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With record investment into the development of DTx across a wide range of therapy areas, healthcare systems are now starting to recognise the value that these innovative interventions can bring to patients. However, in order to achieve reimbursement and sustainable patient access across healthcare systems, companies must prepare early on for how those products will be assessed and how payer relevant value should be demonstrated. This research aims to inform companies who are investing in a DTx regarding the likely processes for assessment across key healthcare systems in Europe and the US, so that relevant requirements for clinical, humanistic and economic evidence generation and value demonstration can be achieved.

The key requirements for the assessment of DTx and that must be addressed through throughout the clinical development programme are:

• A Quality Management Scheme certified according to ISO 13485, to ensure the quality of the DTx is understood across countries
• An internationally recognised system for Information Security Management, to ensure the secure storage of confidential patient data
• The ability for interoperability with healthcare systems, to allow the safe and effective integration with existing electronic patient record systems
• The robust demonstration of clinical effectiveness through the generation of data that shows either an improvement in clinical outcomes, or an improvement in the process for managing a patient. This data should demonstrate the value that the DTx can bring to healthcare systems
• The tools to collect real world evidence, particularly around the rate of use, patient outcomes and process and economic outcomes associated with a new DTx. These data will inform the ongoing evaluation process and should minimise uncertainty
• The demonstration of economic value through budget impact and cost-consequence modelling. These data will inform pricing and reimbursement discussions

It is important that manufacturers developing a DTx do not overlook these requirements at the start of a development programme, as retrospectively trying to address these needs is likely to be complex and suboptimal to support the case for reimbursement.

In conclusion, it is crucial that an evidence-based value proposition is developed for a new DTx, to demonstrate to payers the value the product can bring to healthcare systems and patients, and the rationale for providing reimbursed access. Manufactures should plan for reimbursement from the start of the DTx development by making sure that the requirements for demonstrating relevant clinical and economic value, meeting quality management and information security standards, and integration with electronic record systems are all in place. Furthermore, plans should be in place for ongoing monitoring for how the product is performing in clinical practice, to support potential requests for re-evaluation.

Engaging with stakeholders throughout the life cycle of a product is important to understand what evidence is required and how it will be assessed. Lightning Health has expertise in supporting companies who are developing a DTx, to ensure robust value demonstration across healthcare systems. Contact us today to discuss how we can support your European launch and patient access strategy.

Article published 1 December 2021.