Digital Step Therapy: A Smart Framework for Payer Adoption of Prescription Digital Therapeutics

As prescription digital therapeutics (PDTs) gain FDA authorization and clinical traction, health insurers and policymakers face a growing imperative to define reimbursement strategies that ensure equitable access while delivering demonstrable value. We propose digital step therapy: a modernized framework in which patients initiate care with evidence-based PDTs before escalating to more intensive or costly interventions. Unlike traditional step therapy, which often enforces rigid fail-first hierarchies, digital step therapy can leverage real-time engagement data, patient-reported outcomes (PROs), and modular design features unique to software-based therapeutics. This editorial outlines the rationale, opportunities, risks, and implementation principles for a smart, patient-centered digital step therapy model. It emphasizes the need for clinician override mechanisms, equity-driven usability standards, and regulatory alignment to avoid replicating historical barriers to care. Using CT-132 (Click Therapeutics, Inc., New York, NY, USA) for episodic migraine as an illustrative case, we demonstrate how digital step therapy can deliver a clinically adaptive, data-informed, and payer-aligned approach that promotes early access to safe, scalable interventions, acknowledging implementation barriers, while continuously refining care pathways based on real-world outcomes.