Modernizing Health Care With Digiceuticals

Digiceuticals, also known as digital therapeutics, continue to grow; yet it can be hard to find concrete information to help understand what they are and how they function.¹ In the United States, digiceuticals are not defined at the government level and are treated as medical devices.^1,2 There are, however, other governing bodies and organizations such as the European Data Protection Supervisor, Digital Therapeutics Alliance, and Ministry of Food and Drug Safety that have similar definitions for digiceuticals.¹

Image credit: Sergey Nivens | stock.adobe.com

The Digital Therapeutics Alliance is a non-profit trade association engaged in the promotion and advancement of digital therapeutics.³ This alliance has offered up definitions of digital health, digital medicine, and digiceuticals.³ Digital health captures, stores, or transmits health data via technologies, platforms, and systems that engage people with lifestyle, wellness, and health-related purposes.^4,5 Electronic medical records, patient portals, and lifestyle apps such as Fitbit and Apple Health are considered digital health applications.⁴

Digital medicine is evidence-based software or hardware products that measures or intervenes in human health.^4,5 Examples of digital medicine include digital diagnostics, digital biomarkers, and ingestible sensors.⁴ Finally, digiceuticals have software capabilities that deliver evidence-based therapeutic interventions to prevent, manage, or treat a medical disorder or disease.^4,5

In the United States, digiceuticals categorized as medical devices are regulated by the FDA within the Center for Devices and Radiological Health.² Overall, FDA approval rates of digiceuticals have been improving, which can be attributed to the Precertification (Pre-Cert) Pilot Program under the Digital Health and Innovation Action Plan.⁶ The Pre-Cert Pilot Program was created to keep up with health information technology innovation by softening requirements for digital health companies.⁶ Additionally, it helped ensure more Americans had access to timely high-quality, safe, and effective digital health products.⁶

As medical devices, digiceuticals are distinguished as class I, II, and III based on the level of control necessary to assure the safety and effectiveness of the device.⁷ Class I has the lowest risk of potential for harm, class II is moderate risk, and class III has the highest risk.⁷ Class III includes devices that sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.⁷ All classes require general controls, the baseline requirements for the Food, Drug, and Cosmetic Act.⁷ Class II also requires special controls, if available, whereas class III always requires premarket approval.⁷

There are many factors that may be contributing to the growth of digiceuticals, including an industry shift towards preventative medicine and well-being, rising prevalence of chronic disease states, an aim for personalized patient-centered care, adoption of digital health technologies and advancements, and affordability of digital health care technology.^8,9 There are also many notable advantages of digiceuticals, including a lack of toxicities and limited adverse effects (AEs), continuous monitoring capabilities, opportunities to pair with medications, and empowering patients to be involved in their care.^8,9 In January 2022, a Research and Markets analysis valued the 2021 global market for digital therapeutics at $3.35 billion and estimated it would reach $12.1 billion by 2026.¹⁰

Available digiceutical products on the market range anywhere from compliance assistance devices and cognitive behavioral therapy to neuromodulation devices. It highlights the diversity of indications that we are seeing digiceuticals getting approved for and the potential for more devices to enter the market to treat a variety of conditions.

Propeller is used for management of respiratory diseases including asthma and chronic obstructive pulmonary disease.^11,12 It is an inhaler sensor that pairs to a smartphone app to automatically track medication use and provide personal insights that help manage and reduce symptoms.^11,12 Nerivio is a wireless wearable neuromodulation unit used to treat migraines. It uses self-administered 45-minute treatment controlled by a smartphone app with the device applied to the upper arm at onset of migraine, with non-painful tingling as the goal intensity.^13,14

Neuromodulatory devices, such as Nerivio, are endorsed by the American Headache Society in a 2021 expert consensus for acute migraine.¹⁵ There was a new FDA cleared product in 2024 called Rejoyn which is the first digiceutical product approved for treatment of major depressive disorder.¹⁶ The list of digiceuticals is rapidly growing, and along with it will be the market for these products.

