Economic impact of obstetric events on women of reproductive age living with psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis and psoriasis in Spain.

OBJECTIVE: To estimate the annual cost associated with obstetric events in women of reproductive age with immune-mediated inflammatory diseases, from the perspective of the National Healthcare System. METHODS: A cost-analysis was developed to estimate the impact associated with obstetric events in women of reproductive age with psoriasis (PSO), psoriatic arthritis (PsA), rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA). The analysis considered complications during fertility and conception, in pregnancy and in the postpartum. All parameters were validated and agreed by a multidisciplinary expert panel. Unitary costs (€,2019) were obtained from national, local databases. RESULTS: During fertility and conception, an annual cost per patient of €229 was estimated for a preconception consultation in a patient with PSO, of €3642 for a preconception consultation in patients with PsA, RA and axSpA and €4339 for assisted reproduction. Women with complications in pregnancy had an annual cost per patient of €1214 for a miscarriage in the first trimester, €4419 for a late miscarriage in the second trimester, €11,260 for preeclampsia €3188 for restricted intrauterine growth and €12,131 for threat of premature delivery. In the postpartum, an annual cost per patient of €120,364, €44,709, and €5507 were estimated associated with admissions to neonatology of premature infants of <28, 28-32 and 33-37 weeks, respectively. CONCLUSIONS: This analysis provides insight on the economic burden of complications associated with women of reproductive age for immune-mediated diseases (PSO, PsA, RA, axSpA). Individualization of treatment, additional and close monitoring may reduce the risk and burden of these complications.

Cost-Effectiveness Analysis of Gemtuzumab Ozogamicin for First-Line Treatment of Patients with Cd-33 Positive Acute Myeloid Leukaemia in Spain.

OBJECTIVE: To assess the incremental cost-utility ratio (ICUR) of gemtuzumab ozogamicin (GO) + standard of care (SOC) vs SOC alone for treatment of patients with de novo AML from a Spanish Health Service perspective. METHODS: A cohort state-transition model, with 12 health-states, was used to estimate the lifetime accumulated cost and benefits in terms of quality-adjusted-life-years (QALYs) in AML patients with favourable, intermediate, and unknown cytogenetic profiles. Patient profile was defined based on the ALFA-0701 trial. Therapeutic regimens were defined by 5 haematologists. SOC was assumed to be idarubicin and cytarabine, the combination most used in Spain. QALYs were estimated by applying utilities for the time spent by the cohort in each health-state and utility decrements associated with adverse events (AE). Total cost (€,2020) included drug-acquisition, hematologic stem-cell transplantation, disease management, AE management and end-of-life costs. Unit costs were derived from local databases. All parameters were validated by haematologist. Costs and outcomes were discounted (3%/year). RESULTS: Higher cost/patient (€177,618 vs €151,434) and greater QALYs (5,70 vs 4,62) were obtained with GO+SOC vs SOC. The ICUR was €24,203/QALY gained. CONCLUSION: This simulation suggests that GO + SOC could be a cost-effective option for treatment of patients with de novo AML in first line.

Economic Impact of Obstetric Events on Women of Reproductive Age Living With Psoriatic Arthritis, Rheumatoid Arthritis, Axial Spondyloarthritis and Psoriasis in Spain. / Impacto económico asociado a eventos obstétricos en mujeres en edad fértil con artritis psoriásica, artritis reumatoide, espondiloartritis axial y psoriasis en España.

OBJECTIVE: To estimate the annual cost associated with obstetric events in women of reproductive age with immune-mediated inflammatory diseases, from the perspective of the National Healthcare System. METHODS: A cost-analysis was developed to estimate the impact associated with obstetric events in women of reproductive age with psoriasis (PSO), psoriatic arthritis (PsA), rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA). The analysis considered complications during fertility and conception, in pregnancy and in the postpartum. All parameters were validated and agreed by a multidisciplinary expert panel. Unitary costs (€, 2019) were obtained from national, local databases. RESULTS: During fertility and conception, an annual cost per patient of €229 was estimated for a preconception consultation in a patient with PSO, of €3,642 for a preconception consultation in patients with PsA, RA and axSpA and €4,339 for assisted reproduction. Women with complications in pregnancy had an annual cost per patient of €1,214 for a miscarriage in the first trimester, €4,419 for a late miscarriage in the second trimester, €11,260 for preeclampsia €3,188 for restricted intrauterine growth and €12,131 for threat of premature delivery. In the postpartum, an annual cost per patient of €120,364, €44,709, and €5,507 were estimated associated with admissions to neonatology of premature infants of <28, 28-32 and 33-37 weeks, respectively. CONCLUSIONS: This analysis provides insight on the economic burden of complications associated with women of reproductive age for immune-mediated diseases (PSO, PsA, RA, axSpA). Individualization of treatment, additional and close monitoring may reduce the risk and burden of these complications.

