OBJECTIVES: sinCephalea is digital health application (DiGA) and indicated as a prophylactic treatment to reduce migraine days in patients with episodic migraines. The product applies personalized low-glycemic diet as "active ingredient” together with state-of-the-art digital therapeutics technology to address migraines.

METHODS: A decision tree structure plus Markov model is used to represent a 12-week clinical-trial period, where the probability of treatment response is estimated based on predicted change (at least 30%) in monthly migraine days (MMDs). A Markov structure is then used to represent a post-trial period, where responders and non-responders follow treatment pathways. This modelling approach is predicated upon the assumption that both quality-adjusted life-years (QALYs), resource-utilization and costs can be estimated based on the MMD frequency being experienced by patients. Direct and indirect costs (2021€) were derived from published sources from the societal perspective. QALYs and costs were discounted (3% p.a).

RESULTS: DiGA plus BSC is associated with direct costs of 64,203€ (SD, 2,279€) and indirect costs of 145,557€ (SD, 10,593 €) compared to 65,129€ (SD, 2;565€) of direct costs and 158,458€ (SD, 11,685€) of indirect costs when only BSC is used. DiGA plus BSC had a higher QALYs estimate at 13.81 (SD, 0.43) compared to 13.55 QALYs (SD, 0.40). The utility benefit corresponds to over 3 months in perfect health. DiGA plus BSC is the dominant strategy.

CONCLUSIONS: In patients with episodic migraine, the use of DiGA plus BSC is highly cost-effective and associated with savings for the German healthcare system.