Microscopic observation drug-susceptibility assay vs. Xpert® MTB/RIF for the diagnosis of tuberculosis in a rural African setting: a cost-utility analysis.

OBJECTIVE: To compare the cost-utility of microscopic observation drug-susceptibility assay (MODS) and Xpert® MTB/RIF implementation for tuberculosis (TB) diagnosis in rural northern Mozambique. METHODS: Stochastic transmission compartmental TB model from the healthcare provider perspective with parameter input from direct measurements, systematic literature reviews and expert opinion. MODS and Xpert® MTB/RIF were evaluated as replacement test of smear microscopy (SM) or as an add-on test after a negative SM. Costs were calculated in 2013 USD, effects in disability-adjusted life years (DALY). Willingness to pay threshold (WPT) was established at once the per capita Gross National Income of Mozambique. RESULTS: MODS as an add-on test to negative SM produced an incremental cost-effectiveness ratio (ICER) of 5647.89USD/DALY averted. MODS as a substitute for SM yielded an ICER of 5374.58USD/DALY averted. Xpert® MTB/RIF as an add-on test to negative SM yielded ICER of 345.71USD/DALY averted. Xpert® MTB/RIF as a substitute for SM obtained an ICER of 122.13USD/DALY averted. TB prevalence and risk of infection were the main factors impacting MODS and Xpert® MTB/RIF ICER in the one-way sensitivity analysis. In the probabilistic sensitivity analysis, Xpert® MTB/RIF was most likely to have an ICER below the WPT, whereas MODS was not. CONCLUSION: Our cost-utility analysis favours the implementation of Xpert® MTB/RIF as a replacement of SM for all TB suspects in this rural high TB/HIV prevalence African setting.

Cost-effectiveness study of the microbiological diagnosis of tuberculosis using geneXpert MTB/RIF®. / Estudio de coste-efectividad del diagnóstico microbiológico de tuberculosis mediante geneXpert MTB/RIF®.

INTRODUCTION/OBJECTIVE: To perform a cost-effectiveness analysis of a molecular biology technique for the diagnosis of tuberculosis compared to the classical diagnostic alternative. METHODS: A cost-effectiveness analysis was performed to evaluate the theoretical implementation of a molecular biology method including two alternative techniques for early detection of Mycobacterium tuberculosis Complex, and resistance to rifampicin (alternative1: one determination in selected patients; alternative2: two determinations in all the patients). Both alternatives were compared with the usual procedure for microbiological diagnosis of tuberculosis (staining and microbiological culture), and was accomplished on 1,972 patients in the period in 2008-2012. The effectiveness was measured in QALYs, and the uncertainty was assessed by univariate, multivariate and probabilistic analysis of sensitivity. RESULTS: A value of €8,588/QALYs was obtained by the usual method. Total expenditure with the alternative1 was €8,487/QALYs, whereas with alternative2, the cost-effectiveness ratio amounted to €2,960/QALYs. Greater diagnostic efficiency was observed by applying the alternative2, reaching a 75% reduction in the number of days that a patient with tuberculosis remains without an adequate treatment, and a 70% reduction in the number of days that a patient without tuberculosis remains in hospital. CONCLUSION: The implementation of a molecular microbiological technique in the diagnosis of tuberculosis is extremely cost-effective compared to the usual method. Its introduction into the routine diagnostic procedure could lead to an improvement in quality care for patients, given that it would avoid both unnecessary hospitalisations and treatments, and reflected in economic savings to the hospital.

Adherence clubs for long-term provision of antiretroviral therapy: cost-effectiveness and access analysis from Khayelitsha, South Africa.

