Every connected health solution must show a compelling business case and return on investment (ROI). Sustainable business models are essential to securing organizational support and delivering both short and long-term value from solutions that improve patient experience, care, and outcomes at scale during a brand’s commercial phase. This article looks at digital health solutions that incorporate connected drug delivery devices and the necessity for them to positively impact the core business of developing and selling medicine to make sense inside a pharma company.
The role of connected health solutions in addressing headwinds that impact brand revenue
Specialty biologics are the core of pharma’s business. These are focused increasingly on chronic, complex, and rare patient populations, and will continue to be the largest source of pharma revenue growth over the next 5 years, with a compound annual growth rate of 9.5-12.5%[1].
However, individual therapies face significant revenue barriers:
- Growing competition from therapies with the same mechanism of action
- Challenging launch environments with existing and new drugs vying for market share
- Sub-optimal adherence and persistence to therapy
- Pricing pressures
- Loss of exclusivity and patent expiry
Each person treated by high-cost therapies has a substantial revenue impact for pharma. This creates opportunities to align business models, revenue and ROI to the pharma and brand strategy. However, sustainable business models are not easy to achieve. Separate reimbursement is rare, and it is difficult to measure the relative contribution of connected health on prescription, adherence, and persistence compared to other pharma initiatives. Moreover, tailored business models must be adapted to the specific dynamics of each brand.
Longer-term value streams should also form a part of the connected health value dossier. It is important to account for the value derived from data, such as predictive models, which once a sufficient amount of patient data has been gathered over time, allow for relevant insights to be generated. For example, these insights can help predict which patients are likely to become non-adherent to their treatment plans. More long-term value can also be derived from performing research that informs new models of care and persuades doctors, patients, and payers to adopt the connected health solution.
Return on investment models for pharma during the commercial phase of a brand lifecycle
The above image shows the opportunities for connected health initiatives to impact brand revenue across a brand’s commercial lifecycle. Let’s now look at each of these stages in further detail.
Clinical Development Stage: Prepare a differentiated market position
Pipelines are focusing on more specific patient subpopulations with significant unmet needs.
Competition is increasing, with multiple companies focusing on the same promising mechanisms of action[2].
It is more and more difficult to have a successful launch; 1st year gross sales for new brands decreased by more than 50% from 2016 to 2022
[3].
Additionally, competitive intensity is expected to increase in the next 5 years[4], impacting the revenue of both existing successful therapies and new entrants.
Each brand team needs to choose a mix of initiatives and market strategy to differentiate and stand out. In most cases, a great drug asset will also need a compelling device and digital strategy to stand-out.
Planning for the device and digital strategy must start early. Commercial device selection often starts during Phase II. At this point it is important that that the chosen device supports pharma's future connected health strategy, allowing for potential future connectivity. This ensures the chosen device can seamlessly become part of a connected health ecosystem as part of the brand strategy. While this is a crucial decision for a brand, the industry is reducing complexity and risk with CDMOs providing drug delivery device platforms that enable manual autoinjector, pen, and on-body injectors to be connected.
If connected health is to be part of the brand differentiation at launch, the connected health solution must be selected in Phase III. It is essential that the connected health solution is tailored to address patient, disease, and therapy needs is also created and tested with patients and other key users to ensure that this will be ready at launch to support therapy launch into key markets.
Prepare the Market Stage: Grow the market with above-brand solutions
People living with diseases may not be aware of their sub-variant of the disease or the possibility of treatment. Similarly, doctors may lack the tools to identify patients or be reluctant to diagnose patients for whom they believe there is no treatment. A key goal pre-launch (and beyond) is to build awareness of disease and treatment among both doctors and patients and provide above-brand support to grow the market so it is ready for value extraction at launch.
If a company expects to be first to market with a therapy or is the market leader, growing the overall market size may be an important strategy, with the expectation that the payoff is an increased share of a larger market.
Above-brand connected health solutions that build disease and treatment awareness can be used to achieve this. To support diagnosis, doctors need to be aware of the disease and be convinced that treatment could impact patient outcomes. Patients are looking for reputable sources of information and support living with their condition.
Sponsoring these solutions not only drives awareness but also enhances pharma’s credibility as a trusted above-brand partner for doctors and patients alike.
Pharma may also sponsor disease registries that can support future real-world evidence (RWE).
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Let’s take the example of migraine. If a company is bringing an injected CGRP antagonist to market, they will be facing both low treatment awareness, and a condition that traditionally has low patient persistence to treatment [5]. As seen here with a UK market example, an above-brand solution could help bridge gaps in treatment awareness , which could help to address part of the 30x gap between diagnosis and ongoing treatment.
Commercialization Stage: Increase brand revenue post-launch
Post-launch is where connected health can have the largest impact by:
- Increasing the overall market share for the therapy
- Retaining patients on therapy
- Supporting pricing strategy
These commercial goals are achieved by:
- Creating global connected health solutions that can be configured to the specific needs and resources of local markets
- Differentiating the therapy against others that drives preference at prescription from both patients and their doctors
- Supporting patients in the management of their disease, which includes adherence and persistence to therapy
- Generating evidence that is meaningful to payors to improve commercial position and/or enabling alternative value-based care business models with payers in local markets.
