In President Barack Obama’s 2015 State of the Union address, he announced the launch of the Precision Medicine Initiative, an innovative research effort developed to take into account individual differences in patients’ genes, environments, and lifestyles. By investing more than $200 million to support this initiative, the President hopes to accelerate the design and testing of effective, tailored therapies for cancer.1

One such example of precision medicine in action is BRACAnalysis CDx, the only diagnostic test approved by the U.S. Food and Drug Administration (FDA) for detecting BRCA1 and BRCA2 mutations, which are known to cause hereditary breast and ovarian cancer syndrome. BRACAnalysis CDx is intended to be used as an aid in treatment decision-making for olaparib, a PARP inhibitor indicated as monotherapy in patients with deleterious or suspected deleterious germline BRCA mutated advanced ovarian cancer who have received prior lines of therapy.2

Health care insurers in New Jersey, North Carolina, and Tennessee have, however, stopped covering this FDA-approved genetic test, instead limiting coverage only for cheaper, lower-quality genetic tests not yet approved by the FDA.

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“The earlier you can get the best treatment, the more likely you are to have a successful therapeutic outcome, and that’s especially crucial in ovarian cancers because there is no real go-to cure and the protocol is basically for women who fail every possible medication until they die, which is not fair to the patient or very economically smart,” said Peter Pitts, president and co-found of the Center for Medicine in the Public Interest in New York, New York, and former associate commissioner for external relations for the FDA, in an interview with Cancer Therapy Advisor.

“Not reimbursing for these tests ultimately becomes a penny wise, pound foolish proposition from a financial standpoint, and very cruel for these patients,” Mr Pitts said.

Mr Pitts explained that a patient may be with a given insurance company for only 3 to 5 years, so there is limited short-term incentive for health insurance companies to cover these tests. Under the existing Affordable Care Act model, however, more and more insurance companies, especially prescription benefit managers (PBMs), are denying care to save money and increase their bottom line. Even when discounts are negotiated, they are not shared with the consumer, leaving the consumer to pay the higher price.

Although there are other tests available, they may be less precise than a test that has received regulatory approval. These diagnostic tools may produce more false-positives and false-negatives.

“Moving into personalized or precision medicine does not happen without sensitive diagnostic tests,” Mr Pitts said. “Initially, they allow physicians to know what drugs not to prescribe, and that is certainly a significant money saver and good for the patient, because you want the patient to get the best treatment as quickly as possible.”

“It is actually economically sound if we look beyond the end of the financial quarter, but, unfortunately long-term for payers, now means the end of the quarter rather than the extended useful productive life of the patient,” Mr Pitts told Cancer Therapy Advisor. “The real policy question here is: how do we incentivize the insurance companies and PBMs to do what is right for the patient rather than, strictly speaking, what is right for them in the short term?”                             


  1. Fact sheet: President Obama’s Precision Medicine Initiative [news release]. Washington D.C.: Office of the Press Secretary; January 30, 2015. Accessed October 14, 2016.
  2. BRACAnalysis CDx. Myriad website. Accessed October 14, 2016.