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Prescription Digital Therapeutics: Ongoing Efforts to Expand Awareness, Integrate Into Clinical Practice
Technology is increasingly being utilized in various facets of the health care industry. Digital technology continues to evolve with the goals of improving patient access to care and delivering quality health care to all patients.
Digital therapeutics are expanding and are available as nonprescription and prescription products. The Digital Therapeutics Alliance defines the use of digital therapeutics (DTx) as the delivery of “medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent an extensive spectrum of diseases and disorders.”1 Prescription digital therapeutics (PDTs) are defined as “evidence-based, clinically evaluated software-based treatments prescribed by a licensed health care professional that are delivered via smartphone, tablet, smart watch or laptop computer which are designed to diagnose, monitor or treat the behavioral aspects of some medical conditions.”2,3,4 In contrast to the various health and wellness apps available, PDTs are developed in adherence to Good Manufacturing Practices, only available via prescription, rigorously studied in clinical trials to assess safety and effectiveness, and authorized by the US Food and Drug Administration (FDA) as Class II devices.2,3,5
In 2017, the FDA approved reSET as the first PDT designed to provide cognitive behavior therapy as adjunctive therapy for patients aged 18 and older with substance use disorders.3 There are several FDA-approved PDTs for various medical conditions such as chronic insomnia, substance use disorder, attention-deficit/hyperactivity disorder (ADHD), diabetes, incontinence, posttraumatic stress disorder (PTSD), and irritable bowel syndrome (IBS). PDTs are prescribed alone or in combination with other therapies to treat these conditions.
Per the Digital Therapeutics Alliance website, approved PDTs include:
- reSET: aimed at providing cognitive behavioral therapy (CBT), under the supervision of a clinician as an adjunct to a contingency management system, for patients 18 years of age and older enrolled in outpatient substance use disorder treatment.
- reSET-0: a 12-week (84-day) software application for opioid use disorder.
- Nightware: used to improve sleep in adults aged 22 and older with nightmare disorder or nightmares related to PTSD.
- Somryst: the first and only FDA-approved PDT for chronic insomnia.
- EndeavorRx: the only FDA-prescription video game for patients aged 8 to 12 years with ADHD.
- Mahana IBS: employs CBT to decrease IBS severity.
- RelievRx: a prescription in-home virtual reality (VR) system that uses CBT and other behavioral methods to decrease pain in patients aged 18 years of age and older with diagnosed chronic lower back pain.
- Luminopia: the first FDA-approved binocular therapy for the treatment of amblyopia, the leading cause of vision loss in children.
- Abilify MYCITE: a drug-device combination product comprised of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor intended to track drug ingestion that is indicated in adults for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults.
- BlueStar RX: indicated for use by health care providers (HCPs) and patients aged 18 years and older as an aid in diabetes self-management.
- Insulia: to be used as a supportive aid for insulin titration for patients using any brand of basal insulin.
- Leva: for treatment of incontinence in women, that employs methods for rehabilitation and training of weak pelvic floor muscles.
- Oleena: designed to assist patients with cancer in the management of symptoms and remote monitoring by HCPs.
- Regulora: treatment of abdominal pain from IBS in adults.
- Nerivio: treatment of migraine in those aged 12 years and older.
Roundup: Recent News and Clinical Data
In July 2023, the FDA approved AspyreRx, indicated to provide CBT to patients 18 years or older with type 2 diabetes who are under the care of a HCP. This novel PDT was approved based on findings from a phase 3 trial (ClinicalTrials.gov Identifier: NCT04886388) that included 669 patients with type 2 diabetes mellitus who had an HbA1c ≥7.0%.6,7 After 90 days of use, those in the AspyreRxgroup had significantly lower HbA1c levels, improvement in levels of fasting glucose, lower systolic blood pressure reading, and improved overall quality of life scores, according to the findings.6,7
In March 2023, based on results from a study involving 79 patients with chronic PTSD, the FDA gave 510(k) clearance for the product Prism for PTSD as the first noninvasive, self-neuromodulation adjunct digital therapy for PTSD.8 Utilizing techniques such as neurofeedback, the product coaches patients to lower the amygdala-derived-EFP biomarker, which is correlated with the amygdala and emotion regulation system.8
In May 2023, Click Therapeutics and Boehringer Ingelheim announced the launch of the CONVOKE study (NCT05838625), a randomized, multicenter, 16-week study that will explore the use of PDTs as adjunctive therapies to standard treatments for negative symptoms of schizophrenia in patients 18 years and older.9
Experts at Asembia’s AXS23 Summit said many payers have concerns regarding coverage of PDTs.
