By Kelly A. Briganti, Editorial Director, G2 Intelligence
Prostate cancer testing has received significant attention lately as the industry seeks to find reliable ways of identifying the appropriate treatment strategy for patients diagnosed with such cancer. A new draft local coverage determination proposed by Medicare Administrative Contractor Palmetto GBA notes that “[i]n 2014, nearly 233,000 men in the US will be diagnosed with prostate cancer, which accounts for 14% of all new cancers.” The Centers for Disease Control and Prevention (CDC) indicates that prostate cancer is “the most common cancer among American men” and “one of the leading causes of cancer death among men of all races.” Palmetto’s draft local coverage determination and recent studies of prostate cancer patients recognize the potential for genetic testing to help identify the most appropriate treatment for these patients.
As the CDC notes, some prostate cancers are slow growing and don’t cause health problems. Therefore, not all patients diagnosed with prostate cancer require aggressive treatment but it is difficult for treating providers to determine which patients have an aggressive form of the cancer and which do not.
Recognizing this difficulty, Palmetto proposed a draft local coverage determination (LCD) for an assay that measures cancer aggressiveness. The Oncotype DX® Prostate Cancer Assay is described in the LCD as a “prostate biopsy-based 17-gene RT-PCR assay, representing four molecular pathways (androgen signaling, cellular organization, stromal response and proliferation) that provides a biologic measure of cancer aggressiveness.” It is “indicated for men who are considered candidates for active surveillance.”
The proposal would cover the Oncotype DX® under certain conditions that indicate a patient may be appropriate for observation rather than more aggressive treatment. The comment period ends July 24, 2015.
Specifically, the LCD proposes coverage under the following conditions:
- needle biopsy with localized adenocarcinoma of prostate (no clinical evidence of metastasis or lymph node involvement);
- patient is classified as either very low risk disease or low risk disease (determining factors include Gleason score (from biopsy) and PSA);
- patient’s life expectancy is 10-20 years;
- patient is eligible for both conservative and aggressive treatment “and is considering conservative therapy”;
- no pelvic radiation or androgen deprivation therapy was provided before patient’s biopsy;
- ordering physician must be certified in the Genomic Health™ Oncotype DX® Prostate Cancer Assay Certification and Training Registry;
- patient must be monitored “for disease progression according to active surveillance guidelines as recorded in NNCN guidelines”; and
- “physician must report the development of metastasis or prostate cancer deaths in patients not treated definitively who were deemed low risk by the assay.”
Genomic Health™ must report to Palmetto GBA every 6 months and maintain a registry database of physicians certified in their training program and collect information from referring physicians about test results, treatment recommended based on the results, and any changes in treatment decision. It also must require immediate reports of disease progression, metastases or prostate cancer deaths for patients who weren’t treated definitively and whose Oncotype DX® test result categorized them as low or very low risk.
Takeaway: Proposed local coverage determination recognizes advances in prostate cancer diagnosis and aims to improve treatment and save on treatment costs.