Moving the needle for MS outcomes

Creating an innovative system to gather and apply real-world evidence to help improve patient care and research

By Richard Rudick, M.D.
Vice President, Development Sciences, Value-Based Medicine

July 21, 2016

Some fifteen years ago, the Institute of Medicine began urging creation of a learning healthcare system in the U.S. to improve public health. Such systems rely on real-world evidence to maximize the safety, effectiveness, and value of medical care, and to create continuously improving patient outcomes. Yet, that type of approach requires a reevaluation in how we merge patient care and research to generate evidence within the healthcare environment. Biogen’s goal is to help improve that approach through our Value-Based Medicine (VBM) group.

Lighting the way for outcome-based and precision medicine for MS
VBM was created with the goal of seizing two big opportunities. This first is the move toward healthcare reimbursement models focused less on products and services, and more on patient outcomes — that is, how well a treatment works to lessen or eliminate disease becomes connected to payment for the treatment. The second is the emergence of personalized or precision medicine, a new era in which disease-modifying therapies can be selected for individual patients based on scientific data that predicts the likelihood of benefit — the right medicine, at the right time, for the right patient.

Although these prospects hold the power to transform medicine, there is no roadmap for how to get there — in any disease, but particularly for multiple sclerosis (MS). So, VBM’s goal is to invent and develop innovative methods to help find a path forward.

Global collaboration with leading centers
Our effort is a demonstration project to create a learning health system in MS known as MS PATHS (Partners Advancing Technology for Health Solutions). I like to refer to it as an evidence-generating medical system. Its ultimate purpose is to establish the methodology to measure and optimize outcomes for all patients with MS, creating a guide path for personalized medicine, and a pathway for accelerated translational research.

We are joining forces with ten leading MS centers across the U.S. and Europe in an collaboration to collect comprehensive, quantitative medical information directly from thousands of patients and their providers. Using technology and enhanced patient engagement, we are standardizing and collecting comprehensive clinical and imaging data on every MS patient who agrees to share de-identified data. Because the information is collected at the patient visit, it will be immediately available for better, data-driven medical decisions; and the data will also be de-identified, transferred out of the individual MS centers, and then deposited into a secure database where it can be analyzed, studied, and applied toward advancing knowledge about MS and its treatment. With MS PATHS, our goal is to effectively merge patient care and research — a key component of a learning health system.

Demonstrating a learning health system
In addition, we are working to help how MS is diagnosed and monitored by making the technological and analytical tools not only more efficient, but also more quantitative and precise. We are also collecting blood samples from patients to create a large biorepository that we can harness to identify biomarkers of disease activity and progression, which will move us closer toward precision medicine for MS. Simply put, our goal is to work on multiple fronts to drive innovation and help set a new standard of care for MS.

Once completed, this should be the first demonstration of a learning health system in any neurologic disease. We hope it will set the stage for defining value for MS treatment, and Biogen will be well-positioned to leverage this approach for other major diseases.

I first began working on the development of learning healthcare systems at the Cleveland Clinic, where I worked for 27 years. I decided to come to Biogen to lead the VBM group because I recognized an incredible opportunity to make a major impact in MS. We are working at the edge of the next generation in healthcare, and continuously working to extend Biogen’s leadership into the healthcare setting.

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