Cost-effectiveness Analysis of Digital Therapeutics for Amblyopia.

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

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

Subjects: Data from 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 RCTs for atropine, Luminopia, and CureSight. A quality-adjusted life-year (QALY) was calculated by multiplying utility gain, a value correlated with VA gain, by length of time of benefit.

Main outcome measures: Cost, cost per QALY, 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, whereas 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 per QALY gained of $427 and $101, respectively. Atropine treatment for 16 weeks resulted in a cost per QALY gained of $151. The cost per 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/log arcsec (CureSight).

Conclusions: Treatment of amblyopia with Luminopia or CureSight is cost-effective in comparison with 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 values based on VA gain of Luminopia and CureSight were comparable.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.