In brief
On 2 June the EFPIA published on its website some recommendations aimed at improving the authorization, launch and use of digital therapies (“DTx“) in the EU.
Key takeaways
DTx provide patients with evidence-based therapeutic interventions that are driven by software programs to prevent, manage, alleviate, or treat a medical disorder or disease. They can be used independently or in combination with medications, devices, or other therapies to optimize patient care and achieve positive clinical outcomes.
From a regulatory perspective, DTx are classified as medical devices governed by EU Regulation 2017/745; nevertheless, there are a number of factors that hinder market access for DTx including, the lack of harmonization in regulatory requirements in individual Member States and of a standardized or specific reimbursement pathway for DTx.
To overcome these obstacles, thus improving market access for DTx throughout the EU, the EFPIA recommends: (i) the harmonization of regulatory requirements; (ii) the collaboration between Member States and the Commission to enable harmonization of clinical evidence requirements and data sharing; and (iii) the adoption of clear and transparent national pathways for DTx pricing and reimbursement across all Member States.