Prophylaxis therapy with bypassing agents in patients with haemophilia A and inhibitors undergoing surgery: A cost analysis in Spain.

OBJECTIVES: This study estimated the cost of prophylaxis with activated prothrombin complex concentrate (aPCC) and recombinant activated factor VIIa (rFVIIa) in surgical patients with haemophilia A and inhibitors in Spain. METHODS: A decision-analytic model was developed to estimate the cost to the Spanish National Health System of providing haemostatic coverage in this haemophilia population, with age distribution and average weight derived from the literature, and the annual number of surgeries (0.33 per patient) from local data. Drug costs were calculated from official ex-factory prices with a 7.5% mandatory deduction and recommended dosing regimens. RESULTS: The estimated average costs per patient were €10 100.73 (aPCC) and €14 265.89 (rFVIIa) for dental extraction, €24 043.88 (aPCC) and €62 301.08 (rFVIIa) for minor surgery and €126 595.81 (aPCC) and €347 731.09 (rFVIIa) for major surgery. Assuming an estimated 23 annual surgeries in this population (N = 69), distributed as 19% dental extraction, 50% minor surgery and 31% major surgery, the total annual cost of prophylaxis was €1 209 682.35 with aPCC and €3 221 929.28 with rFVIIa. CONCLUSIONS: aPCC costs were 62.5% lower than rFVIIa. Assuming potential clinical equivalence, aPCC is a potentially cost-saving option for surgical patients with haemophilia A and inhibitors.

Cost-Effectiveness Analysis of Exenatide versus GLP-1 Receptor Agonists in Patients with Type 2 Diabetes Mellitus.

OBJECTIVE: The aim of this study was to assess the efficiency of exenatide 2 mg/week compared with other glucagon-like peptide-1 (GLP-1) receptor agonists (dulaglutide 1.5 mg/week, liraglutide 1.2 mg/day, liraglutide 1.8 mg/day and lixisenatide 20 µg/day) in adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on metformin alone from the perspective of the Spanish National Health System (NHS). METHODS: Quality-adjusted life-years (QALYs) gained and total costs of each assessed drug combined with metformin (2 g/day) were estimated over a 40-year time horizon using the Cardiff Diabetes Model (based on UK Prospective Diabetes Study [UKPDS] 68 equations), which simulates disease progression considering the T2DM-related micro- and macrovascular complications, hypoglycaemia, nausea, body mass index (BMI) changes and treatment discontinuation due to adverse effects (AEs). Drug efficacy derived from an indirect comparison performed in a network meta-analysis. Patient characteristics were obtained from the literature. The baseline utility value (0.80) was derived from the PANORAMA study, applying utility decrements to micro- and macrovascular complications, hypoglycaemia episodes and changes in BMI. Treatment discontinuation due to AEs or poorly controlled diabetes (HbA1c > 7.5%) involved switching to second-line (basal insulin) or third-line (basal-bolus insulin) treatment. Total cost (€, 2018) included the costs of drug acquisition, hypoglycaemia, weight gain, micro- and macrovascular complications, nausea and treatment discontinuation due to AEs. An annual discount rate of 3% was applied to costs and outcomes. Deterministic and probabilistic sensitivity analyses (SA) were performed. RESULTS: In base-case, exenatide 2 mg/week resulted in more QALYs (8.26) than dulaglutide 1.5 mg/week (8.19 QALYs), liraglutide 1.2 mg/day (8.10 QALYs), liraglutide 1.8 mg/day (8.20 QALYs) and lixisenatide 20 µg/day (8.13 QALYs). Total cost/patient was €20,423.27 (exenatide 2 mg/week), €22,611.94 (dulaglutide 1.5 mg/week), €21,065.97 (liraglutide 1.2 mg/day), €24,865.69 (liraglutide 1.8 mg/day) and €21,334.58 (lixisenatide 20 µg/day). Deterministic SA confirmed the robustness of the model. In the probabilistic SA, 95-99% of the 1000 Monte Carlo iterations performed were under a hypothetical willingness-to-pay threshold of €20,000/QALY gained. CONCLUSIONS: Exenatide 2 mg/week would be a dominant strategy (more effective and less costly) versus the other GLP-1 receptor agonists assessed for the treatment of T2DM patients who are not adequately controlled on metformin alone.

[Social costs of diseases: How relevant are they for economic evaluations?] / Costes sociales de las enfermedades ¿Cuán relevantes son para las evaluaciones económicas?

