Digital Therapeutics Alliance Announces Partnership to Strategize European Market Access

The partnership between the alliance and the Healthware Group is aimed at harmonizing assessment criteria and regulatory pathways in Europe.

A new alliance of digital therapeutics (DTx) industry groups is hoping that by partnering together they can help create synergies between the regulatory pathways in the United States and Europe.

The Digital Therapeutics Alliance (DTA), a Virginia-based trade group of digital therapeutics developers and stakeholders, this month announced a partnership with the Healthware Group, a European firm that provides advisory and technology services to digital therapeutics companies. The two groups will hold their first in-person meeting at the Frontiers Health Global Conference in October, they said.

“The primary goal of the DTA/Healthware collaboration to develop a pan-European coalition is to bring decision makers together to discuss what may be the best path forward to ensure safe and effective DTx therapies can be accessible to patients regardless of where they live,” said Megan Coder, Pharm.D., MBA, the chief policy officer at alliance.

To that end, leaders from both groups will work together to analyze existing frameworks and infrastructure and develop recommendations for regulatory environments in Europe that promote safety, efficacy, and access throughout the continent.

The new partnership is part of DTA’s Resource Partner program, a network of industry stakeholders and experts who collaborate to develop resources and advance digital therapeutics. Healthware said it will also support DTA’s Europe Policy Task Group, which is focused on understanding and informing policy issues such as funding, clinician engagement, patient access, and reimbursement in Europe.

This is not the first time DTA and Healthware have worked together. The two groups have collaborated since DTA’s European launch in 2017. The new announcement represents a formalization and expansion of that partnership.

“We are excited to deepen our partnership with DTA to help shape the European policy landscape and ensure DTx companies can scale,” said Healthware CEO Roberto Ascione, M.D. “We are huge advocates for the positive impact digital therapeutics can have on patients and believe that these solutions can help fill care gaps, augment care delivery and most importantly support patients in novel ways.”

Coder told Managed Healthcare Executive® that the regulatory landscape in Europe is significantly different than that of the United States. While the Food and Drug Administration regulates both pharmaceuticals and medical devices, she said the European Medicines Agency is focused primarily on pharmaceuticals, though she said the agency will be engaged when it comes to combination DTx/medication therapies. Instead, she said, medical devices are typically reviewed by government-sanctioned Notified Bodies, after which companies can apply for market access in individual countries.

Given that complexity, Coder said there is a significant opportunity for the DTx/Healthware partnership to harmonize the criteria used to assess digital therapeutics with regard to elements such as clinical evidence, data requirements, and real-world outcomes.

“If this becomes the case, then DTx manufacturers will more clearly understand which requirements they ought to meet when applying for market access approval in multiple regions,” she said. “As such, with more harmonized expectations and pathways, patient access to legitimate, high quality DTx therapies should ideally improve too.”