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As the body of evidence on COVID-19 and post-vaccination outcomes continues to expand, this analysis sought to evaluate the public health impact of the Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, during the first year of its rollout in the US. A combined Markov decision tree model compared clinical and economic outcomes of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) versus no vaccination in individuals aged ≥12 years. Age-stratified epidemiological, clinical, economic, and humanistic parameters were derived from existing data and published literature. Scenario analysis explored the impact of using lower and upper bounds of parameters on the results. The health benefits were estimated as the number of COVID-19 symptomatic cases, hospitalizations and deaths averted, and Quality Adjusted Life Years (QALYs) saved. The economic benefits were estimated as the amount of healthcare and societal cost savings associated with the vaccine-preventable health outcomes. It was estimated that, in 2021, the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) contributed to averting almost 9 million symptomatic cases, close to 700,000 hospitalizations, and over 110,000 deaths, resulting in an estimated $30.4 billion direct healthcare cost savings, $43.7 billion indirect cost savings related to productivity loss, as well as discounted gains of 1.1 million QALYs. Scenario analyses showed that these results were robust; the use of alternative plausible ranges of parameters did not change the interpretation of the findings. The Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) contributed to generate substantial public health impact and vaccine-preventable cost savings in the first year of its rollout in the US. The vaccine was estimated to prevent millions of COVID-19 symptomatic cases and thousands of hospitalizations and deaths, and these averted outcomes translated into cost-savings in the billions of US dollars and thousands of QALYs saved. As only direct impacts of vaccination were considered, these estimates may be conservative. Why was this study done? Vaccination against COVID-19 is a crucial part of the public health response to the pandemic. The first vaccine against COVID-19 to be rolled out in the US was the Pfizer-BioNTech vaccine (also called Comirnaty or BNT162b2). In this study, we investigated how the BNT162b2 vaccine affected US public health and the economy in 2021, the first year of its use. Vaccination against COVID-19 is a crucial part of the public health response to the pandemic. The first vaccine against COVID-19 to be rolled out in the US was the Pfizer-BioNTech vaccine (also called Comirnaty or BNT162b2). In this study, we investigated how the BNT162b2 vaccine affected US public health and the economy in 2021, the first year of its use. What did the researchers do and find? We developed a mathematical model and populated it with published data on COVID-19 to estimate the benefits of receiving 2 BNT162b2 vaccine doses versus receiving no vaccination, in people 12 years and older.Vaccination against COVID-19 is a crucial part of the public health response to the pandemic. The first vaccine against COVID-19 to be rolled out in the US was the Pfizer-BioNTech vaccine (also called Comirnaty or BNT162b2). In this study, we investigated how the BNT162b2 vaccine affected US public health and the economy in 2021, the first year of its use.We estimated that the BNT162b2 vaccine helped prevent around 8.7 million symptomatic COVID-19 illnesses. We also estimated that the vaccine prevented almost 700,000 COVID-19–associated hospitalizations, and more than 110,000 deaths. We estimated that it saved around $30 billion on healthcare costs and $44 billion related to people being unable to work due to illness. Sensitivity and scenario analyses showed that, although changing the model parameters did affect the results, this did not alter the overall conclusion that the vaccine leads to favorable and substantial public health impact.This study did not include estimates for children under 12 years old, or research the benefits of a booster. We cannot assume the results would be the same for other COVID-19 vaccines. This study also did not account for the Omicron variant, which did not emerge until late in 2021. We developed a mathematical model and populated it with published data on COVID-19 to estimate the benefits of receiving 2 BNT162b2 vaccine doses versus receiving no vaccination, in people 12 years and older. Vaccination against COVID-19 is a crucial part of the public health response to the pandemic. The first vaccine against COVID-19 to be rolled out in the US was the Pfizer-BioNTech vaccine (also called Comirnaty or BNT162b2). In this study, we investigated how the BNT162b2 vaccine affected US public health and the economy in 2021, the first year of its use. We estimated that the BNT162b2 vaccine helped prevent around 8.7 million symptomatic COVID-19 illnesses. We also estimated that the vaccine prevented almost 700,000 COVID-19–associated hospitalizations, and more than 110,000 deaths. We estimated that it saved around $30 billion on healthcare costs and $44 billion related to people being unable to work due to illness. Sensitivity and scenario analyses showed that, although changing the model parameters did affect the results, this did not alter the overall conclusion that the vaccine leads to favorable and substantial public health impact. This study did not include estimates for children under 12 years old, or research the benefits of a booster. We cannot assume the results would be the same for other COVID-19 vaccines. This study also did not account for the Omicron variant, which did not emerge until late in 2021. What do researchers think the results mean? In the US, in 2021, the BNT162b2 COVID-19 vaccine contributed to preventing millions of people from getting symptomatic COVID-19 and saved billions of dollars. These results support recommendations for continued widespread vaccine use. In the US, in 2021, the BNT162b2 COVID-19 vaccine contributed to preventing millions of people from getting symptomatic COVID-19 and saved billions of dollars. These results support recommendations for continued widespread vaccine use.

