ModifiedUnitedHealthcarePolicy 2025 P 1103-15

Tafinlar (dabrafenib) prior authorization criteria

Defines UnitedHealthcare prior authorization/notification criteria, initial and reauthorization rules, indications, required mutation status, combination use with Mekinist (trametinib) for multiple tumor types, pediatric automatic processing under 19, and authorization duration (12 months). Effective for Tafinlar (dabrafenib).

Policy Summary

PayerUnitedHealthcare

PolicyTafinlar (dabrafenib) prior authorization criteria

Policy CodePolicy 2025 P 1103-15

Change TypeAnnual review — revised background and references

Effective DateAug 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of BRAF V600/V600E mutation; approvals issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Annual review with updated background and references; effective date 8/1/2025.

12 monthsAuthorization duration

BRAF V600/V600EMutation requirement

MultipleCovered Indications

Age <19 auto-processPediatric handling

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Coverage Summary

Defines UnitedHealthcare prior authorization/notification criteria for Tafinlar (dabrafenib), covering multiple tumor types including unresectable or metastatic melanoma, NSCLC, thyroid cancers, CNS tumors, histiocytic disorders, gallbladder and cholangiocarcinomas, ovarian/fallopian tube/primary peritoneal cancer, pancreatic/ampullary cancer, hairy cell leukemia, salivary gland tumors, GIST, other solid tumors, and pediatric low-grade glioma. Coverage requires documentation of BRAF V600/V600E mutation as specified per indication. Many indications require use in combination with Mekinist (trametinib) or allow combination use; single-agent use is allowed in select situations (e.g., intolerance to combination). Prescriptions for members <19 years auto-process without coverage review. Authorizations are issued for 12 months when criteria are met.

Quick facts / Key thresholds

Authorization duration12 months

Mutation requirementBRAF V600/V600E

Covered IndicationsMultiple tumor types (see criteria)

Pediatric handlingAge <19 auto-process (prescription automatically processes without coverage review)

Effective date2025-08-01

Last review2025-05

Initial Therapy Criteria

Initial Authorization — Melanoma (unresectable/metastatic/adjuvant)

Initial Authorization — Melanoma (unresectable/metastatic/adjuvant). Authorization will be issued for 12 months.

ALL of the following

One of the following:
- Unresectable melanoma
- Metastatic melanoma
- Both of the following:
  - Prescribed as adjuvant therapy for melanoma involving the lymph node(s)

Continuation / Reauthorization Criteria

Provider Actions & Authorization Rules

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Tafinlar per UnitedHealthcare Pharmacy Clinical Pharmacy Programs. When the coverage criteria are met, approvals will be issued for 12 months.

Documentation Required

BRAF mutation documentation required

Coverage requires documentation that the cancer is positive for a BRAF V600 or BRAF V600E mutation as specified for the indication. Mutation status must be detected by an FDA‑approved test or a recognized companion diagnostic.

Applicable Codes

ICD-10 Diagnoses referencedICD-10

No codes listed

Clinical Evidence & References

Background: Tafinlar (dabrafenib) is a BRAF kinase inhibitor indicated for BRAF V600-mutant unresectable or metastatic melanoma and multiple other tumor types either as monotherapy or in combination with Mekinist (trametinib). The FDA label includes accelerated approval for treatment of adult and pediatric patients 1 year and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment, and pediatric indications such as low-grade glioma. The National Comprehensive Cancer Network (NCCN) also recommends Tafinlar (often in combination with Mekinist) across multiple tumor types including melanoma (adjuvant and CNS involvement), NSCLC, thyroid carcinomas, CNS gliomas, ovarian/fallopian/primary peritoneal cancer, pancreatic/ampullary adenocarcinomas, histiocytic neoplasms, hepatobiliary cancers, hairy cell leukemia, salivary gland tumors, and GIST.

Evidence references: Tafinlar package insert (GlaxoSmithKline) April 2025 and The NCCN Drugs and Biologics Compendium, accessed April 10, 2025. UnitedHealthcare P&T approval history and program details reflect annual reviews and updates through May 2025 with an effective date 8/1/2025.

Definitions

Mekinist (term)trametinib, MEK inhibitor often used in combination with dabrafenib (Tafinlar)

BRAF V600E mutation (term)Specific activating BRAF mutation required for many covered indications; detection via FDA-approved test or companion diagnostic

Background

Mechanism and approved indications overview: Tafinlar (dabrafenib) is a BRAF kinase inhibitor. Per FDA labeling, it is indicated as a single agent for unresectable or metastatic melanoma with BRAF V600E mutation detected by an FDA-approved test, and in combination with Mekinist (trametinib) for unresectable or metastatic melanoma with BRAF V600E or V600K mutations and for adjuvant treatment of melanoma involving lymph nodes after complete resection. The combination with trametinib is also indicated for metastatic NSCLC with BRAF V600E, locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E and no satisfactory locoregional options, and for adult and pediatric patients ≥1 year with unresectable or metastatic solid tumors with BRAF V600E (accelerated approval). The NCCN further supports use of Tafinlar with Mekinist across multiple indications and as monotherapy in certain thyroid cancers and other settings.

