Cost Of Pharmacological Treatment Research Articles

Evaluación de eventos clínicos y costes asociados a la adición de dapagliflozina al tratamiento de la enfermedad renal crónica: análisis de compensación de costes

Background and objectives: Chronic kidney disease (CKD) is a serious health problem with an increasing clinical, social and economic impact in advanced stages. Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor that reduces the risk of CKD progression, in addition to provide cardiovascular benefits and reduce all-cause mortality. The aim of this study was to determine the short-term clinical and economic impact of dapagliflozin as an add-on to renin-angiotensin-aldosterone system inhibitors (RAASi) standard therapy for CKD in Spain.Materials and methods: A cost-offset model was used to compare the costs of clinical events and pharmacological per 100,000 CKD patients in a virtual cohort treated with dapagliflozin added to RAASi standard therapy versus RAASi standard therapy alone. Renal (progression to renal failure and acute kidney injury), cardiovascular (hospitalisation for heart failure [HF]), and all-cause mortality events were assessed. The incidence of clinical events by treatment arm was obtained from the DAPA-CKD study, and costs were obtained from national databases and the literature.Results: Over 3 years, treatment with dapagliflozin would reduce progression to renal failure (-33%; 7,221 vs. 10,767), hospitalisation for HF (-49%; 2,370 vs. 4,683) and acute kidney injury (-29%; 4,110 vs. 5,819). The savings associated with this reduction in events was euro258 million per 100,000 patients, of which 63.4% is due to the avoidance of dialysis for renal failure. Considering the event and pharmacological treatment costs, the total net savings were estimated at euro158 million per 100,000 patients.Conclusions: Delaying progression of CKD and reducing the incidence of clinical events thanks to the treatment with dapagliflozin could generate savings for the Spanish National Health System, even when pharmacological costs are taken into account.

Real-World Health Care Outcomes and Costs Among Patients With Juvenile Idiopathic Arthritis in Spain

Background: Juvenile idiopathic arthritis (JIA) is the most frequent chronic rheumatic disease in children. If inflammation is not adequately treated, joint damage, long-term disability, and active disease during adulthood can occur. Identifying and implementing early and adequate therapy are critical for improving clinical outcomes. The burden of JIA on affected children, their families, and the healthcare system in Spain has not been adequately assessed. The greatest contribution to direct costs is medication, but other expenses contribute to the consumption of resources, negatively impacting healthcare cost and the economic conditions of affected families. Objective: To assess the direct healthcare, indirect resource utilization, and associated cost of moderate-to-severe JIA in children in routine clinical practice in Spain. Methods: Children were enrolled in this 24-month observational, multicentric, cross-sectional, retrospective study (N = 107) if they had been treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs), had participated in a previous study (ITACA), and continued to be followed up at pediatric rheumatology units at 3 tertiary Spanish hospitals. Direct costs included medication, specialist and primary care visits, hospitalizations, emergency visits or consultations, surgeries, physiotherapy, and tests. Indirect costs included hospital travel expenses and loss of caregiver working hours. Unitary costs were obtained from official sources (€, 2020). Results: Overall, children had inactive disease/low disease activity according to JADAS-71 score and very low functional disability as measured by Childhood Health Assessment Questionnaire score. Up to 94.4% of children received treatment, mainly with bDMARDs as monotherapy (84.5%). Among anti-TNFα treatments, adalimumab (47.4%) and etanercept (40.2%) were used in similar proportions. Annual mean (SD) total JIA cost was €7516.40 (€5627.30). Average cost of pharmacological treatment was €3021.80 (€3956.20), mainly due to biologic therapy €2789.00 (€3399.80). Direct annual cost (excluding treatments) was €3654.60 (€3899.00). Indirect JIA cost per family was €747.20 (€1452.80). Conclusion: JIA causes significant costs to the Spanish healthcare system and affected families. Public costs are partly due to the high cost of biologic treatments, which nevertheless remain an effective long-term treatment, maintaining inactive disease/low disease activity state; a very low functional disability score; and a good quality of life.

Real-World Health Care Outcomes and Costs Among Patients With Juvenile Idiopathic Arthritis in Spain.

