Colorado Rocky Mountain Health Plans Tafinlar Prior Auth

Coverage Criteria for Tafinlar (dabrafenib)

inv-01: Patients less than 19 years — covered when ALL of the following are met

Covered when ALL of the following are met

Pediatric automatic approval: Patient is less than 19 years of age

Authorization issued for 12 months

inv-02: Melanoma — initial — Covered when ALL of the following are met

Covered when ALL of the following are met

Melanoma indications: One of: unresectable melanoma OR metastatic melanoma OR prescribed as adjuvant therapy for melanoma involving the lymph node(s) when used in combination with Mekinist (trametinib); AND cancer is positive for BRAF V600 mutation

Authorization issued for 12 months

inv-04: CNS metastases / Glioma — initial — Covered when ALL of the following are met

Covered when ALL of the following are met

CNS/glioma indications: Either: (a) patient has metastatic brain lesions AND Tafinlar is active against the primary tumor (melanoma) OR (b) patient has a glioma; AND cancer is positive for BRAF V600E mutation; AND used in combination with Mekinist (trametinib)

Authorization issued for 12 months

inv-05: NSCLC — initial — Covered when ALL of the following are met

Covered when ALL of the following are met

NSCLC indications: Diagnosis of non-small cell lung cancer (NSCLC) AND disease is metastatic OR advanced OR recurrent AND cancer is positive for BRAF V600E mutation AND either used in combination with Mekinist (trametinib) OR used as a single agent if the combination is not tolerated

inv-06: Anaplastic thyroid cancer — initial — Covered when ALL of the following are met

Covered when ALL of the following are met

ATC indications: Diagnosis of anaplastic thyroid cancer (ATC) AND cancer is positive for BRAF V600E mutation AND used in combination with Mekinist (trametinib) AND disease is metastatic OR locally advanced OR unresectable OR prescribed as adjuvant therapy following resection

Authorization issued for 12 months

inv-07: Differentiated thyroid carcinoma — initial — Covered when ALL of the following are met

Covered when ALL of the following are met

Differentiated thyroid carcinoma indications: Diagnosis of follicular, oncocytic, or papillary carcinoma AND unresectable locoregional recurrent disease OR persistent disease OR metastatic disease AND symptomatic disease OR progressive disease AND disease is refractory to radioactive iodine treatment AND cancer is positive for BRAF V600 mutation

Authorization issued for 12 months

inv-08: Biliary tract cancers — initial — Covered when ALL of the following are met

Covered when ALL of the following are met

Gallbladder / Cholangiocarcinoma indications: Diagnosis of gallbladder cancer OR extrahepatic cholangiocarcinoma OR intrahepatic cholangiocarcinoma AND used as subsequent treatment after progression on or after systemic treatment AND disease is unresectable or metastatic AND cancer is positive for BRAF V600E mutation AND used in combination with Mekinist (trametinib)

Authorization issued for 12 months

inv-09: Histiocytic neoplasms — initial — Covered when ALL of the following are met

Covered when ALL of the following are met

Histiocytic disorders: Diagnosis of Langerhans Cell Histiocytosis OR Erdheim-Chester Disease AND cancer is positive for BRAF V600E mutation

Authorization issued for 12 months

inv-10: Initial Authorization — Solid Tumors — Covered when ALL of the following are met for certain solid tumors

Covered when ALL of the following are met for certain solid tumors:

Solid tumor initial authorization: Presence of a solid tumor AND used as subsequent treatment after progression on or after systemic treatment AND disease is unresectable or metastatic AND cancer is positive for BRAF V600E mutation AND used in combination with Mekinist (trametinib)

Authorization will be issued for 12 months

inv-11: Initial Authorization — Ovarian/Fallopian/Peritoneal — Covered when ALL of the following are met

Covered when ALL of the following are met for epithelial ovarian/fallopian tube/primary peritoneal cancer:

Ovarian/fallopian/peritoneal initial authorization: Diagnosis of epithelial ovarian cancer OR fallopian tube cancer OR primary peritoneal cancer AND persistent disease OR recurrence in BRAF V600E positive tumors OR recurrence of low-grade serous carcinoma AND used in combination with Mekinist (trametinib)

Authorization will be issued for 12 months

inv-12: Initial Authorization — Pancreatic/Ampullary — Covered when ALL of the following are met

Covered when ALL of the following are met for pancreatic/ampullary cancer:

Pancreatic/ampullary initial authorization: Diagnosis of pancreatic adenocarcinoma OR ampullary adenocarcinoma AND disease is metastatic OR locally advanced OR unresectable AND cancer is positive for BRAF V600E mutation AND used in combination with Mekinist (trametinib)

Authorization will be issued for 12 months

inv-13: Initial Authorization — Hematologic and Other Tumors (hairy cell leukemia and others) — Covered when BOTH of the following are met

Covered when BOTH of the following are met

Hairy cell leukemia initial authorization: Diagnosis of hairy cell leukemia AND used in combination with Mekinist (trametinib)

Authorization will be issued for 12 months

Salivary gland tumor initial authorization: Diagnosis of salivary gland tumor AND disease is recurrent and unresectable OR metastatic AND cancer is positive for BRAF V600E mutation AND used in combination with Mekinist (trametinib)

Authorization will be issued for 12 months

BRAF V600E-mutated GIST initial authorization: Diagnosis of BRAF V600E-mutated GIST AND disease is gross residual (R2 resection) OR unresectable primary disease OR tumor rupture OR progressive OR recurrent OR metastatic AND used in combination with Mekinist (trametinib)

Authorization will be issued for 12 months

inv-14: Reauthorization — Reauthorization criteria (applies broadly)

Reauthorization — Reauthorization criteria (applies broadly):

Reauthorization: Patient does not show evidence of progressive disease while on Tafinlar therapy

Authorization will be issued for 12 months when criterion met

inv-15: NCCN Recommended Regimens — NCCN-based coverage allowance

NCCN-based coverage allowance:

NCCN recognized regimens: Drug recognized for treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Supports coverage per policy

Tafinlar (dabrafenib) is not indicated for treatment of patients with wild-type BRAF solid tumors. Coverage is limited to tumors with documented activating BRAF V600 mutations as specified elsewhere in this policy.

