Digital measures for value-based healthcare: Current perspectives

In the ever-evolving landscape of healthcare, the concept of value-based care (VBC) has gained substantial momentum in recent years. It represents a significant shift from the traditional fee-for-service model to a more outcome-driven approach.

The Digital Medicine Society (DiMe) and other organisations have been actively engaging with representatives from payers, Health Technology Assessment (HTA) bodies, and outcome experts to explore the potential adoption of digital measures, such as those of physical activity, cognitive decline, or patient behaviours. Here's what we've learned.

Forging new paths is always tough

At first glance, there is still a considerable amount of scepticism regarding the value that digital measurements can bring to the table. Take the case of digitally measured nocturnal scratch. Some payer representatives harbour doubts about whether this specific measure can be a stand-alone determinant in decision-making processes related to continuing or discontinuing drugs or embracing VBC initiatives. However, there is an emerging consensus that, when coupled with standard measures like EASI (Eczema Area and Severity Index), this novel digital endpoint likely offers valuable insights. For example, it can provide more specificity and higher resolution data compared to traditional questionnaires.

Making the connection to traditional clinical measurements is imperative. It is only logical that tying novel digital endpoints to the well-known, validated, and used standard outcome measures will provide a more complete picture of the patient's health. Whether it's dermatology or another therapeutic area, well-established ‘standard’ measures have demonstrated their worth over the years and will not be dismissed for a new shiny toy. We must prove their value first.

In the era of VBC, the focus is shifting to hard clinical outcomes, such as healthcare utilisation, and therapeutic efficacy, rather than the intricate personalised nuances of care. Here, digital measurement can undoubtedly add more context and information about patients' specific course of the disease, aiding care decisions in each individual case.

Healthcare providers need access to comprehensive patient data from various sources to make informed decisions about optimal treatment options for each patient they care for. Integrating data from electronic health records (EHRs), wearable technologies, and other sources into a unified system is a challenge that platform providers are grappling with as we drive towards a learning healthcare system.

Moreover, the billable success criteria measured by standard clinical measures may be difficult to set up and interpret, due to heterogeneity of the diseases, such as atopic dermatitis, chronic obstructive pulmonary disease (COPD), and Alzheimer's disease, to name a few examples. To overcome these challenges, set examples, and pave the way for digital measures, researchers and the digital medicine community must collaborate to build trust in these novel digital endpoints through a robust evidence base.

Research and operational challenges

Rigorous research is required to establish the relationship between new digital measurements and standard reference measures and scores, like EASI in atopic dermatitis, expiratory volume in COPD, or cognitive function evaluations in Alzheimer's disease. Researchers must define where and how the digital measurement provides supplemental evidence and context for the standard outcome measures, in order to see value returned in terms of pricing and reimbursement decisions.

Studies must be conducted to identify baseline responders and set thresholds for decision-making based on these digital metrics. This empirical evidence is crucial to stakeholders regarding the validity and utility of these measures and should be collected early on. Real-world data collected by digital technologies already at the time of clinical trials will be of immense value to establish these future thresholds.

Operational challenges also loom large on the horizon, such as incorporation of digital measurements into contractual agreements. Who should bear the cost of the technologies required for measurement in the post-market setting to support reimbursement decisions - manufacturers or other involved parties? Is the technology readily available and accessible to the target population? How will data accuracy and consistency be maintained?

Digital measures in clinical research offer positive outlook

Optimistic outlooks are driving the broad embrace of digital clinical measures in the development of new therapeutic agents. Digital endpoints are increasingly perceived as valuable tools in clinical research, where they have gained substantial traction and momentum with academia, industry, and regulatory bodies. Digital measurements and endpoints are now being developed, validated, and used in clinical research across a multitude of therapeutic areas.

Coming from the clinical research, perhaps a similar logic from demonstrating efficacy might be applied to the evaluation of outcomes and inform reimbursement decisions in healthcare. There might be a "secret sauce" in combining digital measurements with standard measures, creating a holistic approach to patient care. If this can be demonstrated with pilot programs or through collaboration with one payer, it could serve as a compelling example of how digital measures can be integrated successfully into the healthcare ecosystem.

The way forward

Digital technologies have the potential to revolutionise the healthcare industry by driving the adoption of value-based contracts. Participating in the conversations addressing these important topics has provided valuable insights into the current sentiment towards digital measures in the payer space. Digital measures will likely follow a high-impact trajectory, as long as they stay on the course of demonstrating their value to the audience at the end of making informed care decisions via real-world evidence and pilot programs with payers.

While challenges remain, it's not impossible to envision a future where digital measurements become an integral part of outcomes evaluation and value-based contracting in healthcare. Researchers, practitioners, and stakeholders need to continue to collaborate in order for us to realise the potential of digital measures to transform healthcare. It's a journey worth embarking on, with the ultimate goal of delivering more effective and value-driven care to patients.