A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System—A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology
van Hoof, Marc; Wigren, Stina; Ivarsson Blechert, Johan; Molin, Mattias; Andersson, Henrik; Mateijsen, D. J.M.; Bom, Steven J.H.; Calmels, M. N.; van der Rijt, Antoon J.M.; Flynn, Mark C.; Tongeren, Joost van; Hof, Janny R.; Brunings, Jan Wouter; Anteunis, Lucien J.C.; Marco Algarra, Jaime; Stokroos, Robert Jan; Joore, Manuela A.
(2020) Frontiers in Neurology, volume 11, pp. 1 - 22
(Article)
Abstract
Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery
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with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control). Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL €86 (CI −50.33; 219.20), FR €134 (CI −3.63; 261.30), ES €178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE €-29 CI −160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to €17 (CI −191.80; 213.30) in the Netherlands, in Spain to €84.50 (CI −117.90; 289.50), and in France to €80 (CI −99.40; 248.50). The mean additional cost in Sweden increased to €-116 (CI −326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician. Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).
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Keywords: BAHA, bone conducting device, cost consequence analysis, HTA (health technology assessment), RCT - randomized controlled trial, skin integration, Neurology, Clinical Neurology
ISSN: 1664-2295
Publisher: Frontiers Media S. A.
Note: Funding Information: The following people are acknowledged for significant contributions throughout the investigation by (co-)managing or supporting the conduct of this clinical trial: A. Sandberg and C. Hallberg (Cochlear Bone Anchored Solutions AB), A. Hellgren (Hellgren GCP Consulting AB), A. Oerlemans (Catharina Hospital), M. Bannink-von Hobe (Deventer Hospital), N.E.P.M. Swolfs (Amphia Hospital), Prof. O. Deguine and Dr. M. Marx (Purpan Hospital), M. Gual and M. del Carmen Peset (Clinical University Hospital, Valencia). We acknowledge principal investigators J. Stalfors and M. Eeg-Olofsson (Sahlgrenska University Hospital, Göteborg, Sweden) and B. Kremer (Maastricht University Medical Center, the Netherlands) for locally executing this clinical trial and validating the data they committed to this investigation. We also highly appreciate the careful monitoring by S. Syren-Nordqvist (A+ Science, Stockholm, Sweden), and data management by Per Ekman (Statistiska konsultgruppen, Göteborg, Sweden). Funding. Sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236. Publisher Copyright: © Copyright © 2020 van Hoof, Wigren, Ivarsson Blechert, Molin, Andersson, Mateijsen, Bom, Calmels, van der Rijt, Flynn, Tongeren, Hof, Brunings, Anteunis, Marco Algarra, Stokroos and Joore.
(Peer reviewed)