A Critical Path for Comparative Effectiveness Research and CMS

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  • 10/31/2007
Without fanfare or media coverage the European Medicines Agency reaffirmed that use of epo shoudl be handled by doctors -- not by bureaucrats -- and that there should be no hard and fast hemoglobin level imposed from above, rather a flexible level achieved as befits the needs and quality of life of individual patients.

That puts Europe light years ahead of our CMS that has deemed it cost effective and safe to toss tons of seniors into the dark ages of blood transfusions. I wonder what Pharmalot and others who had predicted a tightening of EMEA guidelines will say? Ditto the fact that the EMEA also took a mature approach to Avandia. But that is a post for another day.

For now, it is clear that CMS over-reached using the wrong data to achieve an over-restrictive decision inconsistent with the emergence of patient-centric medicine. EMEA is moving in that direction. So is FDA. Both have Critical Path programs designed to integrate the tools and knowledge to promote patient variation into the development and use of new drugs. Why not a Critical Path for CMS to achieve the same goal in developing insights into the value of new treatments?

So here's my proposal for a Critical Path for Comparative Effectiveness for CMS. Comments and thoughts welcome.

CMS should initiate a Critical Path for comparative effectiveness much as the FDA developed a Critical Path for drug approval and development. “The Critical Path Initiative is FDA's effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured.” CMS needs to initiate in a manner that is as transparent and as collaborative as that undertaken by the FDA to promote a national effort to modernize the science information the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA critical path are genetic variations and biomedical informatics that predict and inform individual responses to treatment, CMS needs to establish a process to incorporate knowledge and tools that personalize evidence of response in its decisions.

It should to the extent possible use coverage to evidence development, research grants and partnerships with industry, the FDA, NIH, the new Reagan-Udall Critical path institute to “ harness the potential of bioinformation used to evaluate and predict safety, effectiveness, and value of treatments for each patients.

Rather than focusing on coverage decisions, CMS should focus on identifying opportunities and developing tools to improve clinical decision-making based on new science. The FDA has developed a Critical Path opportunities list in cooperation with many interested parties that provides 76 concrete examples of how new scientific discoveries—in fields such as genomics and proteomics, imaging, and bioinformatics—could be applied during medical product development to improve the accuracy of the tests used to predict the safety and efficacy of investigational medical products. CMS should begin the process of developing a similar list of ways new discoveries and tools such as electronic patient records could be used to improve the predictive and prospective nature of medicine.

As a first step, CMS could use the reopening of the ESA coverage decision as example for how to achieve a more targeted and patient-centered use of ESAs in chemotherapy. An opportunities list could be generated around this particular issue with continued coverage conditioned upon participation in Critical Path activities.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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