- A new report from PwC predicts that new entrants, as well as biopharmaceutical and medical device companies, will launch new digital therapeutics and connected health services this year.
These new therapies and services will help patients make changes in their behaviors, give providers better healthcare insights, and provide insurers and employers new tools to manage beneficiaries’ healthcare.
PwC expects that new data sharing procedures and payment models will be used to integrate these products into the broader treatment regimen and regulatory framework for drug and device approvals.
In contrast to branded companion apps and online portals, digital therapeutics and connected devices are validated by the FDA and target specific health outcomes, the report noted.
The FDA has approved new digital therapies, such as Boston-based Pear Therapeutics’ Reset mobile app for the treatment of substance abuse and Stockholm-based Natural Cycles’ birth control app.
Connected devices designed to treat diabetes, central nervous system disorders, and other chronic conditions are expected to enter the market this year.
PwC noted that drug, device, and technology manufacturers are using four primary methods to validate digital therapeutics:
- FDA approval or clearance for use: This requires regulatory review of clinical data to validate health claims made by the product, technology, or service
- Registered clinical trials: These are conducted and registered with a regulatory authority and are the best way for demonstrating safety, efficacy, and patient outcomes
- Observational studies or pilot programs: Data collected from clinical trials or from pilot programs can demonstrate the effects of new products and services.
- Retroactive studies: These can be used to calculate financial outcomes associated with new digital health products or services and may be used as a comparison with existing treatments
Nearly all U.S. consumers want brand new digital therapeutics and related devices as treatment choices, and doctors are considering using these tools as well.
Around half of consumers would be somewhat or very likely to try an FDA-approved health app or online tool for medical treatment, according to a PwC survey.
The FDA’s Digital Software Pre-Certification Program is expected to start granting approvals for these apps and tools this year. Biopharmaceutical and medical device companies are working with the FDA on the Pre-Cert Program in a pilot phase that started in 2017.
The agency's Pre-Cert Program “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market,” the agency explained.
“Because software products can be adapted to respond to glitches, adverse events, and other safety concerns quickly, the FDA is working to establish a regulatory framework that is equally responsive when issues arise to help ensure consumers continue to have access to safe and effective products,” the FDA related.
“In the Pre-Cert program, the FDA is proposing that software products from precertified companies would continue to meet the same safety and effectiveness standard that the agency expects for products that have followed the traditional path to market,” it added.
The opportunity to change patient behaviour is a differentiating aspect of new digital therapeutics and connected devices. For example, mobile apps employing cognitive behavioural therapy can help patients struggling with substance abuse or depression, explained PwC.
In addition, health data collection and sharing can assist individuals to make beneficial lifestyle modifications and can help doctors intervene to stop poor outcomes.
New entrants, pharmaceutical companies, and life sciences firms will need to explore care delivery in more depth in order to succeed in digital therapeutics, advised PwC.
Companies that offer patients positive health results, using data and better links between patients and providers, will also be capable of understanding the skills and procedures needed to change from marketing products to creating health-related solutions, PwC concluded.