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The EuroQol 5-dimension 5-level (EQ-5D-5L) instrument is among the most used preference-based quality of life (QOL) measures for cost–utility analysis. Each dimension is evaluated on five levels. The aim of this study was to clarify whether the EQ-5D-5L, which consists of only five items, correlates with profile-based QOL measures in Japanese oral cancer patients during the perioperative period. One hundred participants with oral cancer undergoing radical therapy completed QOL assessments before treatment, at treatment completion, and 1 and 3 months after treatment using the EQ-5D-5L and Functional Assessment of Cancer Therapy – Head & Neck instrument (FACT-H&N, Japanese version). To clarify how the EQ-5D-5L reflects the FACT-H&N, multiple regression analyses were performed using FACT-H&N subscales. The ceiling effect of the EQ-5D-5L was investigated. The EQ-5D-5L moderately correlated with the FACT-H&N over the entire perioperative period (rs = 0.586, P

Purpose To calculate costs required to prevent center-involved diabetic macular edema (CI-DME) or proliferative diabetic retinopathy (PDR), and to improve the diabetic retinopathy severity score (DRSS) with intravitreal anti-VEGF injections as reported for aflibercept in two randomized control trials. Design Cost-effectiveness analysis modeling based on published data Subjects None Methods Results from PANORAMA and the Diabetic Retinopathy Clinical Research Network ( DRCR.net ) Protocol W were analyzed. Parameters collected included DRSS score, risk reduction of PDR, risk reduction of CI-DME, and number of treatments required. Costs were modeled based on 2020 Medicare reimbursement data practice settings of hospital-based facility and non-facility. Main Outcome Measure Cost to prevent case of PDR and CI-DME, and to improve DRSS stage Results Over 2 years in Protocol W, the cost required to prevent 1 case of PDR was $83,000 ($72,400) in the facility (non-facility) setting; in PANORAMA, the corresponding 2 year costs were $89,400 ($75,000) for the 2Q16 arm, and $91,200 ($89,900) for the 2Q8PRN arm. To prevent 1 case of CI-DME with vision loss in Protocol W, the cost was $154,000 ($133,000). For all CI-DME, with and without vision loss; in PANORAMA, the costs to prevent a case were $70,900 ($59,500) for the 2Q16 arm, and $90,000 ($88,800) for the 2Q8PRN arm. In Protocol W, the overall accumulated total for cost /DRSS unit change at the 2 year point for facility (non-facility) setting was $2700 ($2400)/DRSS. In the first year alone, it was $2100 ($1800)/DRSS and in the second year alone, $6100 ($5300)/DRSS. Conclusion There is a considerable cost associated with the prevention of PDR and CI-DME with intravitreal aflibercept injections. A price per unit of change in diabetic retinopathy severity score is a new parameter which might serve as a benchmark in future utility analyses that could be used to bring perspective to cost-utility considerations.

Objective: To conduct a stratified cost-utility analysis of total versus partial hip arthroplasty as a function of clinical subtype. Method: All cases of this type of intervention were analysed between 2010 and 2016 in the Basque Health Service, gathering data on clinical outcomes and resource use to calculate the cost and utility in quality-adjusted life years (QALYs) at individual level. The statistical analysis included applying the propensity score to balance the groups, and seemingly unrelated regression models to calculate the incremental cost-utility ratio and plot the cost-effectiveness plane. The interaction between age group and American Society of Anesthesiologists (ASA) risk class was assessed in the multivariate analysis. Results: The study identified 5867 patients diagnosed with femoral neck fracture, of whom 1307 and 4560 were treated with total and partial hip arthroplasty, respectively. In the cost-utility analysis based on the seemingly unrelated regression, total hip arthroplasty was found to have a higher cost and higher utility (2465€ and 0.42 QALYs). Considering a willingness-to-pay threshold of €22,000 per QALY, total hip arthroplasty was cost-effective in the under-80-year-old subgroup. Among patients above this age, hemiarthroplasty was cost-effective in ASA class I-II patients and dominant in ASA class III-IV patients. Conclusions: Subgroup analysis supports current daily clinical practice in displaced femoral neck fractures, namely, using partial replacement in most patients and reserving total replacement for younger patients. Resumen: Objetivo: Realizar un análisis de coste-utilidad de la prótesis total de cadera frente a la prótesis parcial. Método: Se analizaron todos los casos intervenidos desde 2010 hasta 2016 en el Servicio Vasco de Salud, recogiendo resultados clínicos y uso de recursos para calcular individualmente el coste y la utilidad en años de vida ajustados por calidad (AVAC). El análisis estadístico incluyó el pareamiento por puntaje de propensión para balancear los grupos y modelos de regresión aparentemente no relacionados para calcular la razón de coste-utilidad incremental y el plano de coste-efectividad. La interacción de grupo de edad y riesgo según la American Society of Anesthesiologists (ASA) se incluyó en el análisis multivariante. Resultados: Se identificaron 1307 pacientes con prótesis total y 4560 con prótesis parcial. Al hacer el análisis de coste-utilidad con modelos de regresión aparentemente no relacionados el resultado fue mayor coste y mayor utilidad para la prótesis total (2465 € y 0,42 AVAC). Para un umbral de 22.000 € por AVAC, la prótesis total fue coste-efectiva en el subgrupo de menores de 80 años. En el grupo de mayores de 80 años la parcial fue coste-efectiva en los casos con riesgo ASA I-II y dominante en los ASA III-IV. Conclusiones: El análisis de subgrupos ratifica la práctica clínica habitual en las fracturas de cuello de fémur desplazadas de intervenir a la mayoría de los pacientes mediante prótesis parcial y reservar la prótesis total para los pacientes más jóvenes.

Objectives To evaluate the 1-year cost-effectiveness between three different initial treatment strategies in autoantibody-negative RA patients, according to 2010 criteria. Methods For this analysis we selected all RA patients within the intermediate probability stratum of the treatment in the Rotterdam Early Arthritis Cohort (tREACH) trial. The tREACH had a treat-to-target approach, aiming for low DAS Results Average quality-adjusted life-years (s.d.), for iMTX, iHCQ and iGCs were respectively 0.71 (0.14), 0.73 (0.14) and 0.71 (0.15). The average total costs (s.d.) for iMTX, iHCQ and iGCs were, respectively, €10 832 (14.763), €11 208 (12.801) and €10 502 (11.973). Healthcare costs were mainly determined by biological costs, which were significantly lower in the iHCQ group compared with iGCs (P Conclusion iHCQ had the lowest healthcare and highest productivity costs, resulting in a non-significant incremental cost-effectiveness ratio. However, iHCQ had the highest chance of being cost-effective at the Dutch willingness-to-pay threshold for healthcare reimbursement. Therefore, we believe that iHCQ is a good alternative to iMTX in autoantibody-negative RA patients, but validation is needed. Clinical trial registration number ISRCTN26791028

Background Biologics are a good therapeutic option for severe, chronic plaque psoriasis; however, they come with significant cost to the health care system. Objective To conduct a cost-utility analysis of outpatient biologics (adalimumab, etanercept, guselkumab, ixekizumab, risankizumab, secukinumab, tildrakizumab, and ustekinumab) available to adults with severe, chronic plaque psoriasis from the perspective of the Australian health care system. Methods A Markov cohort model was constructed to estimate the quality-adjusted life years (QALYs) and costs accrued for treatment pathways commencing with different first-line biologics, over a 96-week time horizon. The model adhered to the Australian Pharmaceutical Benefits Scheme eligibility criteria and guidelines. Results A biologic treatment pathway commencing on tildrakizumab was the most cost-effective first-line treatment (Australian dollar 39,930; total utility of 1.57 QALYs over 96 weeks). First-line secukinumab and risankizumab had incremental cost-utility ratios of Australian dollar 194,524/QALY and Australian dollar 479,834/QALY, respectively, when compared with first-line tildrakizumab. Limitations The efficacy and utility input parameters were derived from international randomized control trials and patients from the United Kingdom, respectively. Findings from this study cannot be generalized beyond Australia. Conclusion Tildrakizumab may be considered as first-line treatment for adult patients with severe, chronic plaque psoriasis embarking on biologic therapy, from the economic perspective of the Australian health care system.

Objective To assess the cost-effectiveness of breast reduction surgery for women with symptomatic breast hypertrophy in Australia. Design Cost-utility analysis of data from a prospective cohort study. Setting, participants Adult women with symptomatic breast hypertrophy assessed for bilateral breast reduction at the Flinders Medical Centre, a public tertiary hospital in Adelaide, April 2007 - February 2018. The control group included women with breast hypertrophy who had not undergone surgery. Main outcome measures Health care costs (for the surgical admission and other related hospital costs within 12 months of surgery) and SF-6D utility scores (measure of health-related quality of life) were used to calculate incremental costs per quality-adjusted life-year (QALY) gained over 12 months, extrapolated to a 10-year time horizon. Results Of 251 women who underwent breast reduction, 209 completed the baseline and at least one post-operation assessment (83%; intervention group); 124 of 350 invited women waiting for breast reduction surgery completed the baseline and 12-month assessments (35%; control group). In the intervention group, the mean SF-6D utility score increased from 0.313 (SD, 0.263) at baseline to 0.626 (SD, 0.277) at 12 months; in the control group, it declined from 0.296 (SD, 0.267) to 0.270 (SD, 0.257). The mean QALY gain was consequently greater for the intervention group (adjusted difference, 1.519; 95% CI, 1.362-1.675). The mean hospital cost per patient was $11 857 (SD, $4322), and the incremental cost-effectiveness ratio (ICER) for the intervention was $7808 per QALY gained. The probability of breast reduction surgery being cost-effective was 100% at a willingness-to-pay threshold of $50 000 per QALY and 88% at $28 033 per QALY. Conclusions Breast reduction surgery for women with symptomatic breast hypertrophy is cost-effective and should be available to women through the Australian public healthcare system.

