Cost Effectiveness Analysis of Digital Therapeutics for Amblyopia.

Purpose: To evaluate the cost-utility of Luminopia and CureSight as therapy for amblyopia compared to current common amblyopic treatments such as glasses, atropine drops, and patching.

Design: Cost analysis based on data from published randomized control trials (RCTs).

Subjects: None; based on data from the Luminopia, CureSight and atropine RCTs.

Methods: A cost-utility analysis was performed using patient preference-based time trade-off utility values from previous literature. Costs for eye examinations were calculated using reimbursement data; device costs for duration of treatment were provided by sales representatives of Luminopia and CureSight. All treatments were inclusive of the cost of eyeglasses. Visual acuity (VA) and stereoacuity outcomes were extrapolated from the randomized control trials (RCTs) for atropine, Luminopia and CureSight. Quality-adjusted life-year (QALY) was calculated by multiplying utility gain, a value correlated with visual acuity gain, by length of time of benefit.

Main Outcome Measures: Cost, cost per quality-adjusted life-year, and cost per stereoacuity gain.

Results: The cost to treat amblyopia with glasses alone for 12 weeks was $514. The cost of treating with patching for 12 weeks was $540 and with atropine for 16 weeks was $652, while the cost of treating with Luminopia or CureSight for 12 weeks was $1951 and $1564 or $1814, respectively. Treatment with glasses alone or patching for 12-weeks resulted in a cost/QALY gained of $427 and $101 respectively. Atropine treatment for 16 weeks resulted in a cost/QALY gained of $151. The cost/QALY for 12-week Luminopia treatment was $618 versus $368 or $427 for 12-week CureSight treatment and $314 or $354 for 16-week CureSight treatment (p<0.05). Cost per stereoacuity gain for 12-week treatment duration was $6421/log arcsec (glasses), $1801/log arcsec (patching), and $3007/log arcsec or $3488 (CureSight).

Conclusion: Treatment of amblyopia with Luminopia or CureSight is cost-effective in comparison to established willingness-to-pay thresholds and can provide a viable treatment option, especially for those who are unable to tolerate patching or atropine penalization. Cost effectiveness based on VA gain of Luminopia and CureSight were comparable.