Economic evaluation of azoles as primary prophylaxis for the prevention of invasive fungal infections in Spanish patients undergoing allogeneic haematopoietic stem cell transplant.

Patients undergoing allogeneic haematopoietic stem cell transplantation (alloHSCT) are at risk of developing invasive fungal infections (IFIs). Even with introduction of oral triazole antifungal agents (fluconazole, itraconazole, posaconazole and voriconazole) IFI-associated morbidity and mortality rates and economic burden remain high. Despite their proven efficacy, it is currently unknown which is the most cost-effective antifungal prophylaxis (AFP) agent. To determine the costs and outcomes associated with AFP, a decision-analytic model was used to simulate treatment in a hypothetical cohort of 1000 patients undergoing alloHSCT from the perspective of the Spanish National Health System. Generic itraconazole was the least costly AFP (€162) relative to fluconazole (€500), posaconazole oral suspension (€8628) or voriconazole (€6850). Compared with posaconazole, voriconazole was associated with the lowest number of breakthrough IFIs (36 vs 60); thus, the model predicted fewer deaths from breakthrough IFI for voriconazole (24) than posaconazole (33), and the lowest predicted costs associated with other licensed antifungal treatment and IFI treatment in a cohort of 1000. Voriconazole resulted in cost savings of €4707 per patient compared with posaconazole. Itraconazole demonstrated a high probability of being cost-effective. As primary AFP in alloHSCT patients 180 days posttransplant, voriconazole was more likely to be cost-effective than posaconazole regarding cost per additional IFI and additional death avoided.

Cost analysis of voriconazole versus liposomal amphotericin B for primary therapy of invasive aspergillosis among patients with haematological disorders in Germany and Spain.

BACKGROUND: The current healthcare climate demands pharmacoeconomic evaluations for different treatment strategies incorporating drug acquisition costs, costs incurred for hospitalisation, drug administration and preparation, diagnostic and laboratory testing and drug-related adverse events (AEs). Here we evaluate the pharmacoeconomics of voriconazole versus liposomal amphotericin B as first-line therapies for invasive aspergillosis (IA) in patients with haematological malignancy and prolonged neutropenia or who were undergoing haematopoietic stem-cell transplantation in Germany or Spain. METHODS: A decision analytic model based on a decision tree was constructed to estimate the potential treatment costs of voriconazole versus liposomal amphotericin B. Each model pathway was defined by the probability of an event occurring and the costs of clinical outcomes. Outcome probabilities and cost inputs were derived from the published literature, clinical trials, expert panels and local database costs. In the base case, patients who failed to respond to first-line therapy were assumed to experience a single switch between comparator drugs or the other drug was added as second-line treatment. Base-case evaluation included only drug-management costs and additional hospitalisation costs due to severe AEs associated with first- and second-line therapies. Sensitivity analyses were conducted to assess the robustness of the results. Cost estimates were inflated to 2011 euros (€). RESULTS: Based on clinical trial success rates of 52.8% (voriconazole) and 50.0% (liposomal amphotericin B), voriconazole had lower total treatment costs compared with liposomal amphotericin B in both Germany (€ 12,256 versus € 18,133; length of therapy [LOT] = 10-day intravenous [IV] + 5-day oral voriconazole and 15-day IV liposomal amphotericin B) and Spain (€ 8,032 versus € 10,516; LOT = 7-day IV + 8-day oral voriconazole and 15-day IV liposomal amphotericin B). Assuming the same efficacy (50.0%) in first-line therapy, voriconazole maintained a lower total treatment cost compared with liposomal amphotericin B. Cost savings were primarily due to the lower drug acquisition costs and shorter IV LOT associated with voriconazole. Sensitivity analyses showed that the results were sensitive to drug price, particularly the cost of liposomal amphotericin B. CONCLUSIONS: Voriconazole is likely to be cost-saving compared with liposomal amphotericin B when used as a first-line treatment for IA in Germany and Spain.

[Utilization of health care resources and cost associated to fasciectomy in Dupuytren's disease in Spain]. / Utilización de recursos sanitarios y costes asociados a la fasciectomía en la enfermedad de Dupuytren en España.

