65 million averted disease cases, $185 billion averted costs of cases, and $136 billion in incremental vaccination costs over a 30-year period from a societal perspective (BCR = 1.4). Increased vaccination coverage (vs. current coverage) is associated with over 33 million additional averted disease cases, $96 billion additional averted costs of cases, and nearly $83 billion in incremental vaccination costs, resulting in a societal BCR of 1.2 over 30 years. Deterministic sensitivity analyses demonstrated that results were most sensitive to disease incidence, vaccine efficacy, and productivity costs for time required for vaccination. CONCLUSIONS: Study results highlight the economic value of vaccination programs for older adults in the US and indicate that efforts to further increase vaccination coverage may be warranted and economically justifiable.
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Vacinas contra Influenza , Vacinação , Idoso , Envelhecimento , Análise Custo-Benefício , Humanos , Programas de Imunização , Pessoa de Meia-Idade , Estados Unidos/epidemiologiaRESUMO
Despite vaccination recommendations, the burden of vaccine-preventable diseases remains high in older adults in the United States (US), contributing to substantial morbidity, mortality, and health care resource use and costs. To adequately plan for health care resource needs and to help inform vaccination policies, burden of disease projections that account for population aging over the coming decades are needed. As a first step, this exploratory study projects the burden of influenza, pertussis, herpes zoster, and pneumococcal disease in adults aged 50 y and older in the US, using a population-based modeling framework with separate decision trees for each vaccine-preventable disease. The model uses projected population estimates from the US Census Bureau to account for changes in the US population over time and then calculates expected numbers of cases and associated costs for each disease, keeping current estimates of age-specific disease incidence, vaccine coverage, and efficacy constant over time. This approach was used to focus the exploratory analysis on the burden of disease that may be expected due to population changes alone, assuming that all else remains unchanged. Due to population growth and the shifting age distribution over the next 30 y, the annual societal economic burden for the four vaccine-preventable diseases is projected to increase from approximately $35 billion to $49 billion, resulting in cumulative costs of approximately $1.3 trillion, as well as more than 1 million disease-related deaths. Given such notable burden, further efforts to increase vaccination coverage and effectiveness in older adults are needed.
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Herpes Zoster , Vacinas contra Influenza , Doenças Preveníveis por Vacina , Idoso , Envelhecimento , Humanos , Estados Unidos/epidemiologia , VacinaçãoRESUMO
Serogroup B (MenB) is the leading cause of meningococcal disease among 16- to 23-year-olds in the United States and has been responsible for all 10 college outbreaks between 2011 and 2017. Outbreak-associated costs levy a substantial and unforeseen burden on colleges/universities and surrounding communities, in part because they involve collaboration with local and state health departments to develop points-of-dispensing (PODs) outbreak response plans and rapid mass vaccination of a large at-risk student population. The MenB outbreak at Providence College in 2015 was used as a case study to develop an Excel-based Meningococcal Outbreak Cost Calculator that uses target populations for mass vaccination to estimate the costs and resources associated with a meningococcal disease outbreak response. Resources include labor, medical supply, and other nonlabor costs (eg, vaccine-related adverse event costs) over an 18-month period following the outbreak declaration. Based on the actual Providence College population partially or fully vaccinated with MenB-FHbp (Trumenba®, Bivalent rLP2086) (3-dose schedule), the calculator estimated aggregate direct costs of $1,350,963 over 18 months post-outbreak for 4,418 individuals. For planned full vaccination of the enrolled undergraduate population (4,795 individuals), the tool estimated total costs of $1,798,399. In both cases, the majority of costs were for medical supplies (88%-89%) and contract services (7%-9%). This calculator can help to plan a mass vaccination campaign for MenB outbreak control, and underscores the need to vaccinate pre-emptively against diverse disease-causing strains before an outbreak occurs.
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Surtos de Doenças/economia , Vacinação em Massa/economia , Infecções Meningocócicas/prevenção & controle , Vacinas Meningocócicas/economia , Universidades/estatística & dados numéricos , Adolescente , Surtos de Doenças/prevenção & controle , Humanos , Meningite Meningocócica/prevenção & controle , Vacinas Meningocócicas/administração & dosagem , Neisseria meningitidis Sorogrupo B/imunologia , Sorogrupo , Estudantes/estatística & dados numéricos , Estados Unidos , Adulto JovemRESUMO
INTRODUCTION: The exogenous boosting (EB) hypothesis posits that cell-mediated immunity is boosted for individuals reexposed to varicella-zoster virus (VZV). Historically, mathematical models of the impact of universal childhood varicella vaccination (UVV) have used limited data to capture EB and often conclude that UVV will temporarily increase herpes zoster (HZ) incidence. AREAS COVERED: We updated a 2013 systematic literature review of 40 studies to summarize new evidence from observational or modeling studies related to EB and its parameterization. We abstracted data on observational study designs and mathematical model structures, EB frameworks, and HZ-related parameter values. EXPERT COMMENTARY: This review identified an additional 41 studies: 22 observational and 19 modeling studies. Observational analyses generally reported pre-UVV increases in HZ incidence, making it difficult to attribute post-UVV increases to UVV versus other causes. Modeling studies considered a range of EB frameworks, from no boosting to full permanent immunity. Mathematical modeling efforts are needed in countries with long-standing vaccination programs to capture the dynamics of VZV transmission and temporal changes that may affect HZ incidence. Use of real-world pre-/postvaccination data on varicella and HZ incidence to validate model predictions may improve approaches to EB parameterization and understanding of the effects of varicella vaccination programs.
