RESUMEN
OBJECTIVE: To assess the costs of oral treatment with Gilenya® (fingolimod) compared to intravenous infusion of Tysabri® (natalizumab) in patients with relapsing-remitting multiple sclerosis (RRMS) in The Netherlands. METHODS: A cost-minimization analysis was used to compare both treatments. The following cost categories were distinguished: drug acquisition costs, administration costs, and monitoring costs. Costs were discounted at 4%, and incremental model results were presented over a 1, 2, 5, and 10 year time horizon. The robustness of the results was determined by means of a number of deterministic univariate sensitivity analyses. Additionally, a break-even analysis was carried out to determine at which natalizumab infusion costs a cost-neutral outcome would be obtained. RESULTS: Comparing fingolimod to natalizumab, the model predicted discounted incremental costs of -2966 (95% CI: -4209; -1801), -6240 (95% CI: -8800; -3879), -15,328 (95% CI: -21,539; -9692), and -28,287 (95% CI: -39,661; -17,955) over a 1, 2, 5, and 10-year time horizon, respectively. These predictions were most sensitive to changes in the costs of natalizumab infusion. Changing these costs of 255 within a range from 165-364 per infusion resulted in cost savings varying from 4031 to 8923 after 2 years. The additional break-even analysis showed that infusion costs-including aseptic preparation of the natalizumab solution-needed to be as low as the respective costs of 94 and 80 to obtain a cost neutral result after 2 and 10 years. LIMITATIONS: Neither treatment discontinuation and subsequent re-initiation nor patient compliance were taken into account. As a consequence of the applied cost-minimization technique, only direct medical costs were included. CONCLUSION: The present analysis showed that treatment with fingolimod resulted in considerable cost savings compared to natalizumab: starting at 2966 in the first year, increasing to a total of 28,287 after 10 years per RRMS patient in the Netherlands.
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Anticuerpos Monoclonales Humanizados/economía , Ahorro de Costo , Servicios de Salud/economía , Inmunosupresores/economía , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Glicoles de Propileno/economía , Esfingosina/análogos & derivados , Anticuerpos Monoclonales Humanizados/uso terapéutico , Costos y Análisis de Costo , Clorhidrato de Fingolimod , Servicios de Salud/estadística & datos numéricos , Humanos , Inmunosupresores/uso terapéutico , Modelos Econométricos , Esclerosis Múltiple Recurrente-Remitente/economía , Natalizumab , Países Bajos , Glicoles de Propileno/uso terapéutico , Esfingosina/economía , Esfingosina/uso terapéuticoRESUMEN
We have completed a multicenter, randomized controlled phase III clinical trial in Stages II and III colon cancer patients with active specific immunotherapy (ASI) using autologous tumor cells with an immunomodulating adjuvant bacillus Callmette-Guerin (BCG) vaccine (OncoVAX) in an adjuvant setting. In this study, patients were randomized to receive either OncoVAX therapy or no therapy after surgical resection of the primary tumor and stratified by stage of disease. Since the biologic essence of the effective tumor immunotherapy is the presence in the vaccine of a minimum number of viable, metabolically active, autologous tumor cells, the processing of the vaccine product, occurred within 48 h after surgery. Analysis of prognostic benefit in the pivotal phase III trial, with a 5.8 year median follow-up, showed that a beneficial effect of OncoVAX is statistically significant for all endpoints including recurrence-free interval, overall survival, and recurrence-free survival in Stage II colon cancer patients. Surgery alone cures approximately 65% of Stage II (Dukes B2, B3) colon cancer patients. In the remaining patients, OncoVAX in an adjuvant setting, significantly prolongs recurrence-free interval (57.1% relative risk reduction) and significantly improves 5-year overall survival and recurrence-free survival. No statistically significant prognostic benefits were achieved in Stage III (Duke's C1-C3) patients. A health economics assessment was performed on these results in Stage II colon cancer patients using disease-free survival and overall survival (for the entire intent-to-treat population). Cost-effectiveness, cost-utility and sensitivity analysis were applied with, cost of life years, recurrence-free life years and quality adjusted life years (QALYs) as the primary endpoints to this analysis. The perspective of the economic analysis was the current direct medical cost established by the health care providers. The introduction of new technologies often leads to additional costs. This report verified that the use of OncoVAX for patients with Stage II colon cancer not only has significant prognostic benefit and positive clinical outcomes, but also showed that OncoVAX therapy yields impressive health economics benefits.