Digiceuticals requiring a prescription will require verifying pharmacists, as always, to assess that it is for the right indication, patient, therapy, timing, and frequency.^17,18 Pharmacists will also play a huge role in analyzing literature to help providers and patients assess if the digiceutical product would be clinically significant in addition to being statistically significant.^17,18 In the outpatient setting, it will be important for pharmacists to continue assessing how patients are doing and making sure they are having a good response to the therapy and being evaluated appropriately.^17,18

As digiceuticals continue to grow, even pharmacists that aren’t involved in prescribing digiceuticals might encounter a patient admitted to the hospital who relies on a digiceutical for their treatment or management of a condition.^17,18 It will be imperative that health care professionals are able to recognize the digiceutical product and work through how to ensure a patient’s therapy is continued in the inpatient setting.^17,18

Pharmacists can continue to incorporate digiceuticals into patient care by learning about the new therapies available through education sessions or by completing individual assessments of products.^17,18 With digiceuticals having limited AEs, they could be appropriate to recommend as an alternative therapy for a patient that has failed with multiple other pharmaceutical products.^17,18 Additionally, having conversations with patients and providers to share the benefits of the various digiceutical products will help ensure there is a positive mindset. Overall, keeping an open mind about digiceuticals and seeking out opportunities to learn more about the various products available will help pharmacists incorporate digiceuticals into patient care.

There are multiple barriers to the successful incorporation of digiceuticals into practice. One of the major concerns with digiceuticals being a software-driven intervention is cybersecurity and privacy concerns.¹ If there is a breach in data protection, then patients are at risk of having their information stolen. There is also a concern about technology failures leading to a glitch in the software or broken devices.¹ This is especially worrisome if patients are relying on their digiceutical for the treatment of a condition. It is important to have backup plans to ensure that patients do not go without therapy.

Currently, there is a lack of federal infrastructure for the regulatory bodies to keep up with the increase in digiceutical products being brought onto the market.¹ Additionally, the technology demand and connectivity to health systems will be another barrier that will need to be addressed in the future.¹ Companies may have to account for patients who do not have access to technology or smartphones and assess if devices that are given to patients to utilize their software will be needed.

Other barriers to digiceuticals include resistance to changing practice from a pharmaceutical focus to a digiceutical mindset.¹ To overcome this, the benefits of deprescribing medications can be discussed in addition to showing that digiceuticals have limited AEs and can be safe alternatives.¹ The time to educate will likely increase initially for patients and providers, but will hopefully decrease overall health care needs as patients become familiar with the products, have improved health, and start to be more independent with their care.¹ Lastly, considering affordability of products is important as currently many digiceuticals are still being assessed by payers for reimbursement.¹ Until digiceuticals become more widely affordable, there may be a lag in their utilization.¹

Future directions of digiceuticals and pharmacy expertise ownership are still to be determined. Specialty pharmacies and ambulatory care settings could be major players in the promotion and assessment of digiceutical products.¹⁹ There will likely be a large emphasis on helping patients get access to these products through patient assistance programs or prior authorizations.¹⁹

Pharmacies excel in understanding the intricacies of getting products approved and could be a catalyst to grow the use of digiceutical products. Educational sessions will also be an area where there might be a push to promote the use of digiceutical products.¹⁹ Lastly, the incorporation of digiceuticals with artificial intelligence in health care settings could help further transform digiceuticals into a powerful tool to assess and predict patient needs.¹⁹

Overall, digiceuticals are evidence-based software therapeutic interventions that prevent, manage, or treat a medical disorder or disease.^4,5,20 They have many strengths including providing personalized health care, improving patient outcomes, and enhancing health care delivery, but there are concerns for data security and privacy as well as resistance to change and adoption of these new technologies.^1,20 There are many opportunities for digiceuticals including remote patient monitoring, data analytics, and expansion to cover more disease states. But there must be ways to combat cybersecurity risks, regulatory complexities, and the extensive training and infrastructure upgrades required to handle the increase in digiceuticals.^1,20

References

1. Wang C, Lee C, Shin H. Digital Therapeutics from bench to bedside. npj Digital Medicine. 2023;6(1). doi:10.1038/s41746-023-00777-z

2. United States Regulatory. Accessed May 14, 2024. https://dtxalliance.org/wp-content/uploads/2022/01/US-Regulatory-and-Reimbursement-Pathways.pdf.

