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OBJECTIVE: In the Brazilian public national healthcare system, botulinum toxin type A has traditionally been the sole treatment option for patients with dystonia. However, as of October 2022, deep brain stimulation (DBS) garnered positive recommendations for the condition. This study aims to assess the cost-effectiveness of DBS in treating adults with generalized and cervical dystonia within the Brazilian healthcare context, considering its recent inclusion. METHODS: A systematic review identified randomized controlled trials assessing DBS efficacy in treating adults with generalized and cervical dystonia. Two cost-utility analyses compared the cost-effectiveness of DBS plus the best clinical practice (BCP) to BCP alone. Markov models, which included 3 health states (no clinical improvement, clinical improvement, and death), employed a 1-year cycle and a lifetime horizon. The study used both 1-way and probabilistic sensitivity analyses. RESULTS: Two randomized controlled trials, one for each condition, revealed superior clinical improvement with DBS when compared to sham simulation. The incremental cost-utility ratio was $ 1121.66 for generalized dystonia and $4556.50 for cervical dystonia. Effectiveness discount rates and age at surgery were identified as influential parameters. In 1000 Monte Carlo simulations, 99.9% of the incremental cost-utility ratio values for generalized dystonia and 74.2% for cervical dystonia fell below the cost-effectiveness threshold in Brazil ($8146.64 per quality-adjusted life year). CONCLUSIONS: From the perspective of the Brazilian public health system, the combination of DBS and BCP appears to be cost-effective for the treatment of both generalized and cervical dystonia when compared to BCP alone.

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BACKGROUND: The economic assessment of health care models in palliative care promotes their global development. The purpose of the study is to assess the cost-effectiveness of a palliative care program (named Contigo) with that of conventional care from the perspective of a health benefit plan administrator company, Sanitas, in Colombia. METHODS: The incremental cost-utility ratio (ICUR) and the incremental net monetary benefit (INMB) were estimated using micro-costing in a retrospective, analytical cross-sectional study on the care of terminally ill patients enrolled in a palliative care program. A 6-month time horizon prior to death was used. The EQ-5D-3 L questionnaire (EQ-5D-3 L) and the McGill Quality of Life Questionnaire (MQOL) were used to measure the quality of life. RESULTS: The study included 43 patients managed within the program and 16 patients who received conventional medical management. The program was less expensive than the conventional practice (difference of 1,924.35 US dollars (USD), P = 0.18). When compared to the last 15 days, there is a higher perception of quality of life, which yielded 0.25 in the EQ-5D-3 L (p < 0.01) and 1.55 in the MQOL (P < 0.01). The ICUR was negative and the INMB was positive. CONCLUSION: Because the Contigo program reduces costs while improving quality of life, it is considered to be net cost-saving and a model with value in health care. Greater availability of palliative care programs, such as Contigo, in Colombia can help reduce existing gaps in access to universal palliative care health coverage, resulting in more cost-effective care.

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INTRODUCTION: Predicting response to inhaled corticosteroids (ICSs) + long-acting ß2-agonist (LABA) by previously detecting the presence of Arg16Gly ADRB2 genotype is a strategy that could reduce and optimize the management of asthmatic patients. There is a need for economic evaluations to facilitate the implementation of such tests. This research aims to evaluate the cost-effectiveness of Arg16Gly ADRB2 screening in children with asthma in Colombia. METHODS: From the perspective of a third-party payer, we conducted a cost-effectiveness analysis to determine the cost and quality-adjusted life-years (QALYs) of genotype-driven asthma prescribing based on the Arg16Gly ADRB2 genotype versus current treatment based on no genetic testing. Using four state-transition models, we estimate cost and QALYs employing micro-simulation modeling with a time horizon of 10 years and a cycle length of 1 week. Cost-effectiveness was assessed at a willingness-to-pay (WTP) value of US$5180. RESULTS: The mean incremental cost of strategy genetic testing versus no genetic testing is US$ -6809. The mean incremental benefit of strategy genetic testing is 16 QALYs. The incremental net monetary benefit of strategic genetic testing versus no genetic testing is US$ 88,893. Genetic testing is the strategy with the highest expected net benefit. The outcomes derived from our primary analysis remained robust when subjected to variations in all underlying assumptions and parameter values. CONCLUSION: Genetic testing of Arg16Gly ADRB2 is a cost-effective strategy to address asthma management in asthmatic children requiring ICS+LABA. This result should encourage the generation of more evidence and the incorporation of such evidence into clinical practice guidelines for pediatric asthma.

