Technologies like wearables and virtual reality could become key tools in engaging neurodiverse patient populations, streamlining provider workflows and tracking outcomes, payers, therapists and tech founders said during a recent virtual roundtable.
“The promise of virtual technologies is to increase access and to create pathways where there’s more affordable care,” Vijay Ravindran, founder and CEO of Floreo, which organized the roundtable, said during the event. Floreo is the maker of VR behavioral therapy content focused on autism and other neurodevelopmental disorders.
While enabling technologies have been around for years, “the pandemic has elevated the conversation even more,” added Solomon Parker, director of intellectual and developmental disabilities program strategy at CareSource.
There is growing evidence of tech’s ability to address geographic and other access barriers, particularly for the underserved, Parker added—a opportunity that his nonprofit managed care plan and Floreo have launched a pilot program in Arkansas to capture.
Technology like VR can also help build up other critical skills for neurodiverse communities that contribute to health and well-being like vocational rehab, individualized education plans or interacting with law enforcement.
“You can more adequately support people in responding to crises in a virtual world,” Amber Valentino, chief clinical officer at Trumpet Behavioral Health, a Floreo customer, said during the panel.
Appealing to clinicians
Doctors have historically been slow to adopt technologies like digital therapeutics. That’s in part due to a reported lack of integration with clinical workflow and a lack of validation of the tech.
“Some doctors, no matter what you present, will not want to be first adopters,” Katya Sverdlov, CEO of JelikaLite, said in the panel.
As use of tech like VR and medical devices gets more mainstream, that will help signal to clinicians or mental health practitioners that these are worth integrating into their practice, she said. JelikaLite is developing a noninvasive therapeutic medical device to reduce autism symptoms.
At the same time, the influence of mental health practitioners cannot be understated, Ravindran said. While other prescription digital therapeutics have focused on winning over physicians, for neurodiverse patients it is often the therapist leading their care. If a patient, or their family, is converted to a helpful technology, their therapist may follow.
“That provider is then an important influencer in what makes sense for a portfolio of families,” Ravindran said.
Autism care, for example, can lean on the advocacy of parents for their child’s well-being as well as their willingness to think outside the box.
“As desperate parents start using different technology and they see benefit, they will be the ones asking their clinicians to incorporate a certain novelty into the practice,” Sverdlov said.
Collecting data on improved outcomes is really key to getting payers on board, Parker noted. Otherwise, it is very difficult to make the case for any tech. And, when it comes to tracking therapeutic progress, tech can help be more objective and efficient, some panelists said.
Good ideas on measuring outcomes in behavioral therapy already exist, Valentino explained. But fitting those recommendations into the existing infrastructure of service delivery can be a huge logistical challenge.
“This is a place where technology has a huge opportunity to improve the efficiency with which we work and to take some of those great ideas and get them into practice in a way that isn’t overly taxing on the providers,” she said.
What’s more, for in-person therapy or treatments, the measurement of outcomes is very qualitative, Sverdlov noted. It depends on the person doing the measuring.
“Digital technologies at least have the potential of doing much more quantitative measurement,” Sverdlov said.
Pursuing FDA approval
Sverdlov’s JelikaLite recently began its third clinical trial and is vying for FDA approval for its noninvasive device to reduce autism symptoms.
“I have children of my own. I would not want to do something to my children’s brain without being sure that what I'm doing is, one, first and foremost safe, and second, that it’s actually going to have some effect,” Sverdlov said.
Obtaining FDA approval would offer peace of mind to all parties involved, according to Sverdlov, including clinicians. It would also help protect JelikaLite against misuse of its product.
Having a stamp of approval from the regulatory body could also help incentivize reimbursement, Ravindran added. Though Floreo is already on the market for use alongside a clinician, it is also interested in pursuing FDA approval.
“It’s a vital step toward being able to create a scalable business,” Ravindran said.
Floreo has Medicaid waivers in several states where its technology is used in prescription form alongside a clinician. “Providers already use treatment codes as part of their lifeblood of their business,” Ravindran said.
That’s why Floreo targeted CPT codes to blend its tech into that workflow. It proposed to the American Medical Association a CPT III code for VR use in therapy, the first of its kind approved in 2022.
“The practice code creates the plumbing for how VR can be incorporated into augmenting treatment,” Ravindran said.
Additionally, obtaining FDA approval would help support pending legislation on prescription digital therapeutics currently in Congress, per Ravindran.
Examining other models to scale
Panelists weighed in on what the high-profile downfall of Pear Therapeutics earlier this year means for their industry. Three of its digital prescription therapeutics had FDA approval, yet the early mover still went bankrupt. Pear’s founder and CEO has said the company struggled to secure reimbursement.
“I think investors learned a harsh lesson: that FDA approval does not equal a successful business,” Ravindran said. The product also has to fit the workflow and expectations of the end user as well as the clinician and to create value in the eyes of the payer, he said.
A lack of focus can also be to the detriment of a company, Sverdlov added. Since then, she has seen the conversation between founders and investors pivot toward focus rather than about pushing in many different directions.
Another player in the prescription digital therapeutics space, Akili Interactive, also had a rough start to 2023, cutting jobs and planned projects to reduce costs. It then unveiled an over-the-counter version of its software targeting attention-deficit/hyperactivity disorder. Its plan is to keep prescription and OTC versions on the market while it pursues formal FDA authorizations.
Such an approach is not one JelikaLite plans to pursue, primarily due to the different risk potential of its technology, which necessitates clinician supervision. But Akili’s move is understandable to Sverdlov: “It is hard to convince clinicians to use something new,” she said.
Going the commercial route can also help demonstrate product-market fit, Ravindran added, and, if widespread adoption picks up, that can help make the case for reimbursement. But for Floreo, direct-to-consumer has not been the strategy because of its mission to make tech accessible to underserved parents, like those on Medicaid. Paying out of pocket could get cost prohibitive.
“Ultimately, our goal also is to reach millions of kids and we have to fit into the current ecosystem to do that,” Ravindran said.
Fierce Healthcare's Anastassia Gliadkovskaya moderated the panel.