Background: Juvenile idiopathic arthritis (JIA) is the most frequent chronic rheumatic disease in children. If inflammation is not adequately treated, joint damage, long-term disability, and active disease during adulthood can occur. Identifying and implementing early and adequate therapy are critical for improving clinical outcomes. The burden of JIA on affected children, their families, and the healthcare system in Spain has not been adequately assessed. The greatest contribution to direct costs is medication, but other expenses contribute to the consumption of resources, negatively impacting healthcare cost and the economic conditions of affected families. Objective: To assess the direct healthcare, indirect resource utilization, and associated cost of moderate-to-severe JIA in children in routine clinical practice in Spain. Methods: Children were enrolled in this 24-month observational, multicentric, cross-sectional, retrospective study (N = 107) if they had been treated with biologic disease-modifying anti-rheumatic drugs (bDMARDs), had participated in a previous study (ITACA), and continued to be followed up at pediatric rheumatology units at 3 tertiary Spanish hospitals. Direct costs included medication, specialist and primary care visits, hospitalizations, emergency visits or consultations, surgeries, physiotherapy, and tests. Indirect costs included hospital travel expenses and loss of caregiver working hours. Unitary costs were obtained from official sources (€, 2020). Results: Overall, children had inactive disease/low disease activity according to JADAS-71 score and very low functional disability as measured by Childhood Health Assessment Questionnaire score. Up to 94.4% of children received treatment, mainly with bDMARDs as monotherapy (84.5%). Among anti-TNFα treatments, adalimumab (47.4%) and etanercept (40.2%) were used in similar proportions. Annual mean (SD) total JIA cost was €7516.40 (€5627.30). Average cost of pharmacological treatment was €3021.80 (€3956.20), mainly due to biologic therapy €2789.00 (€3399.80). Direct annual cost (excluding treatments) was €3654.60 (€3899.00). Indirect JIA cost per family was €747.20 (€1452.80). Conclusion: JIA causes significant costs to the Spanish healthcare system and affected families. Public costs are partly due to the high cost of biologic treatments, which nevertheless remain an effective long-term treatment, maintaining inactive disease/low disease activity state; a very low functional disability score; and a good quality of life.

Use of Drugs in Clinical Practice and the Associated Cost of Cancer Treatment in Adult Patients with Solid Tumors: A 10-Year Retrospective Cohort Study.

Cancer is one of the leading causes of morbidity and mortality in the world. Its growing incidence and prevalence, as well as the advances in diagnostic and treatment tools, motivate an open debate about the economic burden it may place on health systems and have raised concerns about access to this technological innovation. There is a lack of information on the detailed costs of pharmacological treatment of cancer in our health setting. In this context, it is necessary to know the use of drugs in cancer treatment in conditions of real clinical practice. A real-word, evidence-based retrospective cohort study was conducted at Vall d'Hebron University Hospital (VHUH), the largest hospital complex in Catalonia, Spain, in order to determine the use of drugs and the associated cost in real clinical practice for the treatment of solid tumors in adult patients attended at this institution over 10 years (2010-2019). This was a single-center retrospective cohort study of adult cancer patients attended in clinical practice at the Medical Oncology Department of VHUH between 1 January 2010 and 31 December 2019. Data of prescription, preparation, and cost of antineoplastic treatments were analyzed by pharmacological class (cytotoxic drugs, immunotherapy, targeted therapy, radiopharmaceuticals, and others), by antineoplastic agent, and by type of tumor. The number of patients and the pharmaceutical expenditure corresponding to all these subgroups were recorded. The cost per patient in each tumor location was also calculated. The study population included 13,209 patients with an overall pharmaceutical antineoplastic expenditure of EUR 120,396,097, increasing from 7.67% in relation to the total HUVH pharmaceutical expenditure in 2010 to 12.82% in 2019. By pharmacological class, the specific weight of the cost of targeted therapy is relevant (75.22% of pharmaceutical antineoplastic expenditure, 21.3% of patients) compared to the group of conventional cytotoxics (17.25% of pharmaceutical antineoplastic expenditure, 76.37% of patients), while immunotherapy has represented the largest relative increase, from 5% in 2014 to 12% in 2019. Eight targeted therapy drugs represented 50% of the costs of the targeted therapy drug class (palbociclib, trastuzumab, pertuzumab, bevacizumab, nivolumab, cetuximab, pembrolizumab, and trastuzumab emtansine). Eleven tumor sites accounted for 90% of the expenditure in 71% of all patients. Breast cancer had the highest expenditure during the study period (EUR 34,332,210) and at each individual year. Melanoma showed the highest increase, with 9.7% of total pharmaceutical antineoplastic expenditure in 2019 (2% of patients), representing a paradigm of the rising costs of cancer treatment due to the incorporation of new high-cost therapies. The average annual cost per patient was highly variable depending on the pathology. There was a growing increase in costs per patient in most tumor locations, particularly in patients with melanoma (from EUR 1922 in 2010 to EUR 37,020 in 2019), prostate cancer (from EUR 2992 in 2010 to EUR 14,118 in 2019), and non-small cell lung cancer (from EUR 3545 in 2010 to EUR 8371 in 2019). The relevance of the difference in monthly cost per patient that has been identified for the different intrinsic subtypes in breast cancer patients during 2019 (HER2+ EUR 2661/month, Luminal EUR 881/month, Triple negative EUR 386/month) makes us consider suggesting differentiated reimbursement rates for certain clinical conditions. Finally, support treatment with antiemetic drugs, erythropoietin stimulating agents, granulocyte-colony stimulating factor (G-CSF), and bone resorption inhibitors has involved a cost of EUR 5,751,910, which represents 4.6% of the overall pharmacological cost of cancer treatment. This study provides detailed insights on the oncological pharmaceutical expenditure for the treatment for solid tumors in the VHUH, based on real cost information from our hospital practice and for all antineoplastic therapies and types of solid tumors. This type of information on all the different types of cancer can be useful to better understand the economic burden of the disease and can be decisive for allocating public resources and funds for research, especially in those areas where information is scarce and therefore where further studies are needed. The contribution to knowledge of the cost of oncology therapy is of great value due to its realism and scope.

