1. Collaborations are Deepening
A single company is rarely in possession of all the knowledge and skills to successfully develop and launch a DTx. In the last two years we have seen an explosion of partnerships between DTx companies and pharma. But there are other interesting partnerships, particularly in the commercialization and distribution space.
- Digital IBS care startup metaMe Health is launching its digital therapeutic Regulora for IBS in partnership with Indegene who will be responsible for commercializing the product, promoting it to providers, payers, and patients.
- And Akili are partnering with gaming giant Roblox to support distribution of their video game ADHD therapy.
2. Regulatory Processes are Improving
Regulatory processes are starting to become clearer and more streamlined in major markets. The FDA launched its ‘Digital Health Software Precertification (Pre-Cert) Program’ reducing regulatory burdens for DTx while maintaining quality standards. The focus is on the company versus the product, it relies on trust and transparency that the company has a robust process for verifying the continued safety, efficacy and performance of the DTx in the real world.
- Orexo was an early beneficiary of the program, rolling out digital therapeutics for depression and alcohol use disorder under the fast track process.
- Somryst, from Pear Therapeutics, a prescription digital therapeutic using cognitive behavioral therapy to treat insomnia, also benefited from the program.
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3. Reimbursement is Gradually Happening
While reimbursement remains an issue, traction is being gained in major markets.
- CVS and ExpressScripts, the two largest pharmacy benefit managers (PBMs) in the United States, launched digital health formularies with numerous DTx products available.
- In the United Kingdom, the NHS approved reimbursement for the following digital therapeutics: deprexis® for depression, Sleepio for insomnia, and Oviva for diabetes and obesity.
- In Germany the DiGA initiative outlined a legal framework for doctors to prescribe approved DTx products, reimbursed for the vast majority of the population.
And the DTx Alliance is aiming to streamline things. Their DTx Value Assessment & Integration Guide provides healthcare decision makers and DTx manufacturers with an initial framework to assess DTx products, their value, and impact in real-world settings.
4. Solutions are Spanning the Patient Journey
Earlier DTx solutions mostly focused on wellness and prevention. While this will remain important, current solutions also focus on early diagnosis and treatment of chronic conditions. DTx are also being used to treat conditions with no current pharmaceutical solution.
- Sonde Health announced a recent partnership with Koye Pharma, using digital biomarkers to detect and manage COPD. This technology could facilitate early diagnosis as well as management and tracking of the condition.
- Digital musculoskeletal care programs for example offered by Hinge Health, focus on reduction of chronic pain and improving patients’ daily functioning and quality of life.
- A digital therapeutic called Elevida treats fatigue experienced by multiple sclerosis (MS) patients, and is now included in Germany’s DiGA listings. Gaia, the product manufacturer, claim there are no current prescription drugs that treat MS-related fatigue.
5. Core Technologies are Evolving
Not so long ago, a DTx solution was synonymous with a DTx smartphone app. But this is now not always the case. Some recent DTx solutions are using technologies such as video gaming and virtual reality (VR) as their core therapeutic medium.
- AppliedVR is using VR as part of a digital therapeutic that reduces chronic pain intensity long term compared with placebo app.
- BehaVR aims to use immersive VR to treat patients with a range of anxiety and depressive disorders. They are partnering with Sumitomo Pharma co.
- The above example of Akili is an example of using video games as a medicine. As well as ADHD they are exploring other therapy areas including Lupus.
6. Artificial Intelligence & Data are Driving Success
DTX solutions that use artificial intelligence (AI) and machine learning algorithms to enable real-time interventions (e.g. early diagnosis or treatment recommendations) can be particularly powerful. This technology is likely to become more sophisticated across the range of digital therapeutics.
The data captured can be used as real world evidence to further refine the product and add to the clinical evidence base, as well as tailoring interventions to specific individuals.
- Pfizer and Alex Therapeutics are using AI to personalize care in smoking cessation, particularly powerful as people have very personal triggers to restart smoking and motivators to stop using.
- Cognoa recently gained FDA approval to detect autism in kids. It uses machine learning algorithms to analyze videos of the child’s behavior and parental input to come to a diagnosis. The focus is on diagnostics, but imagine this technology integrated with cognitive training delivered by a video game or VR, and using the system to measure improvements in the child’s symptoms and functioning.
7. Therapy Areas are Diversifying
Around 2/3 of all current and pipeline DTx products target psychiatric and neurological disorders. But the range of DTx indications continues to evolve. DTx are not limited to specific therapy areas, and can be developed anywhere there is an unmet need, particularly where behavioral aspects are important.
Mental health and neurological conditions will remain important but other chronic conditions, e.g. cardiology and diabetes are also key, especially where demand for treatment will outstrip treatment capacity.
- CureApp recently landed the first regulatory approval ever in the world for a DTx in Hypertension.
- Sidekick Health has developed a digital behavioral change program SK-241 specifically designed for people with metabolic derangements and non-alcoholic fatty liver disease (NAFLD).
- Better Therapeutics recently completed a trial for BT-001, a prescription digital therapeutic that would be the first of its kind for patients with type 2 diabetes.
8. Clinical Evidence is Accelerating
Clinical evidence obtained through clinical trials and via real world evidence is accelerating. DTx solutions require robust evidence of safety, efficacy and value to gain both regulatory approval and reimbursement.
Analysis of the clinical trials database shows that more than a thousand clinical studies are ongoing in the area of digital therapeutics and mobile health. This complements the 1,600 studies already completed in this space.
These above 8 trends are happening now and will very likely continue into the future. This is good news for patients, as they increasingly get clinical support tailored to their needs via the most appropriate technology. It is also promising for DTx companies, as refined approval and reimbursement processes combined by rich clinical evidence will potentially lead to blockbuster products. But don’t just watch this space, make sure to shape it!
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