To embrace or to fear – a digital therapeutic revolution.

Modern pharma is spoilt for pressures to innovate and diversify away from traditional pill-based solutions. One such anxiety has been the steady rise of supported or independent digital therapeutic delivery. With our lives – now more than ever – so reliant on the tech on our wrist, in our pocket and around our homes, innovators are creating a myriad of meaningful digital therapeutic applications.

Attempts to understand what value the future holds can be frustrated by the sheer all-encompassing breadth of emergent solutions. A brief cross-section:

A neurobehavioral smoking cessation app,

sleep tracking app,

An insulin monitoring wireless implant,

A wearable pain relief device utilizing electrical stimulation,

3D mobile game to treat Amblyopia,

VR environments for neurorehabilitation,

management app for Cancer drug side-effects supported by AI,

It seems reasonable for pharma to apply traditional rules to determine what to classify as a valid therapeutic solution and therefore, a commercial threat or opportunity. For example, is the therapy clinically validated or likely to gain regulatory approval? However, only recently has there been a growing consensus on how DTx should be regulated, especially software-only solutions. Further, some DTxs are being developed with no intention of seeking clinical validation but may still deliver significant benefit. Pharma must balance targeted analysis with a broad one-eye-open approach.

Whilst early innovation of ‘true’ threats has been predominantly confined to the unmet-demand for neurological therapies, early DTx leaders such as Pear Therapeutics have diversified their portfolio by leveraging cross-transferability of their technology and acquiring smaller players to enter more competitive TAs. Many of these leaders help drive the Digital Therapeutics Alliance (DTA), a non-profit trade association that advocates for integrating clinically evaluated digital therapeutics into healthcare; regulators are taking notice.

Pandemic Digital Rocket Fuel

Covid has fundamentally changed our adoption of digital solutions. Though our dependence on grocery delivery will wain, video-conferencing and mobile phone-dependence are likely to remain a frequent feature of our lives. Whilst pharma and healthcare has grappled with digital HCP marketing and remote prescribing, DTx companies have seized the opportunity to provide remote therapeutic accessibility. Public targeted apps such as Calm and Headspace have soared. At the same time, in April 2020, the FDA issued emergency guidance to waive several regulatory requirements for digital health devices to temporarily increase access.

“Increased utilization of digital therapeutic devices may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure to SARS-CoV-2 for patients and health care providers.”FDA guidance

AKILI interactive and Pear Therapeutics both launched products under this guidance and its hard to envisage the FDA putting the lid as tightly back on the box post-pandemic.

Making the medicine go down

Pharma has struggled to grapple whether in-house expertise exists to market and support a software-based product, and to that end, what the market value of these solutions is. There are only snippets of public evidence to guide the market at this stage. One recent example: Somryst – an FDA approved anti-insomnia program – has a list price of $899 for a 9-week course. There have also been plenty of setbacks for some early pharma player partnerships. Last year, Otsuka Therapeutics had to manage the bankruptcy of their ‘digital pill’ partner Proteus Digital Health, ultimately purchasing their assets, whilst in 2019 Sandoz stepped back from a partnership with Pear Therapeutics. Novartis has since made several plays to get back into DTx, demonstrating that strategic business alignment is vital.

Perhaps ‘a spoon full of sugar’ approach would be most comfortable for pharma to swallow. Adjuvant digital therapies can unlock value by partnering existing portfolio products. With the broader trend to beyond-the-pill patient support, symptom tracking apps – such as those supported by Voluntis’ Theraxium oncology platform – offer a way to elevate ‘me-too’ or inferior side-effect profile products above the competition. Adjuvant partnerships can allow pharma to dip their toes into understanding DTx provision.

The longer the DTx market continues to be led by emergent players, the less likely pharma will be able to influence and shape policy to their benefit. To me, the most intriguing angle yet to play out is how DTx companies will seek to leverage pharma: will they ultimately decide they are better to play by their own play book? From pharma’s perspective, the time is now for bold players to lay the foundations for long-term rewards.