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AIS's Health Business Daily
Featured Story Nov. 5, 2009
Health Plans Adopt Prior-Authorization Rules for Genetic Tests, May Use Tests to Push Generics in the Future Reprinted from DRUG BENEFIT NEWS, biweekly news, data and business strategies for health plans, PBMs and pharmaceutical companies. By Jill Brown, Managing Editor, (jbrown@aispub.com) A just-launched study by Medco Health Solutions, Inc. eventually could pave the way for health plans to use genetic testing to identify which patients are appropriate for an inexpensive generic-drug alternative rather than a costly brand-name drug. Today, most health plans don’t actively manage utilization of genetic tests, although that is starting to change. Some plans recently added prior-authorization (PA) requirements for metastatic colorectal cancer patients to get the KRAS genetic test before taking drugs that work on only certain types of tumors.
As part of Medco’s Genetics for Generics strategy, the PBM on Oct. 20 said it would conduct a head-to-head study of two cardiovascular drugs, sanofi-aventis’s Plavix and Eli Lilly and Co.’s Effient, to determine how heart patients’ genetic makeup affects the drugs’ effectiveness. Plavix, the third-largest-selling drug in the U.S. with $4.9 billion in 2008 sales, likely will lose its patent in 2011. The study will investigate whether the two drugs are equally effective in patients with a normally functioning version of the CYP2C19 gene. About 70% to 75% of patients have the normal version of the gene, and thus are “extensive metabolizers” of Plavix. By contrast, Effient is less dependent on genetic variations and thus is more effective in patients without a normally functioning version of the gene.
In sponsoring the trial, Medco is “blazing into new ground and kind of wading into a place that probably no one else is going to pick up,” since neither drug manufacturer would fund a trial that could only limit their market, says Gary Owens, M.D., president of consulting firm Gary Owens Associates and former vice president for medical management and policy at Independence Blue Cross.
If the Medco trial successfully shows that Plavix and Effient are equally effective among patients with a normally functioning gene, it would make sense for health plans to encourage those members to take the generic — even if it means paying for the genetic test, Owens says.
Today, Plavix costs about $4 per day, he explains, while “Effient has come to the market with a premium price. Let’s say for argument that it’s $5.” If the generic version of Plavix costs $1 per day, the health plan can save $4 per patient per day, or $120 per month, by keeping members on Plavix. “I’d pay for that [genetic] test in three months,” Owens says, “and it’s only a one-time test. I don’t have to keep repeating it.” What’s more, he says, “the outcome is going to save money.”
Quest Diagnostics, Inc. is one of the laboratory companies that provides the CYP2C19 genetic test, says spokesperson Wendy Bost. Although she declines to say how much health plans reimburse Quest for the test, she tells DBN that the “Medicare national limitation amount is about $200….That’s the amount that, generally speaking, you would expect that Medicare at the national level might reimburse us up to for performing the test on behalf of one of its beneficiaries.”
Plans Take Wait-and-See Approach
Although enthusiastic about Medco’s study, health plans and PBMs say they’ll wait to review the results before making coverage determinations.
“It’s a great start, actually, for looking at comparative effectiveness across the two medications,” says Lynn Nishida, director of pharmacy services at RegenceRx, the PBM subsidiary of The Regence Group. “We rarely see those kinds of trials.” But, she says, the PBM will have to apply “evidence-based medicine and a critical appraisal when those results are known.”
“When it gets right down to what happens in the clinical setting when you’re working with patients, it [i.e., how the gene functions] may not make a difference at all,” says Diane Priebe, supervisor of medical policy at RegenceRx. “And that’s because there are other things that influence drug metabolism.”
Complicating the coverage process is that “the [genetic] test that they’re proposing to perform in one of their subsets has not been proven to be effective in the clinical setting yet,” she adds.
Payers also must take into account logistical considerations, says Michael Cartier, executive vice president of Envision Pharmaceutical Services, Inc., a Twinsburg, Ohio-based PBM. For example, “what’s the cost of the test, how available is the test, when are test results available and what are the outcomes?” But assuming that the study results are compelling, “I can see a number of formulary changes being made such as step therapy or prior authorizations,” he predicts.
BlueCross BlueShield of Tennessee says it also would consider covering genetic testing for patients who have been prescribed Plavix or Effient. “As the personalization of medicine continues to evolve in our daily lives, these baseline studies will become increasingly important to establish a body of evidence that supports the specific need for specific drugs whose use hinges on certain genetic conditions, especially when choices can be between high-priced branded drugs and generics,” says spokesperson Scott Wilson.
Medco says its study will enroll more than 14,000 patients with acute coronary syndrome who have been newly prescribed the two drugs. Patients using Plavix will provide a saliva sample to determine if they have a normal version of the CYP2C19 gene and thus can metabolize the drug effectively. Patients using Effient won’t need a genetic test since that drug is metabolized in a way that is unaffected by genetic variations. The study will measure the rate of cardiovascular deaths, nonfatal heart attacks and nonfatal strokes over a six-month period.
KRAS Testing Brings Cost Savings
Study results for the KRAS genetic test have led many health plans to recommend that physicians give the test to colorectal cancer patients before prescribing ImClone Systems Inc.’s Erbitux or Amgen Inc.’s Vectibix. Some plans actually have made the test part of the prior-authorization requirement for those drugs.
Data presented at a January 2009 American Society of Clinical Oncology (ASCO) meeting showed that testing colorectal cancer patients for their KRAS mutation status before treating them with Erbitux could save more than $600 million annually. Such tests can run from about $200 to $500. In contrast, a month of Erbitux — or Vectibix — costs about $10,000. The ASCO paper estimates that about one-third of colorectal cancer patients have a KRAS mutation that makes Erbitux ineffective.
Other studies have estimated that more than 40% of patients have this mutation. So not only are these patients taking a drug that won’t do them any good, but they are also taking a toxic drug that could produce adverse side effects.
Here’s a look at some health plans’ KRAS coverage policies:
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