3. About DTA - Digital Therapeutics Alliance. Digital Therapeutics Alliance - Just another WordPress site. April 22, 2024. Accessed May 13, 2024. https://dtxalliance.org/about-dta/.

4. Digital Health Industry Categorization. Accessed May 14, 2024. https://dtxalliance.org/wp-content/uploads/2019/11/DTA_Digital-Industry-Categorization_Nov19.pdf.

5. Defining digital medicine. Digital Medicine Society (DiMe). March 5, 2024. Accessed May 13, 2024. https://dimesociety.org/about-us/defining-digital-medicine/.

6. Watson A, Chapman R, Shafai G, Maricich YA. FDA regulations and Prescription Digital Therapeutics: Evolving with the technologies they regulate. Frontiers in Digital Health. 2023;5. doi:10.3389/fdgth.2023.1086219

7. Center for Devices and Radiological Health. Classify your medical device. U.S. Food and Drug Administration. Accessed May 13, 2024. https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device.

8. Digiceuticals market. Future Market Insights. March 13, 2023. Accessed May 13, 2024. https://www.futuremarketinsights.com/reports/digiceuticals-market.

9. Batta A, Khirasaria R, Singh V. Exploring digital therapeutics: The next paradigm of modern health-care industry. Perspectives in Clinical Research. 2020;11(2):54. doi:10.4103/picr.picr_89_19

10. Watson A, Chapman R, Shafai G, Maricich YA. FDA regulations and Prescription Digital Therapeutics: Evolving with the technologies they regulate. Frontiers in Digital Health. 2023;5. doi:10.3389/fdgth.2023.1086219

11. Propeller® - Digital Therapeutics Alliance. Digital Therapeutics Alliance - Just another WordPress site. February 2, 2024. Accessed May 13, 2024. https://dtxalliance.org/products/propeller/.

12. Yawn BP, McCreary GM, Linnell JA, et al. Pilot study of a patient experience with an ELLIPTA inhaler electronic medication monitor and associated integrated system: A prospective observational study using the COPD patient-powered research network. Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation. 2021;8(4):488-501. doi:10.15326/jcopdf.2021.0218

13. Nerivio® - Digital therapeutics alliance. Digital Therapeutics Alliance - Just another WordPress site. February 2, 2024. Accessed May 13, 2024. https://dtxalliance.org/products/nerivio/.

14. Grosberg B, Rabany L, Lin T, et al. Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: An open-label study. PAIN Reports. 2021;6(4). doi:10.1097/pr9.0000000000000966

15. Ailani J, Burch RC, Robbins MS. The American Headache Society Consensus statement: Update on integrating new migraine treatments into clinical practice. Headache: The Journal of Head and Face Pain. 2021;61(7):1021-1039. doi:10.1111/head.14153

16. Announcing the first and only prescription app for the treatment of depression symptoms. A prescription app you can add to your antidepressant. Accessed May 13, 2024. https://www.rejoyn.com/?ceid=na&utm_source=goog&utm_medium=cpc&utm_term=rejoyn+digital+therapeutic&utm_content=na&utm_campaign=smdd_cpc_goog_b_MddDtc_&utm_creative=na&gad_source=1&gclid=EAIaIQobChMI7-GxoJCMhgMVGExHAR2iygxWEAAYAiAAEgImlvD_BwE.

17. D. Aungst T, Franzese C, Kim Y. Digital Health Implications for Clinical Pharmacists Services: A Primer on the current landscape and future concerns. JACCP: JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY. 2020;4(4):514-524. doi:10.1002/jac5.1382

18. Shafai G, Aungst TD. Prescription digital therapeutics: A new frontier for pharmacists and the future of treatment. Journal of the American Pharmacists Association. 2023;63(4):1030-1034. doi:10.1016/j.japh.2023.03.012

19. 10 November 2023 By Ashifa Trivedi & Sarah Mohamad. Digital Therapeutics: Integration in practice. The Pharmaceutical Journal. November 10, 2023. Accessed May 13, 2024. https://pharmaceutical-journal.com/article/ld/digital-therapeutics-integration-in-practice.

20. Digiceuticals market 2024-2032: Size,share, growth. MarkWide Research. April 11, 2024. Accessed May 13, 2024. https://markwideresearch.com/digiceuticals-market/.