Background: Human cadaveric allograft (HCA) and costal cartilage autograft (CCA) have been described for reconstruction during rhinoplasty. Neither are ideal due to infection, resorption, and donor site morbidity. The clear superiority of 1 graft over the other has not yet been demonstrated. This study assesses comparative costs associated with current grafting materials to better explore the cost ceiling for a theoretical tissue engineered implant. Materials and methods: A cost utility analysis was performed. Initial procedure costs include physician fees (CPT 30420), hospital outpatient prospective payments, ambulatory surgical center payments, and fees for the following: rib graft (CPT 20910), hospital observation, and DRG (155) for inpatient admission. Additional costs for revision procedure, included the following fees: physician (CPT 30345), rib graft, hospital outpatient prospective payment, and ambulatory surgical center payments. Total costs under each scenario were calculated with and without the revision procedure. Comparison of total costs for each potential outcome to the estimated health utility value allowed for comparison across rhinoplasty subgroups. Results: The mean cost of primary outpatient rhinoplasty using HCA and CCA were $8075 and $8342 respectively. Revision outpatient rhinoplasty averaged $7447 and increased to $8228 if costal cartilage harvest was required. Hospital admission increased the cost of primary rhinoplasty with CCA to $8609 for observational admission and to $13653 for 1 day inpatient admission. Revision CCA rhinoplasty with an inpatient admission complicated by pneumothorax increased costs to $21 099. Conclusion: Cost of rhinoplasty without hospitalization was similar between HCA and CCA and this cost represents the lower limit of a practical cost for an engineered graft. Considering complications such as need for revision or for admission after CCA due to surgical morbidity, the upper limit of cost for an engineered implant would approximately double.

Objectives To evaluate the cost-effectiveness of pazopanib for the treatment of metastatic renal cell carcinoma (mRCC) in the first-line settings from a payer perspective. Methods A state-transition model with three health states was developed to estimate the incremental cost per quality-adjusted life years (QALY) gained for pazopanib compared to sunitinib. A lifelong time horizon was adopted in the base-case analysis. The transition probabilities were estimated based on the COMPRAZ trial, utility weights were taken from literature, and costs were based on estimating medical resource utilization data at King Hussein Cancer Centre (KHCC), deriving unit cost inputs from KHCC databases and the Jordan Food and Drug Administration website. Both costs and outcomes were discounted using 3% rate. The model’s uncertainty was tested using a probabilistic and deterministic sensitivity analyses. Key findings The base-case results showed that pazopanib was dominant when using the listed price for both medications. Pazopanib was associated with an incremental saving of −$10 721.55 and an incremental QALY of 0.08. The results were sensitive to utility values and the progression health state cost. The probabilistic sensitivity analysis showed that the probability of pazopanib being cost-effective compared to sunitinib is around 60–70% at KHCC cost-effectiveness threshold values. However, the result was reversed when the price of sunitinib was reduced by 40% making sunitinib the dominant strategy. Conclusions Pazopanib is a potential cost-effective option in the first-line settings for mRCC when the listed price of sunitinib is used. Therefore, price negotiations are recommended before final listing decisions to get the most cost-saving treatment.

Background Cardiovascular diseases are the leading cause of death. Pharmacist-led medication review with follow-up might be cost-effective preventing cardiovascular diseases. Objective To undertake a cost–utility analysis of the addition of pharmacist-led medication review with follow-up to usual care compared to usual care alone for cardiovascular outpatients. Materials and methods A state-transition microsimulation model was built to project outcomes over a lifetime time horizon. Inputs from a cluster randomized controlled trial conducted in primary health care centers in Chile with full-time pharmacists were used. Probabilities were estimated using patient-level data. Utilities and costs associated with each health state were obtained from the literature, whereas the intervention costs were retrieved from the trial. The public third-party payer perspective was used. Uncertainty was evaluated through one-way and probabilistic sensitivity analyses. Results For the base case analysis, an incremental cost-effectiveness ratio of $963 per quality-adjusted life-year was observed which was considered cost-effective. The results were robust to sensitivity analyses and were driven by decreased cardiovascular events resulting in lower mortality. Conclusions Medication review with follow-up was deemed a cost-effective addition to usual care with low uncertainty.

Bhavani Shankara Bagepally,1,2 Usa Chaikledkaew,1,3 Sitaporn Youngkong,1,3 Thunyarat Anothaisintawee,1,4 Montarat Thavorncharoensap,1,3 Charungthai Dejthevaporn,5 Ammarin Thakkinstian1,6 1Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand; 2Department of Non-Communicable Diseases, ICMR-National Institute of Epidemiology, Chennai, India; 3Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand; 4Department of Family Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; 5Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand; 6Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, ThailandCorrespondence: Usa ChaikledkaewSocial Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayudhaya Road, Phayathai, Ratchathewi, Bangkok, 10400, ThailandTel +662-644-8677 ext 5317Fax +662-644-8694Email usa.chi@mahidol.ac.thBackground: Type 2 diabetes mellitus (T2DM) is a leading health issue, causing economic burden in India. Pharmacotherapy is a major cost driver in diabetic care usually funded through out of pocket expenditure; however, there has been a very limited economic evaluation evidence to guide the choice of diabetes pharmacotherapy in India. Therefore, this study aims to evaluate the long-term cost-effectiveness of dapagliflozin (sodium glucose transporter 2 inhibitor) compared to commonly used sulfonylureas as second-line drugs in Indian patients with T2DM.Methods: Cost-utility analysis was employed to estimate the costs and health outcomes using a Markov model with 1-year cycle length during a lifetime horizon based on an Indian payer’s perspective. A treatment pathway with dapagliflozin as second-line therapy was compared to sulfonylureas after failure of initial metformin therapy. Clinical and cost data were collected from literature reviews and available secondary data sources. Both costs and outcomes were discounted at a 3% annual discount rate. The results were presented as the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analyses were performed to test parameter uncertainties.Results: Compared to sulfonylurea, dapagliflozin was estimated to incur an additional cost of ₹182,632 (US$2,446) with an expected 3.49 life years (LY) or 1.72 quality adjusted life years (QALY) gained, resulting in an ICER of ₹52,270 (US$699) per LY gained, or ₹106,133 (US$1,421) per QALY gained. Uncertainty analyses showed that the ICER values were not sensitive to changes in most parameters.Conclusion: Dapagliflozin would be cost-effective compared to sulfonylureas as the second line added to metformin for T2DM patients based on an Indian payer’s perspective.Keywords: economic evolution, cost-effectiveness, sodium glucose transporter 2 inhibitor, type 2 diabetes, India, glibenclamide, gliclazide

BACKGROUND: Acute myocardial infarction (AMI) is a common cause of hospital admissions, readmissions, and mortality worldwide. Digital health interventions (DHIs) that promote self-management, adherence to guideline-directed therapy, and cardiovascular risk reduction may improve health outcomes in this population. The “Corrie” DHI consists of a smartphone application, smartwatch and wireless blood pressure monitor to support medication tracking, education, vital signs monitoring and care coordination. We aimed to assess the cost-effectiveness of this DHI plus standard care in reducing 30-day readmissions among AMI patients in comparison to standard care alone. METHODS: A Markov model was used to explore cost-effectiveness from the hospital perspective. The time horizon of the analysis was 1 year, with 30-day cycles, using inflation-adjusted cost data with no discount rate. Currencies were quantified in US dollars and effectiveness was measured in quality-adjusted life year (QALYs). The results were interpreted as an incremental cost-effectiveness ratio at a threshold of $100,000 per QALY. Univariate sensitivity and multivariate probabilistic sensitivity analyses tested model uncertainty. RESULTS: The DHI reduced costs and increased QALYs on average, dominating standard care in 99.7% of simulations in the probabilistic analysis. Based on the assumption that the DHI costs $2,750 per patient, use of the DHI leads to a cost-savings of $7,319 per patient compared to standard care alone. CONCLUSIONS: Our results demonstrate that this DHI is cost-saving through the reduction of risk for all-cause readmission following AMI. DHIs that promote improved adherence with guideline-based healthcare can result in reduced hospital readmissions. CLINICAL TRIAL REGISTRATION: NCT03760796; https://clinicaltrials.gov/ct2/show/NCT03760796

BackgroundDue to COVID-19’s significant morbidity and mortality, identifying the most cost-effective pharmacologic treatment strategy is critical. As such, we determined the most cost-effective strategy for moderate to severe COVID-19 respiratory infections using the United States health care system as a representative model.MethodsA decision analytic model modelled a base case scenario of a 60-year-old patient admitted to hospital with COVID-19. Patients requiring oxygen were considered moderate severity, and patients with severe COVID-19 required intubation with intensive care. Strategies modelled included giving remdesivir to all patients, remdesivir in severe infections, remdesivir in moderate infections, dexamethasone to all patients, dexamethasone in severe infections, remdesivir in moderate/dexamethasone in severe infections, and best supportive care. Data for the model came from the published literature. The time horizon was 1 year; no discounting was performed due to the short duration. The perspective was of the payer in the United States health care system.ResultsSupportive care for moderate/severe COVID-19 cost $11,112.98/0.8256 QALY. Remdesivir in moderate/dexamethasone in severe infections was the most cost-effective with an incremental cost-effectiveness ratio of $19,764.56/QALY gained compared to supportive care. Probabilistic sensitivity analyses showed remdesivir for moderate/dexamethasone for severe COVID-19 infection was most cost-effective in 88.6% of scenarios and dexamethasone in moderate-severe infections in 11.4% of scenarios. With lower willingness to pay thresholds ($250-$37,500), dexamethasone for severe infections was favoured.ConclusionsRemdesivir for moderate/dexamethasone for severe COVID-19 infections was the0020most cost-effective strategy. Further data is required for remdesivir to better assess its cost effectiveness in treatment of COVID-19.

Background Sacubitril-valsartan is effective in reducing the N-terminal pro-B-type natriuretic peptide level of hospitalized patients with acute decompensated heart failure, with a high acquisition cost compared with enalapril treatment. Objective This study aimed to determine the cost utility of sacubitril-valsartan compared with enalapril for acute decompensated heart failure treatment. Methods A Markov model was constructed to project the total costs, life-years, quality-adjusted life-years (QALYs) of early initiation, and a 2-month delay of sacubitril-valsartan treatment and enalapril treatment in hospitalized patients with acute decompensated heart failure over a lifetime horizon from a Thai healthcare system perspective. Clinical inputs were mainly derived from the PIONEER-HF and PARADIGM-HF trials, together with Thai epidemiological data. Cost data were based on the Thai population. All costs and outcomes were discounted at 3% annually. A series of sensitivity analyses were performed. Results Compared with enalapril, sacubitril-valsartan incurred a higher total cost per year (THB 42,994 [US$1367.48] vs THB 19,787 [US$629.37]), and it gained more QALYs (4.969 vs 4.755). The incremental cost-effectiveness ratio was THB 108,508/QALY (US$3451.26/QALY). Early initiation of sacubitril-valsartan treatment was more cost effective than delayed treatment. Sensitivity analyses revealed that at a level of willingness to pay of THB 160,000/QALY (US$5089/QALY), sacubitril-valsartan was a cost-effective strategy of about 60%. Conclusions Sacubitril-valsartan is cost effective in patients with acute decompensated heart failure. However, the results are highly dependent on the long-term cardiovascular mortality, and they are applicable only to Thailand or countries with a similarly structured healthcare system. Long-term registries should be pursued to decrease the uncertainty around long-term mortality.