Effectiveness of a Person-Centered Prescription Model in Hospitalized Older People at the End of Life According to Their Disease Trajectories and Frailty Index.

This study aimed to comparatively analyze the effect of the person-centered prescription (PCP) model on pharmacotherapeutic indicators and the costs of pharmacological treatment between a dementia-like trajectory and an end-stage organ failure trajectory, and two states of frailty (cut-off point 0.5). A randomized controlled trial was conducted with patients aged ≥65 years admitted to a subacute hospital and identified by the Necessity of Palliative Care test to require palliative care. Data were collected from February 2018 to February 2020. Variables assessed included sociodemographic, clinical, degree-of-frailty, and several pharmacotherapeutic indicators and the 28-day medication cost. Fifty-five patients with dementia-like trajectory and 26 with organ failure trajectory were recruited observing significant differences at hospital admission in the mean number of medications (7.6 vs. 9.7; p < 0.004), the proportion of people on more than 10 medications (20.0% vs. 53.8%; p < 0.002), the number of drug-drug interactions (2.7 vs. 5.1; p < 0.006), and the Medication Regimen Complexity Index (MRCI) (25.7 vs. 33.4; p < 0.006), respectively. Also, regarding dementia-like patients, after application of the PCP model, these patients improved significantly in the intervention group compared to the control group in the mean number of chronic medications, STOPP Frail Criteria, MRCI and the 28-day cost of regular medications (p < 0.05) between admission and discharge. As for the PCP effect on the control and the intervention group at the end-stage organ failure, we did not observe statistically significant differences. On the other hand, when the effect of the PCP model on different degrees of frailty was evaluated, no unequal behavior was observed.

The Impact of Obesity in Saudi Arabia: Healthcare Resource Use and Costs Associated with Obesity-Related Complications.

Saudi Arabia has a high prevalence of obesity, which increases the risk of individuals experiencing multiple chronic complications. Only a few publications highlight the healthcare costs of obesity-related complications (ORCs) in Saudi Arabia. A micro-costing approach was used to estimate the healthcare costs associated with 10 ORCs. Experienced clinicians in public and private practice across different geographical regions in Saudi Arabia were asked to estimate healthcare resource use associated with each ORC, and estimated unit costs were obtained from hospital administrators. Estimated overall annual costs per patient were calculated as a weighted average of separate public and private sector costs. Individuals in Saudi Arabia with any single ORC incurred overall average annual healthcare costs of 2165-7558 US dollars (USD). Heart failure, chronic kidney disease, dyslipidemia, and type2 diabetes (T2D) were the most costly complications, mainly driven by monitoring and/or pharmacological treatment costs. In contrast, asthma, hypertension, and angina were the least costly complications. Costs in private healthcare were higher than in public healthcare; the largest differences (2359-2793USD) were noted for dyslipidemia, T2D, and osteoarthritis, mainly explained by differences in pharmacological treatment costs. These data suggest that ORCs result in a considerable financial burden to the healthcare system, and highlight the substantial cost savings that could be achieved by preventing or delaying the occurrence of ORCs in Saudi Arabia.