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INTRODUCTION: Recent evidence indicates that Maternal Supplementation with Long-Chain n-3 Fatty Acids During Pregnancy Substantially Mitigates Offspring's Asthma. Adding information regarding its cost-utility will undoubtedly allow its adoption, or not, in clinical practice guidelines. This research aimed to determine the cost-utility of LCPUFA supplementation in the third trimester of pregnancy to reduce the risk of wheezing and asthma in infants in Colombia. METHODS: A Markov model was formulated to estimate the cost and quality-adjusted life-years (QALYs) attributed to individuals with severe asthma in Colombia, with a time horizon of five years and a cycle length of two weeks. Probabilistic sensitivity analysis and a value of information (VOI) analysis were conducted to evaluate the uncertainties in the case base. Cost-utility was assessed at a willingness-to-pay (WTP) value of US$5180. All costs were adjusted to 2021 with a 5% annual discounting rate for cost and QALYs. RESULTS: The mean incremental cost of LCPUFA supplementation versus no supplementation was US-43.65. The mean incremental benefit of LCPUFA supplementation versus no supplementation was 0.074 QALY. The incremental cost-utility ratio was estimated at US$590.68 per QALY. The outcomes derived from our primary analysis remained robust when subjected to variations in all underlying assumptions and parameter values. CONCLUSION: Supplementation strategy supplementation with long-chain n-3 fatty acids during pregnancy is cost-effective in reducing the risk of developing asthma during childhood in Colombia.

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OBJECTIVES: The aim of this study is to conduct a cost-utility analysis of the use of the antiviral nirmatrelvir/ritonavir, applied to a vaccinated Brazilian population against COVID-19, from the perspective of the Brazilian Public Health System (SUS). METHODS: A microsimulation model was created with individual-level data and daily cycles, with a 1-year time horizon, to compare the current scenario of standard care with a scenario in which nirmatrelvir/ritonavir is offered to the population. Adults of any age group that received ≥2 doses of the COVID-19 vaccine formed the investigated population. Direct medical costs of the outpatients and inpatients admitted to the ward or intensive care unit were included. The effectiveness of the model was measured in quality-adjusted life-years (QALYs). RESULTS: In all simulations, the use of nirmatrelvir/ritonavir resulted in incremental costs per patient of US dollar (USD)245.86 and incremental effectiveness of 0.009 QALY, over a year. The incremental cost-utility ratio was USD27 220.70/QALY. The relative risk of the vaccinated population was the factor that affected the outcome most, according to the univariate sensitivity analysis. The probabilistic sensitivity analysis resulted in 100% of the simulations being more costly and effective, but that only 4% of them were below the established cost-effectiveness threshold of USD24 000.00/QALY. In the scenario considering only the population over 60 years old and immunosuppressed (of any age), the incremental cost-utility ratio was USD7589.37/QALY. CONCLUSIONS: The use of nirmatrelvir/ritonavir in the treatment of COVID-19 in a vaccinated population was cost-effective only for immunosuppressed individuals and people over 60 years of age.

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INTRODUCTION: The use of comprehensive genomic profiling (CGP) and target therapies is associated with substantial improvements in clinical outcomes among patients with non-small cell lung cancer (NSCLC). However, the costs of CGP may increase the financial pressures of NSCLC on health systems worldwide, especially in low- and middle-income countries. This study aimed to estimate the cost-effectiveness of CGP compared with current genomic tests in patients with NSCLC from the perspective of the Colombian Health System. METHODS: To estimate the costs and benefits of CGP and its comparators, we developed a 2-stage cohort model with a lifetime horizon. In the first stage, we made up a decision tree that calculated the probability of receiving each therapy as result of identifying a specific, actionable target. In the second stage, we developed a partitioned survival model that estimated the time spent at each health state. Incremental cost-effectiveness ratios were calculated for life-years (LYs) and quality-adjusted LYs gained. All costs were expressed in 2019 international dollars (INT$). RESULTS: CGP is associated with gains of 0.06 LYs and 0.04 quality-adjusted LYs compared with current genomic tests. Incremental cost-effectiveness ratios for CGP ranged from INT$861 to INT$7848, depending on the outcome and the comparator. Sensitivity analyses show that the cost-effectiveness decision was sensitive to prices of CGP above INT$7170 per test. These results are robust to most deterministic and probabilistic sensitivity analyses. CONCLUSIONS: CGP may be cost-effective in patients with NSCLC from the perspective of the Colombian Health System (societal willingness-to-pay threshold of INT$15 630 to INT$46 890).

