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

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 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).

Keywords: BAHA; HTA (health technology assessment); RCT - randomized controlled trial; bone conducting device; cost consequence analysis; skin integration.

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.

Figures

Figure 1

Randomization, treatment and follow-up of subjects. *Due to wrong device allocation in the control group, one subject (randomized to the control group) is considered in the safety population of the test group (23).

Figure 2

Incurred incremental costs per country after 1 and 3 years. The incremental mean cost per subject, per country as simulated using 1,000 bootstraps using unrestricted random sampling which was displayed using a density histogram. A positive number indicates a cost saving in favor for the test intervention. For this simulation all subjects remained in their country of origin.

Figure 3

(A) Scenario analysis—cost-consequence analysis after 1 and 3 years. The incremental mean cost per subject, per country as simulated using 1,000 bootstraps using unrestricted random sampling which was displayed using a density histogram. A positive number indicates a cost saving in favor for the test intervention. For this simulation all subjects were all allocated one-by-one to every of the participating countries per simulation. (B) Scenario analysis after 1 and 3 years. The cumulative probability distribution of incremental costs per country. A positive number indicates a cost saving in favor for the test intervention. The country is indicated per line; notice that the sequence of countries differs from the other figures as the order relates to the increment between the test and control intervention. Dashed lines indicate the 2.5, 50, and 97.5%. (C) Cost-consequence analysis after 1 and 3 years. The effect sizes for the different outcome measures (AUCs) over the first year together with the 95% confidence interval are displayed. Note that the APHAB and HUI3 were calculated as the change from (the unaided) baseline.

Figure 4

(A) Scenario analysis—subgroup cost-consequence analysis after 1 and 3 years. The incremental mean cost per subject, per country, per subgroup as simulated using 1,000 bootstraps using unrestricted random sampling which was displayed using a density histogram. A positive number indicates a cost saving in favor for the test intervention. For this simulation all subjects per subgroup were allocated one-by-one to every of the participating countries per simulation. SSD, single-sided sensorineural deafness. (B) Subgroup cost-consequence analysis after 1 and 3 years. The effect sizes for the different outcome measures (AUCs) over the first year together with the 95% confidence interval are displayed. Note that the APHAB and HUI3 were calculated as the change from (the unaided) baseline.