Myriad Gets Final LCD for Prostate Cancer Test

Myriad Genetics announced August 13, 2015, that the company has received final local coverage determination (LCD) for Prolaris, a 46-gene test used to determine the aggressiveness of prostate cancer and guide treatment decisions.¹

The final LCD came from Noridian, the local Medicare Administrative Contractor (MAC) for Myriad; the previous LCD had come from Palmetto GBA, which has the nation’s best-known program for assessment the clinical validity and clinical utility of molecular diagnostic tests, known as MolDX.

The Noridian decision paves the way for Myriad to finally receive reimbursement for Prolaris, which is scheduled to begin October 15, 2015, according to the company’s announcement.¹

According to the press release, the Medicare coverage decision will allow reimbursement for approximately 60,000 patients who are diagnosed each year with localized prostate cancer in the United States, who meet the criteria of a Gleason score of ≤ 6 and serum prostate specific antigen (PSA) level of < 10 ng/ml.

Myriad has had to wait many months for a final date for reimbursement. Palmetto’s decision came on October 16, 2014,² after the company had presented results earlier that year at the American Urological Association.³ It subsequently presented results at the Society of Urological Oncology from the PROCEDE 1000 clinical utility study, which showed that physicians changed treatment decisions in 48% of the cases after using the test. Of these, 73% were reductions and 27% were increases in treatment.¹

Noridian’s decision “is an important step in providing Medicare reimbursement for this life-saving test and will significantly increase patient access to Prolaris testing in the United States,” said Mark Capone, president and CEO of Myriad Genetics, Inc.

Prolaris came on the market in 2010 and costs $3400.³

References

1. Myriad receives favorable Medicare final coverage decision for the Prolaris test [press release]. Salt Lake City, UT: Myriad Genetics; August 13, 2015. https://www.myriad.com/investors/press-release-detail/?newsItemId=927532.

2. Caffrey MK. After delays, reimbursement approvals seen for diagnostic tests. Am J Manag Care. 2014;20 (SP16):SP466.

3. Caffrey MK. Studies see value of Prolaris cancer diagnostic test, but will CMS pay for it? Am J Manag Care. 2014;20(SP11):SP323-SP327.