Over the past month, our HealthXL community members have discussed the opportunities for digital health in retail healthcare, using real-world data (RWD) to increase market access and revenue generation in DTx partnerships among other topics. We’ve put together a snapshot of expert insights from these meetings. 

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#1 On RWD and clinical trial data: 

Traditionally, clinical trial data is favored over retrospective RWD. However, using retrospective RWD can eliminate the need for control groups, reduce risks to patients, and reduce costs. Data from clinical evidence and real-world trials should be used to complement each other, for validation purposes. There is more flexibility in RWD collection, which can create an opportunity to study a wider cohort and better inform economic evidence compared to clinical trials that are highly controlled. As with all study designs, a reduction in bias is key to gathering accurate information through both clinical trials and RWD. 

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#2 On the revenue model that works for pharma-DTx partnerships: 

Offering a DTx solution for free can attract patients, and allows pharma companies to buy space on the DTx platform for ethical promotion and patient engagement. Alternatively, pharma companies can link revenue to the DTx partnership, if user numbers are large enough. Some regulatory bodies will also give the option of a patent extension for tech plus molecular therapies which have shown better outcomes. This can support a conversation with payers and get price protection. 

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#3 On moving from DTx point solutions to platforms: 

Transitioning from point solutions to platforms in DTx can expand the technology's scope and capabilities to address a broader range of medical conditions and patient needs. This can be achieved by integrating multiple DTx solutions into one platform and adding features to support a wider range of user needs. Additionally, it is important to prioritize regulatory requirements, privacy, and security of the operating system.

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#4 Digital health for trigger management in autoimmune conditions: 

Digital health tools are becoming more sophisticated in their ability to identify triggers, reducing the time to diagnosis and treatment. This is especially relevant for autoimmune conditions, many of which are difficult to diagnose and track, and where early diagnosis is key to improving treatment options. Utilizing digital tools can alleviate the HCP burden, as well as incentivize patients toward medication adherence, reducing hospitalization and improving the quality of life for patients. For pharma, these digital tools provide an opportunity to develop combination tools to add to their product catalog and give pharma more ownership over the patient journey.

#5 On how DTx companies can navigate FDA Breakthrough Designation: 

Once the DTx solution is developed and the target population is identified, the reimbursement strategy can be determined. It is important to identify the reimbursement strategy early in the process, to ensure that evidence is generated in a way that satisfies the expectations of both payers and regulators. For Breakthrough Designation to be granted, there needs to be evidence that it ‘could’ more effectively treat or diagnose compared to current devices, whereas 510k approval requires evidence that the device is ‘as effective’ as another FDA approved device. 

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