Diane Giaquinta, PharmD, vice president for market access research with Ashfield Engage, said, “In a survey of 25 payors conducted last summer by Ashfield Engage, about half of commercial managed care payors said they covered one or more PDTs, while less than 25% of Medicare or Medicaid payors, such as Medicare Advantage plans, covered the products. Currently, there are no coverage regulations for PDTs from CMS, but the Access to Prescription Digital Therapeutics Act of 2023 currently under consideration by Congress would add PDTs to the list of services and products covered by CMS. Some 60% of payors surveyed said they anticipated covering at least one PDT by the end of the year.”10
In a study published in Frontiers in Digital Health,3 authors noted the potential advantages of using PDTs continue to evolve, and expanding patient access to PDTs may improve patient access to care, improve health equity, and aid in addressing health care disparities. They also noted that PDTs have many benefits over traditional in-person therapies for the behavioral aspects of many conditions and diseases.3
In a commentary published in Advances in Therapy,5 authors indicated that more work is warranted to expand awareness about PDTs and that implementing these technologies into clinical practice can potentially improve access to care and improve clinical outcomes for patients. The authors wrote, “We believe the adoption of digital technologies in medicine is inevitable and that such adoption will ultimately improve the lives of both clinicians and patients.”5
Conclusion
As the integration of technology continues to expand in health care, PDTs provide prescribers with innovative methods to treat their patients and the ability to monitor their progress via software applications for a range of medical conditions. PDTs can also improve patient access to therapy with convenient delivery of care in their homes or while going about their day. PDTs can improve clinical outcomes and encourage patients to take an active role in their care, which may improve adherence and overall outcomes while also improving patient health-related quality of life.
Pharmacists are well poised to augment awareness about the availability of PDTs and their potential benefits. Due to their frequent encounters with patients, pharmacists can also be instrumental in identifying patients that are ideal candidates for PDTs. In doing so, they can make clinical recommendations accordingly and encourage patients to discuss the issue with their primary HCP.
References:
- Understanding Digital Therapeutics. Digital Therapeutics Alliance. Accessed July 28, 2023. https://dtxalliance.org/understanding-dtx/
- Software as a medical device (SaMD). US Food and Drug Administration. Updated December 4, 2018. Accessed July 28, 2023. https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
- Watson A, Chapman R, Shafai G, Maricich YA. FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate. Front Digit Health. 2023;5:1086219. doi:10.3389/fdgth.2023.1086219
- Prescription Digital Therapeutics. Academy of Managed Care Pharmacy. Accessed July 28, 2023. https://www.amcp.org/policy-advocacy/legislative-regulatory-issues/prescription-digital-therapeutics
- Brezing CA, Brixner DI. The Rise of Prescription Digital Therapeutics in Behavioral Health. Adv Ther. 2022;39(12):5301-5306. doi:10.1007/s12325-022-02320-0
- Better Therapeutics receives FDA authorization for AspyreRx™ to treat adults with type 2 diabetes. News release. Business Wire. July 10, 2023. Accessed July 28, 2023. https://www.businesswire.com/news/home/20230710624673/en/Better-Therapeutics-Receives-FDA-Authorization-for-AspyreRx%E2%84%A2-to-Treat-Adults-with-Type-2-Diabetes
- Hsia J, Guthrie NL, Lupinacci P, et al. Randomized, controlled trial of a digital behavioral therapeutic application to improve glycemic control in adults with type 2 diabetes. Diabetes Care. 2022;45(12):2976-2981. doi:10.2337/dc22-1099
- US FDA Grants GrayMatters Health 510(k) Clearance to Market Prism for PTSD. News release. PR Newswire. March 21, 2023. Accessed July 28, 2023. https://www.prnewswire.com/news-releases/us-fda-grants-graymatters-health-510k-clearance-to-market-prism-for-ptsd-301777149.html
- Click Therapeutics and Boehringer Ingelheim Initiate Pivotal Clinical Trial of Prescription Digital Therapeutics for the Treatment of Negative Symptoms in Schizophrenia. News release. Click Therapeutics. May 4, 2023. Accessed July 28, 2023. https://www.clicktherapeutics.com/press/click-therapeutics-and-boehringer-ingelheim-initiate-pivotal-clinical-trial
- Blum K. Lingering Questions for Payors Regarding Prescription Digital Therapeutics Coverage. Specialty Pharmacy Continuum. June 29, 2023. Accessed July 25, 2023. https://www.specialtypharmacycontinuum.com/Pharmacy-Technology-Report/Article/06-23/Lingering-Questions-for-Payors-Regarding-Prescription-Digital-Therapeutics-Coverage/70708
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