OBJECTIVES: As the scale of the South African HIV epidemic calls for innovative models of care that improve accessibility for patients while overcoming chronic human resource shortages, we (i) assess the cost-effectiveness of lay health worker-led group adherence clubs, in comparison with a nurse-driven 'standard of care' and (ii) describe and evaluate the associated patient cost and accessibility differences. METHODS: Our cost-effectiveness analysis compares an 'adherence club' innovation to conventional nurse-driven care within a busy primary healthcare setting in Khayelitsha, South Africa. In each alternative, we calculate provider costs and estimate rates of retention in care and viral suppression as key measures of programme effectiveness. All results are presented on an annual or per patient-year basis. In the same setting, a smaller sample of patients was interviewed to understand the direct and indirect non-healthcare cost and access implications of the alternatives. Access was measured using McIntyre and colleagues' 2009 framework. RESULTS: Adherence clubs were the more cost-effective model of care, with a cost per patient-year of $300 vs. $374 and retention in care at 1 year of 98.03% (95% CI 97.67-98.33) for clubs vs. 95.49% (95% CI 95.01-95.94) for standard of care. Viral suppression in clubs was 99.06% (95% CI 98.82-99.27) for clubs vs. 97.20% (95% CI 96.81-97.56) for standard of care. When interviewed, club patients reported fewer missed visits, shorter waiting times and higher acceptability of services compared to standard of care. CONCLUSIONS: Adherence clubs offer the potential to enhance healthcare efficiency and patient accessibility. Their scale-up should be supported.

Female authorship positions in health economic evaluations: a cross-sectional analysis.

OBJECTIVE: To investigate the gender of the authors who publish articles of health economic evaluations in medicine and healthcare journals. METHOD: We evaluated a random sample of economic evaluations indexed in MEDLINE during 2019. Gender of the first, last and corresponding author was determined by review of the author's first name. Data were summarized as frequency and percentage for categorical items and median and interquartile range (IQR) for continuous items. We also calculated the index of authors per paper. RESULTS: We included 200 studies with 1365 authors (median of 6 authors per paper; IQR: 4-9). Gender identification was possible for all authors in the study sample: 802 (59%) were men and 563 (41%) were women. The number of female first, last, and corresponding authors respectively were 78 (39%), 68 (34%), and 80 (40%) for health economic evaluations. DISCUSSION: Female scientists were underrepresented as co-authors and in prominent authorship positions in health economic evaluations. This study serves as a call to action for the scientific community to actively work towards equity and inclusion.

Systematic review and cost-effectiveness analysis of the treatment of post-stroke spasticity with abobotulinumtoxinA compared to physiotherapy. / [Artículo traducido] Revisión sistemática y coste-efectividad del tratamiento con abobotulinumtoxinA para la espasticidad postictus en comparación con la fisioterapia.

OBJECTIVE: Post-stroke spasticity is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone. METHODS: A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of post-stroke spasticity in adults were included. The synthesis of information from the review provided the parameters for the design of a CEA of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed. RESULTS: In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment. The cost-effectiveness analysis showed that even in the most conservative scenario, assuming the worst case scenario, the probability of a cost per quality-adjusted life-year (QALY) gained below €40,000, for aboBoNT-A together with physiotherapy is above 0.8, and with certainty below €50,000/QALY when either a direct costs, or a societal perspective was taken. On average, the probabilistic model obtains a negative mean incremental cost-effectiveness ratio of around -15,000 €/QALY. CONCLUSION: The cost-effectiveness analyses show that aboBoNT-A together with physiotherapy would be a cost-effective treatment compared with physiotherapy alone, independently of the perspective considered.

Systematic review and cost-effectiveness analysis of the treatment of post-stroke spasticity with abobotulinumtoxinA compared to physiotherapy.

OBJECTIVE: Post-stroke spasticity (PSS) is a common complication in stroke survivors, causing severe burden to patients living with it. The aim of this review was to conduct a cost-effectiveness analysis (CEA) of the treatment of post-stroke spasticity, in adults, with abobotulinumtoxinA compared to the best supportive care, based on results from a systematic literature review. Given that abobotulinumtoxinA (aboBoNT-A) is always accompanied by the best supportive care treatment, the CEA compared aboBoNT-A plus the best supportive care with the best supportive care alone. METHODS: A systematic literature review in EMBASE (including Medline and PubMed), Scopus, and other sources (Google Scholar) was conducted. Articles of all types, providing information on the costs and/or effectiveness measures for the current treatments of PSS in adults were included. The synthesis of information from the review provided the parameters for the design of a cost-effectiveness analysis of the mentioned treatment of interest. The societal perspective was compared to a perspective where only direct costs were observed. RESULTS: In total, 532 abstracts were screened. Full information was revised from 40 papers and 13 of these were selected as core papers for full data extraction. Data from the core publications formed the basis for the development of a cost-effectiveness model. In all the included papers physiotherapy was the best supportive care treatment (SoC). The cost-effectiveness analysis showed that even in the most conservative scenario, assuming the worst case scenario, the probability of a cost per quality-adjusted life-year (QALY) gained below €40,000, for aboBoNT-A together with physiotherapy is above 0.8, and with certainty below €50,000/QALY when either a direct costs, or a societal perspective was taken. On average, the probabilistic model obtains a negative mean incremental cost-effectiveness ratio of around -15,000 €/QALY. CONCLUSION: The cost-effectiveness analyses show that aboBoNT-A together with physiotherapy would be a cost-effective treatment compared with physiotherapy alone, independently of the perspective considered.

