Over the past month, our HealthXL community members discussed evidence generation strategies for digital therapeutics (DTx), clinical and economic evidence for standalone DTx and non-prescription DTx (non-PDT) patient engagement, among other topics. We’ve put together a snapshot of five expert insights from these meetings.
#1 On evidence generation strategies for DTx: The evidence requirements change depending on the route to market you want to pursue. For example, pharma requirements are not the same as payers. It is critical to know this up front to build the right evidence generation strategy. Tracking safety in the long-term makes a lot of sense for drugs. However, for most DTx products, proving long-term efficacy becomes more important. Even when the product changes to cover new indications, it may not be necessary to focus on safety if it has already been shown for other indications. Safety evidence requirements should be specific to the product and/or disease.
#2 On the comparison of standalone DTx to drugs or standard treatments: Standalone DTx are not comparable to drugs or standard treatment protocols. They are high-quality software systems that are designed to help treat various medical conditions. However, since DTx intervene in the care regimen of a patient and play a substantive role in the therapeutic process, in many countries they are required to meet the same gold standard of clinical and economic evidence as traditional medical treatments through Randomized Clinical Trials (RCT). As they are technology-based solutions, there are challenges in showcasing clinical and economic evidence. We polled experts from our community for their views on comparing standalone DTx to the standard of care.
#3 On leveraging Digital Health to address comorbidities in oncology: An oncology diagnosis represents a huge shift for a patient. This, along with the treatment, can lead to or exacerbate comorbidities that need to be addressed, such as mental health issues and pain. While digital solutions can help ease that burden in several ways, there needs to be a balance to ensure that they are integrated into a care plan gently, rather than adding additional complexity to an already difficult situation. For providers, this means considering how they can seamlessly integrate into a patient's broader care plan. A more open approach to integration and broad-based care could give clinicians more options to recommend to patients without adding any undue burden to either patient or doctor.
#4 On patient engagement with non-prescription DTx products: Personalization is key when scaling a non-prescription DTx product (non-PDT); this is delivering an experience adapted to each patient's needs and giving them the right therapy at the right time. The use of Artificial Intelligence (AI) and Machine Learning (ML) can help gather patient data and use it for a more personalized experience across the patient journey. One of the biggest challenges when going direct to consumer (D2C) is converting patients from acute therapy to maintenance; as soon as they have no symptoms they stop using it. Especially those patients referred from insurance, which only paid for the acute therapy.
#5 On HCP and Patient adoption of DTx in Neurology: Most neurological patients see their physician only once or twice a year. In-between visits, self-care becomes really important. Tools that support this self-care may have more success with patient engagement. However, patients need to be involved in the product development process. There are currently a lot of apps for neurology patients that have accessibility problems (i.e. tiny buttons). For healthcare professionals (HCPs) it’s important that solutions only give physicians the minimum essential actionable information. Too much data can become a burden.
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