Myriad Genetics (MYGN) Disappointed that the MolDx Program Published a Draft Non-Coverage Decision for Vectra DA
December 23, 2016 10:45 AM EST
Myriad Genetics (NASDAQ: MYGN) issued the following statement to StretInsider.com, saying they are disappointed that the MolDx program published a draft non-coverage decision for Vectra DA and strongly disagrees with the conclusions. News of the non-coverage decision for Vectra DA has shares of MYGN down 5.7%.
Myriad Genetics statement:
We are excited that Palmetto, the Medicare administrative contractor (MAC) in charge of the Mol Dx program, has issued a draft LCD for Prolaris, recommending coverage for Medicare beneficiaries with favorable intermediate localized prostate cancer. The decision is an important step in expanding Medicare reimbursement for this life-saving test and will significantly increase patient access to Prolaris testing in the United States.
Favorable intermediate is defined as prostate cancer patients with: “Predominant Gleason grade 3 (i.e. Gleason score 3+4=7), percentage of positive cores <50%, and no more than 1 NCCN intermediate-risk factor) NCCN intermediate risk factors include T2b-T2c, Gleason score 7, and PSA 10-20 ng/mL.”
We believe this criteria applies to approximately 25 percent of men with prostate cancer. Since Medicare is the payer for approximately 60 percent of men with prostate cancer, this draft LCD if approved would expand coverage for about 15 percent of men or approximately 30,000 additional men per year in the United States.
We believe this LCD will be reviewed at the CAC meeting in February and be subject to a 45 day comment period along with a 45 day waiting period if approved. Consequently we would expect the potential impact of this decision from a revenue perspective to be a fiscal year 2018 event.
At the same time, we are disappointed that the MolDx program published a draft non-coverage decision for Vectra DA based on data from the recently published AMPLE study. Myriad strongly disagrees with the conclusions of this study as published, which had significant limitations and shortcomings as described by Dr. Jeff Curtis in his scholarly response to the paper.
For example, a major shortcoming of the AMPLE publication was an unconventional statistical analysis of radiographic progression. When the data are reanalyzed using a more conventional approach, the findings are consistent with multiple prior studies that show Vectra DA accurately predicts radiographic progression in patients with rheumatoid arthritis (RA).-7
The efficacy of Vectra DA has been demonstrated in more than 20 studies with more than 3,000 patients. The strength of the clinical evidence for Vectra DA has been widely recognized as 3 out of 4 rheumatologists have experience with Vectra DA and have ordered it for ~300,000 patients in the United States. Recently, Vectra DA was included in guidelines published by United Rheumatology and will be evaluated for inclusion in the American College of Rheumatology (ACR) guidelines.
Vectra DA remains an important test for rheumatologists and their patients with RA. The Company stands behind the science supporting Vectra DA, and we will work to ensure continued access to this important molecular diagnostic test for all Medicare patients with RA.