Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Mar 17, 2025
Open Peer Review Period: Mar 17, 2025 - May 12, 2025
Date Accepted: Oct 23, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Cost-utility Analysis and Value-based Pricing of Digital Therapeutics for Pulmonary Rehabilitation in Chronic Respiratory Disease
ABSTRACT
Background:
Pulmonary rehabilitation, a non-pharmacological treatment for chronic respiratory diseases (CRD), is underutilized due to limited access and time constraints. In a randomized controlled trial, the digital therapeutic (DTx) EASYBREATH showed superior efficacy to standard treatment. However, evidence on the cost-effectiveness of DTx and appropriate pricing strategies remains limited.
Objective:
This study aimed to assess the cost-effectiveness of DTx through cost-utility analysis and to explore value-based pricing.
Methods:
This economic evaluation was based on an 8-week rehabilitation trial involving 84 participants randomized into either the DTx group or standard treatment group. Costs were estimated from a healthcare system perspective. Quality-adjusted life years (QALY) were estimated by using mapping algorithms to COPD Assessment Test. Cost-utility analysis was conducted to estimate the incremental cost-utility ratio (ICUR), which represents the additional cost per QALY gained. The willingness-to-pay threshold was set at $19,410 per QALY, the Korean Gross Domestic Product per capita in 2006. Scenario, subgroup, and deterministic analyses were performed, along with probabilistic sensitivity analysis using 1,000 simulations.
Results:
Compared to standard treatment, DTx increased QALY by 0.0096 at an additional cost of $85.33, resulting in an ICUR of $8,922 per QALY gained. The maximum value-based price for an 8-week DTx program was estimated at $192. In probabilistic sensitivity analysis, DTx had a 60.2% probability of being cost-effective at the threshold. Subgroup analysis showed that the ICUR remained below the threshold in both elderly (≥65 years, $10,486 per QALY) and the non-elderly (<65 years, $6,784 per QALY) groups.
Conclusions:
DTx for pulmonary rehabilitation was cost-effective compared to standard treatment. These findings highlight its potential benefits for patients with CRD and support its integration into current healthcare systems.
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