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February 19, 2021

HealthXL - Exit & Outcomes PDT report

Reports
HealthXL Research Team

Since the publication of our first report on digital therapeutics (DTx) in 2018,  not a great deal has changed, but at the same time, it has. The definition of DTx has blurred with a wide variety of healthcare and medtech companies co-opting the term to describe their general digital health offerings. In order to cut through some of this noise and confusion, the HealthXL team hone in on a particular subset of DTx which are promising enormous clinical and economic potential: prescription digital therapeutics (PDTs). 


Written in collaboration with Brian Dolan, the leader and founder of Exits and Outcomes (E&O), the upcoming report explores why PDTs are a critical subset of the DTx industry. The HealthXL team identified and analyzed the 30 different PDT companies, with products either currently on the market or in the pipeline. Here's HealthXL and E&Os list of PDTs:

The HealthXL team has sliced and diced this list, identifying trends and classifying the PDT companies by their therapeutic areas of focus (see Market Mapping diagram below). While it is not surprising that chronic disease management and mental health remain the most tapped into areas, new solutions are also emerging across more exotic therapeutic classes including ophthalmology and gynecology.  


Those of you who were lucky enough to catch a sneak peek of the report will have seen some of the exciting themes that we explored in relation to PDT. For anyone that missed out, we have given a quick recap below! 

You can expect key examples of PDT applications, industry implications and a critical viewpoint of the current reality of the DTx environment and those which must be addressed in order to truly deliver on the DTx promise. Also, on this note, keep an eye for upcoming meeting ‘Prescription Therapeutics - The Future of DTx’ on March 1st. Join a small group of digital health enthusiasts to discuss some of the key themes visited in this report. This must not be missed!

So, what exactly does the report explore?


Investment / Solutions Landscape

The top-funded PDT company of 2020 was Biofourmis, obtaining a whopping $100 million in investments. As with other areas of digital health, investment in the PDT space peaked in 2020, likely as a result of the global pandemic. Will we continue to see this increased in investment throughout 2021? Will higher investment = greater traction?

Source: HealthXL Platform


Business Models and Pricing

One of the HealthXL member FAQs  is how different business models can be applied to DTx. Well, the answer is here! We have painstakingly parsed through the detail to define four categories of PDT companies out there (some companies have multiple categories of offerings!)

  1. PDTs with Rx Products that are regulated by the FDA as Rx-only
  2. PDT companies that are regulated by the FDA as Rx-only, but not due to the digital therapeutic component of their product.
  3. PDT companies with over-the-counter solutions (not FDA-regulated as Rx-only products)but who are using a prescription distribution channel.
  4. PDT companies that only have over-the-counter products today but are planning an FDA-regulated Rx-only product.


If this is a topic of particular interest to you, check out our upcoming meeting on the overview of the market and deals in DTx here.

Clinical and Economic Outcomes (NICE, FDA, TGA, DIGA)

Surprisingly, our research showed that only 27% of PDTs have published RCTs to validate their clinical offerings, and only 10% have published economic studies. This highlights the nascency of this space. What level of validation do you think should be required for these prescription products and what level of validation would support economic return?

In the report, we compare and contrast the current frameworks that support the validation of PDTs [NICE (UK), FDA (US), TGA (AUS), DIGA (Germany)], and dig into the rigor of evidence provided for these products vs traditional pharmaceutical agents. We also discuss the use of digital endpoints (or lack thereof) in the clinical validation of these products.

Regulation and Reimbursement

Navigating the regulatory and reimbursement landscape has historically been one of the biggest challenges for digital health. The lack of regulation or coverage by insurers, however, may in fact, be a blessing in disguise. Our report digs into how regulatory bodies, innovators, and corporates around the world are endeavoring to make this a reality.  



Adoption and Enablement

Pharmacy benefit or medical benefit? Neither? Other? Although the recent emergence of digital health formularies shows promise for the adoption of PDTs, research has shown that payers in the US do not anticipate that a formulary approach will be widely adopted for another 3-5 years. Prescription integration remains a key barrier to adoption, although Germany and Belgium are spearheading changes within this space.

The Future of PDT

PDTs are quickly emerging as one of the most spoken about areas of digital health, however many barriers continue to restrict the widespread adoption of these technologies. What needs to happen in politics, within the FDA, within PBMs, in the minds of physicians and consumers to move the needle? We gaze into the crystal ball. 


Make sure you save the date for our upcoming meeting ‘Prescription Therapeutics - The Future of DTx’ on March 1st, where we will explore some of the key findings of this report, including questions on the rigor of clinical and economic evidence required of PDTs, regulatory requirements of PDTs, and prescription pathways (or lack thereof) to bring these therapies to the relevant candidates.

What does the future of DTx look like to you. ? Get in touch with us here!

HealthXL Executive members can access the report for free on the Community Hub. If you are not an Executive member yet, you can access an 11-page snapshot for free here.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

Ready to read more? HealthXL members can access the full peak of the report on the HealthXL Community Hub.

No upcoming Virtual Events scheduled. Please check back again soon.

Are you a HealthXL Member? See the Full Report Here

Non-HealthXL Member? You can purchase the report HERE

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Join our Digital Health Meetings and take a deep dive for 75 minutes into topics like digital therapeutics, patient support, telehealth, clinical trials, dermatology and many more. These Meetings are not regular webinars: No audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And with a free account on our Community Hub, you stay connected and up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.

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