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Objetivo: Comparar o implante transcateter de valva aórtica (TAVI) ao tratamento conservador em pacientes inoperáveis ou à cirurgia de troca valvar (SAVR) em pacientes com risco cirúrgico alto ou intermediário conforme a Society of Thoracic Surgeons (STS), por meio de uma revisão sistemática de avaliações econômicas completas. Avaliar a variabilidade de modelos econômicos, parâmetros, pressupostos e sua influência nos resultados finais. Métodos: Foi realizada uma busca da literatura nas bases Medline, EMBASE, Cochrane Library, Web of Science, SciELO e International HTA Base e busca manual. Foram incluídas análises econômicas completas baseadas em modelos econômicos publicadas entre 2011 e 2022, em português, inglês e espanhol. A qualidade dos estudos foi avaliada usando o instrumento QHES (Quality of Health Economic Studies). Resultados: Foram incluídos 36 estudos, majoritariamente análises de custo-utilidade (64%), da Europa (41%), utilizando dados de eficácia dos estudos PARTNER. O modelo de Markov (61%) foi predominante. O custo da prótese do TAVI foi um parâmetro de impacto na análise de sensibilidade nos três grupos. Os estudos alcançaram uma boa qualidade no instrumento QHES. Conclusão: O TAVI tendeu a ser custo-efetivo em relação aos comparadores. Os modelos não foram homogêneos nos parâmetros, horizontes temporais e taxa de desconto, podendo impactar a custo-efetividade do TAVI e dificultar a comparação dos resultados entre diferentes países e perspectivas.

ABSTRACT Objective: To compare transcatheter aortic valve implantation (TAVI) to conservative treatment in inoperable patients or to valve replacement surgery (SAVR) in patients at high or intermediate surgical risk according to the Society of Thoracic Surgeons (STS), through a systematic review of comprehensive economic evaluations. Evaluate the variability of economic models, parameters, assumptions and their influence on final results. Methods: A literature search was performed in Medline, EMBASE, Cochrane Library, Web of Science, SciELO and International HTA Base and manual search. Complete economic analyzes based on economic models published between 2011 and 2022 in Portuguese, English and Spanish were included. The quality of the studies was evaluated using the QHES (Quality of Health Economic Studies) instrument. Results: Thirty-six studies were included, mostly cost-utility analyses (64%), from Europe (41%), and using efficacy data from the PARTNER studies. The Markov model (61%) was predominant. The cost of the TAVI prosthesis was the most important parameter in the sensitivity analysis in the three groups. The studies achieved a good quality in QHES instrument. Conclusion: TAVI tended to be cost-effective relative to comparators. The models were not homogeneous in parameters, time horizons and discount rate, which may have an impact on the cost-effectiveness of TAVI, making it difficult to compare the results between different countries and perspectives.

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BACKGROUND: In Colombia, the best strategy to establish indication for adjuvant chemotherapy in early breast cancer (EBC) remains unknown. This study aimed to identify the cost-utility of Oncotype DX™ (ODX) or Mammaprint™ (MMP) tests to establish the necessity of adjuvant chemotherapy. METHODS: This study used an adapted decision-analytic model to compare cost and outcomes of care between ODX or MMP tests and routine care without ODX or MMP tests (adjuvant chemotherapy for all patients) over a 5-year time horizon from the perspective of the Colombian National Health System (NHS; payer). Inputs were obtained from national unit cost tariffs, published literature, and clinical trial database. The study population comprised women with hormone-receptor-positive (HR +), HER2-negative, lymph-node-negative (LN0) EBC with high-risk clinical criteria for recurrence. The outcome measures were discounted incremental cost-utility ratio (ICUR; 2021 United States dollar per quality-adjusted life-year [QALY] gained) and net monetary benefit (NMB). Probabilistic (PSA) and deterministic sensitivity analysis (DSA) were performed. RESULTS: ODX increases QALYs by 0.05 and MMP by 0.03 with savings of $2374 and $554 compared with the standard strategy, respectively, and were cost-saving in cost-utility plane. NMB for ODX was $2203 and for MMP was $416. Both tests dominate the standard strategy. Sensitivity analysis revealed that with a threshold of 1 gross domestic product per capita, ODX will be cost-effective in 95.5% of the cases compared with 70.2% cases involving MMP.DSA showed that the variable with significant influence was the monthly cost of adjuvant chemotherapy. PSA revealed that ODX was a consistently superior strategy. CONCLUSIONS: Genomic profiling using ODX or MMP tests to define the need of adjuvant chemotherapy treatment in patients with HR + and HER2 -EBC is a cost-effective strategy that allows Colombian NHS to maintain budget.