BACKGROUND: In the field of the economic evaluation (EE), there is an open debate on the most appropriate perspective to apply. Despite the relevance of the topic, there are hardly any studies that have analyzed the practical consequences of applying the social perspective vs. health care funder. The aim of this study was performed a systematic review of the available evidence to analyze whether the inclusion/exclusion of informal care and/or loss of productivity influence the results and conclusions of economic evaluations. METHODS: A systematic review of the literature was carried out using PubMed and Econlit databases, to determine the publications that contained EE on Alzheimer, Parkinson and Stroke. Inclusion criteria were: a) full EE of the diseases under study; b) from January 2006-July 2016; and c) in English or Spanish. RESULTS: 6,292 references were identified, of which 245 publications meet the selection criteria and were analyzed. After the full-text analysis, 20 references were selected, of which 27 full EE were obtained (20 corresponding to Alzheimer, 1 to Parkinson and 6 to Stroke). In 20 EE (74.1%) the change of the perspective modifies the results, becoming dominant or increasing the saving of the resources by comparing the alternatives from the social perspective. In the remaining 7, the inclusion of social costs involves an increase in the costs of the intervention evaluated against its control. In a single EE, the conclusions vary when including social costs. CONCLUSIONS: The inclusion of social costs can modify the results of EE but their impact on the conclusions is not relevant.

OBJETIVO: En el campo de la evaluación económica (EE), existe un debate abierto sobre la perspectiva más apropiada a aplicar. Pese a la relevancia del tema, apenas hay trabajos que analicen las consecuencias prácticas de aplicar la perspectiva social o la del financiador. El objetivo fue realizar una revisión sistemática para analizar si la inclusión/exclusión de los cuidados informales y/o pérdidas laborales influyen en los resultados y conclusiones de las EE. METODOS: Se realizó una búsqueda sistemática en PubMed y Econlit para determinar las publicaciones que contenían EE sobre Alzheimer, Parkinson e Ictus. Criterios de inclusión: a) EE completas sobre las enfermedades en estudio; b) periodo enero 2006-julio 2016; y c) en inglés o español. RESULTADOS: Se obtuvieron 6.292 referencias, seleccionándose 245 artículos que podían cumplir los criterios de inclusión. Tras el análisis a texto completo, se seleccionaron 20 publicaciones de las cuales se obtuvieron 27 EE completas (20 corresponden a Alzheimer, 1 a Parkinson y 6 al Ictus). En 20 EE (74,1%) el cambio de perspectiva modifica los resultados, pasando a ser dominantes o incrementando el ahorro de recursos comparando las alternativas desde la perspectiva social. En las 7 restantes, la inclusión de los costes sociales supone un incremento en los costes de la intervención evaluada frente a su control. Únicamente en una EE varían las conclusiones al incluir los costes sociales. CONCLUSIONES: En general, la inclusión de los costes sociales puede modificar los resultados de las EE, pero su impacto sobre las conclusiones de las mismas es poco relevante.

Cost-Effectiveness of Fixed-Dose Combinations Therapies for Chronic Obstructive Pulmonary Disease Treatment.

BACKGROUND AND OBJECTIVE: Chronic obstructive pulmonary disease (COPD), a progressive lung disorder associated with decline of respiratory function, affects 10.2% of Spanish adults (40-80 years of age). This study aimed to assess the cost-effectiveness of two fixed-dose combinations of long-acting muscarinic antagonist and long-acting ß2-agonist therapies for COPD, with Spanish National Health System perspective. METHODS: A Markov model with five health states based on severity levels defined by GOLD 2010 criteria was used to simulate in monthly cycles the evolution along a 5-year period of a cohort of moderate-to-severe COPD patients, treated with aclidinium-formoterol (ACL/FF) 400/12 µg or tiotropium-olodaterol (TIO/OLO) 5/5 µg fixed-dose combinations. Clinical data on lung-function improvement were obtained from a network meta-analysis and applied to mean baseline forced-expiratory-volume in 1 s (FEV1) for the first 24-weeks period. Natural history for lung-function decline (41 ml/year) was applied until the end of simulation. Risk of exacerbation and pneumonia occurrence were considered. Pharmaceutical costs were calculated with dosages according to indication and public ex-factory prices. The health state-specific disease management and event costs, and utilities were derived from the literature. Total costs (€ 2016) and benefits [life-year-gained (LYG) and quality-adjusted-life-year (QALY)] were discounted (3.0% yearly). Sensitivity analyses were performed. RESULTS: Both therapies provided the same outcomes (4.073 LYG and 2.928 QALY) at 5-year period. ACL/FF 400/12 µg provided marginally lower costs (€ - 332) compared to TIO/OLO 5/5 µg. CONCLUSION: ACL/FF 400/12 µg was a cost-saving therapy in patients with moderate-to-severe COPD in Spain, and provided equivalent effects compared to TIO/OLO 5/5 µg.