Over the past month, our HealthXL community members discussed digital health evidence requirements, DTx label claims, and DTx - pharma collaborations, among other topics. We’ve put together a snapshot of five expert insights from these meetings.

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#1 On Evidence Generation for Standalone DTx: Randomized Control Trials (RCTs) and Real-World Evidence (RWE) are the two main practices for evidence generation in DTx. While there is no clear answer on which format is more successful, some companies have seen success with a hybrid model. A hybrid design integrates the traditional RCT trial with design aspects to collect real-world data on patients. Traditional RCT’s are what physicians are most familiar with and thus trust, but they aren’t best suited to DTx. DTx solutions are constantly updating and improving. An 18-month RCT isn’t the best fit for an evolving solution. Hybrid models could be a way to both earn physician trust and allow for ongoing changes to digital solutions.  

#2 On evidence requirements from payers and regulatory bodies in oncology digital health: For payers in general, the return of investment will be measured through a cost savings lens or a member attraction and retention lens. FDA/regulatory approval for a digital health tool is not a strict requirement for payers. However, gathering sufficient evidence for partnerships with payers is proving difficult as they want a broader array of evidence than the FDA typically requires. Payers want real world evidence; they want to see the health economics impact and adherence data, which is costly and time consuming to gather, especially for small start ups. What does this say about the state of digital health if payers are more difficult to convince than the regulators?

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#3 On DTx label claims: Label claims cannot be universal for one solution due to regulatory differences across regions. A digital solution could be regulated as a prescription digital therapeutic (PDT) in one region but a non-PDT in another region. Regulations control what claims labels can make about DTx solutions. Therefore, products may not have the same label claims everywhere. This makes it hard for companies to standardize commercialization strategies across countries, which could affect scalability.

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#4 On Pharma - DTx collaborations: To maintain a strong relationship with pharma, DTx companies need to find numerous stakeholders to champion them throughout the partnership. It is important to focus on ROI, endpoints (both shared and individual), and stakeholders management. Keeping stakeholders onboard with a clear problem statement and roadmap is a key component of success.

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#5 On employer partnerships for DTx in mental health: Working with employers requires a different approach than with life science or medical partners. While a strong evidence base is still vital, the focus will be more on productivity and employee satisfaction and less on healthcare outcomes. That said, clinical trials remain an important way to illustrate the efficacy of a solution. Although employers may not have the required expertise to dissect clinical evidence in detail, it is often a foot in the door. Helping employers to understand and navigate clinical evidence could create more opportunities for collaboration.

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