Digital therapeutics and pharma market access: preparing for a new class of medicines

Introduction: The evolution of digital health and therapeutics

In the evolving landscape of healthcare, digital therapeutics (DTx) have emerged as a new class of medicine delivered through software and apps. These evidence-based interventions are intended to treat or manage diseases via digital platforms. The rise of DTx is already reshaping market access dynamics, as industry executives grapple with integrating prescription digital therapies into traditional reimbursement models. Unlike the wellness apps of the past, modern DTx undergoes rigorous clinical testing and U.S. Food and Drug Administration (FDA) review, proving they can safely and effectively improve patient outcomes. The momentum behind digital therapeutics is undeniable –In 2023, the worldwide digital therapeutics market generated a revenue of around 2.65 billion U.S. dollars, increasing significantly from under 300 million U.S. dollars in 2020. Analysts forecast that market revenue will reach 9.65 billion U.S. dollars by 2028. Ignoring DTx is no longer an option—it’s a competitive imperative. In fact, pharma market access is rapidly evolving alongside these innovations, requiring new approaches to reimbursement, distribution, and stakeholder engagement.

Digital health has come a long way from basic tracking apps to clinically validated therapy software. The COVID-19 pandemic accelerated this evolution, making remote app-based treatments more accepted. Today, digital therapeutics stand at the forefront of this digital health movement, offering novel ways to prevent, manage, or treat conditions through software-based therapy. Pharma companies are now entering a pivotal phase where embracing DTx is key to staying competitive. This blog explores the evolving landscape of digital therapeutic, how they’re reshaping pharma market access strategies, what the evolving U.S. regulatory and reimbursement landscape means for the future of prescription digital medicine. 

What are digital therapeutics? Definition and scope

Digital therapeutics refer to software-driven interventions that produce clinical benefits, often as prescribed treatments. In other words, a DTx is not just a wellness app – it is a digital treatment vetted via clinical studies and usually cleared by regulators for a specific medical condition. The Digital Therapeutics Alliance (DTA) defines DTx as “health software intended to treat or alleviate a disease, disorder, or condition by delivering a medical intervention with a demonstrable positive therapeutic impact”.

DTx have been developed for a broad range of conditions, from behavioral health (e.g. substance use disorder, depression) to chronic diseases like diabetes and asthma. For example, Pear Therapeutics pioneered prescription DTx with apps for addiction and insomnia, while other companies are addressing diabetes management and neurological disorders. Each of these digital treatments requires a well-crafted pharma market access approach to reach patients. What sets digital therapeutics apart is the requirement for robust evidence and regulatory oversight. Many DTx have already earned FDA clearance – starting with Pear’s reSET in 2017– and others for indications such as ADHD, opioid use disorder, and anxiety. These products undergo clinical trials and FDA review much like drugs or devices. This rigor gives confidence that they truly deliver outcomes, which is crucial for physician adoption and payer coverage. In short, digital therapeutics are treated as a new class of medicine, and pharma market access planning needs to treat them as such.

How pharma market access strategies must adapt for DTx

Digital therapeutics do not slot into the traditional pharma market access mold, so pharma companies must adjust their approaches. Instead of simply targeting formulary placement with pharmacy benefit managers, pharma market access teams now need to engage new stakeholders like employers and digital health formulary committees. Some leading pharmacy benefit managers have even created separate digital formularies to evaluate and cover DTx, underscoring how pharma market access pathways are branching out. Pricing and reimbursement models also have to be reimagined. A DTx might be reimbursed as a subscription service or via value-based contracts, rather than a one-time drug payment. For instance, manufacturers can negotiate outcome-based agreements – an insurer pays only if the patient achieves certain health goals – to alleviate payer concerns about paying for a software therapy.

Moreover, comprehensive evidence generation becomes even more critical. Market access teams should be prepared with robust clinical trial results and real-world health economic data showing that the DTx improves outcomes or reduces costs (such as hospitalizations). Early collaboration with payers to pilot the product and gather real-world performance can help build the case for broader coverage. Internally, organizations may need to develop new processes for supporting a digital product. From educating sales reps on DTx to setting up patient support for app onboarding. As one industry expert observed, pharma will have to “make sure we’re embracing digital” and rethink some pharma market access tactics for this new category. In short, success with DTx will come from flexibility and innovation in market access strategy, going beyond the playbook for traditional drugs.

U.S. regulatory and reimbursement landscape

In the United States, digital therapeutics are charting new territory with regulators and payers. On the regulatory side, the FDA has embraced DTx within its Software as a Medical Device framework. 

