## Paving the Way for Digital Therapeutics in Mental Health

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Freespira’s Strategic Approach to Market Access: Paving the Way for Digital Therapeutics in Mental Health**

Freespira, Inc. developed an innovative digital therapeutic treatment to address the need for accessible and effective solutions for panic disorder, panic attacks, and post-traumatic stress disorder (PTSD). As the first FDA-cleared, medication-free, at-home treatment, Freespira stands out in the crowded landscape of digital therapeutics, overcoming the limitations of traditional treatments.

**Meeting an Urgent Demand**

Anxiety-related disorders, including panic disorder, panic attacks and PTSD, affect more than 40 million adults in the United States. These conditions often trigger physical symptoms such as chest pain, breathing difficulties, and dizziness, significantly disrupting daily life and well-being. Conventional treatment often falls short due to patient nonadherence, limited availability of specialized care, and the challenge of addressing both physiological and psychological symptoms associated with these disorders.

Freespira targets the root cause—breathing irregularities—through capnometry-guided respiratory intervention. This evidence-based approach helps patients normalize their breathing patterns, reducing hypersensitivity to carbon dioxide commonly observed in individuals with panic disorder and PTSD. Patients complete a single course treatment at home through two daily sessions for 28 days, receiving immediate feedback on their breathing and personalized coaching support.

**Navigating Market Entry and Regulatory Pathways**

In the evolving digital therapeutics landscape, achieving market access and reimbursement is essential for successful commercialization and widespread adoption. Freespira faced challenges when it first applied for FDA clearance due to the developing regulatory environment for digital therapeutics. By gathering clinical evidence and engaging early with stakeholders, including key opinion leaders and healthcare providers, Freespira navigated the regulatory and reimbursement paths effectively. This proactive strategy led to its first FDA 510(k) clearance, validating its clinical claims and paving the way for broader market adoption.

**Building Payer Relationships and Achieving Reimbursement**

Freespira recognized the need to demonstrate clinical efficacy and economic value to payers. To do so, Freespira conducted comprehensive studies demonstrating that more than 80% of patients reported a significant reduction in symptoms of panic disorder and PTSD after just 28 days, with benefits lasting at least a year. Additionally, health economics studies highlighted significant cost savings, including a 35% reduction in total medical costs and a 65% reduction in emergency room costs for patients using the treatment.

Freespira demonstrated consistent clinical outcomes and offered Value-Based Pricing programs to increase payer adoption. By implementing outcome-based contracts that align clinical outcomes with cost-saving targets, Freespira mitigated financial risks for payers. This strategy, which continues today, has successfully included Medicaid, Medicare Advantage, and other government payers. Freespira also explored and continues to use innovative contracting models, such as performance guarantees, encouraging payers to invest in their DTx platform. Their ongoing advocacy efforts aim to secure expanded coverage and favorable reimbursement rates by establishing the treatment’s effectiveness and patient-centered approach.

**Paving the Way for Utilization of Digital Therapeutics for Mental Health Treatment**

Freespira’s commercialization highlights the importance of early stakeholder engagement, strategic flexibility, and evidence generation in navigating regulatory and reimbursement processes for digital therapeutics. By addressing issues such as geographical and socioeconomic barriers, along with limited availability of specialized services, Freespira expands access, improves patient outcomes, and sets a precedent for the future of mental health treatment with digital therapies.

Freespira continues to seek ways to broaden access and adoption of its innovative treatment, ensuring that impactful treatments reach those who need them most. This ongoing commitment to evidence-based practices and payer collaboration serves as a model for other digital therapeutics aiming to achieve similar success in the mental health landscape.