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Pharma Industry On How To Tackle EU Regulatory & Reimbursement Barriers To Digital Therapeutics

 
• By Neena Brizmohun

When it comes to digital therapeutics in Europe, EFPIA says there is a lack of harmonization in the regulatory requirements, and only Belgium and Germany offer value assessment, reimbursement and funding pathways, with more intermittent offerings in countries like France and the UK.

Digital therapeutics deliver software driven, evidence-based therapeutic interventions to patients • Source: Shutterstock

Digital therapeutics (DTx) face unpredictable requirements or standards in Europe for much of the development and commercialization pathway, including marketing authorization, value assessment, reimbursement and pricing, the European Federation of Pharmaceutical Industries and Associations says in a report in which it recommends how to improve access to these technologies.

While there has been some progress in integrating DTx into market access and care pathways, only Belgium and Germany offer value assessment, reimbursement and funding pathways, with more intermittent offerings...

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