Large National Payer Expands Coverage Policy to Include EndoPredict for Guiding Extended Hormone Therapy for Patients with ER+ Breast Cancer
Myriad Genetics, Inc. today announced that a comparative analysis of commercially available prognostic breast cancer tests in patients with early-stage breast cancer has been published in JAMA Oncology. A key finding is that Myriad’s EndoPredict® (EPClin) significantly outperformed Oncotype DX® Recurrence Score at predicting the risk of disease recurrence in patients with early-stage breast cancer.
In the article, Sestak et al. compared the prognostic value that four different commercial tests add to the Clinical Treatment Score (nodal status, tumor size, grate, age, endocrine treatment) for predicting distant recurrence (0-10 years) and late-distant recurrence (5-10 years) of breast cancer. The analysis included data from 774 postmenopausal women with ER+/HER2- breast cancer with node-negative disease or up to three positive lymph nodes, which is the most common form of breast cancer.
The results show that in all patients EndoPredict was the best overall test in predicting distant recurrence in years 0-10 (C-index 0.753; LRX2=69.3) and years 5-10 (C-index 0.761; LRX2=41.6). Importantly, EndoPredict identified the largest group of low-risk patients with 10 years distant recurrence below 10 percent in both node-negative and node-positive disease. EndoPredict also was a much better predictor for overall distant recurrence and for late-distant recurrence than Oncotype DX Recurrence Score. The JAMA Oncology publication can be accessed at: https://doi.org/10.1001/jamaoncol.2017.5524.
“This study demonstrates that EndoPredict, which combines a multigene signature with clinical information, significantly improves the prediction of disease recurrence, specifically in women with node-positive breast cancer,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. “What this means is that EndoPredict can more accurately identify a larger percentage of patients who can safely forgo adjuvant chemotherapy and the associated toxicity.”
These findings are consistent with a previous publication in the Journal of the National Cancer Institute, which also found that EndoPredict was superior to Oncotype DX Breast Recurrence Score in predicting the long-term recurrence of ER+, HER2- primary breast cancer.
Additionally, at the 2017 San Antonio Breast Cancer Symposium in December, the Company presented new predictive data that demonstrated women with a high EndoPredict score responded better to neoadjuvant chemotherapy than those with a low score, while those with a low score responded better to neoadjuvant endocrine therapy.
“We are committed to saving and improving the lives of women with breast cancer, and making sure patients are benefitting from the latest advances in personalized medicine,” said Lancaster. “Our expanding body of evidence strongly supports the use of EndoPredict to aid in clinical decisions regarding the use of chemotherapy and extended endocrine therapy.”
EndoPredict is widely accessible and is covered by more than 90 percent of health insurance plans in the United States. It also is available in several major European markets. For more information, please visit: www.endopredict.com.
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Medical Policy Update
One of the largest private insurers in the United States has expanded its coverage policy on EndoPredict. The new policy supports the use of EndoPredict to aid in the controversial decision of whether or not to extend adjuvant hormonal therapy beyond five years of treatment.
“I applaud payers for recognizing the importance of biomarkers to help physicians and patients make important decisions about whether or not to use extended endocrine therapy out to 10 years,” said Joyce A. O’Shaughnessy, M.D., Celebrating Women Chair in Breast Cancer Research, Baylor University Medical Center, and Chair of Breast Cancer Research at Texas Oncology. “This is another important step toward making personalized medicine a reality for all patients with breast cancer.”