Coste del tratamiento farmacológico de los factores de riesgo cardiovascular en población diabética anciana según género (Estudio ESCADIANE)

AimsTo study the cost of pharmacological treatment used for the control of cardiovascular risk factors in patients with type 2 diabetes mellitus (DM2)> 65 years and the prevalence of cardiovascular complications according to gender. DesignCross-sectional, observational, multicentric study. LocationNational study. ParticipantsPatients with diabetes mellitus 2> 65 years. Main measurementsprevalence of cardiovascular risk factors and their cost in patients with diabetes mellitus 2. ResultsWe studied 947 patients (53% females) with a mean age of 76.2±7.3 years. 14% had suffered acute myocardial infarction (17.8% men vs. 10.7% women, p=.001), 11.9% had stroke (13.7% men vs. 10.5% women; p=ns), 11.3% heart failure (10.9% men vs. 11.7% women, p=ns) and 9% peripheral arterial disease (12.1% men vs. 6.3% women; p=.001). Oral antidiabetic drugs accounted for the highest cost (414.76±210.18 € patient / year), mainly due to DPP-4 inhibitors (49.9% of the cost of antidiabetics), followed by basal insulin (29.95%) and without significant differences between gender. The annual expenditure of antihypertensive drugs per patient/year was higher in women than in men (86.80±32.84 € vs. 78.24 €±26.86, p=0.0001). The antiaggregants significantly lower in women (20.87±7.25 € vs. € 30.21±13.68, p=0.0001). ConclusionsAntidiabetic drugs represented the highest cost in controlling cardiovascular risk factors in diabetic patients> 65 years of age, followed by hypotensives, hypolipements and antiaggregants. Women had higher spending on anti-hypertensives and men on antiaggregants.The most frequent macrovascular complications in men were AMI, arrhythmias and stroke. There were only gender differences for infarction.

Synthetic cannabinoid-associated coagulopathy secondary to long-acting anticoagulant rodenticides: Observational case series and management recommendations.

Synthetic cannabinoids have become increasingly popular drugs of abuse due to low cost and inability to detect these substances on routine drug screenings. In the United States, incidence of synthetic cannabinoid contamination with long-acting anticoagulant rodenticides (LAARs) resulting in coagulopathy and bleeding complications has been described.We sought to describe the natural history, management approach, and outcomes of bleeding secondary to synthetic cannabinoid-associated LAAR toxicity in an observational case series of patients evaluated at an urban academic medical system.We conducted an observational study of patients with suspected exposure to LAAR-contaminated synthetic cannabinoids and associated bleeding treated within the Johns Hopkins Health System.In this 16 subject cohort, hematuria was the most common bleeding symptom at presentation. The majority of the cohort (75%) had international normalized ratio (INR) > 9.6 at presentation. Of the 13 patients with brodifacoum testing, 12/13 (92%) were positive. Twelve patients (75%) had at least 1 INR value below 2 within 24 hours of the first INR measurement. Of this cohort, 1/16 (6%) died in hospital. The median length of hospital stay was 4 days, (interquartile range = 3-6). The average cost of pharmacological treatment for coagulopathy during inpatient hospitalization was $5300 (range, $2241-$8086).In patients presenting with unexplained coagulopathy it is important for emergency department providers to consider LAAR intoxication and consider formal testing for brodifacoum to assist with treatment planning. Use of a standardized management algorithm including intravenous/oral vitamin K, judicious use of blood products and close laboratory monitoring is essential to optimizing outcomes.

