Is digital therapeutics innovation enough for a sustainable future?

Treatments emerging from the digital therapeutics space were once greeted with optimism, due to the potential to aid patients’ health through technology, rather than pharmaceuticals. Ben Hargreaves finds that this is not stopping new solutions from being launched, but tricky commercialisation questions remain.

The digital therapeutics space has suffered a tough period following the surge of enthusiasm experienced during the pandemic. There are major questions over the sustainability of technology emerging in the space, as the rise in optimism over the area’s potential was brought down to earth with a series of bankruptcies.

There is both a demand and a need for patients to receive additional support to manage their health, with the pandemic proving that this approach has a place. In a report on the use of digital health technology during this period, the WHO concluded that such tools can “deliver more efficient and patient-centred care.” However, the same report stated that greater strategic investment in the space is needed and that more work must be done to avoid seeing digital health as a ‘second best’ temporary solution by either patients or professionals.

One of the difficulties facing the area is that the current reimbursement framework is not set up for digital therapeutics. It is difficult to place a value on the treatments, as often they are used as supplement to existing treatments and so are not considered a core part of the therapy process. This has had a chilling impact on funding going into the space, with RockHealth finding that annual venture funding in 2023 dropped to $10.7 billion, representing a major fall from highs of $29.2 billion in 2021.

Despite this, there are still new digital therapeutics moving through to the market, as developers continue to test the waters. A recent example is Otsuka Pharmaceutical, under its newly launched Otsuka Precision Health (OPH) subsidiary, and Click Therapeutics’ Rejoyn, which became the first prescription digital therapeutic cleared by the US FDA for the treatment of major depression disorder (MDD).

New solutions emerge

The digital therapeutic was cleared by the FDA for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients aged 22 years and older who are on antidepressant medication. The purpose of the Rejoyn treatment programme is to reduce MDD symptoms and the clearance by the FDA allows the app to be prescribed by a healthcare professional.

Rejoyn is delivered as a six-week treatment programme and the companies state it works by helping to enhance control of emotion through cognitive training exercises for the brain and brief therapeutic lessons. The cognitive behavioural therapy (CBT)-based lessons take three to four minutes to complete and must be completed three times per week for six weeks; the Emotional Faces Memory Task (EFMT) exercises have a typical duration of 11 to 26 minutes, which must also be completed three times per week for six weeks. The digital therapeutic is delivered via smartphone. In a 13-week study, patients were randomised to receive either Rejoyn or a sham control app, with OPH stating that Rejoyn was found to provide benefit to participants.

Sanket Shah, president of Otsuka Precision Health, spoke with pharmaphorum, highlighting how digital therapeutics are differentiated from pharmaceutical interventions: “OPH prioritises the patient experience, aiming to achieve better outcomes by tailoring interventions to individual needs. This data-driven approach stands in contrast to traditional pharmaceutical models and seeks to unlock new possibilities for improved patient journeys.”

OPH plans to launch the product in the latter half of 2024 but, in terms of pricing, Shah stated that there is no information regarding cost available. One potential challenge may be convincing that the app is effective enough to be prescribed broadly enough to be successful commercially. In the mITT analysis conducted on the trial carried out on Rejoyn, the full or partial response rate to the app was 48.3% with the app and 37.5% with a sham app.

When asked whether OPH would carry out long-term efficacy studies of the app, Shah stated that the company would focus on a ‘variety of technological solutions’ and that there is no information regarding trials or further data from Rejoyn.

Efficacy not enough

Nonetheless, the challenge facing companies working on digital therapeutics is that the efficacy of the treatments does not appear to be enough to create a sustainable commercial model. Pear Therapeutics shocked the digital therapeutics industry when it filed for bankruptcy and subsequently sold off its assets. The collapse of the company came despite its lead app, Reset, showing a statistically significant increase in adherence to abstinence for patients with substance abuse. In trials, the app was found to be effective for 40.3% of patients using the device, compared to 17.6% of patients who did not use Reset.

With strong data from its app, Pear Therapeutics was able to go public and attain a valuation of $1.6 billion at the end of 2021. Only a few years later, the company and its assets were sold for $6 million to four separate bidders. Further reinforcing the difficulty in creating a sustainable commercial model for digital therapeutics was the decision by Akili Interactive to abandon its prescription business and instead pursue a direct-to-consumer model. This change also entailed a 40% reduction in headcount at the business.

Akili and Pear were both considered two of the major pioneers of the digital therapeutics space. For both to struggle to continue with a prescription commercial model calls into question whether it is feasible for the current system to support such therapeutics in the long-term. The demand for access to healthcare at home is clearly there, as evidenced by the pandemic, but the question is whether the appetite exists for payers and healthcare systems to afford the asking price for the space to remain sustainable.