I recently attended the second DTxDM conference of the year, which was held on Sept. 25-26 in Boston, MA. The conference brought together more than 200 senior decision-makers from digital therapeutics companies, pharma, investors, payers, and healthcare providers—nearly double the attendance of the same conference in San Francisco just six months prior.
As the growing attendee count infers, growth in this space is significant. With that growth often comes more questions than answers as many seek to get a solid understanding of the best path forward for their emerging businesses. Here are some of the questions that stood out as the most important that remain to be answered for the industry.
Do we really need clinical trials and FDA clearance or approval?
Probably one of the biggest debates of the conference centered on the need for further validation from randomized clinical trials, real-world evidence, and FDA clearance or approval. While no one approach seems to fit all, everyone was united on the fact that both trials and a nod by the FDA added much needed credibility to the space. That said, clinical evidence and real-world validation will be key to demonstrating the potential impact to healthcare providers as they start to consider the most meaningful patient therapies, whatever those may be.
Alex Waldron, Chief Commercial Officer from Pear Therapeutics, said it best: “If you walk in with efficacy data and cover up your solution with a cloth, if you take the cloth away it doesn’t matter if it’s a pill, an app, or whatever—it works.”
Are partnerships with big pharma the best distribution method?
The pharmaceutical company representatives at the conference were not thrilled by the notion of being simply for distribution but instead stressed the importance of partnerships and collaboration. Attendees seemed to have mixed views of the power of these partnerships. Some believed it provided the commercialization prowess they needed to get off the ground, while others thought it best to remain agnostic and continue to hang on to the control of their products and distribution. There appears to be no right answer here either, but there are clear pros and cons to both.
What’s the right payer strategy and pricing model?
Business models, reimbursement, and payer approaches were hot topics at DTxDM. Those that were further along with these relationships were asked pointed questions about their pricing and strategic approaches and were, rightfully so, guarded in their responses. Many digital therapeutics companies are still challenged with finding the right way to demonstrate health economics, but third-party support for valuation and clinical validation may be the best starting points.
Debra Reisenthel, Chief Executive Officer from Palo Alto Health Sciences, suggested that rather than walking in to payers with a reimbursement approach in mind, it’s best to be open-minded with contract teams and providers.
Are we wellness brands or are we prescription therapies?
The vast majority of attendees were adamant about not getting lumped into wellness providers, which is perhaps why so many sought the validation of the FDA and clinical trials. Many also sighted the risk of becoming another Lumosity without clinical validation at their sides. However, several in the space are already finding success from joining employer wellness plans and partnering with providers. Perhaps this is an area that should not be overlooked as an opportunity should the therapy be a good fit for it.
Are specialty pharmacies the right approach?
Due to the high-touch nature of specialty pharmacists, many digital therapeutics providers spoke about the value these healthcare providers might have in recommending therapies to physicians and patients. One attendee even described this solution as a way around the physician; however, it seems to me that an integrated commercialization model that gets all healthcare providers on board may be the best approach. Perhaps these pharmacies are simply the key opinion leaders (KOLs) that help to fuel the conversations until things take off.
Meanwhile, other questions that DTx providers should be asking that didn’t seem to be top of mind at the conference include:
How are we preventing silos and instead focusing on the whole patient?
Many of the treatment options either on the market or soon to be are focused on one disease state or a single solution. Many patients, however, have several co-morbidities or treatment needs, and both patient and physician may struggle to manage a combination of therapies in order to find what works for them. This suggests that a single sign-on option with many therapies may be a good future state and that the market may benefit from future consolidation.
How does this lend itself to personalized care?
Personalized care was inferred but never fully addressed with digital therapeutics at the conference. The idea being that these complex digital solutions should be able to lend themselves nicely to more personalized care, but yet many providers were talking more about scale and less about individualized treatment. It will be interesting to see who stands out as providing the best treatment path for individuals and the patient population as a whole. Using individual patient profiles and other collected data to drive the best treatment path seems like a natural extension of these digital platforms.
What about HCP adoption?
This was quite possibly the least asked question at the conference but the most critical. As we think through how to get the product in the market, many are focused on finding the right partners and payers for reimbursement but less focused on the teams who are either going to advocate for or admonish this treatment path—the healthcare team. The challenge will be how to do that with today’s time-starved physicians who will need to fully understand and experience the therapy in order to buy in to the validity of the treatment. The team that cracks the behavioral economics code on adoption and advocacy with healthcare providers will undoubtedly see the most long-term success and really thrust the industry forward.