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BACKGROUND: The clinical activities developed by pharmacists in a hospital environment can improve health outcomes and generate savings for hospitals. However, to determine whether pharmaceutical interventions are cost effective, it is essential to define a method according to which cost-effectiveness is intended to be measured. In addition, the quality of economic assessments and the amount of information present in systematic reviews in the literature make it difficult to analyze the effects of this intervention. OBJECTIVE: This paper aims to provide an overview of systematic reviews on the pharmacoeconomic impact of the performance of pharmaceutical care in hospitals. METHODS: A systematic search of the Cochrane Library databases, PubMed or MEDLINE, LILACS, Scopus, Web of Science, Google Scholar, and Open Thesis will be performed using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. The search will involve the use of keywords determined using the Medical Subject Headings database to define the search terms and include the following terms: "pharmacoeconomics," "pharmaceutical care," and "hospital." The study designs to be included will be systematic reviews of good quality. Studies will be included that address pharmacoeconomics; studies that evaluated pharmaceutical care in hospitals; and studies published in Portuguese, English, or Spanish. The primary outcome sought in the systematic reviews will be the cost ratio in monetary units and the outcomes in monetary or natural units. The secondary economic outcomes considered will be determined based on factors associated with the drugs and translated into benefit, efficacy, or utility. RESULTS: It is intended to start this overview in January 2023. Thus far, only previous searches have been carried out to contextualize the theme and build the protocol. CONCLUSIONS: This overview will determine the pharmacoeconomic impact of pharmaceutical care interventions in the hospital environment. In addition, this study will point out which clinical outcomes in natural units are impacted by the performance of pharmaceutical care and the strengths and limitations of each approach. It will also identify gaps in the literature and areas for future work. TRIAL REGISTRATION: PROSPERO CRD42019140665; https://tinyurl.com/bddwnz43.

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OBJECTIVES: This study aimed to determine the cost-utility of ocrelizumab versus rituximab in patients with RRMS, from the perspective of the Colombian healthcare system. METHODOLOGY: Cost-utility study based on a Markov model, with a 50-year horizon and payer perspective. The currency was the US dollar for the year 2019, with a cost-effectiveness threshold of $5180 defined for Colombian health system. The model used annual cycles according to the health status determined by the disability scale. Direct costs were considered, and the incremental cost-effectiveness ratio per 1 quality-adjusted life-year (QALY) gained was used as the outcome measure. A discount rate of 5% was applied to costs and outcomes. Multiple one-way deterministic sensitivity analyses and 10 000 Monte Carlo simulation were conducted. RESULTS: For the treatment of patients with RRMS, ocrelizumab versus rituximab had an incremental cost-effectiveness ratio of $73 652 for each QALY gained. After 50 years, 1 subject treated with ocrelizumab earns 4.8 QALYs >1 subject treated with rituximab, but at a higher cost of $521 759 versus $168 752, respectively. Ocrelizumab becomes a cost-effective therapy if its price is discounted > 86% or if there is a high willingness to pay. CONCLUSIONS: Ocrelizumab was not a cost-effective drug as compared with rituximab in treating patients with RRMS in Colombia.

