Pear's Journey: A Cautionary Tale & Opportunity for DTx Commercialization
Today we’re diving into the world of digital therapeutics (DTx) by exploring the journey of Pear Therapeutics, creators of reSET and reSET-O, two FDA-approved prescription DTxs for Substance Use Disorder (SUD) and Opioid Use Disorder (OUD).
Pear’s story highlights a critical issue facing DTx commercialization: the slow and winding road to reimbursement in the U.S. healthcare market.
Pear's DTx products offer a beacon of hope for patients, but the path to reimbursement has been far from smooth despite their potential for improving patient outcomes.
After receiving FDA approval for reSET-O in December 2018 and Somryst (for chronic insomnia) in March 2020, CMS took until April 2022 to approve HCPCS code A9291, creating a reimbursement pathway for both. Even then, Pear's annual report revealed that only 41% of the 45,000+ prescriptions written in 2022 were reimbursed.
Now let's compare this to Germany's DiGA Fast Track program, which has approved 45 digital therapeutics for reimbursement since May 2020. While it took over two years for just one DTx to become eligible for reimbursement in the U.S., 45 hit the market in Germany. The U.S. tried to catch up with CMS's MCIT/R&N "fast track" rule, but it was rescinded before taking off.
The lesson here? We need a more efficient reimbursement pathway for DTx in the U.S., or we risk more bankruptcies, failures to launch, and limited access to innovative therapies compared to other parts of the world.
As champions of DTx, it is our collective responsibility to:
🔬 Strengthen clinical evidence: Bolster your product's efficacy and safety with well-designed trials to build a stronger case for reimbursement. Listen to our conversation with TMC Innovation’s Emily Reiser (transcript available) on why clinical trials are essential to the ROI recipe for market acceptance and reimbursement.
🌐 Master the regulatory maze: Understand FDA and CMS requirements and seek expert guidance to avoid pitfalls. (Start with our checklist on how to determine if your software platform is considered SaMD)
🤝 Forge strategic partnerships: Collaborate with healthcare providers, payers, and policymakers to push for faster, more efficient reimbursement pathways. We’ve recently joined forces with the Digital Therapeutics Alliance to share our expertise on U.S. Policy, U.S. Commercialization Coverage, and how to get more feedback from stakeholders back to the FDA. Are you a member? If so, we’d love to connect with you there.
Together, let's make DTx a driving force in the future of U.S. healthcare, ensuring patients have access to the innovative therapies they need and deserve.
NGL at ViVE2023!
Conference Schedule
Did you go to ViVE last month? We still haven’t recovered from that whirlwind of a week, but our bags are repacked! We hope to see you at one of these industry events:
Rebecca Gwilt spoke on a panel at AHLA last week on legal issues and considerations for telemedicine companies eager to grow and scale. If you missed it (or you’re not an attorney), you’ll want to check out this post on creating a multi-jurisdictional telehealth business.
Rebecca next visits London May 3-4 to speak at LSX on Scaling Digital Health Companies and Creating Commercially Viable Business Models. We’re seeing more interest from international companies seeking to break into the US healthcare market, so no doubt this will be a popular session!
Carrie Nixon travels to Minneapolis to share the latest federal telehealth policy at gpTRAC’s TelehealthEverywhere Conference. (If you’re not already getting our biweekly LinkedIn Telehealth/Virtual Care state and federal updates, subscribe now.)
Kaitlyn O’Connor heads to Boston for the Evidence-Based Digital Health in Pharma Summit May 24-25. She’ll be on a panel to discuss how we can approach and manage the risk that comes with the implementation of digital health by deciphering what evidence is needed to inform decision-making concerning its adoption.
If you or someone from your company will be at any of these events, please reply to this email and let us know so we can meet.
And that brings this issue to a close…
Thank you for making room for us in your crowded inbox every month. You're busy, and we aim to deliver the most immediately useful information in each issue. You can always reply to our emails with kudos, comments, questions, or constructive criticism—we read every response.
Until next time,
Carrie Nixon, Rebecca Gwilt, Kaitlyn O'Connor
and the entire Nixon Gwilt Law Team