23/06/2020 | BlogPost
Healthware’s 5 year long quest to help our clients design, build, test, and launch Digital Therapeutic solutions (DTx), invariably runs into a couple of predictable speed bumps along the way; the first on questions from our clients on the likelihood of obtaining regulatory approval for them and the other on the feasibility of also being able to arrive at reimbursement agreements on the part of payers.
We can finally put these questions to rest with two significant developments confirming the regulatory and viability of Digital Therapeutics, that mark a wide open path to de-risking and accelerating investments into DTx solutions.
The first of these two events is the announcement that France’s Comité Economique des Produits de Santé recently signed a reimbursement agreement with Sivan, a company that specializes in electronic patient monitoring, and whose Moovecare product can help monitor and track early potential complications for lung cancer patients, sending alerts to their care team. Moovecare’s easy-to-use solution and early detection algorithm (along with the patient’s care teams prompt interventions from its alerts) has been clinically proven to bring about an overall survival gain of 7.6 months as compared to a control group not using Sivan’s product as the company’s website states: “Symptoms management is essential from a psychological and physical point of view when considering treatment option for cancer patients”. Because of its demonstrated efficacy in improving treatment, Moovcare has become the first digital therapeutics reimbursed in France having received a favorable opinion on reimbursement with an ASA III.
The other important development has happened on the other side of the pond, where the US FDA has (finally) permitted the marketing of EndeavorRx, Akili Interactive’s long awaited videogame-based therapy to treat adolescents suffering from ADHD.
EndeavorRx was reviewed through the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
What is important to note here, and proof that time is indeed of the essence, is that Akili Interactive launched EndeavorRx taking advantage of the new guidance from FDA recognizing the need for access to certain low-risk clinically-validated digital health devices for psychiatric conditions including ADHD during the COVID-19 pandemic.
The take-home story for our clients is that Akili’s product has been in development and studies since 2017 (and before any realistic prospect of regulatory approval or reimbursement was on the horizon) but this did not stop them from moving forward with their hypothesis on a groundbreaking product that will change the course of treatment for ADHD, and possibly Alzheimer’s (their next target indication). Thanks to this, Akili was ready to take advantage of a rapidly changing regulatory environment and has taken on a position of leadership in digital ADHD therapies.
Our recommendation is for pharma companies to follow Akili's lead and quickly take advantage of the regulatory and reimbursement opportunities that are materializing globally to do the same in their own therapeutic areas.
|Gerry Chillé is General Partner at Healthware Labs. He can be contacted here for any DTx project ideas you would like to explore.