PRS20 CRITICAL MODEL OF THE INDIVIDUAL AND GLOBAL COST OF THE MEDICAL TREATMENT OF THE PULMONARY ARTERIAL HYPERTENSION IN COLOMBIA

To estimate the costs of specific PAH treatment in Colombia in terms of monotherapy and / or its various combinations (Niza 2018). Costing of the estimated treatment was carried out assuming an indicator patient (adult, 60 kg) with diagnosis of PAH and candidate for pharmacological treatments available in Colombia, according to clinical practice guidelines. Frequency of use and unit costs of pharmacological treatment (official price source, SISMED) were estimated as the minimum, average and maximum price in 2018. We assume the assumption of a 100% adherence for all the analyzed technologies. The data was analyzed. The cost is presented in both COP (USD, €) and normalizing all of the current legal minimum wage (SMLV) in Colombia. The annual treatment with specific drugs for PAH has a wide range of cost (USD 200-243,000, equivalent to 2-16 SMLV) in Colombia. The combination of two drugs (USD 4600-283000; 18-1076 SMLV) and three of them (USD 5200-287000; 20-1092 SMLV) imposes a much higher direct cost to the health system. There was no data on adherence, delay in dispensing or overall percentage of patients under treatment. As in other countries, the cost of pharmacological treatment of PAH in Colombia is high. This impact on costs at the national level will increase significantly due to the improvements that are being made in detection, treatment, adherence and survival in patients with PAH, as it will increase the number of patients and duration of said specific treatments. This forecast makes the indication, prescription and dispensation of these drugs a priority for improvement through integrated actions of HAPREDCO with the Colombian health management system.

Costs of pharmacotherapy of chronic obstructive pulmonary disease in relation to changing Global Initiative for Chronic Obstructive Lung Disease guidelines (2007, 2011, and 2017 updates).

INTRODUCTION Chronic obstructive pulmonary disease (COPD) is one of the most common chronic noninfectious diseases. The clinical management is determined by patient assignment to the severity stage of the disease in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines. OBJECTIVES Our aim was to determine the economic implications of changing GOLD guidelines (2007, 2011, and 2017 updates) and their impact on the direct costs of pharmacological treatment of patients diagnosed with COPD. PATIENTS AND METHODS This analysis was based on data provided by a group of 298 out of 500 randomly selected primary care physicians in Poland (response rate, 59.6%). Each primary care physician provided information on 10 consecutive patients with COPD. These data were used to simulate the economic consequences of the 2007, 2011, and 2017 GOLD guideline updates. RESULTS Regardless of the GOLD guidelines used, pharmacotherapy of patients with a very severe form of COPD was most expensive. Pharmacotherapy costs would be reduced with each subsequent guideline. In the same group of 2597 COPD patients, the average monthly cost of the first‑line pharmacotherapy as well as the overall costs of pharmacotherapy (first- and second‑line) per patient would be the lowest when applying the therapeutic regimen in accordance with the 2017 GOLD guidelines. CONCLUSIONS Implementation of 2011 and 2017 GOLD guidelines, as compared with the 2007 update, would result in a reduction of direct costs of COPD treatment.

Comparison of treatment costs at the Psychiatric Ward in Gryfice between 2016 and 2017, after the introduction of olanzapine long-acting injectable in hospital treatment

Objectives. The aim of this study was to compare the costs of treatment at the Psychiatric Ward in Gryfice between 2016 and 2017, after the introduction of olanzapine long-acting injectable in hospital treatment. Material and methods. Analysis of numerical data of the costs of treatment at the Psychiatric Ward in Gryfice (60 inpatient beds) between 2016 and 2017, data from the central hospital pharmacy – internal expenditure of medicines (OLAI, clozapine and zuclopentixol – acetate and decanoate). In 2016, two patients were treated with olanzapine long-acting injectable; in 2017, it was 25 patients, who met the diagnosis criteria for schizophrenia according to ICD-10 and the indications for the refund of the drug (recurrence of psychotic symptoms as a result of documented persistent lack of cooperation). Results. Compared with 2016, in 2017, there were 104 fewer patients hospitalised (–7%); the number of patient-days decreased by 254 (–1.1%) and the number of patients diagnosed as schizophrenia lowered by 32 (–18.5%). The cost of pharmacological treatment decreased both per patient (reduction by 6.7%) and per patient-day (reduction by 12, 2%). The use of other drugs also decreased. Conclusions. Introduction of olanzapine long-acting injectable in hospital treatment is economically beneficial in the short term. In 2017, as compared to 2016, a reduction in the cost of pharmacological treatment was achieved at the Psychiatric Ward in Gryfice (both per patient and per patient-day). The consumption of other neuroleptic drugs, such as clozapine and zuclopenthixol (acetate and decanoate), decreased, too.

