Digital Therapeutics Groups Publish Report Outlining Regulatory Pathways in Europe

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Two major digital therapeutics groups have unveiled a new report and website aimed at helping digital therapeutics makers and other stakeholders better understand the evolving regulatory landscape in Europe.

The Digital Therapeutics Alliance (DTA), an industry trade group, and Healthware Group, a digital health consultancy, jointly formed the European DTx Policy Coalition, which released the report. The report is the product of engagement with government and industry representatives across several European countries.

Alberta Spreafico, Ph.D., MBA, of the Healthware Group

Alberta Spreafico, Ph.D., MBA, the managing director for digital health and innovation at Healthware Group, said the report is designed to help foster the systemic integration of digital therapies in Europe.

“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 define fit-for-purpose appraisal criteria and adequate access and reimbursement policies is a key," she said, in a press release.

The report comes at a time when prescription digital therapeutics face a conundrum. Swift expansion to new markets can help bring in additional revenue in an industry that has struggled to convince payers to add their therapies to insurance formularies. On the other hand, regulatory approval is only possible with clear regulatory pathways, and the novelty of the therapeutic category means many countries are still figuring out how to evaluate, regulate, and pay for these products.

For instance, in England, digital medical devices are considered to be “digital health technologies,” for which a formal framework is already in existence. Local organizations within the country’s National Health Service have significant power over payment decisions, the report says. In France, digital therapeutics are treated differently from remote patient monitoring technology, and covered under the same regulatory and reimbursement structures as medical devices.

However, while England, France, Germany, and Belgium all have formal frameworks for digital medical devices and digital therapeutics, other countries, such as the Netherlands, Italy, and the Nordic countries have no specific formal classifications for digital therapies and are still in the process of creating regulatory frameworks.

Megan Coder, Pharm.D., MBA, chief policy officer, Digital Therapeutics Alliance

The goal of the report — and the research behind it — is not merely to compile data, but also to promote harmonization across different regulatory jurisdictions, said Megan Coder, Pharm.D., MBA, the chief policy officer at DTA.

“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,” she said, in the press release.

The report’s website also includes a toolkit for payers and regulators as they evaluate digital therapeutics. The toolkit features links to countries’ existing regulatory and reimbursement pathways and databases listing existing digital therapeutics.

However, it also includes resources aimed at boosting greater acceptance of the category of digital therapeutics. Those resources include a “Demystifying DTx” fact sheet, in which the DTA pushes back against common misperceptions about the industry, such as the idea that all digital therapeutics are delivered via smartphone apps or the claim that digital therapeutic developers do not rigorously evaluate their products. The toolkit also has links to a code of ethics and a list of best practices.

Coder said she hopes the report will help lead to a scenario where access to digital therapies is widespread and equitable.

“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,” she said.