Does Personalized Medicine Create a Role for Comparative Effectiveness Research?

An article appeared today in the Drug Benefits News, that draws attention to a situation where health plans are struggling to keep up with evolving technology. The article, written by Neal Learner, notes that the pace of personalized medicine is accelerating, with roughly a dozen new therapies expected to hit the market between now and mid-2010 that will be paired with a genetic test.

Learner writes that proponents of the use of personalized medicine are saying that it will become increasingly popular in the coming years as both providers and payers recognize the ability of tailored therapies to enhance the practice of medicine and reduce costs over time, including by avoiding adverse events.

Felix Frueh, vice president of personalized medicine research and development at Medco Health Solutions, Inc., is quoted in the article as saying that potential savings from the use of genomic testing include a reduction in the number of hospitalizations and physician visits because patients are put on the right medication at the right dose earlier.

The question now is which of these tests have benefit and which do not.

Learner writes that Frueh told the told a Feb. 26 AIS audioconference on personalized medicine that, “Pharmacogenomic outcome studies are key and critically important, and they are also growing in number. In the next few years, we will see the results of many of these studies [that] really help us make decisions on whether or not the clinical impact is sufficient and the economic considerations are affordable.”

Health plans will be paying close attention to the results of these studies to determine which of these tests to cover under their health policies.  Learner notes that Lynn Nishida, director of pharmacy services at Regence says the value of many marketed genetic tests is unknown, adding that the tests may range in price from $50 to $2,000 and higher.

In designing policies, health plans should first identify the tests that can be automatically approved, she said. “What you’re trying to do is narrow down your focus to those genetic tests that you are going to have a more thorough review for medical records,” she said of the tests that may be considered investigational or have not yet been shown to have value.

Like any new technology, insurance companies will struggle with which genomic tests to approve, under what circumstances. This will no doubt create controversy and once again draw charges of carriers playing “god” in making coverage decisions. Could this be a place where comparative effectiveness research conducted at the national level could lead to some consistency among health plans while it creates efficiencies by eliminating the need for each carrier to conduct their own research?

Critics will say that this the government rationing care, but someone — carriers or the government — will need to develop standards for these types of tests.  In 2007, Regence received 55,100 medical claims for genetic tests, representing more than $5 million in billed claims, and this is just the tip of the ice burg.

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