New Digital Therapeutics Guide Aims to Bring High Standards, Clarity

The guide is designed to help spread best practices and help healthcare decision-makers understand the benefits of digital therapeutics.

As digital therapeutics grow in number and availability, an industry group is hoping its new guide brings more clarity to the sector.

The Digital Therapeutics Alliance, a trade group for the growing roster of companies developing clinically validated software to solve healthcare problems, has released its first Digital Therapeutics Value Assessment and Integration Guide. The document, drafted over the course of two years based on insights from manufacturers, clinicians and payers, lays out a framework for the evaluation and implementation of new digital therapeutics.

Megan Coder, Pharm.D., MBA, the alliance’s chief policy officer, told Managed Healthcare Executive that the guide responds to a need that emerged from conversations with industry stakeholders.

“This is something that we didn't initially set out to do,” she said. “But over discussions with our members, in discussions with payers and other decision-making entities, we really learned pretty quickly that there's a lack of clarity in terms of, what even are these products? How should they be evaluated? How do we recognize them? How do we actually assess them?”

The guide, which is available online, deals with a number of those issues, including data security best practices, clinical team engagement, assessment of clinical evidence and cost-benefit analysis.

Those questions matter because digital therapeutics are both similar to and distinct from traditional pharmaceutical products and medical devices. Coder said many of the companies developing DTx solutions have created their own sets of digital therapeutics best practices, based on their experience with pharmaceuticals and/or medical devices.

Healthcare decision-makers have similarly sought to adapt their knowledge of existing categories in order to assess digital therapeutics. Coder said one of the goals of the guide is to clearly define guidelines around digital therapeutics “to a point where it's focused solely on digital therapeutics and not this broader ecosystem that can be nebulously undefined.”

Another aspect of differentiating digital therapeutics is distinguishing them from health and wellness applications that have become ubiquitous in smartphone application stores. Coder said digital therapeutics are different from wellness apps because they have been held to high standards like those laid out in the new guide.

“We're looking at digital therapeutics that are using software to actually treat, manage or prevent a disease or disorder,” she said. “So the idea of having a digital therapeutic for the right therapy for the right patient at the right time is really important.”

Though a growing number of digital therapeutics are being offered to patients via prescription — in which pharmacists dispense access codes, rather than pills — Coder said even digital therapeutics that do not require a prescription still involve evaluation criteria that could be used by healthcare entities to make sure a particular therapeutic is appropriate for a particular patient. She prefers the term “behind the counter” to the term “over the counter,” since the former connotes the appropriate screening.

“So not all products on that behind-the-counter side would require an authorizing physician like they would for the prescription on the side,” she said. “But there are other clinical entities who would have engagement in helping identify what therapies are right for which patients.”

The new guide is the first such unified document that provides industry-wide best practices and frameworks, but Coder said discussions about how to best integrate digital therapeutics into everyday healthcare are continuing.

One of the key tasks going forward is better defining efficacy in clinical trials. While the current guide lists various types of clinical evaluation, she said more work needs to be done to better resolve issues such as optimal clinical trial design and data sufficiency. Without such clarity, she said, digital therapeutics developers face a confusing web of standards and preferences that could vary from state to state and payer to payer.

“If you're going to have decision-makers in every single city, state, region, and nation-level creating their own requirements based upon what they think their needs are for clinical trial requirements, then a digital therapeutic manufacturer has a very low likelihood of being able to meet all of those requirements for all those different entities,” she said.

Ultimately, Coder said, that will lead to limitations on patient access to therapies that could help them.