Assuntos
Vacina contra Varicela/administração & dosagem , Varicela/prevenção & controle , Herpesvirus Humano 3/imunologia , Varicela/imunologia , Vacina contra Varicela/imunologia , Herpes Zoster/epidemiologia , Herpes Zoster/imunologia , Humanos , Imunidade Celular/imunologia , Programas de Imunização/organização & administração , Modelos Teóricos , Vacinação/métodosRESUMO
Trivalent inactivated influenza vaccines (IIV3s) protect against 2 A strains and one B lineage; quadrivalent versions (IIV4s) protect against an additional B lineage. The objective was to assess projected health and economic outcomes associated with IIV4 versus IIV3 for preventing seasonal influenza in the US. A cost-effectiveness model was developed to interact with a dynamic transmission model. The transmission model tracked vaccination, influenza cases, infection-spreading interactions, and recovery over 10 y (2012-2022). The cost-effectiveness model estimated influenza-related complications, direct and indirect costs (2013-2014 US$), health outcomes, and cost-effectiveness. Inputs were taken from published/public sources or estimated using regression or calibration. Outcomes were discounted at 3% per year. Scenario analyses tested the reliability of the results. Seasonal vaccination with IIV4 versus IIV3 is predicted to reduce annual influenza cases by 1,973,849 (discounted; 2,325,644 undiscounted), resulting in 12-13% fewer cases and influenza-related complications and deaths. These reductions are predicted to translate into 18,485 more quality-adjusted life years (QALYs) accrued annually for IIV4 versus IIV3. Increased vaccine-related costs ($599 million; 5.7%) are predicted to be more than offset by reduced influenza treatment costs ($699 million; 12.2%), resulting in direct medical cost saving annually ($100 million; 0.6%). Including indirect costs, savings with IIV4 are predicted to be $7.1 billion (5.6%). Scenario analyses predict IIV4 to be cost-saving in all scenarios tested apart from low infectivity, where IIV4 is predicted to be cost-effective. In summary, seasonal influenza vaccination in the US with IIV4 versus IIV3 is predicted to improve health outcomes and reduce costs.
Assuntos
Análise Custo-Benefício , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/economia , Influenza Humana/prevenção & controle , Vacinação/economia , Vacinação/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Vacinas contra Influenza/imunologia , Masculino , Pessoa de Meia-Idade , Estados Unidos , Adulto JovemRESUMO
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.
Assuntos
Vacinas contra Difteria, Tétano e Coqueluche Acelular/economia , Vacinas contra Difteria, Tétano e Coqueluche Acelular/uso terapêutico , Gerenciamento Clínico , Custos de Cuidados de Saúde/estatística & dados numéricos , Coqueluche/prevenção & controle , Ferimentos e Lesões/economia , Ferimentos e Lesões/terapia , Adolescente , Adulto , Idoso , Criança , Vacina contra Difteria e Tétano/economia , Vacina contra Difteria e Tétano/uso terapêutico , Humanos , Pessoa de Meia-Idade , Modelos Econômicos , Estados Unidos/epidemiologia , Vacinação/economia , Coqueluche/epidemiologia , Adulto JovemRESUMO
OBJECTIVE: To explore the expected long-term health and economic outcomes of telaprevir (TVR) plus peginterferon alfa-2a and ribavirin (PR), a regimen that demonstrated substantially increased sustained virologic response (SVR) compared with PR alone in adults with chronic genotype 1 hepatitis C virus (HCV) and compensated liver disease in the Phase III studies ADVANCE (treatment-naïve patients) and REALIZE (relapsers, partial responders, and null responders to previous PR treatment). STUDY DESIGN: A decision-analytic model was developed to assess the cost-effectiveness of TVR+PR vs. PR in the United States (US). METHODS: Patients first moved through the 72-week decision-tree treatment phase of the model and then entered the cyclic Markov post-treatment phase. Clinical data (patient characteristics, SVR rates, and adverse event rates and durations) were obtained from ADVANCE and REALIZE. Health-state transition probabilities, drug and other costs (in 2012/2013 US dollars), and utility values were obtained from the trials, published studies, and publicly available sources. Outcomes were discounted at 3% per year. RESULTS: Regardless of treatment history, patients receiving TVR+PR were projected to experience fewer liver-disease complications, more life-years, and more quality-adjusted life-years (QALYs) than patients receiving PR. In prior relapsers, TVR+PR was dominant, with lower total medical costs and more QALYs. For the other patient subgroups, incremental costs per QALY gained were between $16,778 (treatment-naïve patients) and $34,279 (prior null responders). Extensive sensitivity analyses confirmed robust model results. CONCLUSIONS: At standard willingness-to-pay thresholds, TVR+PR represents a cost-effective treatment option compared with PR alone for patients with chronic genotype 1 HCV and compensated liver disease in the US. Future analyses are needed to compare TVR+PR with all existing HCV treatment options.