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Cigna to Require Genetic Counseling Prior to BRCA Testing

Posted Aug 21 2013 12:00am

I have blogged previously about the use of companion diagnostics whereby a lab test is used to determine whether a patient is a suitable candidate for an expensive drug, usually an expensive chemotherapeutic agent (see: Companion Diagnostics Gains Wider Acceptance in FDA Despite ChallengesSome Interesting Insights into Companion Diagnostics ). The underlying (reasonable) rationale is that a cancer drug should not be administered without a priori proof that it will be effective to treat the lesion. A similar concept is now being used in the lab world to determine whether the expensive BRCA test should be ordered for screening (see: Cigna Counselor Demand for Breast Cancer Test Targets Myriad ), Below is an excerpt from the article:

Cigna Corp. will become the first U.S. health insurer to require genetic counseling nationwide before it pays for tests for hereditary breast and ovarian cancer, a move that may threaten sales for Myriad Genetics...The policy affects tests for the BRCA1 and BRCA2 genes, the most common cause of hereditary breast cancer, as well as genes for hereditary colon cancer and a heart abnormality called long QT syndrome....It takes effect Sept. 16. Cigna’s ruling may cut sales growth for Myriad if other insurers follow suit....The BRCA tests, costing as much as $4,000, generated 85 percent of revenue [for Myriad]....Bloomberg News reported last year there is a general lack of training and understanding among doctors about complex genetic tests, creating the potential for catastrophic errors that may go undetected for years....Cigna expects to roughly break even on the program, [a Cigna spokesperson] said, as any savings from eliminating inappropriate tests will be mostly offset by higher reimbursement for counseling....Genetic counseling services are available by phone under the Cigna program....It’s been a difficult year for Myriad. The company lost its long-standing monopoly in the U.S. on BRCA tests in June when the Supreme Court invalidated key parts of Myriad’s patents on the genes. In July, Myriad sued Ambry Genetics Corp. and another closely held company that introduced BRCA tests, saying the competing tests violate other Myriad patents. Ambry, in a countersuit filed in August, said Myriad is misusing its patents to “intimidate and chill competition.”

I have personally found that all of the discussions about Myriad and BRCA testing to be fascinating (see:  Myriad Genetics to Rely More on Trade Secrets than TechnologySome BRCA1 and BRCA2 Genes Missed by Myriad ). I did cover the Myriad/Ambry legal news and am anxious to see more competition for BRCA testing (see: Myriad Sues Two Competitors Offering Less Expensive BRCA Testing ). As noted above, this news from Cigna can't be good for Myriad. The pharmaceutical companies dislike companion diagnostics intensely because the lab test reduces overall sales of their products -- drugs are frequently inappropriately prescribed. The same logic applies to expensive lab testing. Myriad, to protect itself, does provide guidelines for BRCA test ordering but I am sure that some physicians may ignore them when working with patients who insist on having the test. Some unnecessary test ordering, I am sure, is also due to a lack of understanding of the test ordering indications by physicians.

Also interesting is that Cigna provides genetic counseling services by phone. It's not clear if the company will only accept their own counseling services for the test. It occurred to me that this is a type of preapproval by the health insurance company prior to an expensive test. Such preapprovals have been in force for many years although usually enforced by the insurance company based on clinical criteria that the test ordering physician must provide. The idea of a trained medical professional, a genetic counselor, providing preapproval strikes me as quite novel. Cigna is one of the largest health insurance companies in the country, so I suspect that many of the others companies may follow suit for BRCA as well as myriad (pun intended) other current and emerging genetic tests.

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