Prescription Digital Therapeutics – Addressing Unmet Needs Among Patients With Mental Health Conditions

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Prescription digital therapeutics (PDTs) that have been authorized by the FDA can help fill gaps in care for mental health conditions and extend the reach of providers who are in short supply, said Arwen Podesta, M.D., in the Managed Healthcare Executive K-Cast video series. Podesta is a New Orleans-based board-certified adult psychiatrist with subspecializations in addiction medicine, forensic psychiatry and integrative medicine.

Definition

Digital therapeutics include any app on your phone that claims to have a therapeutic benefits. Podesta explained that PDTs have been reviewed by the FDA for efficacy and safety, including compliance with the Health Insurance Portability and Accountability Act (HIPAA). They are reviewed under an FDA authorization process, not approval, she said. “It’s a little bit different, but it is still rigorous,” said Podesta, and entails testing the PDTs in randomized clinical trials. PDTs also typically allow for “a whole slew of interactions” between the patient and the provider and allow for collection of data that can help in the monitoring of patients. That data collection creates concern about data breaches, Podesta said, and part of the FDA authorization process is making sure “there are safety nets in place so that the data gathered [are] appropriate for the patient, appropriate for the prescriber and not breaching any HIPAA securities.”

An extension of prescribers

Podesta noted that there is a shortage of providers for insomnia, substance use disorder and many of the other conditions that PDTs are designed to treat. PDTs can help make up for those shortfalls by guiding and monitoring patients. Podesta said she and many of her colleagues can’t see their patients as frequently as they would like to. “I really do view prescription digital therapeutics as extenders of our treatment, because they really can be effective at helping patients in between our appointments or maybe even when they don’t have access to a prescriber,” Podesta said.

Podesta said PDTs have the potential for turning the many hours that people spend on their phone and their devices into a beneficial experience. “You’re scrolling. You’re scrolling. What if you’re scrolling in an app instead and you’re doing something therapeutic that would help diabetes or could help with exercise and hypertension?” Podesta said.

Podesta also spoke about PDTs helping people with substance use disorders deal with cravings at times such as the middle of the night when a therapist or a sponsor in a treatment program isn’t available. In such circumstances, a PDT can help patients deal with the temptation to reach for the phone to contact a dealer, she said. PDTs can also help people with depression, anxiety, post-traumatic stress disorder and other conditions who are in the midst of a crisis when other sorts of help might not be available, Podesta said.

Overcoming hesitancy

PDTs are greeted with some hesitancy, Podesta acknowledged. Some clinicians are concerned about data security. Others may be apprehensive about patient usability, she said. If patients have issues with technology or don't have reliable access to Wi-FI, “perhaps digital therapeutics might not be something that we want to talk about with them initially,” Podesta said. Sometimes clinicians are wary because they are not digitally savvy.

Podesta said she will sometimes broach the subject of prescribing use of PDT with patients by asking them about which health-related apps they have on their phone and why they started using them. She said she will ask them to talk about how the app has worked for them and invite them to speak about any issues that cropped up between having downloaded the app and actually using it and taking the actions it is designed to encourage. To conduct the conversation, Podesta said she sometimes uses techniques from motivational interviewing. Podesta said she also uses the concept of salience when encouraging patients to use PDTs — “not just that they feel better in their success but that the interface itself is something that is enjoyable and successful and gives them a positive feeling.”

Self-management

One of the benefits of PDTs is that they can give patients a sense of control over their disease and participation in their own care, Podesta said. “Being able to have some self-management and feel like they have some autonomy in their disease outcome and their symptom improvement is really something that elevates patients,” said Podesta. Working through the modules of PDT can, depending on the disease and how the PDT works, alter brain chemistry and improve symptoms, she said.

Podesta noted that the American Psychiatric Association is endorses integrative care, which means coordinating psychiatric, primary and other sorts of care. She said that PDTs are “just one more piece of that integrative model” and that the data they collect can help providers assess acuity and whether some patients need to be flagged as having a higher level of need. PDTs can be used to measure symptoms and, for some conditions, encourage the measurement of biomarkers or getting imaging tests that help clinicians monitor an illness, said Podesta. Data collected by PDTs can also be used to more accurately assess the outcomes of treatments. “I think that is an area that payers would very much like to look at because you want to know that the tool that your prescriber is using is actually having efficacy,” Podesta observed.

Successful implementation

Podesta said there are several PDTs that she is satisfied with that are designed to treat the conditions that her patients have, including addiction, attention-deficit/hyperactivity disorder (ADHD) and insomnia. She mentioned EndeavorRx, an FDA-authorized PDT for ADHD for children and adolescents, by name. Podesta said she does not treat children and teens but has overseen the use of PDTs in patients with children and has had her adult patients with ADHD use it with success. Podesta also pointed to a PDT for insomnia that patients with sleep problems can use before bed or in the middle of the night.

Prescribers need to make sure there are support systems in place when they prescribe PDTs, partly because of the nature of the mental health problems that several PDTs target. “If someone is suffering from PTSD or severe depression and they’re on their own and they don’t have any supports…in some of these disease states, actually reaching out and doing something is the last thing that they want to do,” Podesta said. It is important, she said, that staff members are involved. “Everyone on the team needs to understand that we have these prescription digital therapeutics and it might be something that the patient is using and how to help support that.”

Working with payers

Podesta said insurance coverage, just like with new medications, is essential to successfully prescribing PDTs. “Without coverage, I would say I would hesitate to start getting involved with using prescription digital therapeutics. So key for us, as prescribers, is to know what’s covered, by whom and how to get it and how to fulfill it with ease,” Podesta said.

Podesta said payers should cover FDA-authorized PDTs — that they have excellent safety profiles and high levels of efficacy. She also said that the payers cover PDTs for a variety of health conditions.Insurance coverage for PDTs would help address equity issues and the shortage of mental health providers, he said. “I think that payers can help encourage prescribers and facilities and entities to help offer these tools to patients who are in need. We know the need is so high, especially in the mental health space. And we know that the need is so unmet,” said Po. “These PDTs can fill the gap in a way that is beyond what we can do as
individual prescribers.”