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Introduction: HIV is considered one of the most important chronic transmitted diseases worldwide. The Joint United Nations Program on HIV/AIDS in 2020 proposed the strategy "95-95-95" which goals to achieve a 95% of cases identified, receives ART, and will have achieved suppression of the virus. In Ecuador by 2020, according to the Ministry of Public Health, 45,056 persons are living with HIV, principally men between 15 and 49 years, and a mortality rate of 4.8/100,000 habitats. This study aims to determine the cost-utility of applying an early screening to a sexually active population vs. only a high-risk population and if the use of PrEP is justified depending on different contexts. Methods: For the cost-utility evaluation, it was compared: (a) HIV screening performed only in the high-risk population vs. HIV screening in all population sexually active; and (b) the use of ART only for HIV treatment vs. ART as a treatment in diagnosed cases and the use of PrEP (only at a high-risk population of acquiring HIV). Calculation and weight of DALYs for HIV/SIDA were obtained through WHO guidelines. To generate the Markov model for HIV/AIDS, subjects were classified as symptomatic or asymptomatic, as well as the HIV deaths. Results: Cost-benefit analysis (CUA) showed that ICER for early diagnosis had a negative value which means a saving if the strategy will be implemented as a regular test (-$591, -$4,360) and -108 and -934 DALYs, in the case of ART and PrEP, ICER the $30,541-$59,410, which resulted in more than the GDP's threshold and health years between 2,511 and 10,635 in the general population. With a reduction of 70% in the assigned budget for the early diagnosis, Ecuadorian people could lose between 4 and 6 DALYs, while if the budget reduces more than 50% to ART, it will generate a loss of 10-12 years of healthy life. Conclusion: CUA demonstrates that an early diagnosis in a sexually active population is cost-beneficial. This, combined with ART or PrEP, is ideal to add years of healthy life.

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OBJECTIVES: Mechanical thrombectomy (MT) after intravenous thrombolysis (IV-tPA) is an effective and cost-saving treatment for stroke due to large vessel occlusion. However, rates of MT use are low in Argentina. This study was designed to estimate the economic value and the budget impact of incorporating MT after thrombolysis, simulating scenarios from Argentinian compulsory social health insurance (Obras Sociales) and private insurances (Empresas de Medicina Prepaga). MATERIALS AND METHODS: We adapted a previously published cost-utility and budget-impact (CUA and BIA) model to the Argentinian setting. The CUA was carried out for a lifetime horizon with efficacy inputs from the SWIFT PRIME clinical trial. For seven possible health states, we identified local costs (Argentinian Pesos AR$), utility (QALY), and transition/distribution probabilities (5% discounted rate) and performed deterministic and probabilistic sensitivity analyses. The BIA was based on a six-step approach and a static model for a five-year horizon, and two scenarios (staggered growth and no growth). RESULTS: Despite higher incremental procedure costs, IV-tPA and MT was dominant over IV-tPA alone (AR$1,049,062 overall savings). Cost-effectiveness remained in the deterministic sensitivity analysis (100% probability of cost-effectiveness). Increased MT procedure volume resulted in savings in years three (0.96%), four (2.6%), and five (4.4%). By year five, 1,280 patients were treated with MT (versus 480) with overall savings of 1.8% (AR$817,244,417). CONCLUSIONS: MT after IV-tPA is cost-effective in Argentina. Savings offset the incremental hospitalization and long-term costs from the third year onwards. With increased, access the superior efficacy of MT mitigates future disability and comorbidity, reducing overall expenses.

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OBJECTIVES: Several trials have demonstrated the benefit of the CDK 4/6 inhibitors for postmenopausal women with luminal advanced breast cancer. This research aims to compare the cost-utility of the CDK 4/6 inhibitors in patients with no history of resistance to endocrine therapy. METHODS: A Markov model was constructed to estimate the incremental cost per quality-adjusted life-years (QALYs) of treatments from the Brazilian public health system perspective over a lifetime horizon (30 years) with 5% annual discount rate for both benefits and costs. Efficacy parameters were extracted from the pivotal studies. Costs were based on open data from the Brazilian Ministry of Health. The utilities were calculated according to the overall population preferences from a British study. Deterministic and probabilistic sensitivity analyses evaluated the robustness of the results. RESULTS: The most cost-effective drug was ribociclib (US$50 748/QALY), followed by abemaciclib (US$64 052/QALY) and palbociclib (US$65 289/QALY). The univariate analysis showed that the incremental cost-utility ratio (ICUR) was mainly sensitive to the overall survival hazard ratio. The one thousand-probabilistic simulation showed that all ICUR values were above classical thresholds such as 1 to 3 gross domestic product (GDP) per capita per QALY. CONCLUSIONS: Even though there is no established willingness to pay threshold in Brazil, the estimated ICUR for CDK 4/6 inhibitors is >6 times the Brazilian GDP per capita (GDP per capita = US$5694.73), which might be a barrier to their inclusion in the Brazilian public health system.