Background Respiratory syncytial virus (RSV) is associated with substantial morbidity in the United States, especially among infants. Nirsevimab, an investigational long-acting monoclonal antibody, was evaluated as an immunoprophylactic strategy for infants in their first RSV season and for its potential impact on RSV-associated, medically attended lower respiratory tract illness (RSV-MALRTI) and associated costs. Methods A static decision-analytic model of the US birth cohort during its first RSV season was developed to estimate nirsevimab’s impact on RSV-related health events and costs; model inputs included US-specific costs and epidemiological data. Modelled RSV-related outcomes included primary care and emergency room visits, hospitalizations including intensive care unit admission and mechanical ventilations, and RSV-related mortality. Results Under current standard of care, RSV caused 529 915 RSV-MALRTIs and 47 281 hospitalizations annually, representing $1.2 billion (2021 US dollars [USD]) in costs. Universal immunization of all infants with nirsevimab is expected to reduce 290 174 RSV-MALRTI, 24 986 hospitalizations, and expenditures of $612 million 2021 USD. Conclusions An all-infant immunization strategy with nirsevimab could substantially reduce the health and economic burden for US infants during their first RSV season. While this reduction is driven by term infants, all infants, including palivizumab-eligible and preterm infants, would benefit from this strategy.

Aim Androgen deprivation therapy (ADT) has long been the gold standard for patients with metastatic hormone-sensitive prostate cancer (mHSPC). Clinical trials have demonstrated significant survival benefits when docetaxel (DOC) or abiraterone acetate (AA) and prednisone (P) are added to ADT, necessitating comparison of these combination treatments. Methods A systematic review of randomised controlled trials (RCTs) of AA-/ADT-/DOC-containing treatment regimens in newly diagnosed patients with high-risk and/or high-volume mHSPC identified three RCTs (LATITUDE, CHAARTED and GETUG-AFU 15). Network meta-analyses (NMAs) using fixed effects Bayesian methods were performed to compare relative benefits of each treatment on overall survival (OS), radiographic progression-free survival (rPFS) and quality of life (QoL) measured by the Brief Pain Inventory, and the Functional Assessment of Cancer Therapy-Prostate questionnaire. One trial, STAMPEDE, was assessed in exploratory OS analyses. Results The hazard ratio (HR) for OS ranged from 0.85 to 0.92, with the Bayesian probability of AA + P + ADT being better than DOC + ADT ranging between 72% and 87%. For rPFS, the HR ranged between 0.71 and 0.76 (Bayesian probability range: 93%–97%). Exploratory analyses including STAMPEDE found similar trends. AA + P + ADT also showed improved QoL compared with DOC + ADT for at least 1 year of therapy, with results being more pronounced at 3 months. Conclusion Our findings suggest that AA + P + ADT is at least as effective as DOC + ADT in reducing the risk of death in men with mHSPC and better at preventing disease progression and improving QoL. The NMA provides useful insights to clinicians and other decision-makers on the relative efficacy of treatment options for men with mHSPC.

ObjectivesSeniors are particularly vulnerable to complications resulting from influenza infection. Numerous influenza vaccines are available to immunize US seniors, and practitioners must decide which product to use. Options include trivalent and quadrivalent standard-dose inactivated influenza vaccines (IIV3 and IIV4 respectively), as well as a high-dose IIV3 (HD). Our research examines the public health impact, budget impact, and cost-utility of HD versus IIV3 and IIV4 for immunization of US seniors 65 years of age and older.MethodsOur model was based on US influenza-related health outcome data. Health care costs and vaccine prices were obtained from the Centers for Medicare and Medicaid Services. Efficacies of IIV3 and IIV4 were estimated from various meta-analyses of IIV3 efficacy. The results of a head-to-head randomized controlled trial of HD vs. IIV3 were used to estimate relative efficacy of HD. Conservatively, herd protection was not considered.ResultsCompared to IIV3, HD would avert 195,958 cases of influenza, 22,567 influenza-related hospitalizations, and 5423 influenza-related deaths among US seniors. HD generates 29,023 more Quality Adjusted Life Years (QALYs) and a net societal budget impact of $154 million. The Incremental Cost Effectiveness Ratio (ICER) for this comparison is $5299/QALY. 71% of the probabilistic sensitivity analysis (PSA) simulations were

