A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet

Björn Stollenwerk (), Sergio Iannazzo, Ron Akehurst, Michael Adena, Andrew Briggs, Bastian Dehmel, Patrick Parfrey and Vasily Belozeroff
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Björn Stollenwerk: Amgen Europe (GmbH)
Sergio Iannazzo: SIHS Health Economics Consulting
Ron Akehurst: BresMed
Michael Adena: Datalytics Pty Ltd
Andrew Briggs: University of Glasgow
Bastian Dehmel: Amgen Europe (GmbH)
Patrick Parfrey: Memorial University
Vasily Belozeroff: Amgen Inc.

PharmacoEconomics, 2018, vol. 36, issue 5, No 8, 603-612

Abstract: 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.

Date: 2018
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DOI: 10.1007/s40273-017-0605-2

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