OBJECTIVES:

Digital therapeutics (DTx), defined as software-driven therapeutic interventions, are new treatment options for patients. For companies seeking to obtain coverage of DTx, understanding the unique market access challenges and opportunities compared to traditional therapies is crucial. This research aims to provide a landscape of DTx coverage in the US and EU5, with the objective of identifying key market access considerations for obtaining coverage in these markets.

METHODS:

We identified DTx assessed by the High Health Authority in France, the National Institute for Health and Care Excellence in the UK, and the German Federal Institute for Drugs and Medical Devices in Germany, up to 31^st December 2022. No national evaluation pathways for DTx were in place in Spain and Italy. In the US, we looked at large commercial plans (>one million lives covered), governmental plans, and formulary listings of large PBMs (>20% of market share in 2021). We identified key determinants of coverage decision-making using a thematic analysis approach of evaluators’ decisions.

RESULTS:

We identified 74 evaluations of 68 DTx (Germany, n=42; France, n=3; UK, n=1; US, n=19 and n=9 on PBM formularies). No national DTx assessments were conducted in Spain and Italy. Key determinants for decision-making in Europe were a comparative clinical benefit, good data practices, DTx functionality, safety and quality, public health interest (France) and cost-effectiveness (UK). Coverage with evidence development was obtained in most cases (Germany: 27/42, France: 3/3, UK: 1/1). In the US, coverage by health plans and PBM listing was limited due to uncertainty of clinical evidence and lack of long-term data.

CONCLUSIONS:

DTx is a new technology coming to market with little precedence. Our research demonstrates that it is critical for manufacturers to align their evidence package to data requirements by payers. Moreover, the field is evolving, and new pathways are being set up.