The environmental issue is a particular concern for chainsaw oils because these fluids represent a total loss system. The aim of this study is to quantify the environmental impacts of a biobased chainsaw oil made on the farm in Wallonia (a region of Belgium) and to compare it with a model mineral chainsaw oil. With this study, the aim is also to participate in the development of the life cycle assessment (LCA) methodology applied to the biolubricant sector since LCAs on these products are quite limited and rarely sufficiently detailed. In this LCA, the attributional approach is applied. Seven impact categories are studied. The methods for life cycle impact assessment are IPCC, ReCiPe, CML and USEtox. The functional unit is 1 kg of base oil. Seven sensitivity analyses are performed. Results indicate that the biobased chainsaw oil made on the farm has a lower impact for the global warming potential, the abiotic depletion potential, the ozone depletion potential and the photochemical oxidation potential. On the contrary, it has larger acidification, aquatic eutrophication and aquatic ecotoxicity potential impacts. Regarding the contribution of the life cycle stages of the biobased chainsaw oil, the agricultural stage causes the highest contribution in all impact categories. For the mineral chainsaw oil, the refining stage is preponderant for all impact categories except for the global warming potential for which the end-of-life stage contributes the most. When taking additives into account, conclusions regarding the comparison between the oils are not reversed. Even if it was necessary to consume more biobased than mineral chainsaw oil, conclusions regarding the comparison of the oils would not be reversed. In the same way, a different allocation procedure for rapeseed oil and rape meal, a different rape seeds yield or different extraction yields in the refining stage of the mineral base oil do not change the results of the comparison. For the biobased chainsaw oil, the substitution of only one active substance in the agricultural stage could result in an important decrease of the freshwater ecotoxicity impact. The biobased chainsaw oil has a lower impact in four out of the seven impact categories and a higher impact in three impact categories. By providing a detailed LCA on a biobased chainsaw oil, this study contributes to the development of LCA applied to biobased lubricants.

Background The 1-hour (h) algorithm triages patients presenting with suspected acute myocardial infarction (AMI) to the emergency department (ED) towards “rule-out,” “rule-in,” or “observation,” depending on baseline and 1-h levels of high-sensitivity cardiac troponin (hs-cTn). The economic consequences of applying the accelerated 1-h algorithm are unknown. Methods and findings We performed a post-hoc economic analysis in a large, diagnostic, multicenter study of hs-cTnT using central adjudication of the final diagnosis by two independent cardiologists. Length of stay (LoS), resource utilization (RU), and predicted diagnostic accuracy of the 1-h algorithm compared to standard of care (SoC) in the ED were estimated. The ED LoS, RU, and accuracy of the 1-h algorithm was compared to that achieved by the SoC at ED discharge. Expert opinion was sought to characterize clinical implementation of the 1-h algorithm, which required blood draws at ED presentation and 1h, after which “rule-in” patients were transferred for coronary angiography, “rule-out” patients underwent outpatient stress testing, and “observation” patients received SoC. Unit costs were for the United Kingdom, Switzerland, and Germany. The sensitivity and specificity for the 1-h algorithm were 87% and 96%, respectively, compared to 69% and 98% for SoC. The mean ED LoS for the 1-h algorithm was 4.3h—it was 6.5h for SoC, which is a reduction of 33%. The 1-h algorithm was associated with reductions in RU, driven largely by the shorter LoS in the ED for patients with a diagnosis other than AMI. The estimated total costs per patient were £2,480 for the 1-h algorithm compared to £4,561 for SoC, a reduction of up to 46%. Conclusions The analysis shows that the use of 1-h algorithm is associated with reduction in overall AMI diagnostic costs, provided it is carefully implemented in clinical practice. These results need to be prospectively validated in the future.

