LCD L38303: MolDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease

This is a limited coverage policy for Genomic derived tests that assess risk in localized (non-metastatic) prostate cancer. The review is focused on the Decipher® Prostate Cancer Classifier Assay (identified as Decipher® to follow). The test is considered reasonable and necessary to help identify men with localized Prostate Cancer and a life expectancy of at least 10 years who are good candidates for active surveillance according to the most recent National Comprehensive Cancer Network (NCCN) guidelines.

Decipher® is covered for men with prostate cancer:

With localized or biochemically recurrent adenocarcinoma of the prostate (i.e. no clinical evidence of metastasis) who have a life expectancy of greater than or equal to 10 years if they are a candidate for and are considering (or being considered for) at least one of the following:

• Conservative management and yet would be eligible for definitive therapy (radical prostatectomy (RP), radiation or brachytherapy), or;

• Radiation therapy and yet would be eligible for the addition of a brachytherapy boost, or;

• Radiation therapy and yet would be eligible for the addition of short-term androgen deprivation therapy(ADT), or;

• Radiation therapy with short-term ADT yet would be eligible for the use of long term ADT, or;

• Radiation with standard ADT yet would be eligible for systemic therapy intensification using next generation androgen signaling inhibitors or chemotherapy, or;

• Observation post-prostatectomy yet would be eligible for the addition of post-operative adjuvant radiotherapy, or;

• Salvage radiotherapy post-prostatectomy yet would be eligible for the addition of ADT.

The following criteria must also be met for coverage:

• The assay is performed on formalin-fixed paraffin embedded (FFPE) prostate biopsy tissue with at least 0.5 mm of linear tumor diameter or FFPE tissue from a prostate resection specimen, and;

• Result will be used to determine treatment according to established practice guidelines, and;

• Patient has not received pelvic radiation or ADT prior to the biopsy or prostate resection specimen, and;

• Patient is monitored for disease progression according to established standard of care

Other genomic tests that demonstrate an equivalent analytical validity and clinical validity will be considered reasonable and necessary for the same indications. Analytical and clinical validity will be assessed as part of a thorough and comprehensive technical assessment (TA) by the Molecular Diagnostic Services Program (MolDX®) and will similarly attain coverage for indications that are supported by the evidence and intended use within the scope of this policy.

Background

In 2017, over 160,000 men in the United States (U.S.) were diagnosed with prostate cancer, which accounted for 9.6% of all new cancer diagnoses. 1 Clinically localized prostate cancer accounts for ~80% of newly diagnosed cases. 1 The NCCN, classifies these men into risk groups based on clinical and pathological features, which are intended to be used in conjunction with life expectancy estimates to select optimal treatment approaches. 2 Prostate cancer is a heterogeneous disease, which to better risk stratify this patient cohort was the creation of favorable and unfavorable intermediate risk disease groups developed by Zumsteg and Spratt at Memorial Sloan Kettering, now adopted by NCCN guidelines. 3 Recommendations for the treatment of prostate cancer are made based on the risk category of the cancer and additional considerations as noted in Table 1 below.

The primary treatment decisions in localized prostate cancer that are guided by prognosis are the use of definitive therapy versus conservative management with active surveillance, the addition of ADT to radiotherapy, the addition of brachytherapy to external beam radiotherapy, the use of long versus short-term ADT with radiotherapy, and the incorporation of newer forms of more potent ADT such as abiraterone. 2 Similarly, the primary treatment decisions after a patient has undergone a RP include the addition of adjuvant radiotherapy and addition of ADT to post-operative salvage radiotherapy. These treatment recommendations are based on multiple trials, though these guidelines provide little guidance regarding how to select the optimal therapy including how best to personalize treatment intensification or de-escalation.

Table 1: NCCN 2018 V4 - Localized Prostate Cancer Risk Stratification and Treatment