Jm Rodriguez

Cost-Effectiveness of Sacral Neuromodulation Compared to Botulinum Neurotoxin A or Continued Medical Management in Refractory Overactive Bladder

OBJECTIVES This study assessed the cost-effectiveness and health-care budget impact of sacral neuromodulation (SNM) in refractory idiopathic OAB-wet patients in Spain. METHODS A 10-year Markov analytic model was developed to estimate quality-adjusted life-years (QALYs) gained and incontinence episode avoided associated with SNM therapy compared with botulinum neurotoxin A (BoNT-A) or continued optimized medical treatment (OMT). RESULTS At 10 years, the cumulative costs of SNM, BoNT-A, and OMT were €29,166, €29,458, and €29,370, respectively, whereas the QALYs for SNM, BoNT-A, and OMT are 6.89, 6.38, and 5.12, respectively. Consequently, incremental cost-effectiveness ratios (ICERs) for SNM demonstrate that although the initial costs for SNM are higher than those for the other treatments, decreasing follow-up costs coupled with consistently greater effectiveness in the long term make SNM the economically dominant option at 10 years. Sensitivity analyses suggest that 99.7% and 99.9% (for SNM vs. BoNT-A and OMT, respectively) of the 1000 Monte Carlo iterations fall within the €30,000 cost-effectiveness threshold, considered to be acceptable in Spain. The 10-year incremental cost per incontinence episode avoided for SNM also makes this therapy the dominant option compared to BoNT-A or OMT. Additionally, the estimated budget impact of the gradually increased referral for SNM for the management of OAB patients in Spain is small. CONCLUSIONS As a treatment option for refractory idiopathic OAB, at 10 years, SNM provides a considerable possibility of symptom and quality-of-life improvement and is cost-effective compared to BoNT-A or continued OMT.

Cost–effectiveness analysis of sacral neuromodulation (SNM) with Interstim for fecal incontinence patients in Spain

ABSTRACT Introduction: Fecal incontinence (FI) is a condition with a high impact on the psychological and social life of healthy people. Interstim, the sacral neuromodulation (SNM) therapy, has shown higher effectiveness and safety rates than surgical procedures like dynamic graciloplasty or artificial anal sphincter in patients with intact anal sphincter (IAS) and after sphincteroplasty in patients with structurally deficient anal sphincter (SDAS). Objective: To assess the cost-effectiveness of FI management in two scenarios – with and without SNM – and to estimate the potential budget impact of its progressive introduction in the Spanish setting. Methods: Two decision analytical models were developed (IAS and SDAS patients) representing the possible clinical paths for each of the scenarios (with and without SNM), as well as its clinical and economic consequences in the mid-to long term with a Markov model. Clinical and resource use data were retrieved from the literature and validated by a clinician expert panel. Effectiveness was measured with both QALYs and symptom-free years (SFY). A 3% discount rate was used for future costs and benefits (time horizon = 5 years). Prevalence figures were combined with Interstim sales forecasts to estimate the total number of patients to receive therapy over the next 5 years and the associated budget impact. Results: The introduction of Interstim in the therapeutic management of FI has an associated cost-effectiveness of €16 181 (IAS patients) and €22 195 (SDAS patients) per QALY gained. The progressive introduction of Interstim in 75 to 100 patients/year will have an estimated budget impact of 0.1% of incremental costs in patients with FI. Conclusions: Introducing Interstim in the management of FI in IAS and SDAS patients in the Spanish setting has shown to be an efficient measure with an incremental cost–effectiveness ratio below the accepted Spanish threshold (around €35 000/QALY), and with a relatively low additional cost for the Spanish NHS.

Economic evaluation and budget impact analysis of the Endeavor® drug-eluting stent in Spain

OBJECTIVES Endeavor is a drug-eluting stent (DES) with superior results to the bare metal stent (BMS) and similar efficacy to other DES in terms of revascularization. The aim of this study was to assess the costs and benefits of Endeavor, other DES, BMS and coronary artery bypass grafts (CABG) in Spain. METHODS A Markov model with a 5-year time was used to reflect the management of patients with de novo coronary artery lesions in Spain. Model probabilities were derived from systematic reviews and randomized controlled trials of Endeavor. Health resources and costs were obtained from local data and were validated by experts. Effectiveness was measured as the number of revascularizations avoided, the major adverse coronary events (MACE) avoided and the quality adjusted life-years (QALYs) gained. RESULTS Endeavor had higher total costs than the BMS. The cost per revascularization avoided with Endeavor was 6,851 euro (at 1 year) and 10,831 euro (at 5 years). In terms of cost per MACE avoided with Endeavor, the results were 7,003 euro and 11,322 euro, respectively, and in terms of costs of QALY gained were 132,877 euro, 34,229 euro and 10,505 euro at 1, 2, and 5 years, respectively. The budget impact of the progressive introduction of Endeavor would be practically null, representing 0.4% of the total cost of percutaneous coronary interventions at 5 years. CONCLUSIONS The use of the Endeavor stent compared with BMS and CABG represents efficient resource use in patients with coronary artery disease, with cost-effectiveness results below the threshold of efficiency defined in Spain.

