OBJECTIVES : While a minority of mHealth apps can reach commercial success by employing Business-to-Consumer (B2C) or Business-To-Business (B2B) models, there is growing opportunity for companies to take advantage of new mHealth reimbursement routes that are being established across certain countries by healthcare payers. Traditional regulatory frameworks are being adapted and new processes set up to accommodate mHealth’s unique needs. The objective of this research is to explore the reimbursement potential of key global markets to then inform go-to-market strategies in terms of country prioritization when seeking reimbursement.

METHODS : Primary and secondary research was carried out to retrieve information on the reimbursement of mHealth apps across key geographical markets and to gather insights on processes, requirements and decision-makers. Information was then input into an evaluation framework where countries were scored for reimbursement feasibility according to five criteria: 1) Presence of mHealth classification systems; 2) Established reimbursement routes; 3) Specific evaluation tools or models; 4) Number of mHealth apps evaluated; 5) National digital initiatives to support mHealth reimbursement.

RESULTS : There is a substantial difference in the reimbursement feasibility across markets. Countries such as UK, Germany and US demonstrate their reimbursement landscapes to be most progressed, with pathways being piloted or established, and cases of mHealth apps being funded. Countries such the Nordics and Israel are hotbeds for digital health promotion and present increasing opportunities for reimbursement, whereas countries including Spain and Italy lag behind.

CONCLUSIONS : Manufacturers of mHealth apps should seek reimbursement in “high-feasibility” countries; to support submission, they should gather any required data and establish key stakeholder relationships. In “low-feasibility” countries, a company’s strategy should instead be to explore alternative business models (e.g. B2B, B2C) and liaise with policymakers to help drive regulatory and reimbursement change.