Can software really treat disease?
Until recently, many in healthcare would have viewed this question as absurd. After all, most disease is fundamentally biological or physiological. How can software help?
For over a decade, a growing number of companies have sought to answer that question by developing a new class of treatments called digital therapeutics (DTx). DTx are software or software-based solutions intended to treat or manage a disease or medical condition and backed by clinical evidence.
The hope is that these tools can improve clinical outcomes and patient experience through several possible mechanisms of action (MOAs):
- Changing patient behavior, thought patterns, and neurological function
- Guiding patients through digitized versions of care programs known to be effective
- Connecting patients to care teams for more continuous, proactive care
These mechanisms are more powerful than they might seem at first. Consider the central role that patient behavior and thought patterns play in mental and behavioral health conditions such as depression and substance use disorder…and how neurological function is at the heart of stroke recovery and ADHD…and how patient behaviors such as diet, exercise, sleep, smoking, medication adherence, and others drive severity and progression for many chronic diseases, especially cardiometabolic and respiratory conditions…and how the episodic and reactive approach to managing conditions such as type 2 diabetes, chronic kidney disease, and musculoskeletal pain results in worsening disease status, more expensive treatments and procedures, and worse outcomes.
Viewed in that light, DTx hold promise across a wide range of conditions that go well beyond mental and behavioral health (Figure 1).
In addition to being broadly applicable, DTx also offer exciting potential benefits when compared to traditional treatments due to the inherent advantages of software:
- Safety: Low risk overall and virtually no risk of serious adverse events
- Access: Scalable, relatively inexpensive, and convenient for patients
- Transparency: Able to track data on usage and efficacy for individual patients
- Flexibility: Can be personalized for individual patients and improved over time
The Current Progress of DTx Solutions
It’s a compelling idea in theory, but the question remains: Can software really improve outcomes?
Based on the developments of the last few years, the answer to that question seems to be a resounding YES. Since 2017, DTx have made substantial progress towards proving their value as clinical-grade treatment options, including:
- A strong and expanding clinical evidence base featuring randomized controlled trials (RCTs) from companies such as Pear Therapeutics, Akili Interactive, Big Health, Kaia, Propeller Health, Click Therapeutics, and others.
- The first-ever FDA clearance of a prescription digital therapeutic with outcomes claims (for Pear’s reSET) in 2017, followed by three more PDT clearances since (for Pear’s reSET-O and Somryst and for Akili’s EndeavorRx).
- FDA Breakthrough Device Status designation for five DTx (Cognoa, Dthera, The Learning Corp, MedRhythms, and NightWare).
- FDA’s temporary suspension of 510(k) submission requirement for DTx treating psychiatric disorders during the COVID-19 emergency.1
- A growing list of examples of U.S. payers supporting access to DTx, including digital formularies from CVS2 and ExpressScripts.3
Regulators and payers aren’t the only ones who have taken notice of DTx. Biopharma companies across the industry are also intrigued by this emerging category and are actively exploring whether and how to engage. Several biopharma companies have already struck deals with DTx companies to collaborate on DTx development and/or commercialization, including:
- Sanofi and Happify: DTx for psychological symptoms in MS patients
- Otsuka and Click Therapeutics: DTx for major depressive disorder (MDD)
- Pfizer and SidekickHealth: DTx platform across several immunological indications
- BMS and Voluntis: DTx for oncology side effect management and remote monitoring
- Sunovion and BehaVR: DTx for Social Anxiety Disorder
- Multiple biopharma partners4 and Propeller Health: Collaborating on sensor-enabled inhalers and/or pairing Propeller’s sensor and app with particular asthma/COPD drugs
- Orexo and GAIA: DTx for opioid use disorder
- …and others (some of which is summarized in the report “Digital Therapeutics and the Future of Pharma” from Torreya)5
The Value of DTx to Pharma
Biopharma companies realize that DTx could create value in several ways.
