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

August 20, 2024


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.

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The Future is Here: Advanced Manufacturing in Medical Devices with Daniel Matlis

In an era characterized by unprecedented change and technological advancement, the message from industry leaders is clear: digital transformation is no longer optional but a critical necessity for survival and growth.

In this MDIC Studio session, hear from Daniel Matlis, President and Founder of Axendia, as he describes the current state of advanced manufacturing in the life sciences industry and what is yet to come. Matlis offers a comprehensive overview of how novel and innovative applications of existing technologies are reshaping manufacturing processes to enhance product quality and improve patient outcomes. Drawing from Axendia’s extensive primary research and interactions with regulatory officials, industry executives, and clients, Matlis discusses the current landscape and the critical need for broadening the adoption of advanced manufacturing technologies throughout the total product lifecycle.

“We’re living in the age of continuous disruption as and as organizations. We need to realize and prepare for that. And as a result, digital transformation. It’s not a nice to have. It is an imperative for our industry.” As the pace of technological change shows no signs of slowing, the importance of digital transformation will only grow. Companies that embrace this shift will be better positioned to navigate disruptions, meet customer needs, and drive sustainable growth.

Daniel’s insights serve as a reminder that in the age of continuous disruption, digital transformation is not just a strategy but a fundamental requirement. Organizations that recognize this imperative and act accordingly will be the ones that thrive in the digital future.

We invite you to learn more about the Advanced Manufacturing Clearing House and reach out to us with questions about how you can participate at AMCH@MDIC.org.

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Challenges and Barriers to the Adoption of Advanced Manufacturing in MedTech

MDIC Studio Panel: Challenges to Adopting Advanced Manufacturing in MedTech

Join industry leaders Domhnall Caroll, CEO of Digital Manufacturing Ireland, Garth Conrad, Vice President of Quality at Flex Health Solutions, Daniel Matlis, CEO and Founder of Axendia, and Francisco Vicenty, Case for Quality Program Manager at the FDA CDRH in a compelling discussion on the adoption of advanced manufacturing in the medical device field. Discover how companies are tackling barriers such as ROI and internal expertise, common fears and misconceptions industry has on advanced manufacturing, and how regulatory agencies are evolving their approach. Watch the panel and discover how participating in the Advanced Manufacturing Clearing House can improve overall quality and product safety.

The purpose of Advanced Manufacturing Clearing House is to encourage Medical Device Industry to adopt advanced technology across the total product life cycle. Objectives include improving design, supply, production, distribution, tracking, device reliability, overall quality, and safety across the product life cycle. Examples of advanced technologies include but not limited to additive and generative part design, digital twins, and digital threads (e.g., modeling and simulation for virtual design verification, validation and design transfer), and data-driven closed-loop quality.

Learn more or reach out to us at AMCH@MDIC.org

Cover Image Provided Courtesy of FLEX Health Solutions

 

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AMCH: Advancing Manufacturing Through Changing Perceptions

An Invitation to Join the Advanced Manufacturing Clearing House Evolution

Are you ready to share your story of digital transformation? Join Joe Sapiente, Vice President of Clinical Science and Technology at MDIC, and Fransisco Vicenty, Program Manager for Case for Quality at the FDA, as they discuss the evolution of the Advanced Manufacturing Clearing House initiative at MDIC.

Watch the Interview: Advancing Manufacturing Through Changing Perceptions

The purpose of Advanced Manufacturing Clearing House is to encourage Medical Device Industry to adopt advanced technology across the total product life cycle. Objectives include improving design, supply, production, distribution, tracking, device reliability, overall quality, and safety across the product life cycle. Examples of advanced technologies include but not limited to additive and generative part design, digital twins, and digital threads (e.g., modeling and simulation for virtual design verification, validation and design transfer), and data-driven closed-loop quality.

Application open now for AMCH project funding!
Learn more or reach out to us at AMCH@MDIC.org

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Video Series: Navigating the US Public Payer Reimbursement Landscape

April 4, 2024

Understanding the complexities of successfully navigating the reimbursement and coverage processes to commercialize disruptive medical technologies can often be a complicated endeavor for organizations. MDIC has partnered with leading industry experts to review key components of developing a successful reimbursement strategy in a new series of informational videos. These videos highlight how to achieve commercial product success by securing favorable payer coverage, coding, and payment for new technologies.

The series of videos cover reimbursement and coverage best practices for the following key topics:

Navigating the US Public Payer Reimbursement and Coverage Landscape

Navigating the reimbursement and coverage landscape is critical to the short and long-term commercial success of medical technologies. Securing favorable reimbursement with public payers is often a complex and highly specialized process.  Understanding the payer coverage pathway will assist organizations in developing a realistic timeline and planning for success.

