Digital Therapeutics: Mainstream Medicine?

A virtual panel with:
David Zuckerman, Digital Health Partnerships Lead, Takeda
Benjamin Dhont, Head of Strategic Marketing, Voluntis
Karen Donoghue, Interaction Architect & Principal, HumanLogic
Laura Lovett, Executive Editor, MobiHealthNews (moderator)

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Recorded January 20, 2022

What distinguishes digital therapeutics from the mainstream digital health and wellbeing market?
- Digital therapeutics need to have evidence that they achieve their intended clinical benefit. For pharmaceutical companies, this takes the form of clinical trials with accepted end points. This may include regulatory clearance, depending on the classification of the therapeutic. In addition, typically digital therapeutic interventions should be prescribed or recommended by the physicians to patients.
What are the challenges of pairing digital therapeutics with medications?
- Designing the clinical trial is one challenge. Is there a sham app that can be used as a control and accepted by the FDA? How should reimbursement be done, in combination with the medication, or should each be standalone?
- Who are the true prescribers for the therapeutics? Who will onboard the patient and healthcare providers? Pharmacists, nursing support, patient services? How will adherence and usability be addressed?
- Use cases can be challenging, with multiple personas to be considered. There are patients, clinicians, sometimes even patient advocates, and more. Each of these should be considered in the design and proposed workflows surrounding the intervention.
Where are we with determining whether these therapeutics actually work?
- Consumer stats are still important success metrics since these are apps at the end of the day, for example, adoption and churn of users.
- From the pharmaceutical perspective, this is easier to determine for newly public (via IPO or SPAC) digital therapeutic companies who are reporting their data quarter over quarter.
- One key trend that has changed is that the dialogue is less about scaling potential, more about scaling issues – for example, market access differs across the world. More and more companies are grappling with scaling in different countries.
How should we approach usability for these interventions?
- Fitting into clinician workflows is key. It can’t be overstated enough how little time they have, how much they want to just see and receive what they truly need.
- More screen time or usage of the applications is often not the success metric. A clinician will want to only use their time with it if there is an action they need to take. Similarly, if it’s critical for a patient to enter a certain symptom, that is when they should engage with the application.
Where are we in terms of adoption?
- We’ve passed the point now of establishing that some early evidence will help with payment. However, even when the patient doesn’t have to pay, that doesn’t mean the providers will want to engage with the tool or use it, because they may rather spend their time on consultations with patients, which is what they are paid for.
- There also need to be more consideration given to training for healthcare providers, as this is not a typical activity in their practice. This extends even to awareness and discovery of the solutions.
- Additionally, if your experience relies on functionality that the user can control, such as push notification reminders, they may turn off this function, which will break your intended experience. This can impact adoption as well.
Startups and life sciences – how do pharma companies think about Buy vs. Build?
- Does the pharma company have the team to build and test the digital therapeutic product? May not be a skill set existing internally. It also may take too long to develop internally. Can pharma scale it globally, dealing with regulatory around the world? Oftentimes it makes sense to partner at first.
- Key constraints and considerations for partnerships:
  - What is the key problem(s) to be solved? Just aligning this between product company or team and the life science organization can be complex.
  - Timelines and approach can differ greatly: where a software company may develop a beta or MVP version to test iteratively, a pharma company typically doesn’t do this. There is also an annual planning perspective to be considered for pharma – it can be a great fit and idea, but off cycle.
What’s the next big step in the world for digital therapeutics?
- Pulling insights out of the large data sets being generated is one exciting frontier. Another area that can be huge is the form factor – different wearable fabrics, or very unobtrusive therapeutics, are largely untapped. At the end, value back to the end users – providers, patients, families – will be key.