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Draft LCD for GenomeDx's Prostate Cancer Test Proposes Coverage for High Risk Patients


Originally published Oct. 17.

NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA issued a draft local coverage determination (LCD) for GenomeDx Biosciences' Decipher Prostate Cancer Classifier when the test is used for men who have undergone a prostatectomy and are at high risk of recurrence based on standard prognostic tools.

The draft LCD issued this week proposes to limit coverage for Decipher when it is used to "determine which patients traditionally considered high risk of recurrence after radical prostectomy may be closely followed rather than receive post-operative radiation therapy." Specifically, Palmetto said it will cover Decipher for prostate cancer patients who have undergone a radical prostatectomy in the last 60 months and are being considered for postoperative therapy due to additional risk factors for disease recurrence. Patients must have adverse pathology according to their surgical pathology report, have rising PSA levels after an initial undetectable level after surgery, have no evidence of distant metastases, and cannot have received neo-adjuvant treatment before surgery.

The same day that Palmetto issued the draft LCD for Decipher, it also issued a draft determination for Myriad's Prolaris test. However, in the case of Prolaris, Palmetto is willing to cover the test for men with early stage prostate cancer who are at "very low" or "low" risk of progression (see related story, in this issue).

In the draft document, Palmetto mentioned several studies which provided evidence that Decipher, which gauges a 22-biomarker expression signature, can accurately determine which prostate cancer patients deemed by traditional prognostic tools to be at high risk are truly at substantial risk of recurrence and which can be followed closely instead of receiving radiation therapy. "The strength of this data is the consistency with which the Decipher [classifier] score predicts metastasis across intermediate or high-risk patients who may or may not have had a biochemical recurrence," the Medicare contractor wrote in the draft decision.

Noting that the retrospective study populations are heterogeneous, Palmetto wrote that "a prospective trial with randomization and treatment based on the Decipher … score would solve these biases." However, the contractor also acknowledged that prospectively determined data on the impact of Decipher would require more than a decade to acquire, and said that GenomeDx has performed "robust" retrospective trials that provide evidence of the test's clinical utility.

"When applying retrospective analysis to prospective treatment there is the fear that the treatment that normally would have been given is altered based on a test result," Palmetto wrote in its decision. "Consequently, education on the appropriate use of this test and resulting treatment outcomes must be clearly understood by ordering physicians."

As with Prolaris, Palmetto is willing to provide coverage for Decipher when it is ordered by doctors enrolled in a certification and training registry (CTR) program. With this requirement, Palmetto wishes to ensure that appropriate patients are being tested, educate doctors on the safe use of the test, and catch any patients who might experience disease metastases or die after receiving a low Decipher risk score.

In addition to reporting any distant metastases or deaths among patients with low risk scores by Decipher, Palmetto has also asked GenomeDx to report registry and clinical trial data on Decipher to the contractor on an annual basis.

The coverage determination was issued by Palmetto through its MolDx program, a program developed in 2011 in which the contractor evaluates the clinical validity and utility information on molecular tests and determines coverage policies. Noridian is GenomeDx's jurisdictional contractor and will administer Medicare benefits for the test.

Following release of the draft LCD, the public will have 45 days to comment on the policy, starting Nov. 10. Subsequently, CMS will issue a final LCD on Decipher within another 45 calendar days.