Healthware Group, Digital Therapeutics Alliance launch DTx policy report and website

In June 2022, Healthware Group and the Digital Therapeutics Alliance (DTA) formed the European DTx Policy Coalition. Now, the joint team have launched a dedicated website and released an inaugural report to help advance equitable access and adoption of safe and effective digital therapeutics (DTx) and digital medical devices (DMDs).

‘DTx Policy Pathways: the evolving scenario in Europe; Landscape Analysis & Converging Trends’ brings together the collective knowledge and efforts of not just the European DTx Policy Coalition, but stakeholders and representatives from Ministries of Health, national trade associations, and European trade associations, also – with the aim of establishing comprehensive best practice frameworks for the utilisation of DMDs, including DTx.

This first report provides clarity on existing and evolving policies and Health Technology Assessment (HTA) criteria applicable to DTx, identifying converging trends and potential areas of harmonisation and scalability across Europe.

Meanwhile, the newly launched website www.dtxpolicylandscape.org intends to help drive equitable digital healthcare for patients around the world, offering tools and resources designed to provide best practices on DTx integration into healthcare, and empower clinicians, decision makers, and policymakers to recognise and include DTx within regional and national frameworks.

The website is intended as a dedicated resource for all ecosystem stakeholders to continue to access reliable resources and regular updates on the rapidly evolving global scenario. It fosters information sharing and collaboration and supports the development of adequate and enabling policies and system readiness, so as to drive scalable, equitable, and sustainable integration of digital healthcare worldwide.

These developments come as an increasing number of countries across Europe, and worldwide, have developed or are developing appraisal criteria, access, and reimbursement policies for DTx and the broader DMD category. However, while some countries are already providing equitable access and fostering systemic uptake of clinically validated DMDs, others yet lack fit-for-purpose frameworks.

For this reason, the initial DTx Policy Report is focused on providing clarity on existing and evolving policy frameworks in Europe, detailing appraisal criteria being applied in countries with formal frameworks in place and analysing requirements through the common lens of the HTA Core Model. Also identified are converging trends, the aim being to help inform areas of potential harmonisation and scalability across Europe globally.

Megan Coder, chief policy officer and founder of the DTA, commented: “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 […] Moving closer to a globally recognised framework for digital therapies will provide patients and caregivers with new opportunities to optimise how they receive and benefit from healthcare.”

Healthware Group’s managing director of digital health and innovation, Alberta Spreafico, said: "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.”

She continued: "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 the impact of DTx and digitally-enhanced care."

CEO of Healthware Group, Roberto Ascione, also commented: “Since its inception, Healthware has been focused on assisting life sciences 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’.”