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Five years from now, when patients walk into a doctor’s office presenting symptoms of almost any condition you can envision — whether migraine, multiple sclerosis, or obesity — their physician will offer a new kind of treatment plan that involves both pharmaceutical-based medication and a prescription digital therapeutic. Accessible through the patient’s smartphone, the digital therapeutic will deliver personalized, evidence-based interventions to treat their condition, completed through daily lessons and game-like interfaces, all guided by sophisticated algorithms. Medication and digital therapeutic will work together to deliver the best possible outcomes, an approach that will have been well-established through extensive evidence and recommended by practice guidelines.

This future isn’t likely; it is inevitable. The only questions are: When will digital therapies become the standard of care, and who will lead the movement forward?

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I first noticed the potential for software to treat disease back in 2012 when I coined the term “digital therapeutics.” Now, I see the industry is at an inflection point, primed for broad acceptance of prescription digital therapeutics. It is driven by emergence of the latest generation of technologies developed with the rigor of traditional medicines; the need for new business models in our increasingly burdened health care system; and the rapid increase in AI’s power and availability.

Prescription digital therapeutics deliver broad access to the latest in behavioral, cognitive, and skills-based interventions, democratizing care traditionally restricted to patients with access to specialists and academic centers. The more advanced applications also provide neuromodulatory mechanisms of action that safely target specific neural pathways inaccessible to biopharmaceuticals; their consistent use retrains the brain to make new connections for lasting results, providing therapeutic benefits with minimal side effects.

What’s needed is a leader to step forward and seize this opportunity to build the patient journey of the future. That leader must be pharma, not the tech industry.

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Pharma has the exact capabilities to launch these new therapies effectively, at scale, in a way that is best for patients. And prescription digital therapeutics are the essential ingredient in the AI-enablement of pharma’s future: They are how pharma wins the race to bring AI to patient care.

The shift to prescription digital therapeutics requires players who put evidence first, who have strong commercial and regulatory arms, and who have deep expertise in shifting the standard of care to embrace new therapies. Pharma ticks every box. With proven prescription digital products backed by compelling evidence, either at hand or well into development, pharma should have no problem enlisting payers, policymakers, and prescribers. It’s been done before when a new category of therapeutics arises, whether for biologics in the 1980s, immunotherapy and CAR-T in the past decade, or gene therapy today. Pharma must stop viewing prescription digital therapeutics as digital health projects, which is an area where they have historically struggled to succeed, and embrace them instead as new therapeutic programs, where pharma is the expert, bar none.

Using AI to enable more effective, efficient operations is underway everywhere; that’s advisable. We see companies working to bring AI and machine learning to bear in drug discovery, manufacturing operations, commercial launch campaigns, and clinical trials. But those efforts are about efficiencies, not products. Efficiencies are table stakes. Products are the bet that will drive future growth.

To that end, pharma companies may ask, “What will be our killer idea? What will be our equivalent of ChatGPT?” The answer is prescription digital therapeutics.

They are the key to achieving everything pharma wants to do with digital. The reasons are threefold.

First, prescription digital therapeutics deliver AI-driven outcomes to end users: patients. Highly adaptable and personal to each user, prescription digital therapeutics are aligned with pharma companies’ aspiration of putting patients at the center of care. By securely collecting data, prescription digital therapeutics use AI and machine learning not only to engage patients, but also to modify and individualize their treatment, driving truly personalized care and better outcomes.

Secondly, AI-powered digital biomarkers, captured by prescription digital therapeutics via increasingly sophisticated sensors on a patient’s smartphone, deliver insights that can be used to quantify a drug or treatment’s effect. Digital biomarkers enable clinicians to more fully understand a patient’s experience of disease, facilitating personalized support, and allow developers to use the information and predictive power they provide to transform how care is delivered.

Finally, prescription digital therapeutics drive the long-term, high-quality data collection essential for AI to benefit pharma companies. By leveraging prescription digital therapeutics to gain real-world data insights, drug companies inform their portfolio planning and enable development of ever more effective treatments. Without prescription digital therapeutics to drive a direct relationship with patients, the data pharma can access will always be secondhand and imperfect. Realtime, high-fidelity insights will be essential to health care’s value-based future.

If pharma doesn’t step up now, this moment will pass the industry by.

In June, Apple announced iPhone’s iOS 17 update will include new mental health and vision companion apps. Amazon and Google are also making inroads into the space, Amazon through acquisition of RxPass, PillPack, and One Medical, and Google through extension of its Vertex AI tool suite to health care, including its recently announced partnership with the Mayo Clinic. Big Tech’s growing interest in AI-based health care solutions signals that the software ecosystem that will define health care’s future is being shaped now. If pharma fails to seize the opportunity to lead by introducing prescription digital therapeutics into clinical care, they risk becoming a cog in the wheel of Big Tech’s data-driven patient journey of the future.

In that future, patients lose out on the clinical rigor pharma brings to the space. Pharma also suffers. The industry cannot thrive by waiting for the next blockbuster; it’s an unsustainable market strategy as payments shift to value-based and outcomes-driven approaches. The AI-enabled pharma company of the future is a holistic provider of patient care, focused on outcomes, not just scripts.

Prescription digital therapeutics unlock that potential, and in doing so closely align pharma’s capabilities, patient interests, and future economic needs. Companies that continue to think of digital therapeutics as “nice to have,” as a commercial add-on, or as a companion app will be left behind. A pharma company without prescription digital therapeutics will be one without a truly AI-enabled future.

Pharma companies that wait for someone else to drive the first commercial success in this space will likely miss the boat. Big Tech is positioned to step in, which could lead to proliferation of digital solutions that will lack the clinical rigor of medicines. Health systems, electronic health record providers, and digital health companies that use Big Tech’s growing portfolio of AI tools will become the primary owners of AI in the patient journey. In short, if Big Tech remains the only entrant in this race, pharma could be edged out from ever realizing the AI-powered benefits prescription digital therapeutics would confer on them. And tomorrow’s patient journey will rest increasingly in the hands of algorithms in which pharma has had neither authorship nor insight.

Prescription digital therapeutics work. Pharma needs only invest in them as meaningful new pipeline assets, and then ensure their success through their strong relationships with providers and disease area specialists, their expertise with payers, and their commercial infrastructure. The pharmaceutical companies that do the heavy lifting now will have a head start in the AI-enablement of their products and pipeline. Catching up in the world of software is not easy. Move now, or get left behind.

David Benshoof Klein is CEO and co-founder of Click Therapeutics. He is also guest faculty at the Biotechnology Program at Columbia University, NYU’s Stern School of Business, and the Columbia Business School, and was managing director at Opus Point Partners, senior consultant at Pfizer, and a strategic advisor for several publicly traded and privately held life science companies.

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