Table 2.

DTx^a pricing model across different regions.

Region	Reimbursement model	Coverage approach	Challenges	Potential for harmonization
United States	Private insurers, Medicare or Medicaid coverage, and CPTb codes for some DTx	Case-by-case evaluation by private insurers and emerging value-based pricing	Lack of standardization across payers and slow adoption of prescription DTx	Standardizing payer criteria and wider Medicare adoption
Europe	National frameworks in some countries (eg, Germany's DiGAc, France's PECANd), others rely on regional or national health services	Temporary reimbursement while gathering evidence (Germany), conditional models in France	Varying national policies, not all countries have structured reimbursement	DiGA-style frameworks could expand to other EU countries
Canada	Provincial-level assessments, limited national coordination, employer-based insurance	Fragmented provincial funding, some employer and private coverage	No national framework, digital health products evaluated on a case-by-case basis	Adoption of a unified evaluation system across provinces
Australia	Mixed public-private model, some Medicare support for digital health, and private insurer involvement	Medicare covers some telehealth services; private insurers fund digital health	No centralized DTx policy, slow public adoption	National DTx reimbursement framework development
China	Limited national coverage, pilot reimbursement programs, growing role of private insurers	Primarily out-of-pocket or private insurance, limited government funding	Government insurance yet to cover DTx, regulatory pathways still evolving	Potential for structured reimbursement similar to Europe’s DiGA model

^aDTx: digital therapeutics.

^bCPT: Current Procedural Terminology.

^cDiGA: Digitale Gesundheitsanwendungen.

^dPECAN: Patient Engagement and Communication Application Network.