Background Respiratory rate (RR) is one of the most important physiologic measures for predicting patients’ deterioration of clinical condition and final prognosis. In several studies, RR has been the most important predictor of patients’ prognoses. Objectives The objective of this study was to conduct a cost-utility analysis to estimate the cost and effectiveness of automatic respiratory rate monitoring (ARRM) with a non-invasive sensor (RespiraSense™) plus intermittent nurse-led RR monitoring (ARRM strategy) compared with intermittent nurse-led RR monitoring (IM strategy) in patients admitted to hospital in the UK with pneumonia. Methods A decision analytic model was developed based on a hypothetical cohort of patients who were admitted to hospital with pneumonia. After admission, the patients could be monitored with either ARRM or IM strategies. The outcomes of interest included total costs and total effectiveness of each strategy, including length of stay (LoS) in hospital, LoS in intensive care unit, quality-adjusted life-years (QALYs), deaths, and incremental cost per QALY gained. An incremental cost of £20,000 or less per QALY gained was considered cost effective. A lifetime time horizon (38 years) was used to capture the long-term benefits. Probabilistic and deterministic sensitivity analyses were performed. Results Total costs of patient care in ARRM and IM strategies were £1986.9 million and £2079.4 million, respectively. Total incremental QALYs lived were 3548 higher in the intervention arm (ARRM), meaning that the ARRM strategy was dominant (i.e., less costly [£92.6 million less] and more effective). The results were stable in probabilistic and most of the deterministic sensitivity analyses. Results from threshold analysis indicated that a minimum of 7 and 10% improvement in percentage of early detection of respiratory compromise is required for ARRM to become cost effective and cost saving, respectively. Conclusions Our results indicate that ARRM using RespiraSense, in addition to intermittent nurse-led monitoring of RR, in patients admitted to the hospital with pneumonia could be a cost-saving and cost-effective intervention if the minimum clinical thresholds are met.

Study design Cost-utility analysis. Objective This study aimed to investigate the cost-utility of bracing versus observation in patients with thoracic scoliosis who would be indicated for bracing. Summary of background data There is high-quality evidence that bracing can prevent radiographic progression of spinal curvature in adolescent idiopathic scoliosis (AIS) patients with curves between 25° and 40° and Risser 0 to 2 skeletal maturity index. However, to our knowledge, the cost-utility of bracing in AIS has not been established. Methods A decision-analysis model comparing bracing versus observation was developed for a hypothetical 10-year old girl (Risser 0, Sanders 3) with a 35° main thoracic curve. We estimated the probability, cost, and quality-adjusted life years (QALY) for each node based on comprehensive review of the literature. Costs were adjusted for inflation based on Consumer Price Index and reported in terms of 2020 real dollars. Incremental net monetary benefit (INMB) was calculated based on a probabilistic sensitivity analysis using Monte Carlo simulations of 1000 hypothetical patients. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates. Results Our decision-analysis model revealed that bracing was the dominant treatment choice over observation at $50,000/QALY willingness to pay threshold. In simulation analysis of a hypothetical patient cohort, bracing was associated with lower net lifetime costs ($60,377 ± $5,340 with bracing vs. $85,279 ± $4543 with observation) and higher net lifetime QALYs (24.1 ± 2.0 with bracing vs. 23.9 ± 1.8 with observation). Bracing was associated with an INMB of $36,093 (95% confidence interval $18,894-$55,963) over observation over the patient's lifetime. The model was most sensitive to the impact of bracing versus observation on altering the probability of requiring surgery, either as an adolescent or an adult. Conclusion Cost-utility analysis supports scoliosis bracing as the preferred choice in management of appropriately indicated AIS patients with thoracic scoliosis.Level of Evidence: 5.

Background The normal ageing process is accompanied by immunosenescence and a progressive weakening of the immune system. High-dose inactivated influenza quadrivalent vaccine (HD-QIV) has shown greater immunogenicity, relative efficacy, and effectiveness than the standard-dose inactivated quadrivalent vaccine (SD-QIV). The aim of the study was to assess the cost-utility of an HD-QIV strategy compared with an adjuvanted trivalent inactivated vaccine (aTIV) strategy in the population above 65 years of age in Spain. Methods We evaluated the public health and economic benefits of alternatives by using a decision-tree model, which included influenza cases, visits to the general practitioner (GP), visits to the emergency department (ED), hospitalisations, and mortality related to influenza. We performed deterministic and probabilistic sensitivity analyses to account for both epidemiological and economical sources of uncertainty. Results Our results show that switching from aTIV strategy to HD-QIV would prevent 36,476 cases of influenza, 5,143 visits to GP, 1,054 visits to the ED, 9,193 episodes of hospitalisation due to influenza or pneumonia, and 357 deaths due to influenza – increasing 3,514 life-years and 3,167 quality–adjusted life–years (QALYs). Healthcare costs increase by €78,874,301, leading to an incremental cost-effectiveness ratio (ICER) of €24,353/QALY. The sensitivity analysis indicates that the results are rather robust. Conclusion Our analysis shows that HD-QIV in people over 65 years of age is an influenza-prevention strategy that is at least cost-effective, if not dominant, in Spain. It reduces cases of influenza, GP visits, hospitalisations, deaths, and associated healthcare costs.

Background Glaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study was to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective. Methods Simulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses. Results Results of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8368.51 vs. €7134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The cost-effectiveness accessibility curve (CEAC) showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained. Conclusions The results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective.

Background Chronic rhinosinusitis with nasal polyposis (CRSwNP) in the setting of aspirin-exacerbated respiratory disease (AERD) is a disease that is difficult to treat and prone to recurrence. Dupilumab is a promising treatment for these patients, but its cost-effectiveness has not yet been compared with aspirin (acetylsalicyclic acid, or ASA) desensitization, a known and effective treatment. We aimed to compare the cost-effectiveness of ASA desensitization with dupilumab therapy for the treatment of CRSwNP in AERD. Methods Analyses of cost-effectiveness, as measured in quality-adjusted life years (QALYs), and cost-utility, as measured in number of required revision endoscopic sinus surgeries (ESSs), were conducted. Results ASA desensitization after ESS was cost-effective and dominated appropriate medical management. Adding salvage dupilumab was also cost-effective (incremental cost-effectiveness ratio [ICER] $135,517.33), and upfront dupilumab therapy was not cost-effective in any scenario (ICER $273,181.32). The cost-utility analysis demonstrated that, over a 10-year period per patient, appropriate medical management after ESS cost $54,125.31 and resulted in 2.25 revision ESSs, ASA desensitization after ESS cost $53,775.15 and resulted in 2.02 revision ESSs, ASA desensitization with salvage dupilumab cost $121,176.25 and resulted in 1.68 revision ESSs, and upfront dupilumab cost $185,950.34 and resulted in 1.51 revision ESSs. Conclusion Dupilumab for the treatment of severe CRSwNP was found to be cost-effective as salvage therapy under the willingness-to-pay threshold of $150,000. Further analysis highlighted that the cost-effectiveness of dupilumab was most sensitive to drug price and expected gains in quality of life. This suggests that additional investigation into improving patient population selection and tailoring treatment algorithms may improve the cost-effectiveness of dupilumab in specific scenarios.

Objectives To assess the cost-effectiveness of uterine artery embolisation (UAE) and myomectomy for women with symptomatic uterine fibroids wishing to avoid hysterectomy. Design Economic evaluation alongside the FEMME randomised controlled trial. Setting 29 UK hospitals. Population Premenopausal women who had symptomatic uterine fibroids amenable to UAE or myomectomy wishing to avoid hysterectomy. 254 women were randomised to UAE (127) and myomectomy (127). Methods A within-trial cost-utility analysis was conducted from the perspective of the UK NHS. Main outcome measures Quality-adjusted life years (QALYs) measured using the EuroQoL EQ-5D-3L, combined with costs to estimate cost-effectiveness over 2 and 4 years of follow-up. Results Over a 2-year time horizon, UAE was associated with higher mean costs (difference £645; 95% CI -1381 to 2580) and lower QALYs (difference -0.09; 95% CI -0.11 to -0.04) when compared with myomectomy. Similar results were observed over the 4-year time horizon. Thus, UAE was dominated by myomectomy. Results of the sensitivity analyses were consistent with the base case results for both years. Over 2 years, UAE was associated with higher costs (difference £456; 95% CI -1823 to 3164) and lower QALYs (difference -0.06; 95% CI -0.11 to -0.02). Conclusions Myomectomy is a cost-effective option for the treatment of uterine fibroids. The differences in costs and QALYs are small. Women should be fully informed and have the option to choose between the two procedures. Tweetable abstract Fully informed women with uterine fibroids should have a choice between uterine artery embolisation or myomectomy.