Evaluación económica e impacto presupuestario del stent recubierto Endeavor® en España

OBJECTIVES Endeavor is a drug-eluting stent (DES) with superior results to the bare metal stent (BMS) and similar efficacy to other DES in terms of revascularization. The aim of this study was to assess the costs and benefits of Endeavor, other DES, BMS and coronary artery bypass grafts (CABG) in Spain. METHODS A Markov model with a 5-year time was used to reflect the management of patients with de novo coronary artery lesions in Spain. Model probabilities were derived from systematic reviews and randomized controlled trials of Endeavor. Health resources and costs were obtained from local data and were validated by experts. Effectiveness was measured as the number of revascularizations avoided, the major adverse coronary events (MACE) avoided and the quality adjusted life-years (QALYs) gained. RESULTS Endeavor had higher total costs than the BMS. The cost per revascularization avoided with Endeavor was 6,851 euro (at 1 year) and 10,831 euro (at 5 years). In terms of cost per MACE avoided with Endeavor, the results were 7,003 euro and 11,322 euro, respectively, and in terms of costs of QALY gained were 132,877 euro, 34,229 euro and 10,505 euro at 1, 2, and 5 years, respectively. The budget impact of the progressive introduction of Endeavor would be practically null, representing 0.4% of the total cost of percutaneous coronary interventions at 5 years. CONCLUSIONS The use of the Endeavor stent compared with BMS and CABG represents efficient resource use in patients with coronary artery disease, with cost-effectiveness results below the threshold of efficiency defined in Spain.

Concepto e instrumentos

Unidad Docente de Medicina de Familia y Universidad Jaime I, Castellón, España Universidad Jaime I, Castellón, España Departamento de Investigación Clı́nica, Lilly, Madrid, España Economı́a de la Salud, Medtronic, Madrid, España Investigación de Resultados en Salud, Novartis, Barcelona, España Departamento de Psicologı́a de la Salud, Universidad de Alicante, Alicante, España Disponible en Internet el 29 de abril de 2009

Development of a population-based cost-effectiveness model of chronic graft-versus-host disease in Spain.

BACKGROUND Chronic graft-versus-host disease (cGvHD) is the leading cause of late nonrelapse mortality (transplant-related mortality) after hematopoietic stem cell transplant. Given that there are a wide range of treatment options for cGvHD, assessment of the associated costs and efficacy can help clinicians and health care providers allocate health care resources more efficiently. OBJECTIVE The purpose of this study was to assess the cost-effectiveness of extracorporeal photopheresis (ECP) compared with rituximab (Rmb) and with imatinib (Imt) in patients with cGvHD at 5 years from the perspective of the Spanish National Health System. METHODS The model assessed the incremental cost-effectiveness/utility ratio of ECP versus Rmb or Imt for 1000 hypothetical patients by using microsimulation cost-effectiveness techniques. Model probabilities were obtained from the literature. Treatment pathways and adverse events were evaluated taking clinical opinion and published reports into consideration. Local data on costs (2010 Euros) and health care resources utilization were validated by the clinical authors. Probabilistic sensitivity analyses were used to assess the robustness of the model. RESULTS The greater efficacy of ECP resulted in a gain of 0.011 to 0.024 quality-adjusted life-year in the first year and 0.062 to 0.094 at year 5 compared with Rmb or Imt. The results showed that the higher acquisition cost of ECP versus Imt was compensated for at 9 months by greater efficacy; this higher cost was partially compensated for (€517) by year 5 versus Rmb. After 9 months, ECP was dominant (cheaper and more effective) compared with Imt. The incremental cost-effectiveness ratio of ECP versus Rmb was €29,646 per life-year gained and €24,442 per quality-adjusted life-year gained at year 2.5. Probabilistic sensitivity analysis confirmed the results. The main study limitation was that to assess relative treatment effects, only small studies were available for indirect comparison. CONCLUSION ECP as a third-line therapy for cGvHD is a more cost-effective strategy than Rmb or Imt.

