Björn Stollenwerk1,2, Sergio Iannazzo3, Ron Akehurst4,5, Michael Adena6, Andrew Briggs7, Bastian Dehmel8,9, Patrick Parfrey10, Vasily Belozeroff9. 1. Amgen Europe (GmbH), Dammstrasse 23, P.O. Box 1557, 6301, Zug, Switzerland. bjoerns@amgen.com. 2. Helmholtz Zentrum München, Ingolstädter Landstr. 1, 85764, Neuherberg, Germany. bjoerns@amgen.com. 3. SIHS Health Economics Consulting, Via Sebastiano Caboto, 45, 10129, Turin, Italy. 4. BresMed, North Church House, 84 Queen Street, Sheffield, S1 2DW, UK. 5. University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK. 6. Datalytics Pty Ltd, 19/12 Trevillian Quay, Kingston, ACT, 2603, Australia. 7. Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK. 8. Amgen Europe (GmbH), Dammstrasse 23, P.O. Box 1557, 6301, Zug, Switzerland. 9. Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. 10. Memorial University, P.O. Box 4200, St. John's, NL, A1C 5S7, Canada.
Abstract
INTRODUCTION:Etelcalcetide is a novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in haemodialysis patients. The clinical efficacy and safety of etelcalcetide (in addition to phosphate binders and vitamin D and/or analogues [PB/VD]) was evaluated in three phase III studies, including two placebo-controlled trials and a head-to-head study versus the oral calcimimetic cinacalcet. OBJECTIVE: The objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide compared with cinacalcet. METHODS: We developed a life-time Markov model including potential treatment effects on mortality, cardiovascular events, fractures, and subjects' persistence. Long-term efficacy of etelcalcetide was extrapolated from the reduction in parathyroid hormone (PTH) in the phase III trials and the available data from the outcomes study in cinacalcet (EVOLVE trial). Etelcalcetide was compared with cinacalcet, both in addition to PB/VD. We applied unit costs averaged from five European countries and a range of potential etelcalcetide pricing options assuming parity price to weekly use of cinacalcet and varying it by a 15 or 30% increase. RESULTS: Compared with cinacalcet, the incremental cost-effectiveness ratio of etelcalcetide was €1,355 per QALY, €24,521 per QALY, and €47,687 per QALY for the three prices explored. The results were robust across the probabilistic and deterministic sensitivity analyses. CONCLUSIONS: Our modelling approach enabled cost-utility assessment of the novel therapy for SHPT based on the observed and extrapolated data. This model can be used for local adaptations in the context of reimbursement assessment.
RCT Entities:
INTRODUCTION:Etelcalcetide is a novel intravenous calcimimetic for the treatment of secondary hyperparathyroidism (SHPT) in haemodialysis patients. The clinical efficacy and safety of etelcalcetide (in addition to phosphate binders and vitamin D and/or analogues [PB/VD]) was evaluated in three phase III studies, including two placebo-controlled trials and a head-to-head study versus the oral calcimimetic cinacalcet. OBJECTIVE: The objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide compared with cinacalcet. METHODS: We developed a life-time Markov model including potential treatment effects on mortality, cardiovascular events, fractures, and subjects' persistence. Long-term efficacy of etelcalcetide was extrapolated from the reduction in parathyroid hormone (PTH) in the phase III trials and the available data from the outcomes study in cinacalcet (EVOLVE trial). Etelcalcetide was compared with cinacalcet, both in addition to PB/VD. We applied unit costs averaged from five European countries and a range of potential etelcalcetide pricing options assuming parity price to weekly use of cinacalcet and varying it by a 15 or 30% increase. RESULTS: Compared with cinacalcet, the incremental cost-effectiveness ratio of etelcalcetide was €1,355 per QALY, €24,521 per QALY, and €47,687 per QALY for the three prices explored. The results were robust across the probabilistic and deterministic sensitivity analyses. CONCLUSIONS: Our modelling approach enabled cost-utility assessment of the novel therapy for SHPT based on the observed and extrapolated data. This model can be used for local adaptations in the context of reimbursement assessment.
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