Sermsiri Sangroongruangsri,1 Kankamon Kittrongsiri,2 Phunchai Charatcharoenwitthaya,3 Abhasnee Sobhonslidsuk,4 Usa Chaikledkaew1,5 1Social and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand; 2Social, Economic and Administrative Pharmacy (SEAP) Graduate Program, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand; 3Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand; 4Division of Gastroenterology and Hepatology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; 5Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, ThailandCorrespondence: Usa ChaikledkaewSocial and Administrative Pharmacy Division, Department of Pharmacy, Faculty of Pharmacy, Mahidol University, 447 Sri-Ayudhaya Road, Rajathevi, Bangkok, 10400, ThailandTel +662-644-8679 ext 5317Fax +662-644-8694Email usa.chi@mahidol.ac.thPurpose: Type 1 hepatorenal syndrome (type 1 HRS) or hepatorenal syndrome-acute renal injury (HRS-AKI) leads to high short-term mortality rates in patients with cirrhosis. Vasoconstrictor therapy effectively improves survival of these patients and has been a bridge to liver transplantation. The aim of this study was to assess the cost-utility of terlipressin plus albumin (T+A) and noradrenaline plus albumin (N+A) compared to best supportive care (BSC) for treating type 1 HRS patients in Thailand.Methods: A cost-utility analysis using a six-state Markov model was performed from societal and payer perspectives over a lifetime horizon. The clinical outcomes, costs, and utility parameters were obtained from literature, network meta-analyses, and expert opinion. One-way and probabilistic sensitivity analyses were conducted to account for uncertainty.Results: The T+A yielded the highest cost (848,325 Thai Baht (THB)) and health outcomes (2.82 life-years (LY) and 2.27 quality-adjusted life-years (QALY)). Compared to BSC, incremental cost-effectiveness ratios (ICERs) of the T+A and N+A were 377,566 and 412,979 THB per QALY gained, respectively. If N+A is administered outside the intensive care unit, the ICER was 308,964 THB per QALY. The treatment cost after liver transplantation from year 3 onwards was the most influential factor for ICERs, followed by the cost of terlipressin, duration of noradrenaline treatment, and cost of albumin. At the Thai societal willingness-to-pay threshold of 160,000 THB per QALY gained, the probabilities of being cost-effective for T+A, N+A, and BSC were 11%, 20%, and 69%, respectively.Conclusion: The T+A and N+A treatments would not be cost-effective compared to BSC in the Thai setting.Keywords: terlipressin, noradrenaline, HRS-AKI, liver transplantation, economic evaluation, Thailand

Objectives To model the cost-effectiveness of the TYRX Absorbable Antibacterial Envelope when used in patients at increased risk of cardiac implantable electronic device (CIED) infection in the context of 3 European healthcare systems: Germany, Italy, and England. Methods A decision tree model with a lifetime horizon was populated using data from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial, a large multicenter randomized controlled trial. Use of the antibacterial envelope adjunctive to standard of care was compared to standard of care infection prevention alone. Patients in the model were divided into subgroups based on presence of factors known to increase infection risk. Results The antibacterial envelope had the most favorable cost-effectiveness profile when patients had previously experienced CIED infection, had a history of immunosuppressive therapy, or had a Prevention of Arrhythmia Device Infection Trial (PADIT) score indicating high risk of infection (scores ≥6) at cost-effectiveness thresholds of €50 000 in Germany (assumed in the absence of an official threshold), €40 000 in Italy, and £30 000 in England. Probabilistic sensitivity analysis indicated that the antibacterial envelope was likely to be cost-effective in patients with other risk factors (including replacement of high power CIEDs, generator replacement with lead modification, and PADIT scores indicating intermediate risk of infection) when used with some device types and in some countries. Conclusions The absorbable antibacterial envelope was associated with cost-effectiveness ratios below European benchmarks in selected patients at increased risk of infection, suggesting the envelope provides value for European healthcare systems by reducing CIED infections.

Background and purpose — In Malawi, both skeletal traction (ST) and intramedullary nailing (IMN) are used in the treatment of femoral shaft fractures, ST being the mainstay treatment. Previous studies have found that IMN has improved outcomes and is less expensive than ST. However, no cost-effectiveness analyses have yet compared IMN and ST in Malawi. We report the results of a cost-utility analysis (CUA) comparing treatment using either IMN or ST. Patients and methods — This was an economic evaluation study, where a CUA was done using a decision-tree model from the government healthcare payer and societal perspectives with an 1-year time horizon. We obtained EQ-5D-3L utility scores and probabilities from a prospective observational study assessing quality of life and function in 187 adult patients with femoral shaft fractures treated with either IMN or ST. The patients were followed up at 6 weeks, and 3, 6, and 12 months post-injury. Quality adjusted life years (QALYs) were calculated from utility scores using the area under the curve method. Direct treatment costs were obtained from a prospective micro costing study. Indirect costs included patient lost productivity, patient transportation, meals, and childcare costs associated with hospital stay and follow-up visits. Multiple sensitivity analyses assessed model uncertainty. Results — Total treatment costs were higher for ST ($1,349) compared with IMN ($1,122). QALYs were lower for ST than IMN, 0.71 (95% confidence interval [CI] 0.66–0.76) and 0.77 (CI 0.71–0.82) respectively. Based on lower cost and higher utility, IMN was the dominant strategy. IMN remained dominant in 94% of simulations. IMN would be less cost-effective than ST at a total procedure cost exceeding $880 from the payer’s perspective, or $1,035 from the societal perspective. Interpretation — IMN was cost saving and more effective than ST in the treatment of adult femoral shaft fractures in Malawi, and may be an efficient use of limited healthcare resources. publishedVersion

Background In several countries, the dolutegravir (DTG)-based regimen is generally preferred as first-line antiretroviral therapy (ART) over the efavirenz (EFV)-based regimen, but the evidence in low-income countries is limited. Objective Our study aimed to evaluate the cost effectiveness of DTG- versus EFV-based first-line human immunodeficiency virus (HIV) treatment in Ethiopia. Methods We developed a microsimulation model for the progression of HIV/acquired immune deficiency syndrome (AIDS) to examine the cost effectiveness of DTG-based first-line ART compared with an EFV-based regimen from a healthcare payer perspective. We used a lifetime horizon with a 1-month cycle length and a 3% annual discount rate. The primary outcomes were a lifetime cost in US dollars ($), quality-adjusted life-months (QALMs) that converted to QALYs using the formula QALY = QALM/12, and incremental cost-effectiveness ratio (ICER). Deterministic sensitivity analysis was conducted to account for parameter uncertainty. Results Compared with the EFV-based regimen, the DTG-based regimen was associated with an expected lifetime cost of $12,709 (vs. $12,701) and expected QALYs of 15.3 (vs. 14.7 QALYs) per patient, resulting in an ICER value of $13.33 per QALY. From an alternative analysis with a 5-year time horizon, DTG-based ART was found to be dominant, with expected gains of 0.17 QALYs at a lower cost of $1 per patient. The deterministic sensitivity analysis depicted that the maximum increase in ICER value was $72 per QALY, and all ICER values were below the estimated threshold value. Conclusions The DTG-based first-line regimen appears to be cost effective compared with the EFV-based regimen for the treatment of HIV/AIDS patients in an Ethiopian setting.

Background The cost utility of image-guided surveillance using computed tomography (CT) and positron emission tomography (PET)-CT to planned postradiation neck dissection (PRND) was compared for the management of advanced nodal human papillomavirus-positive oropharyngeal cancer following chemoradiation. Methods A universal payer perspective was adopted. A Markov model was designed to simulate four treatment approaches with 3-month cycles over a lifetime horizon: 1) CT surveillance, 2) standard PET-CT surveillance, 3) a novel PET-CT approach with repeat PET at 6 months postchemoradiation for equivocal responders, and 4) PRND. Parameters including probabilities of CT nodal progression/resolution, PET avidity, recurrence, and survival were obtained from the literature. Costs were reported in 2019 Canadian dollars and utilities were expressed in quality-adjusted life years (QALYs). Deterministic and probabilistic sensitivity analyses were performed to evaluate model uncertainty. Results PET-CT surveillance dominated CT surveillance and PRND in the base case scenario, and the novel PET-CT approach was the most cost-effective strategy across a wide range of variables tested in one-way sensitivity analysis. On probabilistic sensitivity analysis, novel PET-CT surveillance was the most cost-effective strategy in 78.1% of model iterations at a willingness-to-pay of $50,000/QALYs. Novel PET-CT surveillance resulted in a 49% lower rate of neck dissection compared with traditional PET-CT, and yielded an incremental benefit of 0.14 QALYs with average cost savings of $1309. Conclusions Image-guided surveillance including PET-CT and CT are more cost effective than PRND. The novel PET-CT approach with repeat PET for equivocal responders was the dominant strategy and yielded both higher benefit and lower costs compared with standard PET-CT surveillance.

Background Although the equitable distribution of diabetic retinopathy (DR) services across Ghana remains paramount, there is currently a poor understanding of nationwide DR treatment services. This study aims to conduct a situation analysis of DR treatment services in Ghana and provide evidence on the breadth, coverage, workload, and gaps in service delivery for DR treatment. Methods A cross-sectional study was designed to identify health facilities which treat DR in Ghana from June 2018 to August 2018. Data were obtained from the facilities using a semi-structured questionnaire which included questions identifying human resources involved in DR treatment, location of health facilities with laser, vitreoretinal surgery and Anti–vascular endothelial growth factor therapy (Anti-VEGF) for DR treatment, service utilisation and workload at these facilities, and the average price of DR treatment in these facilities. Results Fourteen facilities offer DR treatment in Ghana; four in the public sector, seven in the private sector and three in the Christian Health Association of Ghana (CHAG) centres. There was a huge disparity in the distribution of facilities offering DR services, the eye care cadre, workload, and DR treatment service (retinal laser, Anti-VEGF, and vitreoretinal surgery). The retinal laser treatment price was independent of all variables (facility type, settings, regions, and National Health Insurance Scheme coverage). However, settings (p = 0.028) and geographical regions (p = 0.010) were significantly associated with anti-VEGF treatment price per eye. Conclusion Our results suggest a disproportionate distribution of DR services in Ghana. Hence, there should be a strategic development and implementation of an eye care plan to ensure the widespread provision of DR services to the disadvantaged population as we aim towards a disadvantaged population as we aim towards a universal health coverage.

Aim Clinical trials suggest that hyaluronate carboxymethylcellulose (HA/CMC) prevents adhesion-related complications after intra-abdominal surgery, but at a high upfront cost. This study evaluated the cost-effectiveness of HA/CMC for patients undergoing curative-intent open colorectal cancer surgery. Methods Using a Markov Monte Carlo microsimulation model, we conducted a cost-utility analysis comparing the cost-effectiveness of HA/CMC at curative-intent open colorectal cancer surgery versus standard management. We considered a scenario where HA/CMC was used at the index operation only, as well as where it was used at the index operation and any subsequent operations. The perspective was that of the third-party payer. Costs and utilities were discounted 1.5% annually, with a 1-month cycle length and 5-year time horizon. Model input data were obtained from a literature review. Outcomes included cost, quality-adjusted life-years (QALYs), small bowel obstructions (SBOs) and operations for SBO. Results Using HA/CMC at the index operation results in an incremental cost increase of CA$316 and provides 0.001 additional QALYs, for an incremental cost-effectiveness ratio of CA$310,000 per QALY compared to standard management. In our simulated cohort of 10,000 patients, HA/CMC prevented 460 SBOs and 293 surgeries for SBO. Probabilistic sensitivity analysis found that HA/CMC was cost-effective in 18.5% of iterations, at a cost-effectiveness threshold of CA$50,000 per QALY. Results of the scenario analysis where HA/CMC was used at the index operation and any subsequent operations were similar. Conclusions Hyaluronate carboxymethylcellulose prevents adhesive bowel obstruction after open colorectal cancer surgery but is unlikely to be cost-effective given minimal long-term impact on healthcare costs and QALYs.

