CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1255-10

Braftovi (encorafenib) prior authorization

Prior authorization and notification criteria for Braftovi (encorafenib) coverage, including indications, combination regimens, and reauthorization rules for members of the health plan.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBraftovi (encorafenib) prior authorization

Policy CodePolicy 2025 P 1255-10

Change TypeMaterial updates to indications and CRC criteria

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of BRAF V600 mutation status and the specified concurrent regimen to obtain a 12‑month approval.

SourceLink

POLICY UPDATE CHANGES

Added FDA-approved use of Braftovi in combination with Erbitux and mFOLFOX6 for BRAF V600E mutated metastatic colorectal cancer.

Added FDA-approved use of Braftovi in combination with Mektovi for BRAF V600E NSCLC.

Combined and updated initial and reauthorization criteria for colon and rectal cancer; clarified combination regimen options (Erbitux or Vectibix with or without FOLFOX depending on prior oxaliplatin exposure).

Added NCCN recommended regimens statement as acceptability criterion (Category 1, 2A, 2B).

12 monthsAuthorization duration for initial approvals

12 monthsReauthorization duration

BRAF V600E/V600K

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Required mutation testing

Under 19Auto process for

Coverage and Clinical Criteria

inv-01: Initial Therapy - Melanoma

Covered when ALL of the following are met

Melanoma initial: (1) Diagnosis of melanoma; (2) Presence of BRAF V600E mutation; (3) Disease is unresectable or metastatic; (4) Used in combination with Mektovi (binimetinib)

Authorization will be issued for 12 months

inv-02: Reauthorization - Melanoma

Covered when ALL of the following are met

Melanoma reauth: (1) Patient does not show evidence of progressive disease while on Braftovi therapy; (2) Continued use in combination with Mektovi (binimetinib)

Authorization will be issued for 12 months

inv-03: Initial Therapy - Colon/Rectal Cancer

Covered when ALL of the following are met

CRC initial: (1) Diagnosis of colon or rectal cancer; (2) Presence of BRAF V600E mutation; (3) Disease is advanced or metastatic; (4) One of the following: (a) Patient has received prior therapy with an oxaliplatin-based regimen AND used in combination with Erbitux (cetuximab) or Vectibix (panitumumab); OR (b) Patient has not received prior therapy with an oxaliplatin-based regimen AND used in combination with Erbitux (cetuximab) or Vectibix (panitumumab) AND FOLFOX (fluorouracil, leucovorin, and oxaliplatin)

Authorization will be issued for 12 months

inv-04: Reauthorization - Colon/Rectal Cancer

Covered when ALL of the following are met

CRC reauth: (1) Patient does not show evidence of progressive disease while on Braftovi therapy; (2) Continued use in combination with Erbitux (cetuximab)

Authorization will be issued for 12 months

inv-05: Initial Therapy - NSCLC

Covered when ALL of the following are met

NSCLC initial: (1) Diagnosis of non-small cell lung cancer (NSCLC); (2) Presence of BRAF V600 mutation; (3) Disease is advanced, recurrent, or metastatic; (4) Used in combination with Mektovi (binimetinib)

Authorization will be issued for 12 months

inv-06: Reauthorization - NSCLC

Covered when ALL of the following are met

NSCLC reauth: (1) Patient does not show evidence of progressive disease while on Braftovi therapy; (2) Continued use in combination with Mektovi (binimetinib)

Authorization will be issued for 12 months

Braftovi (encorafenib) is not indicated for the treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer (CRC), or wild-type BRAF non‑small cell lung cancer (NSCLC).

Use of Braftovi for tumors that are wild‑type for BRAF is not an indicated use and, per the documented limitations of use, would be considered not medically necessary when requested for these populations.

Initial Authorization Rules by Indication

inv-15: Initial therapy

Covered when ALL of the following are met

Initial therapy by indication: Refer to indication-specific initial authorization criteria: melanoma (BRAF V600E; combination with Mektovi), colon/rectal cancer (BRAF V600E; combination with Erbitux or Vectibix ± FOLFOX depending on prior oxaliplatin exposure), and NSCLC (BRAF V600 mutation; combination with Mektovi)

Authorizations will be issued for 12 months when criteria are met

Continuation / Reauthorization Criteria

inv-16: Continuation therapy / Reauthorization

Reauthorization conditions require lack of progression and continued combination therapy.

General continuation: Patient does not show evidence of progressive disease while on Braftovi therapy AND continued use in combination with the specified agent (Mektovi for melanoma and NSCLC; Erbitux for colorectal cancer)

Authorization will be issued for 12 months

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Braftovi (encorafenib). Approvals are issued for up to 12 months when the specified diagnostic, mutation, and combination-regimen criteria are met.

PA required; approvals issued for 12 months when criteria met
Automated approvals may be granted based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic
Supply limits may apply

Step Therapy

Step Therapy and Regimen Requirements

Coverage is conditional on use in specified combination regimens and prior oxaliplatin exposure where relevant for colorectal cancer. There is no general step-therapy sequence beyond the regimen- and prior-therapy requirements described.