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Vacuna BCG/uso terapéutico , Vacunas contra el Cáncer/uso terapéutico , Neoplasias del Colon/terapia , Adulto , Anciano , Anciano de 80 o más Años , Vacunas contra el Cáncer/economía , Neoplasias del Colon/economía , Neoplasias del Colon/mortalidad , Neoplasias del Colon/cirugía , Terapia Combinada , Análisis Costo-Beneficio , Supervivencia sin Enfermedad , Femenino , Humanos , Inmunoterapia Activa , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Prospectivos , Tasa de SupervivenciaRESUMEN
OBJECTIVE: To determine the incremental cost-effectiveness ratio (ICER) of cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) vs. CHOP plus rituximab (R-CHOP) in diffuse large B-cell lymphoma (DLBCL) patients in the Netherlands. METHODS: A state transition model was developed to estimate the clinical course, costs and quality of life of patients with stage II, III or IV DLBCL receiving initial treatment with CHOP or R-CHOP to arrive at the ICER. The base year for the cost analysis was 2002 and was performed from the societal perspective. Only direct medical costs were included. The time horizon of the model was 15 yr and both costs and effects were discounted at 4%. Sensitivity analyses were performed to determine the effect of varying base-line assumptions of the model. RESULTS: The incremental gain in quality adjusted life years (QALYs) was 0.88 in both the younger and the older patient groups. The costs were 12 343 higher in the younger group of patients and 15 860 in the older patients. This resulted in an ICER of 13 983 for the younger and 17 933 for the older patients per QALY gained. These results were sensitive to the time horizon of the model, other variations had a marginal impact on the outcome. CONCLUSION: The addition of rituximab to standard therapy for DLBCL results in a gain of 0.88 QALYs. The ICER of 13 983 for younger and 17 933 for older patients per QALY gained should, seen in the light of disease severity, be considered acceptable by most policy makers in priority setting for budget allocation.
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Anticuerpos Monoclonales/economía , Linfoma de Células B Grandes Difuso/economía , Anticuerpos Monoclonales de Origen Murino , Protocolos de Quimioterapia Combinada Antineoplásica/economía , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Presupuestos , Análisis Costo-Beneficio , Toma de Decisiones , Humanos , Linfoma de Células B/tratamiento farmacológico , Linfoma de Células B/economía , Linfoma de Células B/mortalidad , Linfoma de Células B Grandes Difuso/tratamiento farmacológico , Linfoma de Células B Grandes Difuso/mortalidad , Método de Montecarlo , Países Bajos , Calidad de Vida , Rituximab , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
OBJECTIVE: To estimate the real costs of allogeneic haematopoetic stem-cell transplantation and to compare these with the historically determined budgets that are made available for this purpose ([symbol: see text] 70,038 for genetically related donors and [symbol: see text] 76,826 for unrelated donors). DESIGN: Cost analysis. METHODS: In the period 1994-1999, the direct medical costs (price level of 1998) of bone-marrow transplantation from related donors (BMT), stem-cell transplantation from unrelated donors (VUD-SCT) and allogeneic peripheral-blood stem-cell transplantation (PBSCT) from related donors were determined on the basis of data on adult patients with either acute myeloid leukaemia (n = 66) or acute lymphocytic leukaemia (n = 31). First, the medical resource use by these patients was determined and multiplied by the unit costs of each of the items. Second, a structural programme for allogeneic stem-cell transplantation brings along costs that are not evident from the registration of the medical resource use (e.g., the costs of pretransplantation screening and the selection of the donor). The costs of these items were calculated by taking inventory in the hospitals and assessed by experts. RESULTS: The average costs per transplanted patient were [symbol: see text] 98,334 (BMT), [symbol: see text] 151,754 (VUD-SCT) and [symbol: see text] 98,977 (PBSCT) during the first two years after transplantation. The greater part of the costs was incurred in the transplantation phase. In VUD-SCT, one-third of the total cost was due to the costs of finding a suitable donor. CONCLUSION: The current budget for allogeneic stem-cell transplantation is insufficient to perform the transplantations adequately. Periodic evaluation of the budgets for complicated procedures based on cost analyses has added value for the evaluation of the development of these procedures in time and can thereby contribute to the quality and continuity of care.