Accelerated postoperative discharge (AD) pathways have demonstrated numerous benefits for patients with adolescent idiopathic scoliosis undergoing PSF. Although early evidence supports the application of AD pathways over more traditional discharge (TD) approaches for patients with neuromuscular scoliosis, the economic impact of these pathways has not been investigated. A decision-analysis model was constructed using a hypothetical 15-year-old male with non-ambulatory CP with a 65-degree thoracolumbar scoliosis and pelvic obliquity undergoing operative treatment with PSF from T2-pelvis with pedicle screw fixation. The literature was reviewed to estimate costs, probabilities, and quality-adjusted life years (QALYs)) for identified complication profiles for discharge pathways. QALYs were constructed using age-matched values for US population average, applying a CP diagnosis corrective value. A probabilistic sensitivity analysis was performed using a second-order Monte Carlo simulations. Incremental cost–utility ratio and incremental net monetary benefit (NMB) were calculated. One-way sensitivity analyses were performed by selective variable variation. AD pathway resulted in an average cost and effectiveness of $67,069 and 15.4 QALYs compared with $81,312 and 15.4 QALYs for TD. AD resulted in a 2.1% greater NMB with a cost-effectiveness ratio of $4361/QALY compared with $5290/QALY in the TD. The cost-effectiveness of TD was inversely sensitive to implant cost variation while the AD maintained effectiveness despite cost variations. This cost–utility analysis demonstrated that the implementation of an AD pathway following PSF for non-ambulatory CP scoliosis is economically more effective, providing a 17.5% cost reduction with enhanced value of care evidenced by a 2.1% greater NMB over a TD pathway. The cost-effectiveness of the AD was maintained despite implant cost variations.

Background: Recent clinical trial results reported that stereotactic radiotherapy (SABR) may improve survival for patients with oligometastatic (OM) cancer. Given that these results come from a phase II trial, there remains considerable uncertainty about this finding, and about the cost-effectiveness of SABR for patients with OM cancer. In this analysis, we estimate the cost-effectiveness of SABR for oligometastatic cancer patients. Methods: A probabilistic time-dependent Markov model was constructed to simulate treatment of oligometastatic cancer patients over five- and ten-year time horizons. The primary data source was the phase II, Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastases (SABR-COMET )trial and supplemented with data from the literature. We estimated the effect of SABR and the standard of care (SoC) using quality-adjusted life-years (QALYs). Costs were measured from a provincial payer perspective (2018 Canadian dollars). Results: In the reference case analysis (five-year time horizon), SABR was associated with additional incremental costs of CAD 38,487 and an incremental QALY gain of 0.84. This resulted in an incremental cost-effectiveness ratio (ICER) of CAD 45,726 per QALY gained. Over a ten-year time horizon, the increased uncertainty in the long-term effectiveness of SABR resulted in an ICER of CAD 291,544 per QALY gained. Estimates from the probabilistic analysis indicated that at a willingness-to-pay (WTP) threshold of CAD 50,000 and CAD 100,000 per QALY gained, there is 54% and 78% probability (respectively) that SABR would be cost-effective using the five-year time horizon. Conclusions: The adoption of SABR therapy requires a considerable upfront capital investment. Our results suggest that the cost-effectiveness of SABR is contingent on the uncertainty in the evidence base. Further clinical trials to confirm the effectiveness of SABR and research into the real-world costs associated with this treatment could reduce the uncertainty around implementation of the technology.

Objectives Continuous chemotherapy has been used to treat patients with metastatic esophageal squamous cell carcinoma (mESCC), despite weak evidence supporting a clinical benefit, associated side effects for the patients, and unjustified medical costs. In the French setting, we conducted a cost-utility analysis alongside the randomized E-DIS trial (NCT01248299), which compared first-line fluorouracil/platinum-based chemotherapy continuation (CT-CONT) to CT discontinuation (CT-DISC) in progressive-free patients after an initial 6-week treatment phase. Methods A partitioned survival analysis was performed using patient-level data collected during the trial for survival outcomes, quality of life (EQ-5D-3L), and medical costs. The mean quality-adjusted life-years (QALYs) and medical costs were estimated over an 18-month period to assess the incremental net monetary benefit and incremental cost-effectiveness ratio. Uncertainty was handled using the nonparametric bootstrap and univariate analysis. Sixty-seven patients with mESCC were randomized and included in the cost-utility analysis. Results On average, CT-CONT slightly decreased the number of QALYs (-0.038) and increased the cost per patient (+ €1177). At a willingness-to-pay threshold of €50 000/QALY, the incremental net monetary benefit was negative (-€3077 [95% confidence interval: -6564; 4359]), and the incremental cost-effectiveness ratio was -30 958€/QALY (CT-CONT dominated). The probability of the CT-CONT treatment option being cost-effective at a willingness-to-pay threshold of €50 000/QALY, compared to CT-DISC, was 29%. Conclusions CT-DISC may be considered as an alternative therapeutic option to CT-CONT in patients with mESCC who have stable disease after an initial chemotherapy treatment phase. A continuous chemotherapy could indeed reduce the number of QALYs because of the disutility associated with the continuous treatment.

Background Hypoglossal nerve stimulation (HNS) with Inspire is a novel treatment indicated for moderate or severe obstructive sleep apnoea/hypopnoea syndrome (OSAHS), intolerant to or unable to be treated with continuous positive airway pressure (CPAP). Objective The aim of this study was to assess the cost effectiveness of treating moderate or severe OSAHS, in patients intolerant to CPAP, with HNS, compared with standard care, from a National Health Service (NHS) perspective. Methods A cohort state transition model was developed to compare HNS with Inspire with no treatment in UK adult patients with moderate or severe OSAHS who have previously tried and have not responded to CPAP therapy. Published literature was applied in the model to estimate incremental cost-effectiveness ratios (ICERs; 2019 Great British pounds per quality-adjusted life-year [QALY] gained), from an NHS and personal social services (PSS) perspective, over a cohort’s lifetime. Results The model base-case predicts that patients undergoing HNS will incur lifetime costs of £65,026 compared with £36,727 among untreated patients. The HNS cohort would gain 12.72 QALYs compared with 11.15 QALYs in the no-treatment arm. The ICER of treating severe OSAHS with HNS is therefore estimated to be £17,989 per QALYs gained. Probabilistic sensitivity analysis found that at a threshold of £30,000/QALY, HNS has a 69% probability of being cost effective. Limitations of the model include uncertainty around the utility data that were not sourced directly from HNS clinical trials. There is further uncertainty in the relationship between change in the Apnoea-Hypopnoea Index (AHI) and reduction in ischaemic heart disease and stroke because of difficulty capturing the reduction in risk over a long time horizon in studies. Conclusions Over a patient’s lifetime, HNS with Inspire is expected to be cost effective when compared with no treatment in patients with severe OSAHS who have tried and have not responded to CPAP, from an NHS perspective. Supplementary Information The online version contains supplementary material available at 10.1007/s41669-021-00266-7.

Published health utility studies are increasingly cited in cost–utility analyses to inform reimbursement decision-making. However, there is limited guidance for investigators looking to systematically evaluate the methodological quality of health utility studies or their applicability to decision contexts. To describe how health utility concepts are reflected in tools intended for use with the health economic literature, particularly with respect to the evaluation of methodological quality and context applicability. We reviewed the critical appraisal and reporting tools described in a 2012 report published by the Agency for Healthcare Research and Quality (AHRQ), supplemented with a keyword search of MEDLINE and EMBASE, to identify existing tools which include health utility constructs. From these tools, a list of relevant items was compiled and grouped into domain categories based on the methodological or applicability aspect they were directed toward. Of the 24 tools we identified, 12 contained items relevant to the evaluation of health utilities. Sixty-five items were considered relevant to the evaluation of quality, while 44 were relevant to the evaluation of applicability. Items were arranged into four domains: health state descriptions; selection and description of respondents; elicitation and measurement methods; and other considerations. As key inputs to cost–utility analyses, health utilities have the potential to significantly impact estimates of cost-effectiveness. Existing tools contain only general items related to the conduct or use of health utility studies. There is a need to develop tools that systematically evaluate the methodological quality and applicability of health utility studies.

Background Severe obesity is associated with adverse health outcomes and increased risk of death. This study evaluates the real-world cost-utility of therapy for severe obesity, from the publicly funded health care system and societal perspectives. Methods We conducted a cost-utility analysis using primary data from a prospective observational cohort of adults living with severe obesity (BMI ≥ 35 kg/m2 and a major medical comorbidity or BMI ≥ 40 kg/m2) who were enrolled in a regional obesity program over 2 years. We extrapolated 10-year and lifetime Markov models, validated and supplemented with literature sources, to compare medical, surgical and standard care therapies. We performed deterministic and probabilistic sensitivity analyses. Results The cohort included 500 adults living with severe obesity, 150 of whom received laparoscopic surgical therapy. From a publicly funded health system perspective, at 2 years, surgical therapy had an incremental cost-effectiveness ratio (ICER) of $54 456 per quality-adjusted life-year (QALY) compared with standard care therapy. Over a lifetime, it had an ICER of $14 056 per QALY. From the societal perspective, at 2 years, surgical therapy had an ICER of $340 per QALY; over a lifetime, it was the dominant option. The results were robust to sensitivity analysis. Interpretation From a public health care perspective, surgery for severe obesity is cost effective, and when approached from a societal perspective, it becomes cost saving. Real-world data support using surgical therapy for severe obesity, and our results contribute to the health economic and clinical literature with regard to a robust analysis from a societal perspective.