Melanoma: must be used in combination with Mektovi (binimetinib)

Step Therapy and Regimen Sequencing

Step therapy note	Details
Coverage sequencing	No explicit step therapy sequencing is specified in the policy. Coverage is conditional on meeting the indication-specific combination regimen requirements; for colorectal cancer the choice of concomitant regimen depends on prior oxaliplatin exposure (if prior oxaliplatin-based therapy, use with cetuximab or panitumumab; if no prior oxaliplatin, use with cetuximab or panitumumab plus FOLFOX).
Prior therapy consideration	CRC initial criteria reference prior oxaliplatin exposure to determine which combination regimen is appropriate (see CRC initial authorization criteria specifying 'patient has received prior therapy with an oxaliplatin-based regimen' vs 'patient has not received prior therapy with an oxaliplatin-based regimen').

Quantity and Supply Limits

Quantity limits / supply policy note

Quantity limit statusSupply limits may be in place for Braftovi (encorafenib).

Typical enforcementLimits applied by program logic or therapeutic-class rules (may affect automated approvals).

Authorization interactionQuantity limits do not replace prior authorization requirement; PA still required per policy.

Background and Drug Information

Braftovi (encorafenib) is a kinase inhibitor that is approved in combination regimens for specific BRAF V600–mutant cancers. It is indicated with Mektovi (binimetinib) for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, with Mektovi for metastatic NSCLC with a BRAF V600E mutation, and with Erbitux (cetuximab) — with or without mFOLFOX6 depending on prior therapy — for metastatic colorectal cancer with a BRAF V600E mutation. The agent is not indicated for tumors that are wild‑type for BRAF.

Definitions and Limitations of Use

Limitations of Use — wild-type BRAF exclusion

Primary limitationBraftovi is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer (CRC), or wild-type BRAF non-small cell lung cancer (NSCLC).

Implication for coverageUse in wild-type BRAF tumors is not an indicated use and would be considered not medically necessary under the documented limitations of use.

Mutation requirementCoverage is limited to tumors with BRAF V600 mutations (V600E or V600K for melanoma; V600E required for CRC and NSCLC per indication).

Policy Revision Timeline

2025-06annual_review/material_updateLatest

Annual review combined criteria sections for colon and rectal cancer and updated initial and reauthorization criteria; background and references updated to reflect use with Erbitux and mFOLFOX6 for BRAF V600E metastatic colorectal cancer.

2025-02update

Background and criteria updated to include new FDA-approved use of Braftovi in combination with Erbitux and mFOLFOX6 for BRAF V600E mutated colorectal cancer.

2024-06annual_review/update

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBraftovi (encorafenib) prior authorization

Policy CodePolicy 2025 P 1255-10

Change TypeMaterial updates to indications and CRC criteria

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of BRAF V600 mutation status and the specified concurrent regimen to obtain a 12‑month approval.

SourceLink

On This Page

Colorectal cancer (BRAF V600E): required combinations depend on prior oxaliplatin exposure — either cetuximab/panitumumab ± FOLFOX as specified

NSCLC: must be used in combination with Mektovi (binimetinib)

Documentation Required

Required Documentation

Documentation must support the diagnosis, documented BRAF V600 mutation status (V600E or V600K where specified), and the patients prior treatment history and the concomitant regimen to be used with Braftovi.

Documented diagnosis (melanoma, CRC, or NSCLC as applicable)
Documented BRAF V600 mutation result (V600E or V600K where required)
Treatment history (including prior oxaliplatin-based regimen when relevant) and planned combination agents (eg, Mektovi, Erbitux/cetuximab, Vectibix/panitumumab, FOLFOX)

Denial Risk

Triggers for Denial / Coverage Exclusions

Coverage may be denied if the indication, mutation status, or combination regimen does not match the policy criteria, or if other plan or federal exclusions apply.

Missing or unconfirmed BRAF V600 mutation (V600E or V600K as required) — denial risk
Use as monotherapy or with non-specified combination agents — denial risk
Regimen mismatch for colorectal cancer (eg, absence of required prior oxaliplatin exposure or absence of required concurrent FOLFOX where specified) — denial risk
Off-label uses not covered by state mandates or compendia exceptions — may be excluded

Annual review updated language and formatting of criteria for melanoma, colon cancer, and rectal cancer; added NCCN-based coverage for advanced and recurrent NSCLC and reauthorization requirement that Braftovi be used with Mektovi for NSCLC.

2023-12update

Background and criteria updated to include FDA-approved use of Braftovi in combination with Mektovi for BRAF V600E NSCLC; references updated.

2022-06annual_review/update

Annual review added continuation of combination therapy to colon and rectal cancer and updated background and references.

2021-06annual_review

Annual review with no change to criteria; references updated.

2020-06update

Updated background and criteria to include new indication of BRAF V600E mutated colorectal cancer and modified criteria to include NCCN recommended use (no longer requiring concomitant Mektovi).

2019-09new_program/annual

Program annual review after initial 2018 program establishment; background updated to include NCCN recommended use in BRAF V600E colorectal cancer.

2018-08new_program

Prior authorization/notification program created for Braftovi (encorafenib).