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Leucemia Mieloide Aguda/terapia , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Trasplante de Células Madre/economía , Adolescente , Adulto , Trasplante de Médula Ósea/economía , Análisis Costo-Beneficio , Femenino , Trasplante de Células Madre Hematopoyéticas/economía , Humanos , Leucemia Mieloide Aguda/economía , Masculino , Persona de Mediana Edad , Leucemia-Linfoma Linfoblástico de Células Precursoras/economía , Obtención de Tejidos y Órganos/economía , Trasplante Autólogo/economía , Trasplante Homólogo/economíaRESUMEN
OBJECTIVE: To determine the average cost-effectiveness ratio of treatment of patients with chronic myeloid leukaemia (CML): with first-line interferon alpha-2a (IFN) or with second-line imatinib following IFN failure. DESIGN: Cost-effectiveness analysis. METHOD: A general cost-effectiveness analysis was performed using a model. This model consists of two phases: an induction phase of eight months, in which newly-diagnosed patients are treated with either IFN or imatinib, and a chronic treatment phase wherein patients are treated according the result of the induction phase. The model calculated the costs and effects of the treatment. Input for this model was derived from literature and expert opinion. Costs were based on real cost prices and tariffs. RESULTS: Treatment with imatinib resulted in 6.67 quality-adjusted life years (QALYs) and treatment with IFN resulted in 4.98 QALYs. Average costs of treatment with 5 million IU/day of IFN were [symbol: see text] 76,969 and [symbol: see text] 53,257 with 3 million IU/day. For imatinib at 400 mg/day the costs were [symbol: see text] 140,765 per patient. Costs per QALY were [symbol: see text] 15,445, [symbol: see text] 10,687 and [symbol: see text] 21,082, respectively. CONCLUSION: The addition of imatinib to the treatment options in CML resulted in increased quality-adjusted survival, but also higher costs of treatment.
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Antineoplásicos/uso terapéutico , Interferón-alfa/uso terapéutico , Leucemia Mielógena Crónica BCR-ABL Positiva/tratamiento farmacológico , Piperazinas/uso terapéutico , Pirimidinas/uso terapéutico , Antineoplásicos/economía , Benzamidas , Análisis Costo-Beneficio , Humanos , Mesilato de Imatinib , Interferón alfa-2 , Interferón-alfa/economía , Leucemia Mielógena Crónica BCR-ABL Positiva/economía , Piperazinas/economía , Pirimidinas/economía , Calidad de Vida , Proteínas Recombinantes , Resultado del TratamientoRESUMEN
OBJECTIVE: To quantify medical costs associated with bone metastases in patients with prostate cancer. Bone metastases in patients with prostate cancer are associated with considerable morbidity, negatively impact quality of life, and can add substantially to medical costs, given a median survival of 30-35 months from diagnosis of bone metastases. METHODS: A retrospective cost analysis from both a community and university hospital in The Netherlands was conducted. Twenty-eight patient records (14 from each hospital) were investigated to assess the impact of skeletal-related events (SREs), including fractures, spinal cord compression, and radiotherapy, on total direct medical costs and cost of hospitalization. Costs are given in EUROS (Euros). RESULTS: The average total cost of treatment was Euros 13,051 per patient over the 24-month follow-up period, which includes an average cost of Euros 6973 per patient to treat SREs. Treatment of SREs more than doubled total treatment costs. Patients in this analysis experienced, on average, one SRE per year, and the cost of SREs varied from Euros 1187 to Euros 40,948. CONCLUSIONS: Occurrence of SREs contributes significantly to the cost of care for patients with advanced prostate cancer. These data suggest that bisphosphonates, which can reduce pain and SREs, may reduce healthcare costs.
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Neoplasias Óseas/economía , Costos de la Atención en Salud , Neoplasias de la Próstata/economía , Anciano , Neoplasias Óseas/complicaciones , Neoplasias Óseas/secundario , Neoplasias Óseas/terapia , Gastos en Salud , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Neoplasias de la Próstata/patología , Neoplasias de la Próstata/terapia , Estudios RetrospectivosRESUMEN
Allogeneic stem cell transplantation (SCT) is one of the most expensive medical procedures. However, only a few studies to date have addressed the costs of HLA-identical sibling transplantation and only one study has reported costs of unrelated transplantation. No recent cost analysis with a proper follow-up period and donor identification expenses is available on related or voluntary matched unrelated donor (MUD) SCT for adult AML or ALL. Therefore, we calculated direct medical (hospital) costs based on 97 adults who underwent HLA-identical sibling bone marrow transplantation (BMT) or peripheral blood stem cell transplantation (PBSCT), and patients who received a graft from a MUD between 1994 and 1999. The average costs per transplanted patient were Euro 98,334 (BMT), Euro 151,754 (MUD), and Euro 98,977 (PBSCT), including donor identification expenses, 2 years follow-up and costs of patients who were not transplanted after they had been planned to receive an allograft. The majority of these costs was generated during the hospitalisation for graft infusion. For MUD transplants, nearly one-third of these costs was spent on the search for a suitable donor. For patients who were alive after 2 years, cumulative expenses were calculated to be Euro 103,509 (BMT), Euro 173,587 (MUD), and Euro 105,906 (PBSCT).