A well-kept secret: Applying IEPs to accelerate digital health commercial adoption
Akira Endo discovered mevastatin, a cholesterol-lowering breakthrough molecule in 1973. But did you know that it initially faced ecosystem-wide scepticism, financial hardships, and even challenges with acceptance by the scientific community? However, once the FDA approved the first statin, it opened the doors for pharma’s best-selling classes of cardiovascular drugs. Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a narrowing window to prove value of innovation.
Pharma has been increasingly active in digital health, which has substantial promise for supporting patients and unlocking value across the care process. However, these pharma-sponsored solutions must also be adopted and used by health systems, providers, and patients, creating a clear need to demonstrate value and address scepticism. To ensure lasting impact and broad adoption with their digital health solutions, pharma must begin to apply integrated evidence plans (IEP) as it has done for drug development; however, digital health presents new and novel challenges and pharma must evolve existing evidence strategies.
In 2025, digital health has evolved beyond its root of SaMDs. As the industry matures, pharma leaders are exploring novel partnerships, building on top of existing solutions, and tapping into existing networks to get new tools in the hands of clinicians and patients. These efforts demand tailored evidence planning. Without this, companies could be faced with a scenario where they burn cash on costly evidence generation, delay time to market, frustrate buyers, create patient dissatisfaction, and face unrecoverable commercial setbacks. No one wants that!
The big question is: which pharma leaders will effectively and successfully evolve their evidence planning and overall evidence strategy for their digital health portfolio, and who will risk being left behind? In 2025, planning only as far as the next major study will not be enough. The stakes are high and time is limited.
Unique evidence strategies: Moving from drugs to digital-specific
While IEPs for drugs have been established and a process well adopted across various biopharma, the IEPs for digital health are in a nascent phase due to key differences – like the product development timeline, the need for real-world evidence, and the evolving expectations around user engagement digitally and beyond. Unlike the linear evidence planning in drug development that is typically budgeted at an average of $40 million starting post-Phase II trials, digital health operates on a sprint, with tighter budgets, broader evidence demands, and iterative product development cycles.
Beyond clinical development and regulatory pathways, there are stark contrasts when it comes to drug and device coverage and reimbursement timelines. Today, an FDA-authorised digital health device featuring novel technologies takes an average of 5.7 years to secure Medicare coverage. In contrast, nearly 90% of newly approved drugs gain Medicare coverage within one year of FDA approval. To capitalise on the promise of digital health, pharma must break free from old paradigms. IEPs for digital health, unlike those for drugs, require reformed tactics – evidence generation meets go-to-market strategy for timely patient access.
The complex reality of stakeholder-specific evidence standards
When it comes to modern-day evidence planning, tackling it piecemeal won't cut it. There is a need to thoughtfully map and streamline the needs of all downstream stakeholders, including regulators, purchasers, health system, clinicians, and patients and their individual evidentiary requirements. While regulators like the FDA prioritise safety and effectiveness data at the individual level, commercial entities and implementers, including health plans, employers, and health systems, focus on population-specific health outcomes, cost-effectiveness, user satisfaction, interoperability, and integration into existing clinical workflows. Without intentionally identifying and integrating diverse needs into a comprehensive evidence strategy, we’re stuck chasing our tails in the digital health maze.
Sometimes, digital health teams can miss the opportunity for more efficient and effective studies that address the requirements of downstream decision-makers, rather than solely zeroing in on regulatory requirements. Since 1976, the FDA has regulated >155,000 devices, ~99% of which used the 510(k) pathway. However, 510(k) does not guarantee market access, as substantial equivalence is not a robust marker for evidence standards. Furthermore, following FDA acceptance, there are a variety of pathways to market for digital health. For example, an FDA-cleared remote monitoring tool may be sold directly to patients, prescribed by clinicians, and reimbursed by third-party payer pharmacy benefits or durable medical equipment benefits, purchased directly by payers for inclusion into their wellness programmes, or bundled into value-based care models. Non-regulated solutions face equally rigorous, if not higher, evidence expectations – making it essential for IEPs to focus on generating the data that resonates with decision-makers across health systems, payers, and employers.