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OBJECTIVES: The objective of this study was to evaluate the cost-utility of the Oxford, CoronaVac, and Janssen COVID-19 vaccines from the perspective of the Brazilian public health system. METHODS: A total of 3 microsimulation models were constructed with individual data to evaluate the 3 vaccines. The simulation contains 7 transition states that are related to the natural history of the disease. The model with a daily cycle has a time horizon of 1 year and uses data from 289 days of the pandemic. The analysis was conducted from the perspective of the Brazilian public health system considering direct medical costs. For the model inputs, outpatient and hospital databases were used with information on treated patients stratified by age. Information on mortality was also stratified based on patients' age in the mortality database (SIM). The efficacy of vaccines to reduce the likelihood of patients becoming ill was evaluated independently for each vaccine. Information on the quality of life of patients in outpatient or hospital treatment and the sequelae resulting from the disease were extracted from the literature. The main outcome of the analysis was quality-adjusted life-years (QALYs). RESULTS: The vaccines showed incremental cost-utility ratios ranging from R$-23 161.3/QALY (Oxford) to R$17 757.85/QALY (CoronaVac). The older the population, the lower was the incremental cost-utility ratio. Given a willingness-to-pay threshold of R$17 586/QALY, all the vaccines were considered cost-effective in the probabilistic sensitivity analysis. CONCLUSIONS: The results of the analysis by age group can help in the preparation of a vaccination prioritization plan.

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BACKGROUND: TNF inhibitors are costly drugs supplied generally on health systems or private insurances. Performance analysis is essential to verify the results achieved by health technologies in these systems. The objective of the study was to compare the two most used biological drugs for the treatment of psoriatic arthritis (PsA) in Brazil. METHODS: A cost-utility analysis was built using a Markov model, with a five-year time horizon, a discount rate of 5%, and from the perspective of the Unified Health System. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Etanercept was the most cost-effective drug. Adalimumab became the most cost-effective drug in one of the four analysis scenarios with a willingness to pay from one gross domestic product per capita. The deterministic sensitivity analysis identified that the cost parameters had the greatest impact on the most effective drug. The probabilistic sensitivity analysis indicated that etanercept is the drug most likely to be cost-effective. CONCLUSION: The difference between the drugs in terms of utility was minimal and the costs were the main factor that impacted the cost-utility ratio, which points to the benefits of price renegotiation for the efficient allocation of resources in the health system.

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BACKGROUND: Adjuvant chemotherapy with trastuzumab for HER2 positive breast cancers has brought considerable benefits to disease-free survival and overall survival. OBJECTIVE: To conduct a cost-effectiveness analysis of the treatment of patients with early and locally advanced HER2 positive breast cancer, within the scope of the Brazilian public health system, comparing adjuvant chemotherapy with and without trastuzumab, for 1 year of treatment. METHODS: A 4-state Markov model was developed to estimate strategy costs and outcomes. RESULTS: Based on the proposed model, we verified an incremental benefit of trastuzumab therapy compared to treatment without trastuzumab with 0.84 quality-adjusted life years (QALY) and 1.16 life years gained (LYG). The use of adjuvant chemotherapy with trastuzumab has an ICER of US$19,599.26 for each quality-adjusted life year and US$14,180.68 for each life year gained in relation to chemotherapy without trastuzumab. CONCLUSION: In Brazil, adjuvant chemotherapy with trastuzumab may be considered cost-effective only if a cost-effectiveness threshold is stipulated with the value starting at three times the Brazilian GDP per capita for QALY or two times the Brazilian GDP per capita for LYG, from health system perspective.

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Abstract Aim: The study aimed to conduct a cost-utility analysis of traditional drug therapy (TDT) provided for hypertensive patients at primary care in comparison to the protocol based on combination with an exercise program (TDT+E) in real-life conditions, adopting a health system perspective. Methods: Longitudinal study based on enrollment of 49 hypertensive adults distributed into two groups, for 12 months. Quality-adjusted life years were estimated using health-related quality of life. Direct health care costs were calculated including inputs and human resources in primary care from medical records. Sensitivity analysis was performed based on multivariate and probabilistic scenarios. Results: Incremental cost-effectiveness ratios of TDT+E in comparison to TDT were +79.69. Sensitivity analysis showed that TDT+E presented advantages considering uncertainties. Conclusion: Our findings show that exercise programs may improve quality of life and life expectancy among hypertensive patients.

