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February 18, 2022

Faster, Better, Richer: Can DTx Unlock the True Value of Real-World Data for Pharma?

Commentary
Alette Brinth
&

Pharma-DTx partnerships Are on the Rise, to the Point of Beginning to Explore Standalone-DTx

While the healthcare industry is buzzing with increased digital health market activity, Digital Therapeutics (DTx) companies have started to pique Pharma’s interest. However, they are still primarily seen as a tool to support their existing biopharmaceutical franchises rather than an independent revenue generator. An analysis of Pharma-DTx partnerships in our recent “DTx: Routes to Market” HealthXL Industry Report highlights that while Pharma-DTx partnerships have been steadily increasing over the last few years, they have been primarily focused on Combination DTx (67%) compared to Standalone DTx (29%).

The fact is, unless DTx are able to achieve the same reimbursement potential as pharmacological treatments, the Standalone DTx value proposition is immediately more difficult for pharma to define as the ROI remains unclear.

Breaking this trend, Bayer’s collaboration with OneDrop has recently borne fruit from a partnership stretching back to 2020. Bayer and OneDrop’s digital health product is an AI-powered app designed to prevent cardiovascular disease. The app is described as a personalized digital health programme which combines one-on-one coaching and heart health advice with data from connected medical devices and biometric measurements (including blood pressure and glucose levels). The software is being marketed firstly at employer health plans, with a D2C version to be launched soon.  With their co-developed standalone digital product, the potential success of Bayer and OneDrop’s product will be an early case study that substantiates a business model which up to this point has been largely untested in the market.  

So, if not financial, what is the true value of DTx for pharma? When we asked the HealthXL community, 36% cited “insights generated by the patient data collected by DTx”, and a further 8% cited “use of the data for clinical research”.

It’s clear that Real-World Data (RWD) is a big value proposition for pharma companies in partnering with DTx companies, but what are the potential benefits that RWD brings?

From Synthetic Control Arms to Label-Claim Extension: The Many Applications of RWD for Pharma

Pharma companies have been utilizing RWD to inform decision-making and improve the market positioning of their drugs and are currently estimated to spend USD $20 million a year on the generation of RWD to support their internal product development programs. 

The real opportunity for pharma lies in utilizing digital and data to generate RWD in a faster and more standardized way. Digital tools have the potential to maximize the impact of the RWD being captured by streamlining data capture, processing and integration from a range of sources to provide a longitudinal view of the patient journey. This further enables the application of advanced RWE analytics (the likes of predictive models, machine learning and unsupervised algorithms) to extract deeper, richer insights from the data and enhance the power of RWD gathered.

Across the drug development pipeline, RWD has several use cases that complement development programs including trial design (e.g. inclusion/exclusion criteria refinement), endpoint selection, outcome prediction and patient recruitment, all of which holds the potential to accelerate timelines, reduce costs and increase the probability of success.  

Synthetic control arms have been successfully deployed for clinical trials by pharma companies including Roche, who achieved not only accelerated FDA approval of Alecensa (for the treatment of lung cancer) but also reimbursement in 20 European markets. RWD has also been successfully utilized to extend label-claims, as in the case of Pfizer who used RWD (including electronic medical records and the Flatiron Health Breast Cancer Database) to obtain approval for Ibrance for the treatment of male breast cancer.

Do DTx Hold the Key to Faster, Better and Richer RWD?

As the healthcare industry starts to adopt more effective ways to leverage digital for gathering and utilizing vast amounts of patient data, DTx offer new opportunities to use data collected during the routine treatment of patients to advance patient outcomes. In support of this, regulatory bodies such as the FDA have committed to considering RWD in regulatory decision-making.

A key differentiator for RWD collected via DTx is the fact that data collected is not periodic but rather continuous and constant, providing a holistic, longitudinal view of the patient’s engagement, progress and health. Patient data collection is widely considered to be potentially one of the most valuable assets that DTx can bring to pharma, yet presently its usage is underexplored. 

At this early stage in the evolution of Pharma teaming up with DTx companies, partnerships are being established in some key therapeutic focus areas such as diabetes, respiratory health and oncology. In the respiratory space, Propeller is no stranger to the Pharma world and has teamed up with several pharma companies including GSK, Boehringer Ingelheim, Novartis and AstraZeneca to support asthma patients with medication adherence while collecting information about the patient’s condition. 

