Picture a world where parents no longer scold their kids for playing video games due to their perceived negative effects, but instead, actively encourage their kids to play their video game because it has been prescribed by a medical practitioner. We are entering an era of prescription video games, where playing certain video games is medically advised

The digital health market has expanded in recent years with wearable devices, smart sensors, medical mobile applications, telehealth and the latest addition of digital therapeutics (“DTx”).[1] DTx is defined by the Digital Therapeutics Alliance as “evidence-based therapeutic interventions driven by high-quality software programs to treat, manage or prevent a disorder or disease”.[2]  DTx aims to increase the effectiveness and accessibility of healthcare by providing a non-drug personalized treatment experience.[3]

Video games, started primarily as entertainment products, however, their capability to materially affect players’ bodies, brains and behavior has become more recognized in the health and video game industry. Video games have been used as therapeutic tools in healthcare for a long time but recently video games have become therapies and treatments themselves. In 2020, EndeavorRx made headlines as the first-ever prescription video game to be cleared by the FDA.[4] The FDA granted marketing authorization to EndeavorRx as a game-based DTx for treating attention deficit hyperactivity disorder (“ADHD”) symptoms in children between the ages of 8 and 12 years, expanding the market for DTx to video games. The FDA clearance of EndeavorRx is a breakthrough for both the video game and the healthcare industry, bringing together two of the biggest industries in the U.S.

EndeavorRx is a first-person racing game, with a traditional game feel, however, it is not just a normal video game. In EndeavorRx the video game experience is used to present the player with multi-task sensory stimuli to enhance attention, while at the same time challenging the player’s motor ability to move through obstacles.[5] The gameplay specifically targets and activates parts of the neural system that plays a key role in attention function, working memory, conflict resolution, focus, and interference processing.[6]  Like most other video games, the difficulty of the game is adjusted according to each player’s progress, by measuring their performance through adaptive algorithms but for EndeavorRx the difficulty adjustment is specifically created in a manner to provide a player with a personalized treatment experience.[7] Developed by professional video game developers, the game provides players with an immersive visual entertaining experience taking their space cadet into different galaxies to complete missions and tasks by saving alien creatures from extinction and providing them with rewards in the form of an in-game currency to upgrade their characters and spaceships.[8] As a game-based DTx, EndeavorRx provides a non-drug option to improve ADHD symptoms in children in a manner which is fun and engaging.

According to EndeavorRx’s instructions for use, it should only be used by the patient for whom the prescription was written, and its use should be under the supervision of a healthcare provider who should manage it as part of a treatment program. In order to ensure that patients only play the game for the prescribed amount of time, there are limitations built into the game to restrict access after the prescribed play for the day has been achieved.

In order to obtain a prescription, parents can either connect live with a virtual doctor online to determine if EndeavorRx is a suitable treatment, or parents can use their Caregiver Guide (provided online) to consult with the child’s healthcare professional, who would then be able to prescribe EndeavorRx if suitable. The prescription is fulfilled by Phil Pharmacy, which specializes in digital treatment prescriptions and provides the patient with an activation code to activate the EndeavorRx app. Currently, EndeavorRx’s website lists the cash price for the treatment as USD99.00, and some insurance companies, Highmark BCBS Insurance is specifically listed, will cover the costs. And, similar to a prescription drug, if the prescription is done, it can be refilled.[9] 

It is not clear if Akili requested that EndeavorRx be cleared as a prescription device or if the FDA decided it should be a prescription device. What is however clear is that having a prescription status distinguishes EndeavorRx from other digital products which aim to promote focus in children. In an interview with the press, Akili’s Chief Medical Officer confirmed that they take the prescription status of EndeavorRx seriously and since it has received prescription status, they have placed restrictions in place to ensure that only individuals with a prescription have access to the game, even preventing their employees from playing it for fun.[10]

The prescription status not only helps with marketing the product but also allows insurance companies to cover the expenses. In 2022 two new bills were introduced in the Senate, the Access to Prescription Digital Therapeutics Act and the Medicaid and CHIP Access to Prescription Digital Therapeutics Act.[11] Both these bills aim to extend Medicare and Medicaid coverage to prescription DTx only, and not to “over-the-counter” or general DTx. This will provide game-based DTx developers with an incentive to obtain FDA prescription approval, for their games to be covered by insurance companies. 

