PharmaVOICE Blog Post

How Digital Therapeutics Developers Can Satisfy Diverse Stakeholder Needs

Posted By: Dan Limbach
June 3, 2019

If there are lingering doubts about the viability or market potential of digital therapeutics (DTx), recent moves by the U.S. Food & Drug Administration should lay them to rest. In December 2018, Pear Therapeutics and its partner, Novartis’ Sandoz unit, received FDA clearance for reSET-O, a prescription-only mobile medical app that helps patients with opioid use disorder remain in outpatient treatment programs. The same month, with support from regulators, the ECG app on the Apple Watch 4 became the first direct-to-consumer product that can notify users of an irregular heart rhythm.

While these two examples stand out, there are dozens of other software-driven products under regulatory review for diagnosing, treating, or preventing medical conditions. As Sandoz CEO Richard Francis said in a press release announcing the reSET-O, digital therapeutics “have the potential to fundamentally change how patients interact with their therapies,” and may represent “the next chapter of medical innovation.”

Download the report here: http://bit.ly/2ZXDMTk.

Now, global regulatory bodies seem poised to weave DTx into the fabric of regulatory decisionmaking and reimbursement. In England, the National Health Service (NHS) and the National Institute for Health and Care Excellence (NICE) are working on a therapy assessment program to increase access to digitally enabled psychological therapies. In Germany, large insurers are driving adoption. Even France, a relative laggard, has started reimbursing for digital medical devices that fit the DTx definition. In the U.S., the FDA is promoting a pilot program that may lead to pre-certification for trusted DTx developers whose products will be paired with, or replace, FDA-approved medical treatments. And, the agency recently released a framework for the use of real world evidence (RWE) in clinical studies highlighting the intent to capture more patient-generated data on mobile devices and in-home-use settings.

Yet DTx developers face a unique set of challenges in bringing this new class of treatments to the market, especially when it comes to payers and reimbursement.  A roadmap is needed to reach commercial success. and a roadmap is needed to commercial success.

Fueled by insights from their end-to-end work with biopharmaceutical customers and through conversations with pioneering companies and alliances in the DTx space, Syneos Health has released a new report that outlines steps needed to make these new innovations to patients, including:

  • the confluence of regulatory, technological, social and economic conditions shaping the DTx market;
  • roadmap recommendations for healthcare stakeholders, including pharma companies considering a partnership, DTx solution providers, payers, hospital systems and investors;
  • key therapeutic target areas for DTx;
  • and “last mile” challenges.

Download the report here: http://bit.ly/2ZXDMTk.

About the Blog Poster: Dan Limbach

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