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Local Coverage Determination (LCD): MolDX: Androgen Receptor Variant (AR-V7) Protein Test (L37701)

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Coverage Indications, Limitations, and/or Medical Necessity

This contractor will provide limited coverage for an Androgen Receptor splice variant 7 messenger RNA protein test (AR-V7) to help determine which patients with metastatic castrate resistant prostate cancer or other androgen receptor containing tumors may benefit from androgen receptor signaling inhibitor therapy and which may benefit from chemotherapy.

AR-V7 is covered as follows:

• Patients will have progressive mCRPC as defined by the Prostate Cancer Working Group 2 guidelines (a minimum of 2 rising prostate-specific antigen (PSA) levels 1 or more weeks apart, new lesions by bone scintigraphy, and/or new or enlarging soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI)).
• Patients will have failed one ARSi, (presently Enzalutamide (Xtandi), Apalutamide (Erleada), or Abiraterone (Zytiga) and future similar class drugs approved by the FDA) .
• Patients will be considered appropriate for treatment by their treating physician for the alternative ARSi as a single agent.
• Circulating tumor cells (CTC) with nuclear expression of AR-V7 protein will be assessed prior to initiation of therapy.
• Decision impact analysis: We expect that < 15% of nuclear AR-V7-positive patients will receive an ARSi.
• Efficacy analysis: Nuclear AR-V7-negative patients who receive an ARSi will have similar or better time on therapy than untested mCRPC patients (meeting above criteria) receiving an ARSi.
• Other Androgen Receptor variant tests that demonstrate an equivalent analytical validity and clinical validity will be considered reasonable and necessary for similar diagnoses and criteria listed below indications. Analytical and clinical validity will be assessed as part of a thorough and comprehensive technical assessment (TA) by the MolDx program and will similarly attain coverage for indications that are supported by the evidence and intended use within the scope of this policy.

Local Coverage Determination (LCD): MolDX: Oncotype DX Breast DCIS Score Assay (Genomic Health) (L36941)

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The Oncotype DX Breast DCIS Score assay is covered only when the following clinical conditions are met:

• Pathology (excisional or core biopsy) reveals ductal carcinoma in situ of the BREAST (no pathological evidence of invasive disease), and
• FFPE specimen with at least 0.5 mm of DCIS length, and
• Patient is a candidate for and is considering BREAST conserving surgery alone as well as BREAST conserving surgery combined with adjuvant radiation therapy, and
• Test result will be used to determine treatment choice between surgery alone vs. surgery with radiation therapy, and
• Patient has not received and is not planning on receiving a mastectomy.

Local Coverage Article: Billing and Coding: MolDX: Oncotype DX Breast Recurrence Score Cancer Assay (A54480)

Oncotype DX Breast Recurrence Score test was developed for patients with the following findings:

• estrogen-receptor positive, node-negative carcinoma of the BREAST
• estrogen-receptor positive micrometastases of carcinoma of the BREAST, and
• estrogen-receptor positive BREAST carcinoma with 1-3 positive nodes

Local Coverage Article: Billing and Coding: MolDX: Oncotype DX Colon Recurrence Score Assay (A54484)

The Oncotype DX Colon Recurrence Score test, developed to predict the recurrence risk for patients with Stage II COLON CANCER.

Local Coverage Determination (LCD): MOLDX: Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (L38339)

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Coverage Indications, Limitations, and/or Medical Necessity

This is a limited coverage policy for Genomic derived tests that assess risk in localized (non-metastatic) prostate cancer. 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.

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 1 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 standards 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 MolDX program and will similarly attain coverage for indications that are supported by the evidence and intended use within the scope of this policy.

Local Coverage Determination (LCD): MolDX: Next-Generation Sequencing for Solid Tumors (L38119)

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Criteria for Coverage

All the following must be present for coverage eligibility:

As per NCD 90.2, this test is reasonable and necessary when the patient has either:

• Recurrent cancer
• Relapsed cancer
• Refractory cancer
• Metastatic cancer
• Advanced cancer (stages III or IV)
• AND has not been previously tested by the same test for the same genetic content
• AND is seeking further treatment

The test has satisfactorily completed a technical assessment by MolDX for the stated indications of the test. The assay performed includes at least the minimum genes and genomic positions required for the identification of clinically relevant FDA-approved therapies with a companion diagnostic biomarker as well as other biomarkers known to be necessary for clinical decision making for its intended use that can be reasonably detected by the test. Because these genes and variants will change as the literature and drug indications evolve, they are listed separately in associated documents such as the MolDX TA forms.