Adding a video game component to DTx contributes to both the effectiveness and accessibility components of DTx, and it also adds an entertaining reward-based component to DTx which makes it more attractive, especially to kids. By utilizing a general video game function of adjusting the difficulty level according to a player’s progress, game-based DTx provides a more effective personalized treatment to players. Further, being a visual method of treatment instead of an informational-based treatment method, game-based DTx is more accessible to younger individuals and individuals who have limited literacy skills. And, the video game component also provides individuals with a stronger sense of agency and achievement, keeping them motivated to engage with the therapy.[12] Game-based DTx has the potential to change the way we think about video games and can bring about disruption in both the video game and healthcare industry. 

The FDA classified EndeavorRx as a game-based DTx through their de novo premarket review pathway for low- to moderate-risk devices of a new type, creating a new regulatory classification for game-based DTx.[13] Game-based DTx creates a unique intersection between the video game industry, the healthcare industry, and regulatory oversight of public health which give rise to several regulatory and legal questions.[14]

Part II of this blog post will discuss the FDA’s clearance of EndeavorRx. 

[1] Amit Dang, Dimple Arora & Pawan Rane, Role of digital therapeutics and the changing future of healthcare, 9 Journal of Family Medicine and Primary Care 2207 (2020).

[2] What is a DTx?, Digital Therapeutics Alliance, https://dtxalliance.org/understanding-dtx/what-is-a-dtx/.

[3] Eunhye Choi, Eun-Ha Yoon & Min-Hyeon Park, Game-based digital therapeutics for children and adolescents: Their therapeutic effects on mental health problems, the sustainability of the therapeutic effects and the transfer of cognitive functions, 13 Frontiers in Psychiatry (2022), https://www.frontiersin.org/articles/10.3389/fpsyt.2022.986687.

[4] Valerie A. Canady, FDA approves first video game Rx treatment for children with ADHD, 30 Mental Health Weekly 1 (2020).

[5] EndeavorRx® – ADHD Video Game Treatment for Kids | FDA-authorized, EndeavorRx, https://www.endeavorrx.com/.

[6] The story behind an FDA-Approved Video Game Treatment for ADHD, The Medicine Maker (2022), https://themedicinemaker.com/discovery-development/the-story-behind-an-fda-approved-video-game-treatment-for-adhd.

[7] Mark Anderson, Prescription-strength gaming: ADHD treatment now comes in the form of a first-person racing game – [News], 57 IEEE Spectrum 9 (2020).

[8] The story behind an FDA-Approved Video Game Treatment for ADHD, supra note 6.

[9] EndeavorRx® – ADHD Video Game Treatment for Kids | FDA-authorized, supra note 5.

[10] The story behind an FDA-Approved Video Game Treatment for ADHD, supra note 6.

[11] Shelley Moore [R-WV Sen. Capito, S.3791 – 117th Congress (2021-2022): Access to Prescription Digital Therapeutics Act of 2022, (2022), http://www.congress.gov/; Shelley Moore [R-WV Sen. Capito, S.5238 – 117th Congress (2021-2022): Medicaid and CHIP Access to Prescription Digital Therapeutics Act, (2022), http://www.congress.gov/.

[12] Choi, Yoon, and Park, supra note 3.

[13] Office of the Commissioner, FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD, FDA (2020), https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd.

[14] Tristin Brynn Hooker & Martha Sue Karnes, More than serious: Medicine, games, and care, 65 Computers and Composition 102727 (2022).