Digital health solutions offer valuable business and healthcare opportunities by addressing key challenges facing pharma across the drug lifecycle. These opportunities begin in R&D, with use cases for making trials more efficient, faster, and more effective by supporting patients to adhere to prescribed protocols, and extend across the commercialization process through pre-launch, expansion, maturity, and loss of exclusivity.
In our recent whitepaper, ‘Device-Enabled Digital Health Solutions: Transforming Chronic Condition Management and Patient Selfcare’, we explored these opportunities in depth, particularly looking at device-enabled digital health solutions, and have included some of the key insights from industry experts below.
1. Accelerate R&D, reduce clinical trial costs, and generate novel data
Digital health solutions play a crucial role in advancing research and development by helping to improve speed, effectiveness, precision, and cost-efficiency. These solutions can improve patient adherence to protocols, requiring fewer patients and/or collecting more data. They also enable better monitoring and allow for real-time interventions, reducing missed data and dropouts. Screening tools can help identify and enroll suitable patients and help to improve access for those facing geographic restrictions. Additionally, digital solutions enable home assessments and support remote monitoring for decentralized clinical trials, allowing for better longitudinal data collection with more data points.
Clinical trials provide a controlled environment to gather diverse data types, such as medication adherence, patient behavior, reported outcomes, and self-management. By linking all these data sources, pharma can better understand what occurs in a patient's journey during treatment and inform patient supports that will be required during subsequent product launch and commercialization. Utilizing digital health solutions in trials can create valuable data sets, which can inform predictive algorithms for safety and management.
"There are some good examples where the data that we can generate in the clinical trial can feed things like self-management predictive algorithms, which we would struggle to develop in a commercial environment because we have limited access to data about the patients in the commercial environment."
Paul Upham, Global Head of Smart Devices – Roche
2. Offer competitive differentiation to support prescription preference
Digital health solutions can help unlock a drug's full potential and deliver value to patients and clinicians in broader condition management beyond supports around the drug itself. Tailored patient support, education, and enhanced selfcare capabilities offered through these solutions can differentiate therapies in the market and drive patient interest and clinician prescription preference versus competing options. Demonstrating the benefits of these solutions can further strengthen their appeal to prescribers and provide additional value through various channels.
These solutions also offer a multi-faceted approach to managing the challenges of loss of exclusivity (LoE). They can differentiate branded products through value-added services after LoE, enhancing patient engagement and supporting patients to achieve better treatment outcomes and quality of life. Furthermore, they can provide real-world data to demonstrate the cost-effectiveness and superior outcomes of solution-enabled branded medications, supporting negotiations on reimbursement and justifying continued use over generics and biosimilars.
3. Improve adherence to therapy
Barriers to drug adherence and persistence are multi-factorial. Digital health solutions help patients through treatment onboarding, adherence, and persistence to prescribed regimens. For the given condition, molecule, and patient context, solutions help with health literacy about the condition and medication, coaching and support on drug delivery (which remains a significant barrier to adherence and persistence for patients at home), and other tailored solutions such as symptom monitoring, side effect monitoring, and assistance with injection anxiety. Connected drug delivery devices, through their sensing capabilities, can provide reliable information previously difficult to obtain in a real-world setting, such as what, when, and how a treatment was administered. This offers a range of benefits, from the ability to understand and support patient adherence to the prescribed regimen to appropriate clinical oversight and review.
‘"We are all creatures of habit, but when people are diagnosed with a condition and start receiving therapy that requires a level of self-management and selfcare, they need to change their habits, which is difficult. And this is where digital health solutions can play a vital role in helping people to develop and maintain new habits, especially when it comes to injection therapy.’"
Florian Kuehni, Product Area Head, Digital Health – Ypsomed AG
4. Improve market access, reimbursement, and pricing position
Pharma companies must increasingly prove the value and effectiveness of their therapies. It is important to understand what payers value to appreciate the breadth of evidence a device-enabled digital health solution can bring to support negotiations with payers for better access terms, pricing, and reimbursement. Payers' priorities include managing population health, balancing cost and quality of care, budget affordability, and budget predictability.
Budget predictability and affordability require a thorough understanding of the population numbers that could potentially receive treatment under various scenarios. Demonstrating a condition's burden is the foundation for discussions with payers and policymakers about reimbursement, especially in rare diseases. The initial tier of evidence might involve providing new insights into a condition's burden and progression, gathered from patient apps/solutions during the market-shaping and pre-launch phases.
Subsequent tiers of evidence can illustrate how patients use treatments and the impact of different treatments and patterns on disease progression and outcomes. While not always directly supporting medication brand claims, this evidence is designed to strategically shape the market in favor of the brand or brand system.
5. Support growth of the overall market
Many brands, especially in underserved areas, aim to grow the market rather than just capture prescription share. Digital health solutions can help at various levels in efforts to expand the addressable market. At a foundational level, they can enable a better understanding of the true burden of an underserved condition, paving the way for market access negotiations and educating on the need and possibility of treatment. In addition, above-the-brand or on-brand solutions (depending on the regulatory system) can be pivotal in supporting patient awareness and engagement with the healthcare system to seek treatment.
At the treatment level, digital solutions can help identify and classify patients for starting, optimizing, or changing treatments. Additionally, these solutions can maintain growth momentum by supporting treatment adherence and demonstrating the resulting improvements in outcomes for patients, healthcare providers, and payers.
The features and benefits of digital solutions can also be a significant component of a market-shaping strategy, particularly when market growth necessitates a shift in where or by whom treatment is administered. For example, this could involve moving treatment from a clinical setting to the patient's home or transitioning from secondary care to primary care.
6. Optimize solution enhancement and business opportunities through data-driven insights
Pharma companies can gain valuable insights into patient behaviors and treatment efficacy by analyzing anonymized data from digital health solutions. This data can highlight opportunities for enhancing solutions and improving the patient experience, potentially leading to innovative products and services. Of course, maintaining patient trust is crucial. Any data usage, even when anonymized, must be clearly defined and evaluated to ensure patients are comfortable with how their information is used.
It must also be acknowledged that our understanding of the full potential of this data is still evolving. The value proposition of digital health solutions is continuously being reshaped, particularly with the rise of AI and large language models. The data generated by device-enabled digital health solutions can be harnessed to feed predictive models, offering benefits that extend far beyond improving medication adherence for a specific brand. Already, there are instances where predictive models are integrated into patient support programs. These models can anticipate when a patient will likely experience a negative health outcome, enabling proactive measures to mitigate or prevent these issues. By predicting such events, these models prepare the patient and their healthcare team and enhance the overall quality of care.
As AI technology and large language models advance, the potential applications of this data will become even more diverse and impactful. Predictive analytics can drive personalized healthcare strategies, optimize treatment plans, and improve patient engagement. Furthermore, these models can support clinical decision-making, streamline healthcare workflows, and ultimately contribute to better health outcomes on a broader scale.
"I don't think we know yet how the full potential of how the data generated by these solutions might be leveraged. We must analyze how this relatively thin but significant stream of medication-taking behavior data influences some of these new models. I'm excited to see what new value propositions emerge from that."
Paul Upham, Global Head of Smart Devices – Roche
Our recent whitepaper explores the business opportunities digital health solutions offer pharma and highlights key lessons learned in their development. These insights have helped shape a more effective path forward, guiding the industry toward smarter, more impactful digital innovations.
With insights from S3 Connected Health, Ypsomed, Roche, and ViiV Healthcare, you can download your free copy today below.
