The nation’s largest healthcare payers are embracing the use of what is known as “comparative effectiveness,” a fancy term for essentially evaluating different therapies for a particular condition based on their costs and efficacy. The trend is a politically popular way to help reign in the cost for drugs, devices, and procedures. And the move reflects a broader focus on cost, rather than care, that is taking place at all levels of the American healthcare system.

 

But it’s important to move beyond criticizing comparative effectiveness in its current form, and instead towards creating a policy roadmap for integrating technologies and science that are more patient-centric into comparative effectiveness thinking.

 

Much the like the U.S. Food and Drug Administration created something called the Critical Path Initiative to apply 21st-century science to accelerate the development of personalized medicine, another national goal should be to create a Critical Path Initiative to apply new approaches to data analysis and clinical insights to promote patient-centric healthcare.

 

Why? Because comparative effectiveness should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, or prevent disease. First steps have been taken. For example, the Department of Health and Human Services has invested in electronic patient records and genomics. Encouraging the Centers for Medicare & Medicaid Services to adopt the use of data that takes into account patient needs would complement such efforts. 

 

The Patient-Centric Health Leadership Forum, a joint program of the Center for Medicine in the Public Interest and the Duke University Center for Research on Prospective Health Care, will shortly initiate a Critical Path for comparative effectiveness much as the FDA developed a Critical Path for drug approval and development.

 

Our goal is to develop proposals to modernize the information used in the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA critical path program are genetic variations and biomedical informatics that predict and inform individual responses to treatment, our goal is to establish a science-based process that incorporates the knowledge and tools of personalized medicine in reimbursement decisions: true evidence-based, patient-centric medicine.

 

One advantage the FDA had in initiating the Critical Path was its dual role in regulating medical products and advancing the public health. Today, evaluation and reimbursement of healthcare is more decentralized and will require a dedicated group to create an agreement about the design of a workable program. It must create a framework for action—opportunities that consumers, employers, insurers, state governments, and the federal can implement. 

 

 

Perhaps the most urgent goal of our project will be to engage CMS in our enterprise and to encourage public health officials to embrace new kinds of evidence development, partnerships with industry, the FDA, National Institutes of Health, and the new Reagan-Udall Foundation to “harness the potential of bio-information to evaluate and predict safety, effectiveness, and the value of treatments for each patient.

 

For example, rather than focusing strictly on coverage decisions, CMS should collaborate with other public and private entities to identify opportunities and develop tools based on new science that improve clinical decision-making based on new science. Under existing rules, CMS has the authority to request and obtain additional data without radically disrupting clinical practice in the absence of its own evidence.