Evidence map›Paper›PMID 29392552›Full record

Trial reportPharmacoEconomics2018

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, Vasily Belozeroff

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in PharmacoEconomics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01785849 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

TypeinterventionalSponsorAmgenRan2013 to 2014Enrolled508ConditionsHyperparathyroidism, SecondaryArmsEtelcalcetide, Placebo
NCT01788046 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

TypeinterventionalSponsorAmgenRan2013 to 2014Enrolled515ConditionsHyperparathyroidism, SecondaryArmsEtelcalcetide, Placebo
NCT01896232 phase3completednot on this map

A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

TypeinterventionalSponsorAmgenRan2013 to 2015Enrolled683ConditionsSecondary Hyperparathyroidism, Chronic Kidney DiseaseArmsEtelcalcetide, Cinacalcet, Oral Placebo, Intravenous Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 6 institutions in 6 countries.

Björn StollenwerkAmgen Europe (GmbH), Dammstrasse 23, P.O. Box 1557, 6301, Zug, Switzerland. bjoerns@amgen.com.ORCID http://orcid.org/0000-0002-3189-409X
Sergio IannazzoSIHS Health Economics Consulting, Via Sebastiano Caboto, 45, 10129, Turin, Italy.
Ron AkehurstBresMed, North Church House, 84 Queen Street, Sheffield, S1 2DW, UK.
Michael AdenaDatalytics Pty Ltd, 19/12 Trevillian Quay, Kingston, ACT, 2603, Australia.
Andrew BriggsHealth Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK.
Bastian DehmelAmgen Europe (GmbH), Dammstrasse 23, P.O. Box 1557, 6301, Zug, Switzerland.
Patrick ParfreyMemorial University, P.O. Box 4200, St. John's, NL, A1C 5S7, Canada.
Vasily BelozeroffAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Amgen (United States) · USBresMed · GBFIT Consulting (Italy) · ITHelmholtz Zentrum München · DEMemorial University of Newfoundland · CAUniversity of Glasgow · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEtelcalcetide 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.

objectiveThe objective of this study was to develop a decision-analytic model for economic evaluation of etelcalcetide compared with cinacalcet.

methodsWe 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.

resultsCompared 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.

conclusionsOur 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.

Indexed as

Decision Support TechniquesAdolescentAdultAgedAged, 80 and overChelating AgentsCinacalcetCost-Benefit AnalysisDrug Therapy, CombinationHealth Care CostsHumansHyperparathyroidism, SecondaryMarkov ChainsMiddle AgedModels, EconomicPeptidesChelating AgentsCinacalcetetelcalcetide hydrochloridePeptidesVitamin D

Identifiers

PMID29392552
OpenAlexW2786627764

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.