PRS20 - Cost-Effectiveness Analysis of Umeclidinium Bromide/Vilanterol 62.5/25 MCG Versus Tiotropium/Olodaterol 5/5 MCG in Symptomatic Patients with Chronic Obstructive Pulmonary Disease in Spain

To assess the cost-effectiveness of once-daily umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 mcg versus once-daily tiotropium/olodaterol (TIO/OLO) 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease (COPD) from a Spanish National Health Service perspective. A linked-equation cohort model was implemented to estimate COPD progression, associated healthcare costs, exacerbation rates, survival, and quality-adjusted life-years (QALYs). Statistical risk equations for clinical endpoints were derived from the ECLIPSE study (Exuzides A, et al. Med Decis Making 2017;37:453-68), and a health state approach was used to calculate costs. Utilities needed for QALYs calculation were estimated from patient baseline characteristics, using a regression fit to Spanish observational data. St George’s Respiratory Questionnaire (SGRQ)-based utilities were tested in a sensitivity analysis. Change from baseline in forced expiratory volume in 1 second (FEV1) was obtained from an 8-week head-to-head crossover study and was included as the main treatment effect in the model: +52 mL (95% confidence interval: 28–77) (Feldman G, et al. Adv Ther. 2017;34:2518-33). Baseline characteristics were sourced from Spanish-specific literature or the head-to-head study if unavailable. Direct healthcare costs (2017 EUR) were obtained from Spanish sources, including exacerbation, COPD management, and pharmacological treatment costs. Costs and benefits were discounted at 3%. Step-up therapy was included for patients deemed to fail current treatment. Over a 3-year time horizon, patients receiving UMEC/VI were predicted to gain QALYs (+0.029) against cost savings of €393/patient. Probabilistic and scenario analyses showed that variation in the main parameters and assumptions did not alter the results; in one-way sensitivity analysis, the results were most sensitive to FEV1 treatment effect. All (100%) probabilistic simulations showed UMEC/VI to be less costly and more effective than TIO/OLO. Treatment with UMEC/VI dominated (less costly and more effective) treatment with TIO/OLO in patients with symptomatic moderate COPD in Spain. Funding: GlaxoSmithKline (study HO-17-17500).

Economic burden of primary compared with recurrent Clostridium difficile infection in hospitalized patients: a prospective cohort study

Few studies have investigated the additional healthcare costs of recurrent C.difficile infection (CDI). To quantify inpatient treatment costs for CDI and length of stay among hospitalized patients with primary CDI only, compared with CDI patients who experienced recurrent CDI. This was a prospective, observational cohort study of hospitalized adult patients with primary CDI followed for three months to assess for recurrent CDI episodes. Total and CDI-attributable hospital length of stay (LOS) and hospitalization costs were compared among patients who did or did not experience at least one recurrent CDI episode. In all, 540 hospitalized patients aged 62±17 years (42% males) with primary CDI were enrolled, of whom 95 patients (18%) experienced 101 recurrent CDI episodes. CDI-attributable median (interquartile range) LOS and costs (in US$) increased from 7 (4-13) days and $13,168 (7,525-24,456) for patients with primary CDI only versus 15 (8-25) days and $28,218 (15,050-47,030) for patients with recurrent CDI (P<0.0001, each). Total hospital median LOS and costs increased from 11 (6-22) days and $20,693 (11,287-41,386) for patients with primary CDI only versus 24 (11-48) days and $45,148 (20,693-82,772) for patients with recurrent CDI (P<0.0001, each). The median cost of pharmacological treatment while hospitalized was $60 (23-200) for patients with primary CDI only (N=445) and $140 (30-260) for patients with recurrent CDI (P=0.0013). This study demonstrated that patients with CDI experience a significant healthcare economic burden attributed to CDI. Economic costs and healthcare burden increased significantly for patients with recurrent CDI.

