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Insurers Tracking Unnecessary Testing with Myriad's BRACAnalysis Tests

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By Turna Ray

This article was originally posted on Oct. 30.

Several insurers have instated prior authorization, prior notification, and mandatory genetic counseling procedures prior to covering Myriad's BRACAnalysis test to ensure that the test is being given to the right patients.

Data from two national insurers, Humana and Aetna, shows that around 20 percent of requests for the test do not meet requirements for BRCA testing under their policy. A United Healthcare official has cited competitors' data suggesting that as much as 80 percent of requests for Myriad's BRCA test are withdrawn after pre-certification and genetic counseling procedures are conducted.

"About 22 percent of requests for testing would not meet the criteria for testing spelled out in [our] policy," an Aetna spokesperson told Pharmacogenomics Reporter this week.

The Aetna spokesperson noted that its BRCA testing criteria are adapted from the US Preventative Services Task Force's cancer screening guidelines, as well as from the American College of Obstetricians and Gynecologists and the American College of Medical Genetics cancer testing recommendations.

Aetna is one national insurer that requires prior authorization and genetic counseling prior to covering Myriad's test. Similarly, United Healthcare has issued a prior notification requirement for BRACAnalysis. Myriad's test, which costs more than $3,000, gauges BRCA 1 and BRCA 2 mutations associated with increased risk of hereditary breast and ovarian cancer.

In a July bulletin, United Healthcare informed Myriad that as of Aug. 16, the company must record and submit for verification the information required to assess a patient's genetic risk for the BRCA mutation and to make a coverage determination [see PGx Reporter 08-26-2009].

"In certain circumstances, physicians may be contacted following notification for additional information," United Healthcare informed in the bulletin. United Healthcare bases its reimbursement criteria on National Comprehensive Cancer Network and US Preventive Services Task Force guidelines.

According to Lee Newcomer, senior vice president of oncology at United Healthcare, competitors that have instituted precertification and mandatory genetic counseling have reported that as much as 80 percent of the requests for Myriad's BRACAnalysis test are withdrawn after these processes.

The insurer provided this information to Pharmacogenomics Reporter this week to clarify prior reporting that interpreted the statistic to suggest that 80 percent of those currently receiving BRCA testing should not be. What Newcomer's comments do suggest, however, is that patients that should not be tested on BRACAnalysis could be unnecessarily tested without additional oversight and educational efforts from insurers [see PGx Reporter 08-12-2009].

According to Rick Schatzberg, chief marketing officer of Generation Health, Humana is another insurer that has reported that around 20 percent of requests for BRACAnalysis are from those that do not meet its coverage criteria. Generation Health is a pharmacy-benefit-manager style startup that is working to help large employers and insurers optimize their use of genetic tests. Based on its access to medical claims data and interactions with insurers, Schatzberg previously told Pharmacogenomics Reporter that payors are particularly concerned about overtesting with Myriad's BRACAnalysis test.

The concern over unnecessary testing may be due to the fact that Myriad has been aggressively marketing BRACAnalysis, the company's top-selling product, through its sales team and direct-to-consumer marketing strategy.

Myriad launched a television advertising campaign in selected Northeastern states in September 2007 for its BRACAnalysis test, and has expanded the marketing campaign to the South and Midwest. After Myriad's DTC campaign launched in the Northeast, many doctors complained that their practices were not equipped to handle the resulting influx of patients who saw the ads and wanted to be tested for BRCA mutations [see PGx Reporter 09-26-2009].

According to Sue Friedman, executive director of the patient advocacy group Facing Our Risk of Cancer Empowered, a growing number of breast and ovarian cancer patients are reporting instances of receiving either too little or the wrong information about their genetic risk for developing cancer from commercial firms [see PGx Reporter 01-07-2009].

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