First, these products represent an additional, evidence-based modality to improve patient outcomes and experience, with similar requirements for evidence generation, regulatory review, and commercialization, consistent with the missions and capabilities of biopharma organizations.
Second, because some DTx can be used alongside drug therapy, they could help biopharma companies optimize the real-world clinical impact of their drugs, either as companion solutions or as drug-digital combination products. This possibility could create value for biopharma companies in a number of ways, including improving adherence and persistence rates (thereby enhancing clinical impact and revenue per patient), differentiating versus competitive brands, creating a positive feedback loop with prescribers, generating real-world data to support coverage and pricing, enabling outcomes-based contracts with payers, and opening new lifecycle management opportunities via label expansion and combination products.
Third, DTx offer a means of gathering rich, patient-level data that can provide valuable insights into the patient journey, patient experience, and disease progression, informing both R&D and commercial activities.
Fourth, DTx could create a means of building a stronger, more direct relationship with individual patients, a longstanding and elusive goal for an industry that rarely interacts directly with the users of its products.
And fifth, DTx may provide new revenue streams, which would be a welcome development as R&D productivity continues to decline across the industry.
The Urgent Need to Embrace DTx
Savvy biopharma companies see these opportunities but also recognize that DTx could pose a threat. Because DTx are highly safe, accessible, and relatively inexpensive compared to branded drugs, they could displace drug therapy in the treatment progression in some indications. Why put a diabetes patient on a costly GLP-1 agent before prescribing a DTx that may help a patient control A1C through behavioral changes alone? In addition to direct competition, DTx may also accelerate the movement to outcomes-based contracting for drugs by demonstrating to payers that such models are feasible and attractive at scale.
These opportunities and threats, along with the rapid recent progress of DTx, underly a strong argument for biopharma to engage with DTx. Additionally, a third reason strengthens this argument and makes action even more urgent: failing to engage with DTx now puts biopharma companies at risk of being left behind.
While it might be tempting to sit on the sidelines and wait for other companies to undertake the difficult and risky work of bringing the first few DTx to market, the fast-follower strategy would be misguided in DTx because of the steep learning curve that biopharma companies will have to work through in this new and different area.
Drug companies can easily underappreciate the substantial differences between drugs and DTx and what those differences mean for the capabilities, internal processes, and expertise that a drug company will need to develop to succeed in DTx. These include obvious skill sets related to software (and, sometimes, hardware) development, such as engineering, user experience, and product management, but they also include the need for different talent and processes for core biopharma functions like clinical development, regulatory, market access, HEOR, and commercial.
The Development of DTx Compared to Drugs
DTx development and evidence generation are much more dynamic and iterative than they are for drugs. Product improvement and evidence generation continue after regulatory clearance and commercial launch and must include a focus on not just efficacy and safety, but also on usability and engagement. Traditional, stage-based biopharma processes, with clear handoffs between discovery, clinical development, and commercial, are not well-suited to DTx.
Similarly, regulators typically treat DTx as medical devices, creating the need for a different skill set and mindset on the regulatory team. And commercial models for DTx are much more variable than for drugs, sometimes including the soft-launch of a product prior to regulatory review, selling to different stakeholders like employers or consumers, and evolving the business model over time in a way that bear little resemblance to the highly standardized model for bringing new drugs to market.
Biopharma companies that engage in DTx now will have a major advantage in learning how to develop and commercialize these products effectively and in building the required organizational capabilities. Early on, drug companies can rely on DTx partners for technical expertise and innovation, product development, and even clinical development and regulatory expertise in some cases, but over time, biopharma companies will need to develop many of these capabilities internally.
Many questions remain about the future of DTx, but we now know that they can be effective, safe, affordable, and accessible treatment options for patients and their healthcare providers in at least some circumstances. With those qualities, it is a safe bet that they will eventually earn a role of some kind in clinical care. Once they do, they will present opportunities and, possibly, threats to biopharma companies. Drug companies that find ways to engage with DTx now can stay ahead of the curve and have a hand in shaping this future. Those that don’t may find themselves scrambling to catch up for years.