OBJECTIVE: To estimate the healthcare resource utilization and their associated costs secondary to fasciectomy of Dupuytren s disease (DD) treated under usual medical practice in Spain. METHODS: This multicenter, observational, retrospective cohort study, extracted data through the revision of medical records of three tertiary public hospitals. Each center should recruit 40 patients operated for DD, as principal diagnose of Minimum Data Set, in which the surgical procedure conducted was fasciectomy, during 2007-2009. To collect all the resources used during surgery, a specific chart form was designed. Demographic (age, gender, occupational status), clinical (stage of contracture and comorbilities) and healthcare utilization (hospitalizations, medical visits, tests, drugs) data were collected under medical routine. Comparisons between stage of contracture grouped (I: stage N, 1 & 2; II: stage 3 & 4) and centers were made. RESULTS: A total of 123 subjects (52% group I; 86.2% men; 35.8% active workers) were identified. 81.3% of patients presented at least one comorbidity, being hypertension the most frequent. 28.4% of patients were operated in ambulatory surgery and 71.6% hospitalized. All the patients had follow-up visits after surgery, 27% needed physical therapy, 88% performed preoperative tests and 8% visit the emergency room after surgery. Healthcare mean (SD) costs were as follows: fasciectomy €1,074 (0); hospitalizations €978 (743); ambulatory €186 (10); follow-up visits €260 (173); emergency rooms €13 (53); tests €78(43); drugs €7 (9); physical therapy €46 (134). Mean total costs were €2,250 (839). There were no significant differences between study groups grouped by stage of contracture. However, the center and the severity of the CD seem explanatory variables of cost, p<0.05. CONCLUSIONS: Healthcare resources utilization for surgical treatment of Dupuytren's disease may cost €2,250 (839) per fasciectomy treated under usual medical practice.

Modelling the cost-effectiveness of pregabalin versus usual care in daily practice in the treatment of refractory generalised anxiety disorder in Spain.

PURPOSE: To model the cost-effectiveness (CEA) of the use of pregabalin versus usual care (UC) in outpatients with refractory generalised anxiety disorder (GAD) treated in daily practice in mental health settings in Spain. METHODS: This CEA model used data extracted from a 6-month prospective non-interventional trial: the Amplification of Definition of ANxiety (ADAN) study, which was conducted to determine the cost-of-illness in GAD subjects. Refractory subjects were those who reported persistent symptoms of anxiety and showed suboptimal response in the Hamilton-anxiety scale (HAM-A ≥ 16) after a standard dose regimen of anxiolytics other than pregabalin, alone or in combination, over 6 months. The pregabalin arm was documented with data extracted from patients who received pregabalin in the study for the first time, added or replacing the existing therapy. In the UC arm, treatment might include one or more of the following: a serotonin selective reuptake inhibitor, a serotonin-norepinephrine reuptake inhibitor, other anti-depressants, a benzodiazepine or an anti-epileptic drug other than pregabalin. The time horizon of the modelling was 6 months in the base-case scenario, and the National Health System perspective was chosen to calculate costs. Effectiveness was expressed as quality-adjusted life years (QALYs) gained, which were derived using the EQ-5D questionnaire, at baseline and end-of-trial visits. Results of the CEA model was expressed as an incremental cost-effectiveness ratio (ICER) per QALY gained. Probabilistic sensitivity analysis using bootstrapping techniques was also carried out to obtain the cost-effectiveness plane and the corresponding acceptability curve. RESULTS: Data from a total of 429 subjects per arm (mean HAM-A score 25.7) meeting eligible criteria for inclusion in CEA modelling were extracted from the original trial. Compared with UC, pregabalin (average dose 218 mg/day) was associated with significantly higher QALY gain; 0.1209 ± 0.1030 versus 0.0994 ± 0.0979 (P = 0.003), but increased healthcare costs as well; 1,272 ± 1,240 versus 1,070 ± 1,177 (P < 0.069) and drug costs 525 ± 252 versus 219 ± 211 (P < 0.001), resulting in an ICER of 15,804/QALY (95 % CI 6,661; 37,186) for healthcare costs and 15,165/QALY (7,947; 31,754) when drug costs were considered alone. A total of 94 % of re-samples fell below the threshold of 30,000 per QALY. CONCLUSIONS: This evaluation modelling suggests that pregabalin may be cost-effective in comparison with UC in outpatients with refractory GAD treated in mental healthcare settings in daily practice in Spain.

Prospective study of the use of healthcare resources and economic costs in patients with fibromyalgia after treatment in routine medical practice.