Cost-effectiveness analysis of the SAPIEN 3 transcatheter aortic valve implant in patients with symptomatic severe aortic stenosis.

INTRODUCTION AND OBJECTIVES: Transcatheter aortic valve implant has become a widely accepted treatment for inoperable patients with aortic stenosis and patients at high surgical risk. Its indications have recently been expanded to include patients at intermediate and low surgical risk. Our aim was to evaluate the efficiency of SAPIEN 3 vs conservative medical treatment (CMT) or surgical aortic valve replacement (SAVR) in symptomatic inoperable patients at high or intermediate risk. METHODS: We conducted a cost-effectiveness analysis of SAPIEN 3 vs SAVR/CMT, using a Markov model (monthly cycles) with 8 states defined by the New York Heart Association and a time horizon of 15 years, including major complications and management after hospital discharge, from the perspective of the National Health System. Effectiveness parameters were based on the PARTNER trials. Costs related to the procedure, hospitalization, complications, and follow-up were included (euros in 2019). An annual discount rate of 3% was applied to both costs and benefits. Deterministic and probabilistic sensitivity analyses (Monte Carlo) were performed. RESULTS: Compared with SAVR (high and intermediate risk) and CMT (inoperable), SAPIEN 3 showed better clinical results in the 3 populations and lower hospital stay. Incremental cost-utility ratios (€/quality-adjusted life years gained) were 5471 (high risk), 8119 (intermediate risk) and 9948 (inoperable), respectively. In the probabilistic analysis, SAPIEN 3 was cost-effective in more than 75% of the simulations in the 3 profiles. CONCLUSIONS: In our health system, SAPIEN 3 facilitates efficient management of severe aortic stenosis in inoperable and high- and intermediate-risk patients.

PCSK9 inhibitors: Ratification of the role of LDL cholesterol in cardiovascular prevention. Towards a convergence of European and North American prevention guidelines? / Inhibidores de PCSK9: ratificación del papel del colesterol LDL en prevención cardiovascular. ¿Hacia la convergencia en las guías de prevención europeas y norteamericanas?

The epidemiological association of cholesterol associated with low density lipoproteins (LDL-c) levels and the development of atherosclerotic vascular disease has been ratified by mendelian randomization studies. Paradoxically, the success of statins led to the underestimation of other lipid-lowering therapies and even the measurement of LDL-c. Recent studies show that the reduction of LDL-c to extraordinarily low levels through absorption inhibition, and, in a particularly intensive manner, with monoclonal antibodies against pro-protein convertase subtilisine Kesine 9 (PCSK9) continues to offer cardiovascular protection. However, the high cost and limited experience with PCSK-9 inhibitors advised a prudent use of them. An appropriate selection of patients most likely to benefit from treatment with PCSK9 inhibitors emerges as the basis for a consensus of international guidelines: the combination of a high absolute vascular risk and a greater expected benefit by the starting LDL-c levels.

Would the Use of Edoxaban Be Cost-effective for the Prevention of Stroke and Systemic Embolism in Patients With Nonvalvular Atrial Fibrillation in Spain?

