BRAFTOVI (encorafenib)
SELF-ADMINISTRATION - ORAL
Indications for Prior Authorization:
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Melanoma: Indicated in combination with Mektovi (binimetinib tablets), for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test
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Colorectal Cancer (CRC): In combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Coverage Criteria:
1. For diagnosis of melanoma:
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Dose does not exceed 450 mg (six 75 mg capsules) once daily; AND
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Prescribed by or in consultation with an oncologist; AND
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Patient has unresectable, advanced, or metastatic melanoma; AND
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Cancer is BRAF V600E or V600K mutant type as detected by an FDA-approved test (i.e., THxID-BRAF assay) or a test performed at a facility approved by the Clinical Laboratory Improvement Amendments (CLIA); AND
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Documentation supporting Braftovi will be used in combination with Mektovi (binimetinib) tablets
2. For diagnosis of colorectal cancer (CRC):
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Dose does not exceed 300 mg (four 75 mg capsules) once daily; AND
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Prescribed by or in consultation with an oncologist; AND
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Patient has Colon cancer or rectal cancer; AND
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Cancer is either unresectable/advanced disease OR metastatic disease; AND
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Cancer is BRAF V600E or V600K mutant type as detected by an FDA-approved test (i.e., THxID-BRAF assay) or a test performed at a facility approved by the Clinical Laboratory Improvement Amendments (CLIA); AND
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Documentation supporting Braftovi will be used in combination with Erbitux (cetuximab); AND
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Patient has received prior therapy (e.g., RAF, MEK, or EGFR inhibitor)
Reauthorization Criteria:
1. For diagnosis of melanoma:
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Dose does not exceed 450 mg (six 75 mg capsules) once daily; AND
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Patient does not show evidence of progressive disease while on therapy
2. For diagnosis of colorectal cancer (CRC):
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Dose does not exceed 300 mg (four 75 mg capsules) once daily; AND
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Patient does not show evidence of progressive disease while on therapy
Coverage Duration:
1. For diagnosis of melanoma and colorectal cancer (CRC):
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Initial: 1 year
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Reauthorization: 1 year
Additional Information:
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Strong or moderate CYP3A4 inhibitors: Avoid coadministration. If unavailable, reduce Braftovi dosage
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Strong or moderate CYP3A4 inducers: Avoid coadministration with Braftovi
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Avoid coadministration of Braftovi with hormonal contraceptives
Policy Updates:
- 08/27/2019 - Initial review
- 06/01/2023 - Updating policy to include new indication (CRC) and formatting
References:
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Braftovi Prescribing Information. Array BioPharma Inc. Boulder, Colorado. February 2022.
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National Comprehensive Cancer Network. Clinical practice guidelines in oncology: melanoma cutaneous v.3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf. Accessed June 1, 2022.
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National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 1.2022. Accessed June 1, 2022.
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National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Rectal Cancer. Version 1.2022. http://www.nccn.org/professionals/physician_gls/PDF/rectal.pdf. Accessed June 1, 2022
Last review date: June 1, 2023