Managed Care - February 2009 - (Page 24) Today, it has seven. A four-member team is building up Humana’s know-how. “We cover a lot of tests and these policies are being rewritten monthly to try to keep up,” says Hochheiser. Savings can be hard to identify, but the costs are showing up loud and clear on insurers’ financial radar systems. “We are seeing a fairly dramatic increase in the number of orders for genetic tests,” says Hadley. “Costs are rising ahead of general health care inflation rates.” There is already plenty of evidence to suggest that there is significant waste involved in genetic testing. Citing research from Aetna, Hochheiser says that 20 percent of tests done to identify an amplification of the HER2 gene — a mutation linked to a particularly aggressive form of breast cancer — aren’t done correctly. That research prompted Aetna to recently offer to pay for a second test at a certified laboratory, such as Genzyme Genetics, which has a reliable track record. So far, Aetna doesn’t have a highly restrictive list of labs. To help shed more light on the subject for doctors and members, Hochheiser says that Humana is preparing to reveal a genetic counseling arrangement of its own, allowing doctors to call in and ask for guidance and members to call for counseling on how they should respond to test results. Jerry Conway, vice president for managed care at Genzyme Genetics, says that Aetna, Cigna, and UnitedHealthcare have been very active. “Regional plans are much slower to seek guidance and ask questions and become active.” Failing the cost-benefit analysis B ack in 2007, the FDA suggested that the best method for determining the right dose for the blood-thinner warfarin involved a genetic test. Specific genetic variations could identify who was most sensitive to warfarin, which is taken every day by 2 million Americans. Most important, said the agency, a test could alert a doctor if a patient was at risk of suffering a major bleed if given the wrong dose. “The idea behind genetic testing — also known as pharmacogenetic-guided dosing — is to help guide the initial, and possibly lower, dose of warfarin for patients found to possess certain variants of the genes cytochrome P450 CYP2C9 and vitamin K epoxide reductase, or VKORC1,” reported Mark Eckman, MD, professor of medicine at the University of Cincinnati. “The hope is that more accurate dosing will translate into decreased major bleeds during the initiation phase of warfarin dosing, which is the first month or so.” Now that doctors have had some time to work with the new guidelines, Eckman went back over the data to see how it all works in practice. And while he found that the outcomes for patients had improved because of genetic testing, the genetic testing proved to be woefully inadequate when subjected to a cost-benefit analysis. Genotype-guided dosing was delivered at a cost of $170,000 per quality-adjusted life year gained, and in only 1 in 10 cases did it prove cost-effective. But Eckman said that the numbers would work under the following circumstances: • If it is used with patients at high risk for hemorrhage • If the test prevents more than 32 percent of major bleeding events • If it is available within 24 hours for patients diagnosed with nonvalvular atrial fibrillation • If the test costs less than $200 Flying blind All the insurers contacted say they face a particularly thorny challenge in bringing genetic testing and counseling into mainstream medical practices: an antiquated coding system that has a long way to go before catching up with the revolution in genetics. “It’s kind of a mess,” says Hadley. “The coding for genetic testing is very difficult. That’s one of the reasons why it’s very difficult to follow. It makes it difficult to get information on what tests are being “This could be accomplished if testing were done inhouse, at lower cost and without delays,” he said in a report published in the Annals of Internal Medicine. “Personalized, predictive medicine offers great promise, but we need to carefully examine the benefits and understand the costeffectiveness of such strategies before we spend a lot of money on very expensive tests.” done and what is being done with the results. “I can’t really easily get a report to tell me how many tests I got for cystic fibrosis,” he adds. “We can order it and the claims department will send me a report on annual genetic testing, all lumped together. A genetic testing code is nonspecific.” Insurers are left to fly blind. “You might have a bill come in for a genetic test 24 MANAGED CARE / FEBRUARY 2009
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