With a positive Medicare coverage decision, as well as the expected publication of clinical trial results, more health plans may extend coverage to a genetic test that predicts the recurrence of colon cancer, one of the most prevalent and costly cancers in the United States.

In a notice posted on its website Sept. 29, Palmetto GBA said that following its assessment of the Oncotype DX Colon Cancer Assay, it has concluded that “the test meets criteria for analytical and clinical validity and clinical utility as a reasonable and necessary Medicare benefit.” As of Sept. 18, the contractor began reimbursing for the test’s use in patients who have been diagnosed with stage II colon cancer.

Palmetto is the Part B Medicare administrative contractor for Jurisdiction I, which includes California. But because only one laboratory processes the Oncotype DX test — Genomic Health’s lab in Redwood City, Calif. — the Palmetto decision impacts all Medicare beneficiaries.

According to the American Cancer Society, colorectal cancer is the third most common cancer in the United States when skin cancers are excluded. For 2011, it estimates there will be 101,700 new cases of colon cancer and 39,510 of rectal cancer. Colorectal cancer is the second-leading cause of death when statistics for both men and women are combined; it is expected to kill almost 50,000 people this year. If caught in its early stages, though, colon cancer is considered curable.

The Genomic Health test helps predict how likely the risk of colon cancer recurrence is for people with stage II colon cancer. This will help identify those who may benefit from additional treatment following surgery. According to the company, about 30% of people diagnosed with colon cancer are stage II.

Treatment for colon cancer can be costly. For example, CareFirst BlueCross BlueShield spent more than $30 million in 2008 on total colon cancer costs for fewer than 9,000 patients, according to a Jan. 28, 2010, AIS audioconference. That was the second highest cancer spend for the plan behind breast cancer, which cost CareFirst more than $72 million — but for more than 32,000 patients.

The list price of the Oncotype DX test for colon cancer is $3,280, says a Genomic Health spokesperson.

Only Two U.S. Plans Cover Test

Although many health plans have coverage policies for the Oncotype DX breast cancer test, according to Genomic Health only two commercial health insurers in the United States reimburse for the Oncotype DX colon cancer test: Kaiser Permanente and Group Health Cooperative. Clalit Health Services Ltd., a public payer in Israel, also has a coverage policy for the test.

“At Kaiser Permanente, our physicians make care decisions together with their patients, depending on the individual’s medical history, risk factors, and goals,” a Kaiser spokesperson tells SPN. “We review the latest clinical research to ensure that our physicians and their patients have access to the latest medical knowledge. Our physicians are strong advocates for evidence-based health care that is tailored to the needs of individual patients. This means that our physicians and their patients discuss the care choices — medicines, therapies, and tests such as Oncotype DX — that are clinically appropriate for that individual and decide together which will best meet the patient’s care needs.”

According to Kaiser, “We believe that our physician-led approach helps educate patients about their options, and ultimately leads to better health outcomes. This is a unique strength of our integrated care delivery system, which includes our own physicians, hospitals and health coverage capabilities.”

Most commercial plans, as well as the National Comprehensive Cancer Network, consider the data for this test insufficient to support its use.

“WellPoint considers the Oncotype DX test investigational and not medically necessary as documented in medical policy Gene.00016,” says John F. Whitney, M.D., WellPoint medical director of medical policy. He tells SPN, though, that “for members in a Medicare plan, where applicable, we will follow CMS rules on coverage.”

According to Aetna Inc.’s clinical policy bulletin, “Oncotype DX is considered experimental and investigational for node positive breast cancer, colon cancer, and all other indications.”

Elaine Manieri, vice president of pharmacy at BlueCross BlueShield of Tennessee, tells SPN that the plan “currently considers the use of Oncotype DX testing for predicting the likelihood of disease recurrence for stage II colon cancer to be investigational, and so it is not covered in our plans.” She explains that the reasoning “is largely based on the lack of ample, high-quality evidence needed to confirm the effect of the test on health outcomes.”

Whitney agrees. “So far, there has been no information made available, either in abstract form or in the published peer-reviewed medical literature, as to the ability of such genetic testing to improve or potentially improve outcomes in people with colon cancer, such as by definitively providing direction in determining or changing therapy based on the results of such testing.”

QUASAR Study Will Be Published

However, it appears that this situation may be changing soon. A Genomic Health spokesperson tells SPN that the “landmark QUASAR validation study, which demonstrated that the Oncotype DX colon cancer test can predict individual recurrence risk in stage II colon cancer patients following surgery, has been accepted for publication by the Journal of Clinical Oncology.” The timing of that is to be determined, she adds.

Plans that spoke with SPN say they will reassess their coverage policies for the test once those data are available.

“When peer-reviewed studies on the use of Oncotype DX for colon cancer are published, we will review them,” says WellPoint’s Whitney.

Commercial health plans often keep a close eye on CMS coverage decisions, sometimes following its lead after observing the impact of its actions. So will the recent Medicare decision have a favorable influence among plans?

According to Whitney, WellPoint “review[s] all policies at least annually. We will review the Medicare decision when we next review this policy.” The date for the review has not yet been scheduled, says a spokesperson for the plan.

“With the recent announcement from Medicare, we anticipate that the medical policy will be reviewed again once the Quick and Simple and Reliable (QUASAR) study has been completed and published,” Manieri tells SPN.

The Palmetto decision, the Genomic Health spokesperson maintains, “adds further acceptance of the Oncotype DX Colon Cancer Assay. We anticipate that the publication of the QUASAR study will further enhance our dialogue with payers as they are considering their coverage decisions.”

View Palmetto’s determination at http://tinyurl.com/3zxfwxb.

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