Digital Health at the Heart of the Matter

With gaps in the use and dosing of medication and the increasing complexity of treatment, e.g., the requirement for multiple medications and lifestyle changes, Amgen is steering two digital health initiatives to address the failings of “traditional” approaches to the treatment and rehabilitation around heart failure and heart attacks. In the US, the Amgen congestive heart failure (CHF) study will compare guideline-directed CHF therapy that uses digital health data with traditional practices that do not, while in Europe the company is involved in the creation of a digital “tele-rehabilitation solution” to make cardiac rehabilitation accessible to more patients in the immediate aftermath of a heart attack.

For the CHF study, Amgen is collaborating with Datos Health (New York, NY, and Tel Aviv, Israel). Datos is providing the remote care automation platform to collect and then cleanse, validate, and tag the health data. CHF care typically requires personalized dosing-titration of multiple interacting medications, but “this can be a delicate balancing act,” Uri Bettesh, Datos Health CEO, told Pharm Exec. Patients are usually only checked during periodic, in-person visits and, unless there is a significant adverse event between visits, it is only then that physicians can find out how patients are responding to the latest dosing and titrate the doses accordingly. “As a result, many patients must live with suboptimal doses for extended periods of time, which can affect their quality of life and may negatively impact long-term outcomes.”

The shift to digitally enabled remote patient engagement and data collection, says Bettesh, enables continuous monitoring of patients’ vitals—including blood pressure, heart rate, and daily physical activity—as well as symptoms and program adherence. This approach, he adds, could accelerate or improve identification of the effects of dosing changes and lead to more rapid treatment decisions.

While the CHF study is still in its early stages, “the sites are aggressively recruiting patients and feedback from patients has been very positive thus far,” says Bettesh. With providers having better visibility into a patient’s continuum of care journey, and more patients adapting to remote monitoring, Bettesh envisions a future of increased program adherence and faster, more data-based care decisions.

‘Future-proofing’ cardiac rehabilitation

The Amgen–Datos study has been launched in seven leading US teaching hospitals. Meanwhile, in Europe, Amgen has teamed with Liva Healthcare (Copenhagen, Denmark, and London, UK)on a program to make cardiac rehabilitation accessible to more patients in the immediate aftermath of a heart attack, co-creating a digital tele-rehabilitation solution, Rehab+. Rehab+ supports patients for more than 12 months, helping them to “transition from a passive, recovery mindset into an active one of self-care,” André Sode, CEO of Liva Healthcare, told Pharm Exec. Part of OPTIMISE, an Amgen-led cardiovascular program that aims to transform patient care and demonstrate improvement in outcomes, Rehab+ supports and equips patients to stay engaged with their own health and manage their cardiac risk factors. Where Amgen Europe and Amgen Spain are the program leaders, Liva is providing the technology platform, which includes a patient app. “Through the app, patients will have regular support from a professional human coach and receive educational content based on their personal needs and situation. Patients can also track their own progress in real time and engage with a support group of peers to keep them motivated,” says Sode.

Currently, only one-third of the one million people who have a heart attack each year in Europe have access to cardiac rehabilitation to reduce their risk of a second heart attack, notes Roman Stampfli, vice president of marketing and innovation at Amgen. Sode says that the Rehab+ program will “future-proof cardiac rehabilitation” and make it accessible to more patients in the immediate aftermath of a heart attack. The program will be launched in four rehabilitation centers across Spain and the Netherlands and evaluated by Maastricht University. Liva reportsthat uptake of the program in additional countries will be discussed following this evaluation.

Julian Upton is Pharm Exec’s European and Online Editor. He can be reached at jupton@mjhlifesciences.com.