The agency has cleared or approved a number of DTx in recent years, establishing that a prescription app can meet safety and efficacy standards. For example, FDA approvals include Pear’s reSET for substance use and reSET-O for opioid use disorder, a video game-based therapy for pediatric ADHD (Akili’s EndeavorRx), and others for conditions like insomnia and anxiety. The FDA even convened a Digital Health Advisory Committee to help evaluate such products. This regulatory acceptance means digital therapeutics can legitimately be brought to market as “prescription” interventions – a crucial precondition for pharma market access.

Reimbursement, however, is still catching up. Currently, coverage for DTx by insurance plans is limited and inconsistent, which has been a major barrier to commercial success. Encouragingly, steps are being taken to address this gap. In 2022, the U.S. Congress introduced the Access to Prescription Digital Therapeutics Act to pave the way for Medicare to cover DTx. While that legislation is pending, the Centers for Medicare & Medicaid Services (CMS) has begun creating billing codes that recognize digital therapeutic services. In 2024, CMS proposed new payment codes for digital behavioral therapy tools – a sign that federal payers are acknowledging DTx. 

Similarly, some private insurers have experimented with covering specific digital therapeutics (often for mental health or diabetes) on a pilot basis. It will likely take time for reimbursement norms to solidify; until then, DTx companies have often pursued alternative channels like employer programs or cash-pay models. For pharma companies, staying closely attuned to these regulatory and policy developments is vital. As new codes, coverage policies, and guidelines emerge, those changes will directly impact pharma market access strategies for DTx. The landscape is moving in a favorable direction, but proactive navigation is required to ensure these products can be paid for just like traditional treatments.

Key challenges and gaps for digital therapeutics

• Reimbursement resistance

  A top challenge is persuading insurers to pay for DTx. Many payers remain hesitant to cover software-based therapies, lacking standard reimbursement categories. This hesitation has hampered DTx commercial uptake – for example, despite FDA-approved products, market leader Pear Therapeutics struggled to generate revenue and ultimately filed for bankruptcy in 2023. Clearly, without coverage and coding in place, even proven digital therapeutics face steep pharma market access hurdles.

   

• Provider acceptance

  Physicians and clinicians must be willing to prescribe digital therapeutics, but some remain skeptical or unaware. From a pharma market access perspective, if clinicians do not adopt these tools, even the best DTx will stall. Getting providers on board involves education about the clinical evidence and how to integrate DTx into practice workflows. If doctors don’t view a digital therapeutic as a legitimate treatment option, patient access will suffer. Pharma companies need to engage medical professionals early, highlighting success stories and making the prescribing process seamless (for instance, integrating DTx prescription into electronic health record systems).

   

• Patient engagement

  Using a digital therapeutic requires active patient participation – downloading an app, logging in regularly, completing exercises, etc. Ensuring high engagement and adherence is critical; otherwise, outcomes will fall short. DTx developers often use techniques like gamification, reminders, or coach support to keep patients involved. For pharma, this means treating user engagement as a key success metric. A well-designed, user-friendly DTx that patients actually stick with will drive better real-world results and strengthen the case for payer support.

   

• Demonstrating value

  Finally, there is a gap in how the value of DTx is quantified. Pharma market access teams must build a compelling health economics narrative for digital therapeutics. This includes demonstrating measurable improvements such as lower HbA1c levels in diabetes or reduced relapse rates in addiction. It’s also important to show how DTx can help lower overall healthcare costs. Generating real-world evidence and clear cost-benefit analyses will be key to convincing payers that these therapies are worth covering.

• Data and privacy

  Additionally, DTx developers must address data privacy and security concerns to prove value and reliability. Stakeholders need clear assurance that the product protects patient data and uses it responsibly ultimately strengthening its position in pharma market access.

   

Case study: Pear Therapeutics

Pear therapeutics – Early success and market access pitfalls: Pear Therapeutics was a trailblazer in digital therapeutics, gaining FDA clearances for multiple prescription DTx (including the first-ever clearance for a DTx, reSET in 2017). It proved that software could be an FDA-sanctioned treatment. However, Pear’s commercial trajectory highlighted the difficulties of securing sustainable pharma market access for DTx. Coverage for its products (for addiction and insomnia) remained limited, and revenue did not meet expectations. In 2023, Pear filed for bankruptcy protection, raising concerns about the viability of stand-alone DTx companies when payers are slow to reimburse. The Pear case underscores that robust clinical evidence must be coupled with payer adoption; without reimbursement, even a clinically effective digital therapeutic can falter in the market.

Emerging trends and industry outlook

As the digital therapeutics sector matures, several trends are shaping the pharma market access landscape. One notable trend is consolidation and collaboration. After the initial boom-and-bust cycle, pharma companies and larger health-tech firms have acquired or merged with many DTx companies, often stepping in to stabilize the market. This consolidation is leaving a core of stronger players often backed by pharma partnerships.