Hosted by:  Joel Brill, MD, FACP, Chief Medical Officer, Predictive Health

Reimbursement Professionals: Keely Scamperle, FACHE, CPC, CCS-P, CHC and Tamara Rook, MBA

Navigating the US Coding Processes

The reimbursement elements of coding, coverage, payment, and health policy are dynamic and should be considered early and often throughout the product life cycle.  The coding process and pathway can often seem complicated but are critical for organizations to understand as a key component of a successful commercialization and adoption strategy.  Learn about some of the ins-and-outs of the AMA CPT® and RUC processes as well as stakeholder considerations relative to navigating the process here.

Hosted by: Joel Brill, MD, FACP. Chief Medical Officer, Predictive Health

Reimbursement Professionals: Keely Scamperle, FACHE, CPC, CCS-P, CHC and Tamara Rook, MBA

Developing a Dynamic US Reimbursement and Coverage Strategy

A successful reimbursement and coverage strategy requires ongoing assessment and adjustment to the dynamic environment and its key stakeholder requirements.  It also requires an understanding of benefit categories and the role of pricing and fee schedules. Learn from subject matter experts on how to develop a successful market access strategy for new technologies.

Hosted by: Joel Brill, MD, FACP, Chief Medical Officer, Predictive Health, former Payer Medical Director

Reimbursement Professionals: Liesl Oldstone, MBA, PhD, RPh, Mark Domyahn, MBA

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Medical Device Innovation Consortium Selects Simon Mason to Lead National Evaluation System for health Technology Coordinating Center

April 17, 2023

Senior health care executive moves to advance the role of real-world evidence in medical device ecosystem

April 17, 2023

FOR IMMEDIATE RELEASE

[Arlington, VA.] – The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has named Simon Mason as its new President. In his new role, Mr. Mason will lead strategy and operations for NESTcc to serve its stakeholders, including patients, providers, payers, medical device manufacturers, regulators, and others.

With a thirty-year career spanning roles in executive management as well as product and business development, Mr. Mason joins NESTcc from Pharmaspectra, a business acquired by IQVIA, where he most recently served as Chief Operating Officer. At Pharmaspectra, he led development and commercialization of a data lake of scientific and medical affairs information utilized by pharmaceutical and medical device companies.

“I’m honored to join the great team at NESTcc and work with this unique organization’s network collaborators, partners, customers, and other stakeholders to change the paradigm of clinical research through the appropriate use of real-world evidence,” said Mr. Mason. “Together, we will drive continued innovation for the benefit of patients and all medical device stakeholders.”

NESTcc is focused on advancing the use of medical device real-world evidence (RWE), and Mr. Mason’s experience in building healthcare data businesses positions him strongly to advance NESTcc’s mission. As President, he will lead NESTcc’s continued development of a trusted not-for-profit platform for the timely generation of RWE and its collaborative work on advancing RWE methodologies to address pre- and post-market challenges in the medical technology space.

“We’re thrilled to welcome Simon to NESTcc to build on the organization’s strong foundation and accelerate its development to support medical device innovation,” said Andrew Fish, JD, President & CEO of MDIC. “Simon’s operational and commercialization expertise make him an excellent candidate to lead NESTcc’s work in advancing the use of real-world evidence for the benefit of patients and all medical device stakeholders.”

“Simon is an innovator and accomplished leader in building healthcare data companies, and I’m excited to collaborate with him to guide NESTcc’s strategic priorities and deliver ever greater value for stakeholders across the medical device ecosystem,” said Diane Wurzburger, Chair of the NESTcc Governing Committee and Executive of Regulatory Affairs & Quality for GE Healthcare.

“CDRH congratulates Simon in his new role as the President of NESTcc,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH). “We look forward to working with Simon and leveraging his expertise to support our shared goal of advancing medical device safety and innovation.”

NESTcc is delighted to welcome Simon Mason as its new President and looks forward to working with him to continue advancing the use of real-world evidence across the medical device ecosystem.

About the National Evaluation System for health Technology Coordinating Center

In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design™. For more information, visit http://www.nestcc.org.

About the Medical Device Innovation Consortium

Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to break down barriers in the medical technology life cycle to accelerate innovation and adoption of safe, effective, and high-quality medical technologies. The consortium brings together medical technology manufacturers, researchers, regulators, payers, patients, and health care providers as trusted collaborators to solve complex challenges in the scientific and technical disciplines that propel medical technology development, approval, adoption, and access. MDIC’s work improves regulatory pathways, advances medical device quality, enhances patient safety and access, and facilitates the development of better evidence for approval, coverage, and utilization decisions. For more information, visit http://www.mdic.org.

Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (U01 FD 006292). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

Contact

Todd West
twest@mdic.org

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