A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet
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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.
The objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide compared with cinacalcet.
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.
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.
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.
Compliance with Ethical Standards
Financial support for this study was provided by Amgen. The funding agreement ensured the authors’ independence in designing the study, interpreting the data, writing, and publishing the report.
Conflict of interest
SI, MA, RA, PP and AB contributed to the development of the study through a consulting agreement with Amgen. BS, BD and VB are employed by Amgen and holders of Amgen stock and/or stock options.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published. The authors thank the Amgen biostatistical department for the support provided. Furthermore, we thank Kirsten Westerhout for valuable feedback within the later stages of the model development.
- 4.Floege J, Kim J, Ireland E, Chazot C, Drueke T, de Francisco A, Kronenberg F, Marcelli D, Passlick-Deetjen J, Schernthaner G, Fouqueray B, Wheeler DC, Investigators ARO. Serum iPTH, calcium and phosphate, and the risk of mortality in a European haemodialysis population. Nephrol Dial Transplant. 2011;26(6):1948–55.CrossRefGoogle Scholar
- 5.Natoli JL, Boer R, Nathanson BH, Miller RM, Chiroli S, Goodman WG, Belozeroff V. Is there an association between elevated or low serum levels of phosphorus, parathyroid hormone, and calcium and mortality in patients with end stage renal disease? A meta-analysis. BMC Nephrol. 2013;14:88.CrossRefGoogle Scholar
- 7.KDIGO group. KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease—mineral and bone disorder. Kidney Int Suppl. 2017;7(1):1–59.Google Scholar
- 9.Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of etelcalcetide vs placebo on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: two randomized clinical trials. JAMA. 2017;317(2):146–55. https://doi.org/10.1001/jama.2016.19456.CrossRefPubMedGoogle Scholar
- 10.Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of etelcalcetide vs cinacalcet on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: a randomized clinical trial. JAMA. 2017;317(2):156–64. https://doi.org/10.1001/jama.2016.19468.CrossRefPubMedGoogle Scholar
- 12.Husereau D, Drummond M, Petrou S, et al. Consolidated health economic evaluation reporting standards (CHEERS)—explanation and elaboration: a report of the ISPOR health economic evaluations publication guidelines good reporting practices task force. Value Health. 2013;16:231–50.CrossRefGoogle Scholar
- 14.Garside R, Pitt M, Anderson R, Mealing S, Roome C, Snaith A, D’Souza R, Welch K, Stein K. The effectiveness and cost-effectiveness of cinacalcet for secondary hyperparathyroidism in end-stage renal disease patients on dialysis: a systematic review and economic evaluation. Health Technol Assess. 2007;11(18):iii, xi–xiii, 1–167.Google Scholar
- 18.Evolve Trial Investigators, Chertow GM, Block GA, Correa-Rotter R, Drueke TB, Floege J, Goodman WG, Herzog CA, Kubo Y, London GM, Mahaffey KW, Mix TC, Moe SM, Trotman ML, Wheeler DC, Parfrey PS. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N Engl J Med. 2012;367(26):2482–94.CrossRefGoogle Scholar
- 30.Belozeroff V, Cooper K, Hess G, Chang CL. Healthcare use and costs before and after parathyroidectomy in patients on dialysis. BMC HSR. 2013;13(1):248.Google Scholar
- 32.Gutzwiller FS, et al. Cost effectiveness of sucroferric oxyhydroxide compared with sevelamer carbonate in the treatment of hyperphosphataemia in patients receiving dialysis, from the perspective of the National Health Service in Scotland. Pharmacoeconomics. 2015;33(12):1311–24.Google Scholar