Budget impact analysis of delayed-release dimethyl-fumarate in the treatment of relapsing-remitting multiple sclerosis in Italy

INTRODUCTION: Multiple Sclerosis (MS) is a condition with a significant economic and social burden that affects young adults, in their active working phase. The most recent evaluations show an annual average social cost of € 38-39 thousand per patient. Today the approval of the new oral therapies allows physicians to select further options that can meet patients’ clinical unmet needs.OBJECTIVES: To evaluate the economic impact of a recently approved therapy, delayed-release dimethyl-fumarate (DMF; also known as gastro-resistant DMF), on the overall management costs of relapsing-remitting multiple sclerosis (RRMS) in Italy.METHODS: A budget impact model, adopting the perspective of the Italian National Healthcare Service (NHS), was used to compare healthcare costs of two different treatment scenarios: a) base-case, where DMF is not available for RRMS patients (Scenario A), vs. b) alternative-case, where DMF is available for RRMS patients (Scenario B). Healthcare costs sustained by the Italian NHS to manage the RRMS population (drug treatment, administration, therapy and disease monitoring, relapse management, treatment-related adverse events) have been calculated over 3 years and compared for the two scenarios. Impact of relapses for the disease modifying therapies (DMTs) included in the analysis was estimated using an elaboration of the results from published mixed treatment comparison. RRMS population treated with DMTs was estimated using Italian prevalence and incidence data. According to these estimates, the number of treated patients amounted to 36,078 at Year 1, 38,832 at Year 2, and 40,673 at Year 3.RESULTS: According to the current price and to the assumptions reported in the methodology section, it was estimated that the introduction of DMF (Scenario B) determines a decrease of the budget impact, if compared with the base case (Scenario A) in the perspective of Italian NHS. Over three years, the budget impact would be € 1,376 mln in the Scenario A and € 1,354 mln in the Scenario B (-22.18 mln €; -1.61% relative budget variation). The main drivers for cost-saving were pharmacological treatment costs and reduced burden of relapses (corresponding to more than 1,800 avoided relapses).CONCLUSIONS: At the current cost conditions applied in Italy and according to the described assumptions, the use of DMF is economically sustainable for the Italian NHS. Plausibly, the introduction and usage of this new therapy in RRMS patients will ensure clinical benefits for patients without resulting in additional costs for the Italian NHS.[In Italian]

Cost-effectiveness analysis of pazopanib in second-line treatment of advanced soft tissue sarcoma in Spain.

To assess the efficiency of pazopanib compared with trabectedin in the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) after chemotherapy failure. The progression of STS was modeled using a partitioned survival analysis model. Survival curves for pazopanib and trabectedin were modeled using data from PALETTE phase III clinical trial and based on unadjusted indirect comparison. Effectiveness was measured in quality-adjusted life years (QALY). The Spanish National Health System perspective was considered over a 10-year time horizon, including direct health care costs (<euro>, 2014). A discount rate of 3% was applied to both costs and outcomes. The robustness of the results was evaluated using univariate and probabilistic sensitivity analyses (PSA). Pazopanib was associated with better health outcomes than trabectedin (0.705 versus 0.686 QALY). Pazopanib also showed lower direct health care costs (<euro>21,861 versus <euro>45,338), mainly due to lower cost of pharmacological treatment (<euro>13,762 versus <euro>33,392), administration (<euro>57 versus <euro>2,955) and AE management (<euro>658 versus <euro>1,695) costs. PSA confirmed that pazopanib was a dominant option in 71% of the simulations performed. In this analysis, and from a health economics perspective, pazopanib was the option of choice versus trabectedin in the treatment of adult patients with advanced soft-tissue sarcoma after chemotherapy failure.

정신지체 및 자폐스펙트럼장애에서 다양한 치료방법의 사용실태

Objectives : The purpose of this study was to investigate the use of various treatment modalities including pharmacotherapy, educational-behavioral therapy, and complementary alternative treatment for children with mental retardation (MR) or autism spectrum disorder (ASD) in Korea. Methods : The sample consisted of 50 parents who have children with MR (N=28) or ASD (N=22) : 38 boys, 12 girls ; mean age 14.06 (4.14) years old. A questionnaire was composed of the experienced modality, duration, cost, satisfaction, etc. Results : According to the results, 56.0%, 100.0%, and 36.0% of children with MR or ASD have experienced pharmacological treatment, educational-behavioral therapy and complementary alternative medicine (CAM), respectively. Children who experienced educational-behavioral therapy and CAM experienced 3.52 kinds of education-behavioral therapy and 2.78 kinds of CAM, respectively. Monthly cost of pharmacological treatment was lowest among three modality categories. Regarding treatment satisfaction by parental report, the lowest score was recorded for CAM. Conclusion : Parents who have a child with MR or ASD are trying many treatment modalities and feeling the burden of their treatment.

