BY ANDREW MATTHIUS ON PM360
Swing Therapeutics, a digital therapeutics (DTx) company, has turned to a couple of virtual solutions to help close that last mile of commercialization that has been proving a difficult barrier for many DTx companies to cross despite a rapidly growing market. Estimates predict the DTx market to reach $11.2 billion in the U.S. by 2030 according to Nova One Advisor and $35.78 billion globally by 2030 according to Strategic Market Research, however, several DTx have failed to catch on after hitting the market due to either low awareness among doctors and patients or a market access environment that has yet to fully embrace these therapeutic options.
“Currently, Medicare doesn’t have a benefits category for digital therapeutics and that’s been a barrier,” Mike Rosenbluth, PhD, Chief Executive Officer at Swing Therapeutics, told PM360 in an interview. “Commercial payers can follow Medicare, so if there’s no standards by payers in terms of what they’ll pay for, some investors may be more cautious to invest in a sector that does not have mature business models.”
While payers may be slow to adopt DTx, that has not been the case on the regulatory side, according to Dr. Rosenbluth who says the “FDA has been very supportive of this field.” The agency has already approved nine prescription DTx, which are regulated as medical devices under the Software as a Medical Device (SaMD) program. Additionally, the FDA established the Enforcement Policy for Digital Health Devices during the COVID-19 Public Health Emergency to expand the availability of DTx options that treat things such as anxiety and depression in order to help patients at a time when they might not be able to see their doctors in person.
As part of this policy, Swing Therapeutics’ Stanza, a DTx designed to deliver behavioral therapy to people with fibromyalgia, was made commercially available to patients at the end of 2022. Previously, Stanza was granted the FDA’s Breakthrough Device Designation. The mobile app uses acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), to help improve the psychological symptoms associated with fibromyalgia, including anxiety, depression, and sleeplessness in adult patients.
“Fibromyalgia is a chronic widespread pain condition that is thought of as a central sensitization syndrome where there’s no peripheral injury that’s causing the pain but the brain is amplifying and very sensitized to pain signals,” Dr. Rosenbluth explains. “The three FDA approved medications for fibromyalgia work in a proportion of patients but they also have a lot of side effects and no new drug for fibromyalgia has made it to market since 2009. CBT is considered a first-line treatment for fibromyalgia, but people don’t tend to get it because of lack of access. So, we’re committed to changing that and getting this digital therapeutic out there.”
Increasing Access Via a Telemedicine Clinic
To help expand access of Stanza, Swing Therapeutics launched Swing Care, a telemedicine clinic focused specifically on the treatment of fibromyalgia, in October 2022. Swing Therapeutics serves as the clinic’s Management Services Organization (MSO), which is responsible for providing administrative support to the practice. However, the clinic itself is physician-owned with all medical decisions made by the practicing physicians along with its medical director, Andrea Chadwick, MD who is Associate Professor in the Department of Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Medical Center.
“Swing Care is designed to bridge the gap between patient awareness and access to Stanza when medically appropriate,” Dr. Rosenbluth says. “The clinic does digital advertising to raise patient awareness. And if they join the clinic, they can also get access to appropriate medication management to holistically treat the condition.”
Swing Care services include monthly clinician appointments, ongoing clinician messaging, and behavioral therapies. Currently, Swing Care is only available for patients in Texas, but Dr. Rosenbluth says the plan is to expand to more states in the near future.
However, Stanza is not limited to Swing Care members as the DTx can be prescribed by any physician. Dr. Rosenbluth explains that Swing Care simply offered the company a way to explore a patient access pathway to help those medically in need of Stanza get the therapy at a time when the market access landscape for DTx is still developing.
For example, the Access to Prescription Digital Therapeutics Act of 2022, which was introduced in the Senate in March 2022, could provide Medicare coverage and reimbursement for prescription DTx if passed. And in December 2022, the Senate introduced another bill, the Medicaid and CHIP Access to Prescription Digital Therapeutics Act, which could lead to coverage for prescription DTx under Medicaid and the State Children’s Health Insurance Program (CHIP).
“All of the industry partners are working at it along with several senators and congress people, so hopefully that will lead to change,” Dr. Rosenbluth says. “In the meantime, there are some payers that are being more innovative such as Highmark, which has issued a positive coverage decision for some prescription digital therapeutics. There are also different business models such as directly contracting with payers or going through employer benefits.”
Embracing Decentralized Clinical Trials
As Swing Therapeutics also works toward getting full FDA approval, it has embraced another virtual solution—the decentralized clinical trial (DCT). The company partnered with Curavit Clinical Research, considered to be the world’s first ever all-virtual contract research organization (VCRO), to expand the reach of its pivotal multicenter, randomized controlled study called PROSPER-FM. The hybrid trial is expected to enroll about 270 participants recruited from 15 to 25 physical sites plus Curavit’s virtual site.
The study is comparing Stanza to an alternate digital therapeutic, a digital symptom tracker that Swing developed based on similar apps that have been validated for chronic pain management. The study will last for 12 weeks and will measure clinical endpoints through patient-reported outcomes like the Patient Global Impression of Change (PGIC) Scale and the Revised Fibromyalgia Impact Questionnaire (FIQ-R) as well as instruments that measure pain intensity and interference, sleep interference, depression, anxiety, pain acceptance, mindfulness, and quality of life.
Curavit’s virtual site and recruitment process have quickly helped to ramp up participation in the trial. Compared to physical sites that started at the same time, Curavit has enrolled 10x more patients in its virtual site. The VCRO has a lot of experience with DTx decentralized trials as more than 50% of its clients are in the space.
“We have a very rigorous process to screen and educate potential participants into this trial because a lot is expected from them,” Joel Morse, Co-Founder and CEO of Curavit, explained to PM360 in an interview. “We had to ensure that the participants are aligned with the protocol, inclusion/exclusion criteria, and that the data can be used for FDA approval. We’ve also been working with Swing to make sure that they are high-quality participants by adherence and they are doing all of the activities they’re required to do and staying in the trial. So far, we are seeing participants who at are top of the bell curve if you will.”
Curavit recruits potential participants through web advertising on Facebook, Reddit, and Twitter to build awareness of the trial. The ad directs people to a landing page that offers a combination of education about the trial as well as a self-screening questionnaire to test eligibility. If eligible, they are presented with an opportunity to have a 90-minute live engagement with a Curavit clinical research coordinator, who makes sure they are aligned with the study’s protocol and inclusion/exclusion criteria. Ultimately, this process weeds out more than 50% of the people who initially self-screened correctly.
Curavit also manages the process for patients to get their mandatory urine drug screening by lining them up with their nearest Quest Diagnostics lab and providing them with a QR code that includes payment for the session and the information for where to send the results. Once they pass through all of this, participants are scheduled to meet with the principal investigator (PI), a board-certified rheumatologist, who can ensure the patient’s diagnosis of fibromyalgia. At that stage, Curavit also works with the participant to download the application, set it all up, and make sure they know how to use it.
In a previous prospective single-arm clinical trial (REACT-FM), Swing found that 88% of participants were satisfied with Stanza and 91% preferred either using the app alone or in combination with other approved fibromyalgia medications, compared to using approved medications alone.
“At the end of the day, we’re trying to help patients change their relationship with pain,” Dr. Rosenbluth says. “The overarching idea of ACT is to help people accept what’s going on in your body and to separate your thoughts and feelings from yourself, so you can let those feelings pass. And then we’re trying to drive behavior change by helping people identify their values and taking committed action aligned with those values. It helps patients take control over their choices rather than letting their symptoms dictate their life.”