Leveraging the Full Value of Digital Biomarkers Requires Payer Buy-In

When deployed widely across both clinical and real-world environments, digital biomarkers related to things like gait or voice fluctuations have the potential to lead to accelerated diagnoses, individually tailored care plans and perhaps even improved outcomes for people living with neurodegenerative or neuromuscular¹ diseases.

Earlier this year, the Digital Medicine Society (DiME) released a framework of defining the value of digital endpoints: "Three Ps" of digital endpoint value; Patients, Pharma, Payers.

As the Global Value and Access Strategy Lead at Biogen Digital Health, I'm in a unique position to understand this ecosystem from a holistic perspective, and I see that patient groups and pharmaceutical players are readily embracing and recognizing the value the new digital endpoints can bring, but I also recognize a reluctance and/or passivity from that third "P," the payer sector.

Getting payer buy-in, thus acceptance and recognition, will be critical toward realizing the vast potential of this exciting new technology. Here's where I see the future of digital biomarkers heading, as well as the steps that can help ensure payers are on board.

Neurology is often described as the next frontier in medicine. Cardiovascular disease and diabetes, for example, have had established markers like cholesterol levels or HbA1c for blood sugar for about half a century. But in neurology it is only over the past two decades that technologies have enabled scientists and physicians to look into the brain of living patients using biomarkers that directly measure brain pathologies.

These advances meant that physicians don’t have to rely only on assessments of symptoms in diagnosing a patient.

Digital biomarker technology can play a key role in complementing the diagnostic journey — giving health care providers, patients and payers alike valuable insight into disease progression and drug response.

Let's consider remote patient monitoring, for instance. In a clinical setting, patients often experience bursts of adrenaline that affect the data clinicians can collect or the once yearly check happens on a good day or a bad day.  With passive monitoring via unobtrusive sensors — a wearable device or patch, perhaps — health care providers could observe patterns and identify anomalies in patients' everyday routines. Active but remote monitoring where patients complete a few tests once or twice a month will give insights into the individual’s illness and condition.

In a neurological condition like Multiple Sclerosis (MS), this could lead to a more complete picture of a patient's disease state. Digital biomarkers could also prove valuable during disease-modifying drug development and trials, illuminating specific physiological or behavioral ways in which patients are responding to treatment.

Despite these potential benefits, payers — insurance companies, or state-based health care providers, depending on the market we're talking about — have thus far been hesitant to embrace new digital endpoints. Mostly we observe a passive "wait and see" attitude so far, despite the value improved endpoints can bring to value assessments.

There are several reasons for this. For one, to date there are no established validation guidelines or benchmarks for measuring how digital biomarkers reflect real-world outcomes — and payers want measurable data they can trust. Secondly, there is a tendency for technology to move at a fast clip, which can lead to a lack of understanding and awareness. (This is not something unique to the medical or health care industry.)

But the truth is that digital endpoints are, by their very nature, value focused. Digital biomarkers have the potential to provide data continually which could potentially help bring new drugs and treatments to the market in a value-oriented way. That's in part because digital biomarkers allow us to get much closer to the patient from an early stage in their treatment journey.

For someone with Parkinson's, for instance, there's only so much that can be gleaned in a clinical setting, and sometimes early symptoms are overlooked altogether. If you can identify concrete data points via passive monitoring around how a patient navigates real-world scenarios, like their gait for example.  These insights, in turn, can lead to improved ability to determine patient-relevant outcome measures on a large scale.

Collaborative efforts will be critical in turning these hypotheticals into realities.

An open-source approach, for example, may be one way to convince payers of the value of digital biomarker technologies and continued testing. A cross-industry consortium that takes perspectives from patients, stakeholders and key medical experts into account to agree upon endpoints, for instance, would be much more convincing to payers than data originating from a single source or company. Biogen Digital Health has already been involved in facilitating such collaborative discussions — in early 2022, we co-hosted a series of workshops with the DiMe Society and a number of influential players from the payer sector to discuss and demystify this very topic.

Finally, payers must also step up to the plate. They can do so first and foremost by being open to discussions about digital biomarker technology and its potential. They may also consider contributing to efforts to provide clarity on what "success" looks like. Instead of a passive approach, they can play a key role in establishing guidelines for conducting validation studies. Or even start requesting data from continued remote monitoring to allow for better, more patient centric value assessments.

The payoff ultimately benefits all parties — each one of the Three Ps. And the sooner we work together to develop streamlined processes and a common vocabulary related to digital biomarker technology, the sooner it can begin making a real impact on people's lives.