Informing the future of digital therapeutics: lessons learnt

Introduction

Digital therapeutics (DTx) are software-based interventions that leverage digital platforms to provide patient treatments from afar, expanding access to care and surpassing temporal and spatial boundaries. One subset of DTx is prescription digital therapeutics (PDTs), which are DTx that must be prescribed by a licensed healthcare practitioner. Although these technologies hold immense promise, their translation into real-world clinical settings remains a challenge. Pear Therapeutics, one of the DTx leading companies, was the first to obtain Food and Drug Administration’s (FDA) approval for its three PDTs for substance use disorder, opioid use disorder and insomnia. However, it filed for Chapter 11 bankruptcy in 2023 (1). Pear Therapeutics’ experiences provide an opportunity to reflect on lessons learned and identify strategies to optimize future PDT development and implementation.

In this letter, we apply an implementation science lens to understand the challenges facing the PDT field and identify strategies to support the adoption of these interventions in routine care. We use the Consolidated Framework for Implementation Research (CFIR), namely characteristics of the outer setting (i.e., macro-level factors affecting implementation) and those intrinsic to the innovation (i.e., DTx products and evidence) to characterize determinants of DTx implementation (2) and align them with promising implementation strategies, using Pear Therapeutics as a case example (3). The determinants and corresponding strategies are summarized in an implementation research logic model (Figure 1).

Figure 1.

Implementation research logic model for DTx implementation success. This figure illustrates considered key elements of proper DTx implementation including implementation determinants, chosen strategies, mechanisms of action, implementation outcomes, and ultimately, the desired outcomes. DTx, digital therapeutics.

Addressing the lack of payer reimbursement with facilitated reimbursement strategies

Within the outer setting domain, the lack of payer reimbursement remains a critical impediment to the effective adoption and implementation of DTx. Policies allowing reimbursement for DTx have been at a standstill for many years (4). The Centers for Medicare and Medicaid Services (CMS) introduced a new Level II Healthcare Common Procedure Coding System (HCPCS) billing code in 2022 for prescription digital behavioral therapy. CMS characterized this singular code as “sufficient at the time”, encompassing very different PDTs. The introduction of this code brought a myriad of concerns. It lacked a predetermined reimbursement rate, which posed challenges in utilization due to the unique pricing and characteristics of each PDT. Additionally, limited guidance from CMS and ambiguous reimbursement rates led to individual adjudication of claims by Medicare and commercial insurers. In the case of Pear Therapeutics, only half of DTx prescriptions for their products were covered by insurance (5). Consequently, the company could not meet revenue targets due to a lack of coverage density.

To address these challenges, clear solutions are needed. First, the representation of the wide-ranging spectrum of DTx products would be ensured by the establishment of product-specific billing codes with fixed reimbursement rates. This specificity in coding enables the proper categorization and billing of different DTx, providing consistency in reimbursement and reducing uncertainty for providers. Second, the provision of clear, comprehensive guidance from CMS would aid in appropriately using and reimbursing these codes, minimizing confusion among healthcare providers and payers. Finally, the advocacy for uniform review criteria across different payers ensures consistent coverage decisions. Had such measures been in place, it is possible Pear Therapeutics would have experienced more streamlined reimbursement processes, with a less administrative burden and a more improved patient access to DTx.

Bridging the evidence gap: enhancing adoption through readiness assessment and stakeholder engagement

Achieving reimbursement for DTx requires a protracted process of evidence accumulation, dissemination, and implementation. Pear Therapeutics’ clinical efficacy evidence stands among the most robust in the PDT domain, with over 40 published studies, including several large randomized controlled trials (6). However, when approaching payers, it is increasingly important to show tangible value and large-scale pragmatic effectiveness, such as improved patient outcomes and increased adherence in different settings and across different populations. In 2020, the Institute for Clinical and Economic Review (ICER) cited the inability to find robust evidence that smartphone apps for opioid use, including reSET-O, could provide sustained benefits over multiple years (7). When it comes to treatment adherence and post-market effectiveness, Pear Therapeutics conducted only one study that assessed patient engagement, usage and associated outcomes of opioid use and treatment (8). A high rate of dropout (91%) was evident among patients who initiated reSET-O and were completing 12 weeks in a feasibility and acceptability study assessing reSET-O, reinforcing the need for vendors to provide evidence on high engagement to encourage use and patient uptake (9). Further, research has also shown that many healthcare providers are not ready to fully embrace these tools in clinical practice in the light of workflow limitations and other competing priorities, making it challenging to connect patients to these app-based treatments in clinical settings (10,11). In 2021, Pear Therapeutics reported 14,000 prescriptions for its three PDTs, of which only half resulted in patients downloading and accessing therapeutic software content. Providing studies specifically examining uptake, adherence and use of Pear Therapeutics’ products in real-world settings may have helped provider buy-in and patient adoption.

Readiness assessments could have served as a crucial mechanism for Pear Therapeutics to generate evidence of potential uptake and stakeholder buy-in. Given Pear Therapeutics’ time pressures, hybrid effectiveness-implementation designs (12) are efficient research approaches that simultaneously measure both effectiveness and implementation outcomes (13) including readiness, adoption, compatibility, adaptability, costs, feasibility, and sustainability of a DTx in a specified setting. This dual focus helps in tailoring strategies that can improve both the clinical and operational aspects of deploying DTx. Engaging stakeholders is also essential for the successful development and implementation of DTx. In the Digital Treatments for Substance Use Disorder (DIGITS) implementation study and its formative evaluation, one key facilitator identified was the high engagement from clinical leaders and licensed independent clinical social workers (10). Developing evidence on effectiveness requires the proactive participation and engagement of multidisciplinary teams encompassing a diverse array of stakeholders, including patients, clinicians, technology developers, economists, and policymakers. This collective effort is instrumental in optimizing the likelihood of acceptance and ensuring the adoption and scalability of DTx.

Conclusions

The evolving landscape of DTx holds immense promise for transforming behavioral healthcare. Pear Therapeutics not only proved to be a leading company in the industry but also served as a guide for future endeavors by other DTx companies. Its setbacks provided valuable lessons for other companies in the DTx space striving for success, and its experiences emphasized the need for a nuanced approach to the successful implementation of DTx.

Supplementary

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Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.