Background To estimate the cost -utility of imrecoxib compared with diclofenac, as well as the addition of a proton pump inhibitor to both two treatment strategies, for patients with osteoarthritis, from a Chinese healthcare perspective. Methods A Markov model was built. Costs of managing osteoarthritis and initial adverse events were collected from a Medical Database which collected information from 170 hospitals. Other parameters were obtained from the literature. Subgroup analyses were conducted for people at high risk of gastrointestinal or cardiovascular adverse events. Deterministic and probabilistic sensitivity analyses were performed. Results Imrecoxib was highly cost-effective than diclofenac (the ICER was $401.58 and $492.77 in patients at low and high gastrointestinal and cardiovascular risk, respectively). The addition of a proton pump inhibitor was more cost -effective compared with single drug for both treatment strategies. Findings remained robust to sensitivity analyses. 59.04% and 57.16% probability for the co-prescription of imrecoxib and a proton pump inhibitor to be the most cost-effective strategy in all patients considered using the cost-effectiveness threshold of $30,000. Conclusions The addition of a proton pump inhibitor to both imrecoxib and diclofenac was advised. Imrecoxib provides a valuable option for patients with osteoarthritis. Uncertainties existed in the model, and the suggestions can be adopted with caution.

Objective: The goal of this research was to perform a cost–utility analysis of abdominal hysterectomy (AH), compared with laparoscopic hysterectomy (LH), at the Ramathibodi Hospital, of Mahidol Uni...

This study aimed to estimate the cost-utility of stereotactic body radiotherapy (SBRT) plus cetuximab for patients with previously irradiated recurrent squamous cell carcinoma of the head and neck.We constructed a Markov health-state transition model to simulate costs and clinical outcomes of recurrent squamous cell carcinoma of the head and neck. Model parameters were derived from the published literature and the National Health Insurance Administration reimbursement price list. Incremental cost-effectiveness ratio and the net monetary benefit were calculated from a health payer perspective. The impact of uncertainty was modeled with one-way and probabilistic sensitivity analyses.In the base-case, SBRT plus cetuximab compared to SBRT alone resulted in an ICER of NT$ 840,455 per QALY gained. In the one-way sensitivity analysis, the utility of progression-free state for patients treated with SBRT plus cetuximab or SBRT alone and the cost of progression-free survival for SBRT+Cet were the most sensitive parameters in the model. Probabilistic sensitivity analysis showed that the probability of cost-effectiveness at a willingness-to-pay threshold of NT$ 2,252,340 per QALY was 100% for SBRT plus cetuximab but 0% for SBRT alone.This study showed that SBRT+Cet was cost-effective and benefited patients with previously irradiated rSCCHN.

David W Polly,1 A Noelle Larson,2 Amer F Samdani,3 William Rawlinson,4 Hannah Brechka,4 Alex Porteous,4 William Marsh,4 Richard Ditto5 1Department of Orthopedic Surgery, University of Minnesota, Minneapolis, MN, USA; 2Mayo Clinic, Rochester, MN, USA; 3Temple University, Philadelphia, PA, USA; 4Costello Medical Consulting Ltd, Cambridge, UK; 5Zimmer Biomet, Warsaw, IN, USACorrespondence: David W Polly Tel +1 612-273-7951Fax +1 612-273-7959Email pollydw@umn.eduPurpose: Anterior vertebral body tethering (VBT) is a non-fusion, minimally invasive, growth-modulating procedure with some early positive clinical outcomes reported in pediatric patients with idiopathic scoliosis (IS). VBT offers potential health-related quality of life (HRQoL) benefits over spinal fusion in allowing patients to retain a greater range of motion after surgery. We conducted an early cost-utility analysis (CUA) to compare VBT with fusion as a first-choice surgical treatment for skeletally immature patients (age > 10 years) with moderate to severe IS, who have failed nonoperative management, from a US integrated healthcare delivery system perspective.Patients and Methods: The CUA uses a Markov state transition model, capturing a 15-year period following index surgery. Transition probabilities, including revision risk and subsequent fusion, were based on published surgical outcomes and an ongoing VBT observational study (NCT02897453). Patients were assigned utilities derived from published patient-reported outcomes (PROs; SRS-22r mapped to EQ-5D) following fusion and the above VBT study. Index and revision procedure costs were included. Probabilistic (PSA) and deterministic sensitivity analyses (DSA) were performed.Results: VBT was associated with higher costs but also higher quality-adjusted life years (QALYs) than fusion (incremental costs: $45,546; QALYs gained: 0.54). The subsequent incremental cost-effectiveness ratio for VBT vs fusion was $84,391/QALY gained. Mean PSA results were similar to the base case, indicating that results were generally robust to uncertainty. The DSA indicated that results were most sensitive to variations in utility values.Conclusion: This is the first CUA comparing VBT with fusion in pediatric patients with IS and suggests that VBT may be a cost-effective alternative to fusion in the US, given recommended willingness-to-pay thresholds ($100,000–$150,000). The results rely on HRQoL benefits for VBT compared with fusion. For improved model accuracy, further analyses with longer-term PROs for VBT, and comparative effectiveness studies, would be needed.Keywords: idiopathic scoliosis, cost-effective analysis, spinal fusion, vertebral body tethering, pediatric

Background: The study assessed the cost-utility of selective internal radiation therapy (SIRT) with Y-90 resin microspheres versus sorafenib in UK patients with unresectable hepatocellular carcinoma ineligible for transarterial chemoembolization. Materials & methods: A lifetime partitioned survival model was developed for patients with low tumor burden (≤25%) and good liver function (albumin–bilirubin grade 1). Efficacy, safety and quality of life data were from a European Phase III randomized controlled trial and published studies. Resource use was from registries and clinical surveys. Results: Discounted quality-adjusted life-years were 1.982 and 1.381, and discounted total costs were £29,143 and 30,927, for SIRT and sorafenib, respectively. Conclusion: SIRT has the potential to be a dominant (more efficacious/less costly) or cost-effective alternative to sorafenib in patients with unresectable hepatocellular carcinoma.

Background In early oral cavity cancer, elective neck dissection (END) for the clinically node-negative (cN0) neck improves survival compared with observation. This paradigm has been challenged recently by the use of positron emission tomography-computed tomography (PET-CT) imaging in the cN0 neck. To inform this debate, we performed an economic evaluation comparing PET-CT-guided therapy with routine END in the cN0 neck. Methods Patients with T1-2N0 lateralized oral tongue cancer were analyzed. A Markov model over a 40-year time horizon simulated treatment, disease recurrence, and survival from a US health care payer perspective. Model parameters were derived from a review of the literature. Results The END strategy was dominant, with a cost savings of $1576.30 USD, an increase of 0.055 quality-adjusted life years (QALYs), a net monetary benefit of $4303 USD, and a 0.22 life-year advantage. END was sensitive to variation in cost and utilities in deterministic and probabilistic sensitivity analyses. PET-CT became the preferred strategy when decreasing occult nodal disease to 18% and increasing the negative predictive value (NPV) of PET-CT to 89% in 1-way sensitivity analyses. In probabilistic sensitivity analysis, assuming a cost effectiveness threshold of $50,000 USD/QALY, END was dominant in 64% of simulations and cost effective in 69.8%. Conclusion END is a cost-effective strategy compared with PET-CT in patients who have node-negative oral cancer. Although lower PET standardized uptake value thresholds would result in fewer false negatives and improved NPV, it is still uncertain that PET-CT would be cost effective, as this would likely result in more false positive tests.

Irma M Puspitasari,1,2 Dewi Legianawati,1 Rano K Sinuraya,1,2 Auliya A Suwantika1,2 1Department of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, Indonesia; 2Center of Excellence in Higher Education for Pharmaceutical Care Innovation, Universitas Padjadjaran, Sumedang, IndonesiaCorrespondence: Irma M PuspitasariDepartment of Pharmacology and Clinical Pharmacy, Faculty of Pharmacy, Universitas Padjadjaran, Jalan Bandung, Sumedang KM 21, Jatinangor, Sumedang, 45363, IndonesiaTel +62 22 84288888 (Ext 3510)Email irma.melyani@unpad.ac.idPurpose: Cervical cancer is the second most common type of cancer and cause of death from cancer in Indonesia. In 2013, cervical cancer was the most prevalent cancer in Indonesia, with a rate of 0.8 per 1000 women. Based on the National Guidelines for Cervical Cancer Medical Services in Indonesia, the recommended therapy for stages IIB-IIIB cervical cancer is chemoradiation or radiotherapy. This study aimed to evaluate the cost-effectiveness of chemoradiation and radiotherapy for treating stage IIB-IIIB cervical cancer in a national referral hospital in Indonesia.Patients and Methods: A cross-sectional study from a healthcare perspective using retrospective patient data was conducted. The included patients had stage IIB-IIIB registered cervical cancer, were in the hospital between January 1, 2015 and December 31, 2017, received chemoradiation or radiotherapy, were ≥ 18 years old, and had complete clinical data and detailed cost of therapy data. The incremental cost-effectiveness ratio (ICER) were calculated, and a sensitivity analysis was performed.Results: The average treatment cost per patient was $2944 and $3231 for radiotherapy and chemoradiation, respectively. Despite the fact that the treatment effectiveness of chemoradiation (69.1%) was considered to be higher than that of radiotherapy (63.2%), chemoradiation had more potential side effects than radiotherapy. In a comparison with radiotherapy, the ICER of chemoradiation was $48.6 per complete response rate. Additionally, the cost of radiotherapy was the most influential parameter impacting the ICER.Conclusion: Chemoradiation was considered to be more costly than radiotherapy. Additionally, the effectiveness of chemoradiation was higher than that of radiotherapy. A cost utility analysis (CUA) is required for further investigation.Keywords: Indonesia, cancer treatment, side effects, incremental cost-effectiveness ratio

