Very good language in both regarding personalized medicine and patient-level data. Especially the Federal Coordinating Council report. Less so the IOM panel which was filled (with a couple of exceptions) with underachievers and people who were likely to benefit from preserving the status quo. The devil will be in how the dough is doled out for research and how the results are applied when it comes to reimbursing for new technologies in Medicare, Medicaid, VA, etc.
From the IOM report:
"This focus of CER reflects the growing potential for individualized and predictive medicine—based on advances in genomics, systems biology, and other biomedical sciences—through the analysis of subgroups with demographic, ethnic, physiologic, and genetic characteristics that could be useful factors in clinical decisions."
Then there is this:
"A common misapprehension is that CER will lead to uniform, “one-size-fits-all” care that ignores the ways that patients differ. In fact, CER done well should give providers the means to tailor the choice of treatment to the individual patient’s characteristics and preferences. Better comparative effectiveness studies will make it possible to measure the implications of individual differences in disease severity and the presence of comorbidities, to identify predictors of response to treatment, and to incorporate other aspects of a person’s health and preferences. For example, CER might assess the added value of using genomic information in addition to traditional clinical predictors to determine the best treatment for a cancer in a particular patient."
There is no misapprehension. The fact is CER has used data from medical claims and randomized trials to compare drug A to drug B to figure out -- on average -- which one provides the most "benefit" for the least amount of money. And CMS is stil proposing such studies today. Moreover, CER is still framed as head to head comparisons conducted largely through randomized clinical trials that take forever and are biased by the cost contaiment goals of government and by definition exclude patient variation as opposed to continuous feedback loop for improving clinical practice.
Read more here
From the IOM report:
"This focus of CER reflects the growing potential for individualized and predictive medicine—based on advances in genomics, systems biology, and other biomedical sciences—through the analysis of subgroups with demographic, ethnic, physiologic, and genetic characteristics that could be useful factors in clinical decisions."
Then there is this:
"A common misapprehension is that CER will lead to uniform, “one-size-fits-all” care that ignores the ways that patients differ. In fact, CER done well should give providers the means to tailor the choice of treatment to the individual patient’s characteristics and preferences. Better comparative effectiveness studies will make it possible to measure the implications of individual differences in disease severity and the presence of comorbidities, to identify predictors of response to treatment, and to incorporate other aspects of a person’s health and preferences. For example, CER might assess the added value of using genomic information in addition to traditional clinical predictors to determine the best treatment for a cancer in a particular patient."
There is no misapprehension. The fact is CER has used data from medical claims and randomized trials to compare drug A to drug B to figure out -- on average -- which one provides the most "benefit" for the least amount of money. And CMS is stil proposing such studies today. Moreover, CER is still framed as head to head comparisons conducted largely through randomized clinical trials that take forever and are biased by the cost contaiment goals of government and by definition exclude patient variation as opposed to continuous feedback loop for improving clinical practice.
Read more here
