Challenges and Opportunities for Digital Therapeutics: Key Requirements to Demonstrate Value Across the EU, UK, and US


Kipentzoglou N1, Zegaoui Y2, Satherley A2, Whitehouse J2, Thompson A3
1Lightning Health, London, LON, UK, 2Lightning Health, London, UK, 3The University of Manchester, Manchester, UK


The rapid growth of digital therapeutics (DTx) has the potential to transform healthcare delivery, with over $2.88 billion invested across this sector in 2019. Despite significant technological advances, frameworks for the assessment and reimbursement for DTx are still evolving across the EU, UK, and US. This research defines the key areas of commonality and divergence for DTx payer evaluation across countries, to inform core requirements for clinical and economic value demonstration to support reimbursement.


A comprehensive review was conducted covering the EU, UK, and US to identify the processes for assessment for DTx, the clinical/HEOR evidence requirements and implications for pricing and reimbursement. In-depth consultations were also undertaken with DTx manufacturers and budget holders regarding practical considerations for evidence generation to meet requirements for payer evaluation.


There is significant variation in the processes for the evaluation of DTx across the EU, UK, and US. This ranges from fragmented systems varying by health plan in US with a focus on short term cost-minimisation, assessment of medical benefit to inform a price agreement in Germany and France, and evaluation of cost-effectiveness in the UK. Consistent requirements include the need for a credible clinical and/or economic benefit, data protection/cybersecurity and interoperability. However, key differences exist in how these criteria are assessed and the implications for reimbursement.


Payer value demonstration is an essential consideration in the development programmes for DTx. Critical requirements are a clinically relevant impact on objective outcomes and QoL (if relevant), subjective outcomes including user experience and impact on care, and potential cost savings or a disaggregated summary of costs and effects to allow selection and evaluation of relevant factors. Potential for access agreements to minimise payer risks and ongoing real-world data can also be important to support the case for reimbursed patient access.

Conference/Value in Health Info

2021-11, ISPOR Europe 2021, Copenhagen, Denmark

Value in Health, Volume 24, Issue 12, S2 (December 2021)




Clinical Outcomes, Health Policy & Regulatory, Health Service Delivery & Process of Care, Medical Technologies

Topic Subcategory

Clinical Outcomes Assessment, Digital Health, Reimbursement & Access Policy, Telemedicine


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