Acromegaly: a Latin American perspective

Acromegaly: a Latin American perspective

Efficiency of initiation with ambrisentan versus bosentan in the treatment of pulmonary arterial hypertension

To evaluate the efficiency of initiation with endothelin receptor antagonists, ambrisentan or bosentan, followed by sequential combination with phosphodiesterase-5 inhibitors and prostanoids in the treatment of pulmonary arterial hypertension, from the Spanish National Health System perspective. A Markov model was developed based on the four New York Heart Association functional classes. A panel of three experts reached a consensus on patient management based on clinical practice. Patients revised their treatment every 12 weeks, based on their health status and previous medication records. Pharmacological treatment costs and costs associated with very frequent adverse events (AE) were considered in a horizon of 60 weeks. Outcomes were measured in qualityadjusted life years (QALY). A probabilistic sensitivity analysis was performed. No clinically relevant differences in QALY per-patient and year were found for initiation with ambrisentan and bosentan: 0.6853 and 0.6902, respectively. Initiation with ambrisentan resulted in lower pharmacological treatment and AE management costs: ?35,550 and ?117 versus ?40,224 and ?171. In the sensitivity analysis, initiation with ambrisentan resulted in a negative significant cost difference: ?-4,982; CI95%[?- 8,014; ?-2,500]; while no significant differences in QALY were found: -0.0044; CI95%[-0.0189; 0.0101]. Initiation with ambrisentan followed by sequential combination with phosphodiesterase-5 inhibitors and prostanoids yields comparable outcomes at lower costs than initiation with bosentan.

Costs of management of patients with coronary artery disease in Poland: the multicenter RECENT study

Treatment of coronary artery disease (CAD) generates the major part of public health expenditure in the developed countries. The aim of the study was to estimate costs associated with the diagnosis and treatment of patients with CAD in Poland. Costs were estimated in a representative sample of 2593 patients with CAD receiving general practitioner (n = 1977) or specialist care (n = 616) in 2005 (the multicenter RECENT study). Data from the National Health Fund, Social Insurance Institution, Central Statistical Office, and current literature were used. The total annual cost of CAD reached €2254.17 per patient, with 48% accounting for direct medical costs (drugs, medical consultations, laboratory tests, diagnostic procedures, invasive treatment, hospitalizations, emergency care) and 52% for indirect costs (related to absence at work and disability). Eighty-one percent of total direct medical costs were covered by the public payer (including 30% of pharmacological treatment costs). Direct medical costs covered by the public payer were higher in men and in patients with more severe angina symptoms (both P <0.05). In the model based on the lowest prevalence of CAD (estimated based on the real population of patients treated in 2005), direct medical costs covered by the public payer reached €617.6 million, i.e., around 7% of the total public health expenditure in Poland in 2005. Modern management of CAD imposes enormous economic burden on the public health system in Poland. There is a need to develop and implement strategies that would optimize health care costs associated with the treatment of CAD.

Análisis comparativo de costos directos y funcionamiento global en personas afectadas por trastorno bipolar I y II, en tratamiento ambulatorio

ObjectiveTo evaluate the direct costs, the functional level and the employment rate reported for a random sample of people with Bipolar Disorders (BD) I and II that are cared for as outpatients. MethodsThe direct costs of outpatient treatment for 165 patients diagnosed with types I and II bipolar disorders were compared and analyzed (the monthly cost of pharmacological treatments, the number of consultations per month, the number of hospitalizations and the days spent in hospital). Global functioning was estimated and their employment was recorded. Results51,5% (N=85) of the patients had been diagnosed with type I BD and 48.5% (N=80) with BD type II. 40,6% of the patients were unemployed; the GAF score was 73 ± 12,59. Monthly costs of pharmacological treatment were $480 ± $350,4 per patient, with no difference between the type of BD. A larger percentage of type I BD patients had been hospitalized and received anti-psychotic drugs, whereas a greater percentage of BD II patients received anti-depressants and went to a psychologist. DiscussionPatients diagnosed with BDI and BD II must face pharmacological treatments that imply an average cost equal to one quarter of the minimum income in our country, independent of the type of bipolar disorder they suffer. Both groups of patients presented a high level of unemployment and relatively low global functioning scores.