Coverage under this policy may be affected by state mandates and the member’s specific benefit plan. Any applicable federal requirements, the member’s benefit design, and other UnitedHealthcare policies or utilization management programs may also affect coverage determinations.

For reauthorization, the policy requires documentation showing the member does not have evidence of progressive disease while on Tafinlar. Progressive disease while receiving Tafinlar is a basis to deny reauthorization as not medically necessary.

Initial Therapy Authorization Rules

inv-32: Initial therapy — Initial therapy authorization rules are indication-specific and require documentation of BRAF V600 mutation and other indication-specific requirements

Initial therapy — Initial therapy authorization rules are indication-specific and require documentation of BRAF V600 mutation and other indication-specific requirements

See coverage.criteria_sets: Initial authorization nodes per indication require mutation positivity and indication-specific conditions (see coverage.criteria_sets entries).

Authorizations generally for 12 months

inv-33: Initial Therapy — Initial authorization rules vary by indication but commonly require diagnosis confirmation and use with Mekinist (trametinib).

Initial Therapy — Initial authorization rules vary by indication but commonly require diagnosis confirmation and use with Mekinist (trametinib).

General initial therapy: Indication-specific diagnostic confirmation (see indication), tumor BRAF V600E positivity where specified, disease stage (e.g., unresectable/metastatic), and combination use with Mekinist (trametinib)

Reauthorization and Continuation Criteria

inv-34: Reauthorization — Continuation/reauthorization requirements

Reauthorization — Continuation/reauthorization requirements

Continuation: Patient does not show evidence of progressive disease while on Tafinlar therapy

Authorization issued for 12 months upon reauthorization

inv-35: Reauthorization/Continuation Therapy — Reauthorization is permitted when there is no evidence of disease progression on therapy.

Reauthorization/Continuation Therapy — Reauthorization is permitted when there is no evidence of disease progression on therapy.

Continuation: Patient does not show evidence of progressive disease while on Tafinlar therapy

Authorization issued for 12 months

Provider Requirements and Actionable Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tafinlar. Initial approvals are indication- and criteria-specific and are generally issued for 12 months when criteria are met. Lack of required documentation (including mutation testing or disease state) may result in denial. UnitedHealthcare may use automated approval based on prior claims/medication history, diagnosis codes (ICD-10), and/or claim logic; supply limits may apply.

Prior authorization required; initial approvals typically issued for 12 months when criteria are met
Automated approval/re-approval may be granted based on prior claim/medication history, ICD-10 diagnosis codes, and/or claim logic — supply limits may apply

Documentation Required

Initial Authorization — Solid Tumors

For initial authorization of solid tumors (tumor-agnostic indication), all of the following must be documented: presence of an unresectable or metastatic solid tumor; use as subsequent treatment after progression on or after prior systemic treatment; tumor positive for BRAF V600E mutation; and used in combination with Mekinist (trametinib).

Step Therapy and Sequencing Rules

Step	Requirement
1
Combination with Mekinist (trametinib) is required for NSCLC; single‑agent Tafinlar (dabrafenib) is allowed only if the combination is not tolerated.

Step	Requirement
1
Use as subsequent treatment after progression on or after systemic treatment (for eligible solid tumors); disease must be unresectable or metastatic and BRAF V600E mutation positive, and when indicated used in combination with Mekinist (trametinib).

Background and Drug Information

Tafinlar (dabrafenib) is a BRAF kinase inhibitor indicated for treatment of tumors harboring activating BRAF codon 600 mutations. As a single agent it is indicated for unresectable or metastatic melanoma with BRAF V600E mutation detected by an FDA‑approved test. In combination with Mekinist (trametinib) it is indicated for additional BRAF V600E and V600K–mutant malignancies including metastatic NSCLC with BRAF V600E, locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E, pediatric unresectable or metastatic solid tumors with BRAF V600E after prior therapy, and pediatric low‑grade glioma with BRAF V600E

Definitions and Key Terms

BRAF V600 mutation (definition)

DefinitionMutation in codon V600 of the BRAF gene (examples: V600E, V600K) as detected by an FDA-approved test

Clinical implicationPresence of a BRAF V600 mutation is required documentation for covered indications of Tafinlar in multiple tumor types

Testing requirementMutation must be identified using an FDA‑approved test per the product label and policy references

NCCN Recommended Regimens (definition and usage)

DefinitionRegimens recognized by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Policy useNCCN-recognized regimens support coverage per this policy when the compendium lists the regimen for the cancer indication

Policy Revision History

2025-05annual_reviewLatest

Annual review updated background and references.

2024-05added_criteria

Added coverage criteria for hairy cell leukemia, salivary gland tumor, and GIST per NCCN; updated background and references.

2022-08updated_indication

Updated background and coverage criteria to include new indication for solid tumors with BRAF V600E mutation per package insert.

OpenPayer

Tafinlar (dabrafenib) — Prior Authorization and Coverage Criteria

Coverage Criteria for Tafinlar (dabrafenib)

Initial Therapy Authorization Rules

Reauthorization and Continuation Criteria

Provider Requirements and Actionable Rules

Step Therapy and Sequencing Rules

Background and Drug Information

Definitions and Key Terms

Policy Revision History