INTRODUCTION AND OBJECTIVES: To assess the cost-effectiveness of edoxaban vs acenocoumarol in the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) in Spain. METHODS: Markov model, adapted to the Spanish setting from the perspective of the National Health System, stimulating the progression of a hypothetical cohort of patients with NVAF throughout their lifetime, with different health states: stroke, haemorrhage, and other cardiovascular complications. Efficacy and safety data were obtained from the available clinical evidence (mainly from the phase III ENGAGE AF-TIMI 48 study). The costs of managing NVAF and its complications were obtained from Spanish sources. RESULTS: Edoxaban use led to 0.34 additional quality-adjusted life years (QALY) compared with acenocoumarol. The incremental cost with edoxaban was 3916€, mainly because of higher pharmacological costs, which were partially offset by lower costs of treatment monitoring and managing NVAF events and complications. The cost per QALY was 11 518€, within the thresholds commonly considered cost-effective in Spain (25 000-30 000 €/QALY). The robustness of the results was confirmed by various sensitivity analyses. CONCLUSIONS: Edoxaban is a cost-effective alternative to acenocoumarol in the prevention of stroke and systemic embolism in patients with NVAF in Spain.

Cost effectiveness analysis of fesoterodine compared to mirabegron in first-line therapy setting for overactive bladder with urge urinary incontinence, from the Spanish National Health System perspective. / Análisis de coste efectividad de fesoterodina comparado con mirabegron en el marco de tratamiento de primera línea para vejiga hiperactiva con incontinencia urinaria de urgencia, desde la perspectiva del Sistema Nacional de Salud español.

OBJECTIVES: To evaluate the cost-effectiveness of first-line treatment of Overactive Bladder (OAB) with fesoterodine relative to mirabegron, from the Spanish National Health System (NHS) perspective. METHODS: A decision tree model was developed to represent a typical clinical process of 52-week of treatment for an OAB patient with urge urinary incontinence (UUI) initiating first-line therapy with fesoterodine 4mg, including optional titration to 8mg, vs.mirabegron 50mg. Efficacy data were obtained from a Bayesian indirect treatment meta-analysis. Patients with UUI of less than one episode/day were defined as treatment responder and persistence was assessed at weeks 4, 12 and 24. At week 12, non-responders discontinued treatment permanently. Quality-adjusted life years (QALYs) were calculated based on time spent in responder and non-responder states. OAB-related drug and medical care costs including physician visits, laboratory tests, incontinence pads, and comorbidities (fracture, skin infection, urinary tract infections and depression) were modeled and expressed in €2015. RESULTS: At week 52, the percentage of responders was 20.8% for patients starting on fesoterodine 4mg who optionally titrated to 8mg and 19.4% for patients treated with mirabegron. QALYs were slightly higher with fesoterodine than mirabegron (0.7703vs. 0.7668, difference=0.0035). Fesoterodine treatment also had slightly higher total costs than mirabegron (3,296€vs. 3,217, difference=79€), resulting in a cost of 22,523/QALY€ gained for fesoterodine versus mirabegron. Probabilistic sensitivity analysis confirmed the slight advantage of fesoterodine with a 61.1% probability of being cost-effective at the 30,000€ willingness-to-pay for 1QALY threshold. CONCLUSIONS: Given the relatively small 1-year cost difference between the two treatments, fesoterodine can be considered a cost-effective option relative to mirabegron for the first-line management of OAB with UUI in Spain.

Clinical and economic benefits of integrated pump/CGM technology therapy in patients with type 1 diabetes in Colombia. / Beneficios clínicos y económicos de la terapia con bomba de insulina integrada a sistema de monitoreo continuo de glucosa en los pacientes diabéticos tipo 1 en Colombia.

OBJECTIVE: To assess the long-term clinical and economic impact of integrated pump/CGM technology therapy as compared to multiple daily injections (MDI), for the treatment of type 1 diabetes (T1D) in Colombia. METHODS: The CORE Diabetes Model was used to simulate a hypothetical cohort of patients with T1D. Mean baseline characteristics were taken from a clinical study conducted in Colombia and a healthcare payer perspective was adopted, with a 5% annual discount rate applied to both costs and outcomes. RESULTS: The integrated pump/CGM improved mean life expectancy by 3.51 years compared with MDI. A similar increase occurred in mean quality-adjusted life expectancy with an additional 3.81 quality-adjusted life years (QALYs). Onset of diabetes-related complications was also delayed as compared to MDI, and mean survival time free of complication increased by 1.74 years with integrated pump/CGM. Although this increased treatment costs of diabetes as compared to MDI, savings were achieved thanks to reduced expenditure on diabetes-related complications. The estimated incremental cost-effectiveness ratio (ICER) for SAP was Colombian Pesos (COP) 44,893,950 (approximately USD$23,200) per QALY gained. CONCLUSIONS: Improved blood glucose control associated to integrated pump/CGM results in a decreased incidence of diabetes-related complications and improves life expectancy as compared to MDI. Using recommended thresholds from the World Health Organization and previous coverage decisions about health technologies in Colombia, it is a cost-effective alternative to MDI for the treatment of type 1 diabetes in Colombia.