Background : Health technology assessment (HTA) has been reinforced in France, notably with the introduction of economic evaluation in the pricing process for the most innovative and expensive treatments. Similarly to the National Institute for Clinical Excellence (NICE) in England, the National Authority for Health (HAS), which is responsible for economic evaluation of new health technologies in France, has published recommendations on the methods of economic evaluation. Since economic assessment represents a major element of HTA in England, exploring the differences between these methodological guidelines might help to comprehend both the shape and the role economic assessment is intended to have in the French health care system. Methods : Methodological guidelines for economic evaluation in France and England have been compared topic-by-topic in order to bring out key differences in the recommended methods for economic evaluation. Results : The analysis of both guidelines has revealed multiple similarities between France and England, although a number of differences were also noted regarding the elected methodology of analysis, the comparison of studies’ outcomes with cost-effectiveness thresholds, the study population to consider, the quality of life valuation methods, the perspective on costs, the types of resources considered and their valuation, the discount rates to apply in order to reflect the present value of interventions, etc. To account for these differences, modifications will be required in order to adapt economic models from one country to the other. Conclusion : Changes in HTA assessment methods occur in response to different challenges determined by the different philosophical and cultural considerations surrounding health and welfare as well as the political considerations regarding the role of public policies and the importance of their evaluation. Keywords : health technology assessment; guidelines; France; UK; economic evaluation (Published: 12 March 2015) Citation: Journal of Market Access & Health Policy 2015, 3 : 24966 - http://dx.doi.org/10.3402/jmahp.v3.24966

Background and Objectives: Influenza is a common respiratory disease occurring in seasonal patterns, and may lead to severe complications in frail populations such as the elderly. In Poland, influenza vaccination is recommended for people aged ≥65 years; however the vaccine coverage rate in the elderly is very low. The fact that influenza vaccine is neither reimbursed by the National Health Insurance (Narodowy Fundusz Zdrowia [NFZ]) nor financed via a National Immunization Program (NIP) could be a reason for the low coverage rate. This study assessed the cost effectiveness of the full reimbursement of an influenza vaccination programme in Poland for people aged ≥65 years. Methods: A decision-analytic model was developed to compare costs and outcomes associated with the current situation in which influenza vaccination is not reimbursed and a new situation in which it would be fully covered by the NFZ. The model was parameterized to Poland using data from the literature and from the Central Statistic Office of Poland. Within the elderly population, 50% were considered to be at high risk of influenza complications. An influenza attack rate of 3.5% was used for calculation purposes. Influenza-associated hospitalizations and death rates were estimated at 439.9 per 100 000 person-years and 79.1 per 100 000 person-years, respectively. Cost estimates were derived from a cost study conducted in Poland. Costs are presented in Polish Zloty (PLN) [2009 mean exchange rate: 1 PLN= €0.232]. Only direct medical costs were included to fit to the NFZ perspective. To reflect the seasonality of influenza, a time horizon of 1 year was chosen. Life-years and quality-adjusted life-years (QALYs) accumulated over future years were discounted at a rate of 5% as recommended by Polish guidelines. Deterministic and probabilistic sensitivity analyses were conducted. Results: In Poland, the introduction of the public funding of influenza vaccination for people aged ≥65 years would cost PLN 79 million when an increase in coverage rate from 13.5% to 40% is assumed. 23 900 cases of influenza, 1777 hospitalizations and 548 premature deaths would be averted each year due to the influenza vaccination programme. Fifty-seven persons would need to be vaccinated to prevent one case of influenza. To prevent one hospitalization and one death due to influenza, 842 and 2809 individuals would need to be vaccinated, respectively. The new strategy would be very cost effective compared with the current situation with an incremental cost-effectiveness ratio (ICER) of PLN26 118/QALY, which is below the 2009 yearly gross domestic product (GDP) per capita. Deterministic sensitivity analyses demonstrated that the most influential variables for the ICER were vaccine efficacy against death, excess hospitalization rate, utility norms, influenza attack rate, vaccine efficacy against hospitalization, and discount rates. All ICERs computed were below the threshold of 3 GDP per capita. From the probabilistic analysis, the proposed new influenza vaccination programme, if implemented, was predicted to be cost effective from the NFZ perspective with a probability of 100%, given the same threshold. Conclusion: Implementing a vaccination programme in Poland in which influenza vaccination would be fully reimbursed by the NFZ for people aged ≥65 years would be a very cost-effective strategy.

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.