Digital medicine is the use of technology to measure or intervene in certain health conditions and is overseen by the FDA, unlike digital health apps or technologies.
During a session at the Asembia 2022 Specialty Pharmacy Summit, presenter Jayne Hornung, BSPharm, chief clinical officer at Managed Markets Insight & Technology (MMIT), discussed the growing role for digital therapeutics and why most payers have been hesitant to cover them.
Digital therapeutics deliver medical interventions directly to patients using software to treat, manage, and prevent a spectrum of diseases and disorders, Hornung said. Typically used as an add-on treatment, these technologies can include telehealth, mobile apps, and wearable devices. Importantly, digital medicine is the use of technology to measure or intervene in certain health conditions and is overseen by the FDA, unlike digital health apps or technologies.
Some digital therapeutics are prescription-based and are designed to directly treat diseases. Much like traditional prescription drugs, prescription digital therapeutics are designed and thoroughly tested in clinical trials. Some examples include EaseVRx for patients with chronic lower back pain; Parallel for patients with irritable bowel syndrome; and Monarch eTNS for the treatment of attention-deficit hyperactivity disorder (ADHD).
Like pharmaceuticals, gaining market access for prescription digital therapeutics begins with FDA approval. The FDA’s Digital Health Center of Excellence (DHCoE) provides regulatory advice for the regulatory review of digital health technologies and will align and coordinate digital health work across the FDA. Notably, Hornung said the FDA wants to tailor a regulatory pathway specifically for digital technologies, but many questions still exist in this process.
EndeavorRx is a prescription video game for children between 8 and 12 years of age with predominantly attentive or combined-type ADHD. It was approved by the FDA in June 2020 as an add-on treatment and was evaluated in 5 clinical trials with more than 600 children. When used 25 minutes per day for 5 days a week for at least 4 weeks, researchers found significant responses and adverse effects that were the same as those found with commonly used pharmaceutical treatments.
Importantly, Hornung said this is a cost-effective treatment, at $150 per month or less than $100 per month for patients without insurance coverage. Treatments such as this could make a huge difference for patients like her stepson, who Hornung said has struggled with ADHD.
“Something like this gives us hope and another product in our arsenal,” Hornung said.
Despite positive clinical trial findings and a favorable cost profile, Hornung said national pharmacy coverage for EndeavorRx shows that nearly 50% of plans do not show coverage on their formularies, 25% have coverage, 25% show that it is not covered, and no plans have it on the list of preferred treatments.
An MMIT survey included perspectives from experts involved in health system formulary committees and pharmacy benefit managers. The survey found that payers have concerns about the need for robust clinical trials, as well as potential adverse reactions or harms from some technologies. Furthermore, questions remain about whether these technologies will help close health care inequity gaps or drive them further apart.
Nearly 80% of panelists in the survey rated the priority of prescription digital therapeutics as low to moderate. Furthermore, only 30% of respondents had received a provider request for a prescription digital therapeutic, most of which were denied. Hornung noted that the majority of these requests were for patients with insomnia.
“There’s not been a lot of push from providers or employer groups for the payers to look at these products and evaluate them,” Hornung said.
She noted that this is a great area for value-based contracting if the groundwork is laid properly. Despite hesitations, payers do agree that the greatest value with prescription digital therapeutics is in clinical outcomes, although only one-quarter of the plans in the panel have contracts in place with prescription digital therapeutics manufacturers.
Turning to the future of prescription digital therapeutics, Hornung said answering payers’ questions and responding to their concerns will be key.
“I think it boils down to [the lack of a] standard tried-and-true process and the payers just aren’t comfortable,” she said.
Legislation is in place that, if passed, could help make prescription digital therapeutics more embraceable. The Access to Prescription Digital Therapeutics Act of 2022 would expand Medicare coverage to prescription digital therapeutics and, importantly, does have bipartisan support. If passed, it would help ensure that these technologies are tested for safety and efficacy and have a defined FDA approval process.
Finally, Hornung said prescription digital therapeutics need to do 3 things: provide clinical evidence supporting improved outcomes; provide a great patient experience; and reduce payer costs. By filling all 3 of these needs, Hornung said payers will begin to recognize the value in prescription digital therapeutics.
Hornung J. Digital Therapeutics Are Promising, So Why Is Payer Uptake So Slow? May 2, 2022. Presented at Asembia 2022 Specialty Pharmacy Summit.