Budget impact analysis of the fentanyl buccal tablet for treatment of breakthrough cancer pain

Josep Darbà,1 Lisette Kaskens,2 Rainel Sánchez-de la Rosa31University of Barcelona, Barcelona, 2BCN Health Economics and Outcomes Research SL, Barcelona, 3Medical and HEOR Department, TEVA Pharmaceutical Industries Ltd, Madrid, SpainBackground: The purpose of this study was to assess the economic impact of the fentanyl buccal tablet for the management of breakthrough cancer pain (BTcP) in Spain.Methods: A 4-year budget impact model was developed for the period 2012–2015 for patients with BTcP from the perspective of the Spanish National Health System. BTcP products included in this model were rapid-onset opioids containing fentanyl (buccal, sublingual, or nasal transmucosal). Prevalence data on cancer, BTcP, opioid use, and number of BTcP episodes were obtained from the literature. Input data on health care resources associated with opioid use and opioid-induced side effects were obtained by consulting experts in oncology from different Spanish hospitals. Resources used included drugs, medical and emergency visits, other nonpharmacologic treatments, and treatment of opioid-induced side effects. Unit costs were obtained from the literature, and a 3% discount rate was applied to costs. Based on the unit costs for drugs and health care resources, the annual BTcP treatment costs per patient associated with each fentanyl product were determined to estimate the overall budget impact based on the total treatment population and the percentage of drug utilization associated with each product. One-way sensitivity analyses were conducted to test the robustness of the model.Results: Patients treated with oral opioids for BTcP were estimated at 23,291 in 2012, with an increase up to 23,413 in 2015. The average annual budget savings, with an increase of fentanyl buccal tablets, fentanyl sublingual tablets, and intranasal fentanyl spray, and a decrease in oral transmucosal fentanyl citrate, was estimated at €2.6 million, which represents a 0.5% decrease in the total costs of BTcP over the next 4 years. Results of the sensitivity analysis showed that the model was most sensitive to drug cost per day for the fentanyl buccal tablet. A 50% decrease in the daily cost of the fentanyl buccal tablet resulted in the largest overall decrease in budget impact of €5.4 million.Conclusion: The increase in use of the fentanyl buccal tablet leads to overall savings in the budget impact for the Spanish National Health System. Although the economic impact of treatment for BTcP was shown to increase over 4 years due to population growth, the average annual cost per patient was reduced by €29 with increased use of the fentanyl buccal tablet.Keywords: cancer, breakthrough pain, economic analysis, costs, rapid onset opioid

Relationship between patient dependence and direct medical-, social-, indirect-, and informal-care costs in Spain

Josep Darbà,1 Lisette Kaskens2 1Department of Economics, University of Barcelona, 2BCN Health Economics and Outcomes Research SL, Barcelona, Spain Objective: The objectives of this analysis were to examine how patients' dependence on others relates to costs of care and explore the incremental effects of patient dependence measured by the Dependence Scale on costs for patients with Alzheimer's disease (AD) in Spain. Methods: The Co-Dependence in Alzheimer's Disease study is an 18 multicenter, cross-sectional, observational study among patients with AD according to the clinical dementia rating score and their caregivers in Spain. This study also gathered data on resource utilization for medical care, social care, caregiver productivity losses, and informal caregiver time reported in the Resource Utilization in Dementia Lite instrument and a complementary questionnaire. The data of 343 patients and their caregivers were collected through the completion of a clinical report form during one visit/assessment at an outpatient center or hospital, where all instruments were administered. The data collected (in addition to clinical measures) also included sociodemographic data concerning the patients and their caregivers. Cost analysis was based on resource use for medical care, social care, caregiver productivity losses, and informal caregiver time reported in the Resource Utilization in Dementia Lite instrument and a complementary questionnaire. Resource unit costs were applied to value direct medical-, social-, and indirect-care costs. A replacement cost method was used to value informal care. Patient dependence on others was measured using the Dependence Scale, and the Cumulative Index Rating Scale was administered to the patient to assess multi-morbidity. Multivariate regression analysis was used to model the effects of dependence and other sociodemographic and clinical variables on cost of care. Results: The mean (standard deviation) costs per patient over 6 months for direct medical-, social-, indirect-, and informal-care costs were estimated at €1,028.10 (€1,655.00), €843.80 (€2,684.80), €464.20 (€1,639.00), and €33,232.20 (€30,898.90), respectively. Dependence was independently and significantly associated with direct medical-, social-, informal-, and total-care costs. Conclusion: The costs of care for patients with AD in Spain are substantial, with informal care accounting for the greatest part. Interventions that reduce patient dependence on caregivers may be associated with important reduction in direct medical-, social-, informal-, and total-care costs. Keywords: Alzheimer, Dependence Scale, direct medical care costs, social care costs, indirect care costs, informal care costs

Cost-utility of denosumab for the treatment of postmenopausal osteoporosis in Spain

Josep Darbà,1 Lisette Kaskens,2 Francesc Sorio Vilela,3 Mickael Lothgren4 1Department of Economics, Universitat de Barcelona, 2BCN Health Economics and Outcomes Research SL, 3Amgen SA, Barcelona, Spain; 4Amgen (Europe) GmbH, Zug, Switzerland Background: The objective of this study was to estimate the cost-effectiveness of denosumab for fracture prevention compared with no treatment, generic bisphosphonates, and strontium ranelate in a cohort of osteoporotic postmenopausal women in Spain. Methods: A Markov model represented the possible health state transitions of Spanish postmenopausal women from initiation of fracture prevention treatment until age 100 years or death. The perspective was that of the Spanish National Health System. Fracture efficacy data for denosumab were taken from a randomized controlled trial. Fracture efficacy data for alendronate, ibandronate, risedronate, and strontium ranelate were taken from an independent meta-analysis. Data on the incidence of fractures in Spain were either taken from the published literature or derived from Swedish data after applying a correction factor based on the reported incidence from each country. Resource use in each health state was obtained from the literature, or where no data had been published, conservative assumptions were made. Utility values for the various fracture health states were taken from published sources. The primary endpoints of the model were life-years gained, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios for denosumab against the comparators. Results: Denosumab reduced the risk of fractures compared with either no treatment or the other active interventions, and produced the greatest gains in life-years and QALYs. With an annual acquisition cost of €417.34 for denosumab, the incremental cost-effectiveness ratios for denosumab versus no treatment, alendronate, risedronate, and ibandronate were estimated at €6,823, €16,294, €4,895, and €2,205 per QALY gained, respectively. Denosumab dominated strontium ranelate. Sensitivity analyses confirmed the robustness of these findings. Conclusion: Our analyses show that denosumab is a cost-effective intervention for fracture prevention in osteoporotic postmenopausal women in Spain compared with alendronate and risedronate, and is a dominant treatment option compared with strontium ranelate. Keywords: osteoporosis, post-menopausal, cost-utility, denosumab, Spai