DTx Product Case Study: Freespira®

Panic disorder and panic attack: 85% panic attack free immediately post-treatment & 81% panic attack free at 12 months post-treatment

PTSD: At 6-months post-treatment, 89% reported significant decrease in CAPS-5 Score (validated PTSD assessment) & 50% were in remission

Digital therapeutics deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

Product Overview

Medical conditions:

Post-traumatic stress disorder (PTSD), panic disorder, and panic attacks

Target patient population:

Patients over 18 years old with PTSD, panic disorder, or suffering from panic attacks associated with other medical or behavioral health conditions

What to expect:

Significant reduction or elimination of panic and/or PTSD symptoms

Clinical
Overview

Indications for use:

Freespira is indicated as an adjunctive treatment for symptoms associated with panic disorder (PD) and/or post-traumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions

Outcomes:

Panic: 85% panic attack free immediately post-treatment; 81% panic attack free 12 months post-treatment; 94% clinically significant reduction in panic symptoms at 12 months post-treatment; and 85% treatment adherence 

PTSD: At 6-months post-treatment, 89% had significant reduction in CAPS-5 Score (validated PTSD assessment); 50% of patients were in remission; and 77% treatment adherence

Directions:

After receiving training by a clinician or Freespira coach, patients complete an at-home 28-day protocol with two 17-minute breathing sessions each day, for one month. Four weekly virtual coaching sessions are also included.

Risks & warnings:

Not indicated for patients who are younger than 18 years old, are pregnant, or have chronic obstructive pulmonary disease (COPD) or emphysema

Place in therapy:

Freespira is adjunctive to current treatments for PTSD and panic. However, neither psychotherapy nor medications are required for patients using Freespira.

Product
Access

Product description:

Freespira is a digital therapeutic product that incorporates a handheld tablet with pre-loaded software that provides patients with specific breathing protocols, in addition to a device that measures patient breathing rate and exhaled carbon dioxide in real time. Respiratory information is uploaded to a secure server for review by the Freespira coach and/or patient’s therapist. The patient receives virtual personalized training and coaching. 

Prescription status:

Authorization from a licensed healthcare provider is required. A prescription from a physician is not necessary.

Patient access:

Patients may self-refer into the program or are referred by a healthcare provider. The Freespira Patient Care Team determines any necessary copay/coinsurance payments, collects payments or creates a flexible payment plan, then ships devices to the patient’s home and schedules training. The Freespira device is self-contained and does not require additional equipment.

Provider access:

Healthcare providers are able to access the Freespira dashboard using a unique login and password to monitor patient progress as they work toward meeting their daily/weekly goals during the 28-day protocol. This dashboard also provides clinical outcomes, using data from the symptom assessments that patients complete each week.

Coverage options:

One coverage example is Highmark Health, who offers Freespira as a covered benefit for eligible commercial insurance members who are over 18 years of age and have panic disorder, panic attacks, or PTSD. Deductibles and co-insurance apply. For patients who receive Freespira through employers, there are no out-of-pocket costs associate with product use. Freespira is also offered as self-pay product if insurance companies to not offer coverage.

Product availability:

Freespira is available in:

  • USA: FDA-cleared Class II Medical Device

Engaging users. Driving outcomes.

The only FDA-cleared, evidence-based, drug-free digital therapeutic that can reduce or eliminate the symptoms of panic disorder, panic attacks, and PTSD

Clinical
Trials

Study Title: Feedback of End-tidal pC02 as a Therapeutic Approach for Panic Disorder. Alicia E. Meuret, Ph.D., Frank H. Wilhelm, Ph.D., Thomas Ritz, Ph.D., and Walton T. Roth, M.D.

Study Design: Randomized Controlled Trial

Outcomes: 68% panic attack free 12 months post-treatment; 93% clinically significant reduction in panic symptoms 12 months post-treatment; and 91% treatment adherence

Study Title: A Multisite Benchmarking Trial of Capnometry Guided Respiratory Intervention for Panic Disorder in Naturalistic Treatment Settings. David F. Tolin, Patrick B. McGrath, Lisa R. Hale, Daniel N. Weiner, and Ralitza Gueorguieva

Study Design: Mutli-Center Study

Outcomes: 71% panic attack free immediately post-treatment; 79% panic attack free 12 months post-treatment; 82 % clinically significant reduction in panic symptoms 12 months post-treatment; and 84% treatment adherence

Study Title: Investigation of Freespira in the Treatment of PTSD. Michael J. Ostacher, MD, MPH, MMSc. Associate Professor of Psychiatry, Department of Psychiatry and Behavioral Sciences Stanford University School of Medicine. Palo Alto VA. Submission in process to peer-reviewed journal.

Study Design: Single Arm Trial (n=55)

Outcomes: At 6-months post-treatment, 89% had significant reduction in CAPS-5 Score (validated PTSD assessment); 50% of patients were in remission; 77% treatment adherence

Study Title: Evaluating the Impact of Freespira on Panic Disorder Patients’ Health Outcomes and Healthcare Costs within the Allegheny Health Network. Kaplan, A., Mannarino, A.P. & Nickell, P.V. Appl Psychophysiol Biofeedback (2020)

Study Design: Health Economic Study

Clinical Outcomes:  85% panic attack free immediately post-treatment; 81% panic attack free 12 months post-treatment; 94% clinically significant reduction in panic symptoms 12 months post-treatment; and 83% treatment adherence

Economic Outcomes: 50% reduction in overall medical costs; 64% reduction in emergency room costs; and 53% reduction in medication costs measured at 12 months post treatment