PRESS RELEASE | Milan, Italy and Washington DC, US 9 June 2023 – Following the formation of the European DTx Policy Coalition by Healthware Group and the Digital Therapeutics Alliance (DTA) in June 2022, the joint team is pleased to release a dedicated website and its inaugural report entitled: “DTx Policy Pathways: the evolving scenario in Europe; Landscape Analysis & Converging Trends”.
Through the European DTx Policy Coalition, the Digital Therapeutics Alliance and Healthware Group, as the official knowledge partner, have been actively engaging stakeholders and representatives from Ministries of Health, national trade associations, and European trade associations. Their collective efforts aim to establish comprehensive best practice frameworks for the utilization of digital medical devices (DMD), including digital therapeutics (DTx).
Their first report “DTx Policy Pathways: the evolving scenario in Europe; Landscape Analysis & Converging Trends” provides clarity on existing and evolving policies and Health Technology Assessment (HTA) criteria applicable to Digital Therapeutics (DTx), identifying converging trends and potential areas of harmonization and scalability across Europe.
The tools and resources featured on the www.dtxpolicylandscape.org website, are designed to provide best practices on DTx integration into healthcare, empowering clinicians, decision makers, and policymakers to recognize and include DTx within regional and national frameworks. By providing these resources, the website will contribute to driving equitable digital healthcare for patients around the world.
An increasing number of countries across Europe, as worldwide, have developed or are developing appraisal criteria, access, and reimbursement policies for DTx and the broader Digital Medical Device (DMD) category. While paving new pathways, there is also a patchwork of nomenclatures and approaches being applied and while some countries are already providing equitable access and fostering systemic uptake of clinically-validated DMDs, others lack fit-for-purpose frameworks – ultimately limiting equitable, scalable, and timely access to clinically-validated DMDs.
To address this challenge, this initial DTx Policy Report is focused on providing clarity on existing and evolving policy frameworks in Europe. The report details fit-for-purpose appraisal criteria being applied in countries with formal frameworks in place, analyzing requirements through the common lens of the Health Technology Assessment (HTA) Core Model®. Converging trends are also identified to help inform areas of potential harmonization and scalability across Europe and globally.
The DTA and Healthware are also launching the www.dtxpolicylandscape.org as a dedicated resource for all ecosystem stakeholders to continue to access reliable resources and regular updates on the rapidly evolving global scenario. By fostering information sharing and collaboration, the aim is to support the development of adequate and enabling policies and system readiness that will drive scalable, equitable and sustainable integration of digital healthcare worldwide.
"We have the privilege of working with policymakers and payors from across the world to chart ways to provide equitable patient access to digital therapies," said Megan Coder, Chief Policy Officer & Founder of Digital Therapeutics Alliance. "During this first phase of the Coalition, we've developed a comprehensive set of resources for decision makers to enable greater clarity and harmonization in how digital therapeutics are evaluated and implemented. Moving closer to a globally recognized framework for digital therapies will provide patients and caregivers with new opportunities to optimize how they receive and benefit from healthcare.”
"With DTx and, more generally, Digital Medical Devices delivering meaningful clinically-validated health outcomes, it is important to enable equitable and sustainable access to them and defining fit-for-purpose appraisal criteria and adequate access and reimbursement policies is a key", explained Alberta Spreafico, Managing Director Digital Health & Innovation at Healthware Group, "We are proud to join forces with the Digital Therapeutics Alliance as knowledge partner, to support all ecosystem stakeholders through in-depth knowledge, continuous monitoring of the evolving scenario and curation of valuable resources on www.dtxpolicylandscape.org, to help scale systemic integration and impact of DTx and digitally-enhanced care."
“Since its inception, Healthware has been focused on assisting life science companies in communicating, connecting, and building innovative solutions which enable better healthcare. Whether it’s new ways to market innovative drugs or digital solutions, fostering the growth of the ecosystem through thought leadership, or building ground-breaking patient solutions, our focus has always been built on a clear vision of Future Health. I’m proud of the work our team has done in collaboration with the DTA to help support the adoption and access of DTx globally through the development of this valuable resource,” said Roberto Ascione, CEO at Healthware Group.
Join the effort to deliver scalable, equitable digital healthcare to patients globally! Find more information and to download the report here.