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.

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.

[Budgetary impact for the National Health System of apixaban prophylaxis of venous thromboembolism in patients undergoing total knee or hip replacement]. / Impacto presupuestario para el Sistema Nacional de Salud de la prevención del trombolismo venoso con apixaban en pacientes sometidos a artroplastia total de rodilla o cadera.

BACKGROUND: Due to high health care costs of venous thromboembolism (VTE), economic analyses are needed to determine the efficiency of different drug treatments. Consequently, a study was conducted to estimate the budgetary impact for the National Health System (NHS) with apixaban for prevention of venous thromboembolism (VTE) in total hip (THR) or knee (TKR) replacement. METHODS: Cost considered: the drugs for the prevention of VTE (apixaban, dabigatran, enoxaparin, fondaparinux, other heparins, rivaroxaban and warfarin) and the complications of VTE in the short term and in 5 years (deep vein thrombosis, pulmonary embolism, bleedings and the post-thrombotic syndrome). The effectiveness of prophylaxis was estimated using a meta-analysis. The VTE rates and death with apixaban are lower in THR and TKR than enoxaparin (-3.5% and -10.0%, respectively) with less bleeding events (-0.7% and -1.6%, respectively). Population data and unit costs were obtained from Spanish sources. TIME HORIZON: 5 years. All costs were discounted by 3.5% annually. Five years after commercialization, the use of apixaban was estimated to account for 23% of the prophylaxis of VTE and the use of enoxaparin decrease from the 60% to 33%. RESULTS: Apixaban´s introduction for the prophylaxis of VTE would have a significant impact for the NHS, resulting in a saving of 547,422 Euro over a period of 5 years. In the case of outpatient administration of heparin did not have a cost, the savings for the NHS five years amount to 270,068 Euro. CONCLUSIONS: According to this study, the introduction of apixaban may reduce the rate of VTE and bleeding compared with enoxaparin, decreasing the expenditure of NHS in VTE prophylaxis.

[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.