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ABSTRACT Introduction: We performed cost-effectiveness and cost-utility analyses of the modified International Consortium on Acute Promyelocytic Leukemia protocol in Mexico for the treatment of acute promyelocytic leukemia Acute Promyelocytic Leukemia. Methods: We performed a three-state Markov analysis: stable disease (first line complete response [CR]), disease event (relapse, second line response and CR) and death. The modified IC-APL protocol is composed of three phases: induction, consolidation and maintenance. Cost and outcomes were used to calculate incremental cost-effectiveness ratios (ICERs); quality-adjusted life-years were used to calculate incremental cost-utility ratios (ICURs). Results: The CR was achieved in 18 patients (90%), treated with the IC-APL protocol as the first-line option; one patient (5%) died in induction, another one never achieved CR (5%); of the 18 patients that achieved CR, 1 relapsed (5.5%). The median treatment cost of the IC-APL protocol was $21,523 USD. The average life-year in our study was 7.8 years, while the average quality-adjusted life-year (QALY) was 6.1 years. When comparing the ICER between the IC-APL and the all-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) protocols, we found the different costs of $6497, $19,133 and $17,123 USD in Italy, the USA and Canada, respectively. In relation to the ICUR, we found the different costs to be $13,955 and $11,979 USD in the USA and Canada, respectively. Conclusion: Taking into account the similar response rates, lower cost and easy access to the modified IC-APL regimen, we consider it a cost-effective and cost-utility protocol, deeming it the treatment of choice for our population.

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BACKGROUND: Different approaches have been used by dentists to base their decision. Among them, there are the aesthetical issues that may lead to more interventionist approaches. Indeed, using a more interventionist strategy (the World Dental Federation - FDI), more replacements tend to be indicated than using a minimally invasive one (based on the Caries Around Restorations and Sealants-CARS). Since the resources related to the long-term health effects of these strategies have not been explored, the economic impact of using the less-invasive strategy is still uncertain. Thus, this health economic analysis plan aims to describe methodologic approaches for conducting a trial-based economic evaluation that aims to assess whether a minimally invasive strategy is more efficient in allocating resources than the conventional strategy for managing restorations in primary teeth and extrapolating these findings to a longer time horizon. METHODS: A trial-based economic evaluation will be conducted, including three cost-effectiveness analyses (CEA) and one cost-utility analysis (CUA). These analyses will be based on the main trial (CARDEC-03/ NCT03520309 ), in which children aged 3 to 10 were included and randomized to one of the diagnostic strategies (based on FDI or CARS). An examiner will assess children's restorations using the randomized strategy, and treatment will be recommended according to the same criteria. The time horizon for this study is 2 years, and we will adopt the societal perspective. The average costs per child for 24 months will be calculated. Three different cost-effectiveness analyses (CEA) will be performed. For CEAs, the effects will be the number of operative interventions (primary CEA analysis), the time to these new interventions, the percentage of patients who did not need new interventions in the follow-up, and changes in children's oral health-related quality of life (secondary analyses). For CUA, the effect will be tooth-related quality-adjusted life years (QALYs). Intention-to-treat analyses will be conducted. Finally, we will assess the difference when using the minimally invasive strategy for each health effect (∆effect) compared to the conventional strategy (based on FDI) as the reference strategy. The same will be calculated for related costs (∆cost). The discount rate of 5% will be applied for costs and effects. We will perform deterministic and probabilistic sensitivity analyses to handle uncertainties. The net benefit will be calculated, and acceptability curves plotted using different willingness-to-pay thresholds. Using Markov models, a longer-term economic evaluation will be carried out with trial results extrapolated over a primary tooth lifetime horizon. DISCUSSION: The main trial is ongoing, and data collection is still not finished. Therefore, economic evaluation has not commenced. We hypothesize that conventional strategy will be associated with more need for replacements of restorations in primary molars. These replacements may lead to more reinterventions, leading to higher costs after 2 years. The health effects will be a crucial aspect to take into account when deciding whether the minimally invasive strategy will be more efficient in allocating resources than the conventional strategy when considering the management of restorations in primary teeth. Finally, patients/parents preferences and consequent utility values may also influence this final conclusion about the economic aspects of implementing the minimally invasive approach for managing restorations in clinical practice. Therefore, these trial-based economic evaluations may bring actual evidence of the economic impact of such interventions. TRIAL REGISTRATION: NCT03520309 . Registered May 9, 2018. Economic evaluations (the focus of this plan) are not initiated at the moment.

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PURPOSE: The SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma. METHODS: This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs). FINDINGS: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926-24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses. IMPLICATIONS: This economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.

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