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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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