Gianni Ghetti,1 Maria Claudia D’Avella,2 Lorenzo Pradelli1 1Department of Health Economics and Outcome Research, AdRes, Turin, Italy; 2Department of Market Access, Sanofi, Milan, ItalyCorrespondence: Gianni GhettiDepartment of Health Economics and Outcome Research, AdRes, Via Vittorio Alfieri 17, Turin, 10121, ItalyTel +39 011 765 1239Email g.ghetti@adreshe.comPurpose: Cutaneous squamous cell carcinoma (CSCC) is a common cancer that in most cases is curable with surgery. About 3– 5% of patients develop advanced CSCC (aCSCC) and are no longer responsive to surgery or radiation therapy. The aim of this study was to assess the cost-effectiveness and cost-utility of cemiplimab, the first systemic therapy approved in Italy for patients with aCSCC, vs platinum-based chemotherapy from the Italian National Health Service (SSN) perspective.Methods: A partitioned survival model, which included three mutually exclusive health states, was developed to estimate costs and outcomes for patients with aCSCC, over a 30-year time horizon (lifetime). No direct evidence of the comparative efficacy and safety of cemiplimab versus other therapies currently exists. Therefore, a simulated treatment comparison (STC) was conducted to estimate the comparative efficacy of cemiplimab versus chemotherapy. Individual patient data for cemiplimab were collected from the EMPOWER-CSCC 1 trial whereas chemotherapy data were derived from a retrospective study. In the STC a regression model was used to predict outcomes for cemiplimab in the population observed in the comparator study. Costs of drug acquisition/administration and management of adverse events were included. Costs and outcomes were discounted at 3% per year. Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were calculated; sensitivity and scenario analyses were performed to assess the robustness of results.Results: In the base-case, treatment with cemiplimab was associated with a gain of 4.89 LYs and 3.99 QALYs, compared with a platinum-based chemotherapy regimen, resulting in an estimated ICER of 27,821 €/LY gained and an ICUR of 34,110 €/QALY gained. Both ICER and ICUR were below the commonly used Italian SSN willingness to pay thresholds.Conclusion: The use of cemiplimab, compared with a platinum-based chemotherapy regimen, can be considered a cost-effective option for the treatment of aCSCC patients in Italy.Keywords: Italian National Health Service, ICER, partitioned survival model, non-melanoma skin cancers

Home‐based chemotherapy (HC) is a new treatment alternative to hospital‐based chemotherapy treatment (IP) and is administered via portable intravenous pumps at the patient's home. HC reduces the demand for inpatient bed capacity in hospitals and reduces the cost of an infusion. This study takes a societal perspective while conducting the cost‐utility and budget impact analyses (BIA) of HC and IP with an mFOLFOX6 regimen on patients with stage III colon cancer. We conducted a cost‐utility analysis with a 6‐month time horizon. The parameter inputs for the model were gathered from a retrospective cohort study on patients diagnosed with stage III colon cancer at Ramathibodi Hospital, Bangkok. The resource usage of HC and IP was determined based on medical records. The per‐unit direct medical, home health service, and adverse events (AE) management costs were gathered from the standard cost list. The health outcome of treatment was measured in terms of quality‐adjusted life years. Disutility related to AE was calculated. We conducted a sensitivity analysis for the uncertainty results and performed BIA based on the societal perspective on a 1‐year time horizon. HC provided a cost‐saving of $1,513.37 per patient for the period of treatment. Thus, assuming 526 patients per year, the use of HC could achieve a cumulative annual cost‐saving of $828,436. HC is a cost‐saving strategy compared to IP for stage III colon cancer treatment. We recommend that the service reimbursement should include national standardization in chemotherapy regimens as well as practice guidelines and protocols to prevent serious AEs., Home‐based chemotherapy is a cost‐saving strategy compared to hospital‐based chemotherapy for stage III colon cancer treatment. We recommend that the service reimbursement should include national standardization in chemotherapy regimens as well as practice guidelines and protocols to prevent serious adverse events.

Background Rheumatoid arthritis is a chronic autoimmune disease that primarily causes inflammation, pain and stiffness in the joints. People with severe disease may be treated with biological disease-modifying anti-rheumatic drugs, including tumour necrosis factor-α inhibitors, but the efficacy of these drugs is hampered by the presence of anti-drug antibodies. Monitoring the response to these treatments typically involves clinical assessment using response criteria, such as Disease Activity Score in 28 joints or European League Against Rheumatism. Enzyme-linked immunosorbent assays can also be used to measure drug and antibody levels in the blood. These tests may inform whether or not adjustments to treatment are required or help clinicians to understand the reasons for treatment non-response or a loss of response. Methods Systematic reviews were conducted to identify studies reporting on the clinical effectiveness and cost-effectiveness of using enzyme-linked immunosorbent assays to measure drug and anti-drug antibody levels to monitor the response to tumour necrosis factor-α inhibitors [adalimumab (Humira®; AbbVie, Inc., North Chicago, IL, USA), etanercept (Enbrel®; Pfizer, Inc., New York, NY, USA), infliximab (Remicade®, Merck Sharp & Dohme Limited, Hoddesdon, UK), certolizumab pegol (Cimzia®; UCB Pharma Limited, Slough, UK) and golimumab (Simponi®; Merck Sharp & Dohme Limited)] in people with rheumatoid arthritis who had either achieved treatment target (remission or low disease activity) or shown primary or secondary non-response to treatment. A range of bibliographic databases, including MEDLINE, EMBASE and CENTRAL (Cochrane Central Register of Controlled Trials), were searched from inception to November 2018. The risk of bias was assessed using the Cochrane ROBINS-1 (Risk Of Bias In Non-randomised Studies – of Interventions) tool for non-randomised studies, with adaptations as appropriate. Threshold and cost–utility analyses that were based on a decision tree model were conducted to estimate the economic outcomes of adding therapeutic drug monitoring to standard care. The costs and resource use were considered from the perspective of the NHS and Personal Social Services. No discounting was applied to the costs and effects owing to the short-term time horizon of 18 months that was adopted in the economic analysis. The impact on the results of variations in testing and treatment strategies was explored in numerous clinically plausible sensitivity analyses. Results Two studies were identified: (1) a non-randomised controlled trial, INGEBIO, that compared standard care with therapeutic drug monitoring using Promonitor® assays [Progenika Biopharma SA (a Grifols–Progenika company), Derio, Spain] in Spanish patients receiving adalimumab who had achieved remission or low disease activity; and (2) a historical control study. The economic analyses were informed by INGEBIO. Different outcomes from INGEBIO produced inconsistent results in both threshold and cost–utility analyses. The cost-effectiveness of therapeutic drug monitoring varied, from the intervention being dominant to the incremental cost-effectiveness ratio of £164,009 per quality-adjusted life-year gained. However, when the frequency of testing was assumed to be once per year and the cost of phlebotomy appointments was excluded, therapeutic drug monitoring dominated standard care. Limitations There is limited relevant research evidence and much uncertainty about the clinical effectiveness and cost-effectiveness of using enzyme-linked immunosorbent assay-based testing for therapeutic drug monitoring in rheumatoid arthritis patients. INGEBIO had serious limitations in relation to the National Institute for Health and Care Excellence scope: only one-third of participants had rheumatoid arthritis, the analyses were mostly not by intention to treat and the follow-up was 18 months only. Moreover, the outcomes might not be generalisable to the NHS. Conclusions Based on the available evidence, no firm conclusions could be made about the cost-effectiveness of therapeutic drug monitoring in England and Wales. Future work Further controlled trials are required to assess the impact of using enzyme-linked immunosorbent assays for monitoring the anti-tumour necrosis factors in people with rheumatoid arthritis. Study registration This study is registered as PROSPERO CRD42018105195. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 8. See the NIHR Journals Library website for further project information.

IMPORTANCE: Indication for liver resection (LR) for localized hepatic metastases from breast cancer (BC) is still a matter of debate. OBJECTIVE: A literature review of recent scientific papers pertaining to hepatectomies for BC liver metastases (LM). EVIDENCE REVIEW: We based our systematic review on case series on literature reviews, comparative studies and cost-utility analysis which have been selected based on criteria regarding surgery, possible prognostic factors and evaluation of long-term survival. FINDINGS: There is a strong inhomogeneity in the reported data, with 5-year survivals ranging from 21% to 58%. There is no agreement in the evaluation of prognostic variables predicting good survival, with the only exception of the time of treatment of the primary BC until the diagnosis of metastases. Three out of the four comparative studies report better survivals for patients who underwent a hepatectomy in comparison to those treated with chemotherapy alone, but their strength in terms of scientific evidence is weak. The only cost-utility analysis revealed that 2 out of the 3 scenarios considered were in favor of the treatment with surgery followed by conventional chemotherapy. CONCLUSIONS: There is no definitive proof on the effectiveness of LRs for BC LM. Surgery can be proposed when it is possible to perform radical surgery, with R0 margins and saving at least 30% of the liver with its vascular and biliary connections. Stable skeletal metastases are not a contraindication. The interval between treatment of the primary location and diagnosis of hepatic metastases is the only prognosis criteria available.

BackgroundDuchenne muscular dystrophy is a rare degenerative neuromuscular disorder with pediatric onset. Recent approvals in Duchenne have placed attention on the economic evaluation in pricing and reimbursement decisions across a range of rare conditions. We sought to assess the appropriateness of the EQ-5D, a common measure of generic health state utility, for use among patients and caregivers affected by Duchenne.MethodsAn international, cross-sectional sample of adults with Duchenne and caregivers reported patient health status using self- or proxy-reported EQ-5D-3L. Appropriateness was assessed across 6 domains of concern raised by stakeholders in Duchenne. These concerns were that the EQ-5D/EQ-VAS would not capture meaningful differences in health status, correlate with disease-specific measures, reflect real health status, exhibit face validity, be accurately interpreted, and be low burden. We evaluated these concerns by comparing EQ-5D index score and EQ-VAS scores to other condition-specific functional measures and open- and closed-ended questions.ResultsIn total, 263 participants (74% response) completed the survey, 24% of whom were adult patients. Most participants lived in the United States or United Kingdom (58%). Patient age ranged from 1 to 48 y. EQ-5D index was higher in ambulatory than nonambulatory patients (0.60 v. 0.30, P < 0.001) and was negatively correlated with upper limb impairment ( r = 0.61, P < 0.001). Three-quarters of respondents agreed that EQ-5D measured real health status (74%). Most respondents interpreted EQ-VAS anchors of best and worst imaginable health as full health (61%) and death/near death (58%). Respondents indicated the EQ-5D was easy to understand (86%) and answer (71%).ConclusionsContrary to anecdotal concerns, we found support for the appropriateness of EQ-5D to assess health status in Duchenne. While other measures may be more sensitive to specific outcomes in Duchenne, there may be some value in results using the EQ-5D measure.