 Indeed, pharma companies are increasingly deeply involved – moving from tentative pilots to formal alliances and investments. Companies like Novartis, Pfizer, Otsuka, and Sanofi have all invested in or partnered with DTx developers to integrate digital therapies into their portfolios. Such partnerships signal that digital therapeutics are becoming mainstream rather than niche.

Analysts project that the U.S. DTx market could grow to around $21 billion by 2034, reflecting confidence in the field’s potential.

There is growing recognition of the value of DTx in areas like mental health and chronic disease management. Healthcare systems are increasingly seeking cost-effective interventions beyond traditional drugs. As a result, digital therapeutics are gaining traction as a standard component of care and a key element of pharma market access planning. For pharmaceutical executives, the window is now open to shape how DTx are adopted. Those who act early and form strategic partnerships can establish leadership in this emerging space. On the other hand, those who wait may end up reacting to competitors’ moves. The industry outlook suggests that digital therapeutics will only become more prominent. Pharma’s role in this evolution is pivotal.

Strategic recommendations for pharma leaders

• Strategic partnerships

  Collaborate with established digital therapeutics companies rather than going it alone. A strategic partnership (or acquisition) can provide access to proven technology and know-how, while the pharma partner contributes its expertise in clinical development and market access. By joining forces early, companies can develop DTx with payer and provider requirements in mind, making pharma market access smoother.

• Invest in evidence and value demonstration

  Treat a digital therapeutic like any other therapy when it comes to evidence. Conduct robust clinical trials to prove efficacy, and gather real-world data to demonstrate outcomes and cost savings. Build an economic case showing how the DTx can reduce other healthcare expenditures (for example, fewer hospital visits). Strong data will be the cornerstone of convincing payers and providers to support the product. All of this evidence will feed into a solid pharma market access dossier when negotiating with payers.

• Engage payers and plan for reimbursement

  It is suggested to plan for reimbursement well before FDA approval. Consider arranging pilot programs or presenting your clinical and economic data to insurer medical directors. Work on securing billing codes (CPT codes or other designations) and be open to novel payment models like outcome-based or per-member-per-month pricing. Proactively addressing reimbursement in the planning phase will improve pharma market access success at launch.

• Educate providers and patients

  Develop a comprehensive education and support plan for healthcare providers and patients. Physicians need to understand how to use the DTx and how it benefits their patients; this might involve CME sessions, demo apps, or integration with clinical workflow tools. Patients will benefit from onboarding assistance and ongoing support (such as coaching or tech help) to maximize engagement. By driving provider buy-in and patient adherence, you’ll create advocates for the DTx, which in turn supports pharma market access efforts.

• Focus on user experience and outcomes:

  Ensure the digital therapeutic is user-friendly, engaging, and truly helps patients achieve better outcomes. High user satisfaction and tangible health improvements will generate positive real-world evidence. Pharma teams can then share these outcomes with payers and providers as proof of value. In digital therapeutics, a strong product experience directly drives clinical impact. A well-designed DTx that patients stick with is far more likely to succeed commercially. Keeping the patient at the center of design will ultimately bolster pharma market access by yielding the results that stakeholders want to see.

Embracing the digital therapeutics revolution: A call to action for pharma

As digital therapeutics become a core part of healthcare, pharma companies must take proactive steps to adapt. The rise of DTx is transforming how treatments reach patients, meaning pharma market access strategies need to evolve in tandem. We have seen that success in this arena requires more than just good software – it demands early payer engagement, provider education, and a clear demonstration of value. The U.S. market is gradually putting the pieces in place (regulatory approvals, billing codes, legislative support) to treat digital therapeutics as a new class of medicine. Pharma organizations that incorporate DTx into their plans now can position themselves as leaders in this emerging field. They will improve patient outcomes while unlocking new growth opportunities. Those that delay risk playing catch-up in a few years when digital therapeutics are standard practice and part of the expected pharma market access toolkit.

Read more: The power of prescriptive analytics in healthcare: Improving patient outcomes

Netscribes: Your partner in digital therapeutics strategy

As you navigate this evolving landscape from a pharma market access perspective, having the right insights and strategy is essential. Netscribes combines AI-driven research with deep market expertise to help life sciences and pharma companies succeed in this new era. Our growth consulting services support you in building a winning market entry strategy for digital therapeutics from understanding the competitive landscape and payer expectations to identifying the right partnership opportunities. We’ve empowered global pharma leaders with actionable intelligence and strategic guidance across the digital health ecosystem. If you’re looking to optimize your market access strategy for digital therapeutics, connect with Netscribes to see how we can support your journey.
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