Costo efectividad del tratamiento de denervación renal vs. mejor tratamiento médico estándar disponible en el control de la hipertensión resistente en Colombia / Cost-effectiveness renal denervation therapy vs. the best standard medical treatment available in the control of resistant hypertension in Colombia

Objetivo: Mediante la adaptación a Colombia del modelo realizado por BresMed y previo análisis de transferibilidad, se realizó un análisis de costo-efectividad del tratamiento de denervación renal vs. mejor tratamiento estándar en el control de la hipertensión resistente y los eventos cardiovasculares relacionados. Métodos: Se construyó un modelo de Markov con 32 estados de salud y siete resultados finales: accidente cerebrovascular, infarto del miocardio, enfermedad coronaria, falla cardiaca, enfermedad renal crónica terminal, mortalidad cardiovascular y muerte. Se consideró un horizonte de toda la vida, la perspectiva desde el pagador y una tasa de descuento del 3%. Para el cálculo de las probabilidades de sufrir eventos se utilizaron las ecuaciones de riesgo de Framingham y las efectividades se tomaron del estudio clínico SYMPLICITY HTN-2. Los costos se extrajeron del entorno local y las tasas de mortalidad del Observatorio global de salud de la Organización Mundial de la Salud. Los resultados incluyeron los costos de cada alternativa de tratamiento, así como los años de vida ajustados a calidad ganados. Se realizaron análisis determinístico y probabilístico. Resultados: El tratamiento de denervación renal produjo 12,48 años de vida ajustados a calidad ganados a un costo de US $46.509 vs. 11,68 años de vida ajustados a calidad ganados del mejor tratamiento estándar a un costo de US $41.199, con un costo incremental por años de vida ajustados a calidad ganados de US $6.612. Tanto el análisis de sensibilidad univariado como el probabilístico, mostraron la robustez de los resultados. Conclusiones: El tratamiento de denervación renal, con un costo incremental por años de vida ajustados a calidad ganados de $6.612, muy por debajo de 1 PIB per cápita de Colombia, mostró ser altamente costo-efectivo.

Objective: By adapting to Colombia the model conducted by BresMed and preliminary analysis of transferability, an analysis of cost-effectiveness of treatment of renal denervation vs. best standard treatment in the control of resistant hypertension and cardiovascular events, was performed. Methods: A Markov model was constructed with 32 health states and seven outcomes: stroke, myocardial infarction, coronary artery disease, heart failure, terminal chronic kidney disease, cardiovascular mortality and death. A horizon of lifetime, from the payer perspective and a discount rate of 3% was considered. To calculate the odds of experiencing a cardiovascular event, Framingham risk equations and effectiveness were taken from the trial SYMPLICITY HTN-2. Costs were extracted from the local environment and the mortality rates from the global health observatory of the World Health Organization. The results included the costs of each alternative of treatment, as well as the quality adjusted life years (QALY). Deterministic and probabilistic analyzes were performed. Results: Treatment of renal denervation generated 12.48 quality adjusted life years gained at a cost of U.S. $ 46,509 vs .11.68 years of quality adjusted life years gained by the best standard treatment at a cost of U.S. $ 41,199, with an incremental cost per year of quality adjusted life of U.S. $ 6,612 . Both univariate sensitivity analysis and probabilistic analysis showed the strength of the results. Conclusions: Treatment of renal denervation, with an incremental cost per quality -adjusted life years gained of $ 6,612, well below 1 GDP of Colombia per capita, showed to be highly cost-effective.