Notably, RWD data from 7,500 patients generated by Propeller was used in a study to demonstrate that a whopping 84% of asthma patients may be using their inhaler incorrectly, making their medication less effective. This example clearly shows how DTx-generated RWD is positioned to bridge the gap between clinically predicted efficacy and real-world effectiveness of the medication, presenting the opportunity to enhance the patient’s experience and outcomes over and above the medication being prescribed while simultaneously gathering patient data to inform the development of future therapies. 

The fact is that no matter how conclusive the clinical evidence collected for a therapeutic is, researchers are not provided with any insights into how the medication performs in the real world, outside the controlled environment of the clinic. Partnerships such as that announced between Novartis and Kaiku Health last year to help patients receiving BRAF and MEK inhibitor treatment manage melanoma through DTx could be opening new avenues for researchers to explore the benefits of incorporating RWD to enhance their research in developing novel treatments. 

Future-Gazing

Ultimately, RWD could be the catalyst for pharma partnerships with DTx as the ROI is realized through the patient data generated. For Pharma, partnerships with DTx companies are an opportunity to gather faster, better and richer RWD continuously feeding back into drug development and commercialization strategies. 

With Pharma-DTx partnerships on the rise, all the indicators are pointing in the same direction, stacking evidence to grow confidence in DTx as an efficient way to access RWD.



Interested in the DTx routes to market? Download our recent “DTx Go-To-Market report” to read more about the Pharma-DTx route to market.

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Don't miss out on the discussion of the latest insights and reports on digital health. Meet with peers and take a deep dive for 75 minutes. Unlike at webinars, you can freely exchange experiences and insights to solve challenges and design the future of DTx.

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Masterclass: DTx Reimbursement in the US - PBMs as Coverage Scale Catalysts

10th August @ 10:45AM EDT

Are you a DTx or Pharma company seeking wide-spread reimbursement of a DTx product in the US? Join this Masterclass led by Mike Pace to learn more about this topic and share your experiences with others working in this space.

Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
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11th August @ 10:45AM EDT

Digital Health solutions are top of mind for biopharma companies in 2022, and Software as Medical Device (SaMD) is a crucial cornerstone for top-tier companies. Join this Masterclass led by BrightInsight to dive deeper into this topic and discuss this further with your peers working in this space.

Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight
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16th August @ 10:45AM EDT

It is one of the key questions that every digital therapeutic (DTx) company must answer - what business model will set them up for success in the long run? Join this meeting to discuss this further and share your experiences with your peers working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC
Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
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Managing Partner , DTxCC
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Payers Partnerships for DTx

17th August @ 10:45AM EDT

Digital Therapeutics (DTx) vendors face many challenges on their journey to commercialization, such as generating clinical data, health economics evidence and achieving regulatory status. Join this meeting to discuss this topic further and share your experiences with others working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Kevin Darcy
Kevin Darcy
Director, Link Strategy at Veeva Systems
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Elena Mustatea
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CEO, Bold Health
Kevin Darcy
Kevin Darcy
Director, Link Strategy at Veeva Systems

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Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: DTx Reimbursement in the US - PBMs as Coverage Scale Catalysts

10th August @ 10:45AM EDT

Are you a DTx or Pharma company seeking wide-spread reimbursement of a DTx product in the US? Join this Masterclass led by Mike Pace to learn more about this topic and share your experiences with others working in this space.

Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: Value, Cost and Pricing in Regulated Digital Health Solutions

11th August @ 10:45AM EDT

Digital Health solutions are top of mind for biopharma companies in 2022, and Software as Medical Device (SaMD) is a crucial cornerstone for top-tier companies. Join this Masterclass led by BrightInsight to dive deeper into this topic and discuss this further with your peers working in this space.

Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight
Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight

Executive 1-2-1 with the HealthXL Digital Health Community

15th August @11AM EDT

Do you want to network with other innovators and leaders in digital health? Are you looking to identify potential partners? Join us for the new HealthXL style of virtual speed networking and meet other members working in this space!

Featuring
Aahuti Rai
Aahuti Rai
Strategic Advisor, Healthcare Innovation at Four Points Consulting Ltd
Chris Wasden
Chris Wasden
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Aahuti Rai
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Strategic Advisor, Healthcare Innovation at Four Points Consulting Ltd
Chris Wasden
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Head of Pharma Speciality Solutions & Corporate Strategy, Twill
Digital Therapeutics (DTx)
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Sustainable Business Models for DTx

16th August @ 10:45AM EDT

It is one of the key questions that every digital therapeutic (DTx) company must answer - what business model will set them up for success in the long run? Join this meeting to discuss this further and share your experiences with your peers working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC
Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC

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