OBJECTIVES: To estimate the burden and to prospectively analyse resources utilisation and costs in a cohort of treated patients with fibromyalgia (FM) in daily practice. METHODS: Prospective, observational, multicentre, 3-month study in 232 patients with FM according to the ACR criteria (98% women, 47 years), with no concomitant systemic diseases, followed in rheumatology units. The control group consisted of 110 subjects without FM or any other systemic condition, paired by age and gender. Clinical assessment, use of healthcare resources and treatments, out-of-pocket expenses, occupational status, days off work, and calculation of lost workdays equivalents were recorded. RESULTS: Patients had worse clinical status, four times the control group's healthcare costs, twelve times its indirect costs and six times its total costs. After the treatment, there was significant clinical improvement in the patient group, the healthcare costs were significantly reduced in all components except for drugs costs, which increased (p<0.001), and out-of-pocket expenses, which remained unaltered. Indirect costs were reduced (p<0.05) in the FM group only, mainly due to fewer days off work. The patient group presented a significantly greater variation in montly total costs than the controls; -€193.75 ± 781.9 vs. -€26.22 ± 402.7, p=0.006. The patients who most reduced their healthcare costs were actively employed. CONCLUSIONS: Treated patients with FM in daily practice improved their clinical status and were accompanied by a significant reduction in the cost of the illness. The extra cost of drugs is substantially compensated for by less use of other healthcare resources and fewer days off work.

An economic evaluation of pregabalin versus usual care in the management of community-treated patients with refractory painful diabetic peripheral neuropathy in primary care settings.

OBJECTIVE: To estimate the cost-effectiveness of pregabalin versus usual care (UC) in the management of community-treated patients with refractory painful diabetic peripheral neuropathy (pDPN) in primary care settings (PCS) in Spain. METHODS: Data was extracted from a 12-week registry study assessing costs of neuropathic pain in Spain. Pregabalin-naïve outpatients treated with UC or newly prescribed pregabalin were selected for inclusion in the cost-effectiveness analysis. Effectiveness was expressed as quality-adjusted life years (QALY) gain. Perspectives of the Spanish National Health System (NHS) and society (2006) were applied for cost calculations. Results were expressed as incremental cost-effectiveness ratio (ICER). Bootstrapping techniques (10,000 re-samples) were used to obtain the probabilistic ICER and the cost-effectiveness acceptability curve. RESULTS: A total of 189 patients were included in the economic analysis. Compared with UC, pregabalin was associated with higher QALY gain in a period of 12-weeks; 0.0406±0.0343 versus 0.0285±0.0350 (p=0.167). Overall total costs (€1368±1229 vs. €1258±1474; p=0.587) and healthcare costs (€628±590 vs. €469±420; p=0.134) were similar for both pregabalin and UC, respectively. ICERs for pregabalin varied from €5302 (95% CI: dominant; €144,105) for total costs to €14,381 (dominant; €115,648) for healthcare costs. Probabilistic sensitivity analyses showed that 79-84% of ICERs were below the threshold of €30,000/QALY. CONCLUSION: This study suggests that pregabalin may be cost-effective in the management of community-treated refractory outpatients, with pDPN when compared with usual care in the primary care setting in Spain. These findings may help policy makers when making health decision in the management of diabetes in the community.

[Fixed drug combinations in hypertension: a budget impact analysis for the Spanish Health System on the marketing of a fixed combination of olmesartan/amlodipine]. / Las combinaciones fijas en hipertensión: análisis de impacto presupuestario para el Sistema Nacional de Salud Español de la comercialización de la combinación fija de olmesartan/amlodipino.

OBJECTIVE: To carry out a budget impact analysis (BIA) of olmesartan/amlodipine (20/5, 40/5 and 40/10mg) marketed as a fixed combination (FC) in its approved indication for the National Health System (NHS). DESIG: We developed a decision tree model in order to estimate usual hypertension treatment algorithm in Spanish clinical practice. SETTINGS: The BIA has been developed from the perspective of the NHS for a period of 3 years (years 2010-2012). PARTICIPANTS: Spanish hypertensive population ≥ 35 years old. INTERVENTIONS: Introduction into the market of a fixed combination (FC) olmesartan/amlodipine in Spain. PRIMARY MEASURES: Expected costs to be assumed by the Spanish NHS (RRP-VAT) for hypertensive population able to be treated with the FC versus currently assumed costs by the NHS with free combination olmesartan and amlodipine. RESULTS: Estimated pharmaceutical costs in hypertensive population treated with olmesartan and amlodipine (2 pills) would be €25.2M (1(st) year), €26.4M (2011), €27.6M (2012), with a total 3-year period of €79.2M. According to patient tree model, the population able to be treated with FC would be 71,283 patients (2010), with a growth rate of 4.8% in the successive years, which supposes an annual cost of €21.2M (2010), €21.8M (2011) and €22.4M (2012), with a total 3-year period of €65.4M. The BIA shows savings of €13.8M in a total 3-year period. CONCLUSION: The BIA of FC olmesartan/amlodipine could generate net savings of €13.8M for the NHS in the period ranging from years 2010 to 2012.