Cost-Utility Analysis and Value-Based Pricing of Digital Therapeutics for Pulmonary Rehabilitation in Chronic Respiratory Disease: Economic Evaluation Based on a Randomized Controlled Trial

Background: Pulmonary rehabilitation, a nonpharmacological treatment for chronic respiratory diseases, is underused due to limited access and time constraints. In a randomized controlled trial, the digital therapeutics (DTx) demonstrated superior efficacy to standard treatment. However, evidence on the cost-effectiveness of DTx and appropriate pricing strategies remains limited. Objective: This study aimed to evaluate the cost-effectiveness of DTx through cost-utility analysis and to explore a value-based price for its implementation. Methods: An economic evaluation was based on an 8-week randomized controlled trial involving 84 participants assigned to either the DTx group or standard treatment group. Costs were estimated from a health care system perspective. Quality-adjusted life years (QALYs) were estimated by using mapping algorithms from the chronic obstructive pulmonary disease assessment test to EQ-5D-3L. 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 US $19,410 per QALY. Sensitivity analyses included probabilistic sensitivity analysis, deterministic sensitivity analysis, and subgroup and scenario analyses, including a 1-year Markov model. Results: Compared with standard treatment, DTx increased QALY by 0.0096 at an additional cost of US $85.33, resulting in an ICUR of US $8890 per QALY gained. The maximum value-based price for an 8-week DTx program was estimated at US $192. In probabilistic sensitivity analysis, DTx had a 60.2% probability of being cost-effective at the set willingness-to-pay threshold, with 88.6% of iterations in the northeast quadrant falling below the threshold. The deterministic sensitivity analysis showed that ICURs remained below the willingness-to-pay threshold under all tested assumptions, with the maximum ICUR (US $15,644/QALY) also staying below the threshold. Subgroup analysis confirmed cost-effectiveness in both older adults (≥65 y) and non–older adults (<65 y) populations, and in both chronic obstructive pulmonary disease and interstitial lung disease groups. The 1-year Markov model estimated an ICUR of US $4398 per QALY. Conclusions: DTx for pulmonary rehabilitation demonstrated the cost-effectiveness compared with standard treatment. These findings support its potential for improving outcomes in patients with chronic respiratory disease and provide a pricing framework to facilitate its integration into health care systems.