Objectives Fungal infections in humans are superficial or systemic and are found to be life threatening. They are common among the middle age group and particularly in females and immunocompromised patients. Methods This study was conducted to evaluate the prescription pattern of antifungal drugs and their economic burden on patients. The study was designed as a single centered, cross-sectional retrospective pharmacy database study of utilization of antifungal drug therapy and their cost analysis. Data for the period from 1 January 2019 to 31 December 2019 were retrieved from the inpatients and outpatient electronic pharmacy records along with the unit dose prices of antifungal drug in the study hospital. Key findings Antifungals use was more among females (67.05%) compared with males (34.91%). The use was predominant among middle age group (31–45) with Clotrimazole being the most utilized lower cost topical drug and fluconazole the next preferred systemic drug with least toxicity. Variconazole is a novel drug utilized the least among all age groups due to its adverse effects and higher cost. Clotrimazole is the drug of choice topically due to low cost and lesser absorption orally. Fluconazole is the next preferred drug that can be given systemically and its use remain unchanged due to lower cost and least toxicity in immunocompromised patients. Conclusions Variconazole although have adverse effects and used rarely it is the drug preferred in invasive treatments when benefit outweighs the risk. Variconazole is highly expensive drug used in invasive treatments and its adverse drug reactions, and cost need to be monitored.

Background/Aims: Macromastia can cause physical and psychological problems. Conservative treatments such as physiotherapy and painkillers lead to substantial long-term costs, without any proven medical benefit. In contrast, surgical treatment with reduction mammoplasty leads to improvements in nearly all respects. This study analyzed the costs of reduction mammoplasty and calculated an incremental cost-utility ratio for the treatment. Patients and Methods: The data on 76 patients who underwent reduction mammoplasty between 2008 and 2016 were collected using a two-part questionnaire (preoperative and postoperative) as well as the patients’ files. Topics examined besides demographic data included physician visits, medical imaging, integrative medical procedures, remedial procedures, rehabilitation and convalescent measures, drug intake, medical aids, exercise activity, and sick leave days before and after surgery. The data were used to calculate costs per year after surgical treatment for symptomatic macromastia. Costs of surgery, including the process of obtaining insurance reimbursement and postoperative complications, were taken into account to calculate the one-time costs of reduction mammoplasty. Results: The patients’ quality of life and satisfaction with the breasts improve after surgery. The one-time costs of reduction mammoplasty per patient amount to EUR 5,885, and the annual costs after surgery are EUR 200. The incremental cost-utility ratio for surgical treatments shows a saving of EUR 380 per quality-adjusted life-year (QALY) gained. Conclusions: These results show that reduction mammoplasty is a treatment that not only improves a patient’s quality of life but also saves money in the longer term in comparison with expensive and ineffective conservative treatment for macromastia.

Contains fulltext : 243950.pdf (Publisher’s version ) (Open Access) INTRODUCTION: Efficacy of lenalidomide plus rituximab (R-LEN) compared to rituximab monotherapy (R-mono) for patients with previously treated follicular lymphoma (FL) was investigated in AUGMENT (NCT01938001). Our aim was to evaluate the cost-effectiveness of R-LEN versus R-mono in this setting from a Dutch perspective. AREAS COVERED: Cost-effectiveness was assessed through a partitioned survival model from three perspectives (i.e. societal, healthcare, and societal, including future non-medical costs). Patient-level data from AUGMENT informed effectiveness parameters (i.e. long-term survival) and health state utilities. Resource use and prices were based on AUGMENT and the literature. Clinical experts validated efficacy input parameters and results. Uncertainty was explored through sensitivity and scenario analyses. EXPERT OPINION: R-LEN resulted in 1.7 incremental discounted quality-adjusted life years (QALYs). Total incremental discounted costs were 67,161 EUR from a societal perspective. In conclusion, R-LEN was cost-effective at a willingness-to-pay (WTP) threshold of 50,000 EUR/QALY in the base-case analyses(incremental cost-effectiveness ratio = 40,493 EUR/QALY). Scenario and sensitivity analyses indicated some level of uncertainty regarding this conclusion, depending on the chosen WTP-threshold and perspective.

Telehealth is a useful adjunct in hypertension (HTN) management. Despite obvious short-term clinical benefit, long-term social impact and cost-effectiveness have not been fully investigated.Predictive modeling of long-term clinical and social outcomes and the cost-effectiveness analysis of blood pressure (BP) telemonitoring and remote counseling (BPTM) in patients with HTN.A Markov cohort-based (1000 patients in each study arm) model was developed and adopted a 10-year time horizon with 12-month time cycles. Cost and outcome data collected from the three-month study of 240 patients (160 in BPTM group and 80 controls, 48 y.o.). All patients started at a non-complicated HTN well state with a certain possibility of disease progression in a number of health states over a discrete time period. BPTM was compared with usual care in terms of 10-year healthcare costs, quality adjusted life years (QALY) using a Ministry of Health of Russian Federation perspective.In the long-term run when compared with usual care BPTM was more effective in terms mortality (67 versus 91 patients lost and 9.6 versus 9.71 life years gained) and costs (cost of illness 102 508 000 RUR versus 145 237 700 RUR). Taking quality of life measures into account, the effect of BPTM was also more pronounced (8.31 versus 7.82 QALYs gained). The resultant incremental cost-utility ratio for BPTM was 275 178.98 RUR/1 QALY gained/1 patient (134 837.70 RUR/0.49 QALY/1 patient).According to the results of predictive modeling, implementation of BPTM into clinical practice is likely lead to reduced cardiovascular morbidity and mortality in a cost-effective way.Телемедицинское наблюдение является ценным дополнением в лечении артериальной гипертензии (АГ). Несмотря на очевидные краткосрочные клинические преимущества, отдаленная перспектива и экономическая эффективность подобных вмешательств изучены недостаточно. Цель. Дать прогноз клинических исходов в долгосрочной перспективе с параллельным определением экономической эффективности телемониторирования артериального давления (АД) и телемедицинского дистанционного консультирования (ТМДК) у пациентов с АГ. Материалы и методы. На основании 3-месячного наблюдения 240 пациентов (160 в группе ТМДК и 80 в группе контроля) с неосложненной АГ построена марковская модель для предсказательного моделирования и экстраполяции результатов на 10 лет с годичным циклом для гипотетической когорты пациентов (n=1000). Пациенты находились в начальном состоянии АГ и могли переходить в иные ее осложнения. В конце каждого цикла вероятности перехода между состояниями транслированы в число пациентов, находящихся в каждом из них. Оценивали показатель сохраненных лет жизни (LYG) с поправкой на ее качество (QALY). Затраты оценивались с позиции системы здравоохранения. Результаты. В результате моделирования число умерших пациентов 91 в группе контроля и 67 в группе ТМДК. Показатели LYG составили в группе контроля 9,6 года, в группе ТМДК 9,71 года. QALY составил 7,82 года в группе контроля против 8,31 года в группе ТМДК. Суммарные затраты на лечение АГ и возможных осложнений на конец исследуемого горизонта планирования составили 145 237 700 руб. в группе контроля и 102 508 000 руб. в группе ТМДК, а стоимость 1 QALY в последнем случае составила 27 5178,98 руб. (134 837,70 руб./0,49). Заключение. Согласно результатам моделирования, можно говорить о долгосрочной клинико-экономической эффективности внедрения ТМДК в стандартную практику лечения пациентов с АГ.

BackgroundChanging demographics across the UK has led to general practitioners (GPs) managing increasing numbers of older patients with multi-morbidity and resultant polypharmacy. Through government led initiatives within the National Health Service, an increasing number of GP practices employ pharmacist support. The purpose of this study is to evaluate the impact of a medicines optimisation intervention, delivered by GP practice-based pharmacists, to patients at risk of medication-related problems (MRPs), on patient outcomes and healthcare costs.MethodsA multi-centre, randomised (normal care or pharmacist supplemented care) study in four regions of the UK, involving patients (n = 356) from eight GP practices, with a 6-month follow-up period. Participants were adult patients who were at risk of MRPs.ResultsMedian number of MRPs per intervention patient were reduced at the third assessment, i.e. 3 to 0.5 (p p = 0.001). Using the intention-to-treat (ITT) approach, the number of telephone consultations in intervention group patients was reduced and different from the control group (1 [0–3] to 1 [0–2] vs 1 [0–2] to 1 [0–3],p = 0.020). No significant differences between groups were, however, found in unplanned hospital admissions, length of hospital stay, number of A&E attendances or outpatient visits. The mean overall healthcare cost per intervention patient fell from £1041.7 ± 1446.7 to £859.1 ± 1235.2 (p = 0.032). Cost utility analysis showed an incremental cost per patient of − £229.0 (95% CI − 594.6, 128.2) and a mean QALY gained of 0.024 (95% CI − 0.021 to 0.065), i.e. indicative of a health status gain at a reduced cost (2016/2017).ConclusionThe pharmacist service was effective in reducing MRPs, inappropriateness of medications and telephone consultations in general practice in a cost-effective manner.Trial registration:ClinicalTrials.Gov, NCT03241498. Registered 7 August 2017—Retrospectively registered,https://clinicaltrials.gov/ct2/show/NCT03241498

Objective: Gastrointestinal bleeding, a side effect of clopidogrel, is usually prevented by proton-pump inhibitors (PPIs). Due to omeprazole's inhibitory effects on the liver enzyme CYP2C19, its concomitant use with clopidogrel is argued to increase the risk of myocardial infarction (MI) recurrence, as CYP2C19 activates clopidogrel. Pantoprazole as an alternative PPI has shown no inhibitory effect on CYP2C19. This study investigates the cost-effectiveness of concomitant use of clopidogrel and pantoprazole in MI patients compared to the simultaneous use of clopidogrel and omeprazole. Methods: We used the Markov-modeling technique with a hypothetical cohort of 1000 acute MI patients aged 55 years using Microsoft Excel 2013 software. The study was done from the payer perspective, and a lifetime horizon with 1-year cycles was considered in the model. Life-years gained (LYG) and quality-adjusted life-years (QALYs) were used to quantify the health effects of these interventions. Two separate scenarios of public tariffs and private tariffs with various discount rates (0%, 3%, and 7.2% discounts (only for costs)) were evaluated, and an incremental cost-effectiveness ratio (ICER) was used to report the results. One-way and probabilistic sensitivity analyses were used to deal with uncertainty. Data were sourced from published literature and tariff book of the Iranian ministry of health. Findings: The estimated ICERs were 342 USD/QALY and 236 USD/LYG per patient for the base-case scenario. Conclusion: Abiding by the WHO threshold for cost-effectiveness, the concomitant use of pantoprazole and clopidogrel can be considered cost-effective compared to the use of omeprazole and clopidogrel.