Playing the long game amidst opaque and non-standardised evidence needs
Even when individual stakeholder needs are apparent, today industry lacks a benchmark for what’s “good enough” vs “what’s standard” evidence to support the clinical, economic, and healthcare value of digital health. It’s a double whammy for the field – misaligned evidence requirements coupled with inconsistent reimbursement for digital medicine across payers. To add a third strike against digital health, sometimes novel digital health doesn’t fit into existing regulations and benefit categories of the FDA and CMS, with non-congruent evidentiary standards. Not only that, the evidence available at the time of FDA authorisation for digital health products, including breakthrough devices, may not be sufficient to substantiate the CMS’ coverage criteria for being “reasonable and necessary”, resulting in delayed patient access for up to 8 years. For example, digital health products with the FDA’s Breakthrough designation may have limited evidence on long-term effects on health outcomes and treatment durability. This could impact payer’s and physician’s decisions to provide patient access, even after FDA authorisation.
Opportunities to reimagine evidence generation and value approaches
Take, for instance, cancer immunotherapy: the high costs and complexities of treating severe events like Cytokine Release Syndrome (CRS) create major barriers to patient access. CRS, common in CAR-T therapies, can range from mild symptoms to life-threatening conditions, with treatment costs exceeding $500,000 in the US. Innovative digital programs are showcasing remote monitoring in-home, with technology to monitor vital signs and neurologic symptoms for 30 days post CAR-T infusion. The RPM program's triaging algorithm generates alerts based on predetermined parameters to guide escalation of care if needed. It presents new pathways for pharma to unlock the value of digital health by generating the right evidence – utilising advanced symptom and risk prediction models for early interventions, integrating digital platforms that deliver care to patients, and showcasing economic returns for payers and long-term value for the healthcare system – ensuring adoption by health systems first, followed by payers and employers.
Kick start your IEPs today
The need for IEP has never been greater as various pharma continues to navigate the digital health maze. Successful IEPs must address needs of all adoption and scaling stakeholders, overcome scepticism and mistrust in pharma provided solutions, and be tightly integrated with product development and go-to-market planning. Leveraging IEPs with these characteristics and applying this foundational tool is key to maximising success in digital health.
About the authors
Dr Smit J. Patel serves as the director, digital health and AI, at the Digital Medicine Society (DiMe), a 501(c)(3) global non-profit organisation dedicated to better health powered by digital medicine. Smit’s work focuses on applied approaches to the safe, effective, ethical, and equitable use of digital technologies to advance clinical research, clinical care, and public health. He is an Advisory Board member for the Brown-Lifespan Center for Digital Health and serves on advisory committees for digital health program(s) at the Association of Community Cancer Centers (ACCC) and American Pharmacists Association (APhA). To help share the future of ideas, he serves as a member of the Harvard Business Review (HBR) Advisory Council. Smit earned his Doctorate in Pharmacy from the Ohio State University. He currently holds a faculty position for the Digital Health Innovation Certificate Program at the Brown University School of Professional Studies. Additionally, he is a Global Shaper at the World Economic Forum, a Forbes 30 under 30 scholar, a TEDx speaker, and MIT-Harvard Health Innovation alumnus.
Sean Glynn is a senior consultant in the medical & evidence practice, specialising in digital connected health at ZS. Glynn has 15+ years of experience working with a broad range of Fortune 100 organisations, including pharma and biopharma, and is in his ninth year working in the digital health space. He joined ZS Associates in early 2021 and is working on projects that require design, development, and execution of clinical trials to evaluate connected devices and SaMD. Prior to joining ZS, Glynn was the director of HEOR for a digital connected health device company. In this role, he had responsibilities for generating and disseminating evidence of the company’s health and economic benefits for a variety of health sectors. Glynn also led the company’s involvement in DCT’s with National Jewish Health, Boston Children’s Hospital, and the NIAID. He has a BSc in Psychology and an MSc in Organisational Development. He is currently pursuing an MSc in Pharmaceutical Outcomes and Policy, with a focus on Applied Pharmacoeconomics, from the University of Florida.
Maurice Solomon is a principal at ZS and a senior leader in the firm’s digital and connected health practice. Solomon has over a decade of strategy, corporate development, and product/solution design experience in the digital health space, both as a consultant and within industry overseeing a portfolio of digital solutions. He has supported a range of clients on engagements ranging from digital strategy and value case development with a focus on both standalone opportunity evaluation, to support for core brand objectives, landscape analysis, ecosystem strategy, financial analysis, and value story. Prior to joining ZS, Solomon was senior director, services & eSolutions, with a major life sciences firm, overseeing a digital solution portfolio, including partnerships, pilot development, and expansion of successful programmes to commercial scale. He holds an MSc in Economics from the University of Michigan and a BA in Math and Economics from Whitman College.