Concept and tools [Concepto e instrumentos]

Unidad Docente de Medicina de Familia y Universidad Jaime I, Castellón, España Universidad Jaime I, Castellón, España Departamento de Investigación Clı́nica, Lilly, Madrid, España Economı́a de la Salud, Medtronic, Madrid, España Investigación de Resultados en Salud, Novartis, Barcelona, España Departamento de Psicologı́a de la Salud, Universidad de Alicante, Alicante, España Disponible en Internet el 29 de abril de 2009

PCN76 A SIMULATION MODELLING APPROACH TO QUANTIFY THE COST-EFFECTIVENESS OF EXTRA-CORPOREAL PHOTOPHERESIS IN CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD) IN SPAIN

PCN74 ADDING ZOLEDRONIC ACID TO ENDOCRINE THERAPY IN PREMENOPAUSAL WOMEN WITH HORMONE-RESPONSIVE EARLY BREAST CANCER CAN BE COST-EFFECTIVE FROM ITALIAN, SPANISH, AND PORTUGUESE HEALTH-CARE PERSPECTIVES, BASED ON THE ABCSG-12 TRIAL Taneja C, Delea TE, Kaura S, Sternini P, Gerzeli S, Gnant M PAI, Brookline, MA, USA; Policy Analysis Inc., Brookline, MA, USA; Novartis Pharmaceuticals Corporation, Florham Park, NJ, USA; Novartis Oncology, Origgio, Italy; University of Pavia, Pavia, Italy; Medical University of Vienna, Vienna, Austria OBJECTIVES: To retrospectively estimate the cost-effectiveness of adding zoledronic acid (ZOL; 4 mg intravenously q6m) to adjuvant endocrine therapy (ET; goserelin plus tamoxifen or anastrozole) in premenopausal women with endocrine-responsive early breast cancer (ERBC) from Italian, Spanish, and Portuguese health-care perspectives. METHODS: A Markov model projected lifetime outcomes and costs of care for ERBC patients receiving 3 years’ adjuvant ET or adjuvant ET plus ZOL. Cost-effectiveness was measured as the incremental cost per quality-adjusted life-year (QALY) gained. Probabilities of BC recurrence were from the ABCSG-12 trial. Other probabilities and country-specifi c costs were from published literature. Results were generated under two scenarios: 1) benefi ts of ZOL persist to the 7-year maximum follow-up (trial benefi t); 2) benefi ts persist until recurrence or death (lifetime benefi t). RESULTS: Expected ZOL costs (medication and administration) were c1500 (Italy), c2100 (Spain), and c2300 (Portugal). Under the trial benefi t scenario, resulting savings from reduced BC recurrence partially offset costs by c900 (both Spain and Italy) and c200 (Portugal). Therefore, projected total ZOL costs were c600 (Italy), c1300 (Spain), and c2100 (Portugal). Projected QALY gains with ZOL were 0.46 (Italy), 0.47 (Spain), and 0.33 (Portugal). Costs per QALY gained were c1304 (Italy), c2766 (Spain), and c6364 (Portugal) (all favorable). Under the lifetime benefi t scenario, savings from reduced BC recurrences completely offset ZOL costs and yielded net savings of c2900 (Italy) and c2100 (Spain). Incremental total costs were c1400 for Portugal. Projected QALY gains with ZOL were 1.57 (Italy), 1.59 (Spain), and 0.96 (Portugal). The cost per QALY gained for Portugal was highly favorable (c1458). CONCLUSIONS: Adding ZOL to ET in premenopausal women with ERBC can be highly cost-effective (7 years.

PHP63 CONSENSUS OF KEY DECISION MAKERS AND EXPERTS ON THE PRESENT AND FUTURE ON THE ASSESSMENT OF HEALTH TECHNOLOGIES IN SPAIN

PHP59 TRENDS IN COMPARATIVE EFFECTIVENESS OF TOP 20 HIGHEST SELLING DRUGS Aggarwal S, White N, Stevens C PAREXEL INTERNATIONAL, Bethesda, MD, USA OBJECTIVES: The recently made coverage decisions by UK’s NICE, Scotland’s SMC and the allocation of

PPN4 ECONOMIC EVALUATION COMPARING BMP-2 (INDUCTOSTM) VERSUS CURRENT TREATMENT IN CHRONIC LOWER BACK PAIN IN THE SPANISH SETTING

1.1 Billion for comparative effectiveness research by the United States, are strong indicators of trends in pricing and reimbursement that are likely to be observed in the future. To gain an additional insight into these trends, we analyzed the cost effectiveness studies for the top twenty highest selling drugs (