Adherence and persistence to therapy is especially important because there is a pattern of adherence trajectories that is seen repeated in almost all therapeutic areas, which can be seen here in a Psoriasis case [6].
:
- continuously high adherence after a fall on initiation
- high-then-low adherence
- consistently moderate adherence
- moderate then-low adherence
Each person follows their individual pattern of adherence within these cohorts, with personal, individual support needs. The overall proportion of days covered (PDC) varies from moderate to low depending on the disease, (While PDC measures medication possession, actual adherence and persistence are often lower in practice).
Connected health solutions address these issues and drives brand revenue by:
- Offering a differentiated, engaging solution with connected therapy support to help drive clinician and patient preference for the brand.
- Addressing the therapy initiation fall-off by providing personalized initiation to therapy for complex diseases that ensures patients follow the prescribed regimen, while reducing burden on the healthcare system to train patients in titration, medication loading, and side-effect management.
- Increasing therapy adoption and persistence in each archetype by leveraging connected drug delivery devices to measure objective adherence, compare it against personalized care plans, and deliver timely, well-designed interventions tailored to individual barriers. Adherence and compliance do not provide value to patients on their own. Pharma needs to address broader challenges living with the disease and improve each patient‘s experience, in order to earn the right to be there the next time they take their medication. Studies have shown that using a connected injection device accompanied by a digital health solution that supports patients in this way has a positive impact on adherence, leading to better treatment consistency and, ultimately, enhanced outcomes[7].
- Generating insights regarding adherence and persistence rates, which enables pharma to enter into differentiated value-based care or alternative contracts with payers. By understanding and influencing adherence, pharma can mitigate non-adherence risks and align part of payments with adherence outcomes.
- Enabling evidence that supports pricing by demonstrating improved compliance with care plans, improved adherence and persistence, and ultimately clinical evidence showing improved treatment outcomes and health economic impact.
A tailored and thoughtful strategy that uses the appropriate mix of these initiatives can deliver a population-level increase in adherence and persistence to therapy. Companies have proven adherence and persistence to therapy with connected health solutions. For example, Merck has published data showing adherence rates that began at 10% higher than the market average and grew to 25% higher as their overall solutions were extended [8].
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PDURS – A new option for generating ROI in the US
In the US, we are already seeing pharma companies adopt the PDURS framework as an additional pathway for generating ROI. This framework can be an effective way to address aspects of the disease that remain unmet by the drug or are difficult to reach pharmacologically, so that when the drug and SaMD are added together they provide a more complete therapeutic solution.
For instance, while drug therapies effectively treat long-term chronic conditions, many patients also suffer from co-morbidities such as low mood, anxiety, and depression, which can hinder treatment adherence. A digital therapeutic designed for managing depression could provide patients with high-quality mental health support, improving their ability to start and maintain therapy. Similarly, SaMD can enhance therapeutic efficacy by offering behavioral and disease management support in conditions where lifestyle changes are critical. For example, when treating multiple sclerosis (MS), SaMD can provide cognitive training, fatigue management, and medication adherence support, complementing disease-modifying therapies to enhance patient well-being and treatment success.
Ultimately, PDURS could become an essential part of drug asset strategies, helping pharma differentiate their therapies, improve patient outcomes, and sustain revenue.
In summary
With growing competitive pressures, rising expectations from patients and healthcare providers, and an increasing focus on value-based care, pharma companies must adopt digital solutions to differentiate their therapies and maintain revenue beyond traditional development. The future of connected health lies in its integration with commercial strategies, enhancing treatment adherence and patient engagement while generating real-world evidence.
To learn more about how S3 Connected Health works with pharma companies to develop differentiated connected health solutions, leveraging our Affinial Digital Health Platform, get in touch with us here.
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[1] IQVIA: Global Use of Medicines 2024 outlook to 2028, January 2024. ↩
[2] Fougner et al., “Herding in the drug development pipeline,” Nature Reviews Drug Discovery, April 28, 2023, Volume 22 ↩
[3] IQVIA: LAAD Claims Data ↩
[4] Evaluate Pharma: 2028 competitive intensity by marketed product ↩
[5] Kernick et. al “Preventive treatment patterns in the adult migraine population: an observational UK study over 7 years”, BMC Primary Care 2024 ↩
[6] Li et al 2014, CEOR. GBTM for Enbrel & Humira in psoriasis. Commercial + Medicare ↩
[7] De Arriba et al ‘Use of connected injection device has a positive effect on catch-up growth in patients with growth disorders treated with growth hormone therapy’ Frontiers of endocrinology 2024 ↩
[8] Koledova E, et al. Optimizing adherence using a connected injection device can improve growth outcomes. 2021 Limmroth V, et al. Assessment of Medication Adherence Using a Medical App Among Patients With Multiple Sclerosis Treated With Interferon Beta-1b: Pilot Digital Observational Study (PROmyBETAapp). J 2019 Patti F, et al. BetaEval Global: Prospective, Multinational, Observational Cohort Study of Patients Using BETACONNECT®. Patient Prefer Adherence. 2020;14:771-779. ↩