Revision History

7/2013P&T approval

Initial prior authorization criteria approved for Tafinlar (dabrafenib).

2/2014P&T approval

Updated approval for combination therapy with Mekinist (trametinib).

5/2014P&T approval

Auto-update to get on cycle (change control entry).

Policy Summary

PayerUnitedHealthcare

PolicyTafinlar (dabrafenib) prior authorization criteria

Policy CodePolicy 2025 P 1103-15

Change TypeAnnual review — revised background and references

Effective DateAug 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of BRAF V600/V600E mutation; approvals issued for 12 months when criteria are met.

SourceLink

On This Page

Used in combination with Mekinist (trametinib)

Cancer is positive for BRAF V600 mutation

BRAF V600 mutation includes V600E and V600K as applicable per FDA/NCCN guidance.

Initial Authorization — CNS cancers (metastatic brain lesions/glioma)

Initial Authorization — CNS cancers (metastatic brain lesions/glioma). Authorization will be issued for 12 months.

ALL of the following

One of the following:
- Both of the following:
  - Patient has metastatic brain lesions
  - Tafinlar is active against primary tumor (melanoma)
- Patient has a glioma
Cancer is positive for BRAF V600E mutation
Used in combination with Mekinist (trametinib)

Initial Authorization — Non-small cell lung cancer (NSCLC)

Initial Authorization — Non-small cell lung cancer (NSCLC).

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Disease is one of the following:
- Metastatic
- Advanced
- Recurrent
Cancer is positive for BRAF V600E mutation
One of the following:
- Used in combination with Mekinist (trametinib)
- Used as a single agent if the combination of Mekinist and Tafinlar is not tolerated

Initial Authorization — Anaplastic thyroid cancer (ATC) and other thyroid carcinomas

Initial Authorization — Anaplastic thyroid cancer (ATC) and other thyroid carcinomas. Authorization will be issued for 12 months.

ALL of the following

ONE of the following diagnoses:
- Anaplastic thyroid cancer (ATC)
  - Diagnosis of anaplastic thyroid cancer (ATC)
  - Cancer is positive for BRAF V600E mutation
  - Used in combination with Mekinist (trametinib)
  - One of the following disease states:
    Metastatic
    Locally advanced
    Unresectable
  - OR:
    Prescribed as adjuvant therapy following resection
- Follicular/Oncocytic/Papillary thyroid carcinomas
  - One of: Follicular carcinoma; Oncocytic carcinoma; Papillary carcinoma
  - One of the following disease states:
    Unresectable locoregional recurrent disease
    Persistent disease
    Metastatic disease
  - One of the following:
    Patient has symptomatic disease

Initial Authorization — Gallbladder and Cholangiocarcinomas

Initial Authorization — Gallbladder and Cholangiocarcinomas. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of one of the following:
- Gallbladder cancer
- Extrahepatic Cholangiocarcinoma
- Intrahepatic Cholangiocarcinoma
Used as subsequent treatment after progression on or after systemic treatment
Disease is unresectable or metastatic
Cancer is positive for BRAF V600E mutation
Used in combination with Mekinist (trametinib)

Initial Authorization — Histiocytic disorders

Initial Authorization — Histiocytic disorders. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of one of the following:
- Langerhans Cell Histiocytosis
- Erdheim-Chester Disease
Cancer is positive for BRAF V600E mutation

Initial Authorization — Other solid tumors (histology-agnostic BRAF V600E)

Initial Authorization — Other solid tumors (histology-agnostic BRAF V600E). Authorization will be issued for 12 months.

ALL of the following

Presence of solid tumor
Used as subsequent treatment after progression on or after systemic treatment
Disease is unresectable or metastatic
Cancer is positive for BRAF V600E mutation
Used in combination with Mekinist (trametinib)

Initial Authorization — Epithelial Ovarian / Fallopian Tube / Primary Peritoneal Cancer

Initial Authorization — Epithelial Ovarian / Fallopian Tube / Primary Peritoneal Cancer. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of one of the following:
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
One of the following:
- Persistent disease
- Recurrence in BRAF V600E positive tumors
- Recurrence of low-grade serous carcinoma
Used in combination with Mekinist (trametinib)

Initial Authorization — Pancreatic / Ampullary cancer

Initial Authorization — Pancreatic / Ampullary cancer. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of one of the following:
- Pancreatic adenocarcinoma
- Ampullary adenocarcinoma
Disease is one of the following:
- Metastatic
- Locally advanced
- Unresectable
Cancer is positive for BRAF V600E mutation
Used in combination with Mekinist (trametinib)

Initial Authorization — Hairy cell leukemia

Initial Authorization — Hairy cell leukemia. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of hairy cell leukemia
Used in combination with Mekinist (trametinib)

Initial Authorization — Salivary gland tumor

Initial Authorization — Salivary gland tumor. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of salivary gland tumor
Disease is one of the following:
- Recurrent and unresectable
- Metastatic
Cancer is positive for BRAF V600E mutation
Used in combination with Mekinist (trametinib)

Initial Authorization — BRAF V600E-mutated GIST

Initial Authorization — BRAF V600E-mutated GIST. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of BRAF V600E-mutated gastrointestinal stromal tumor (GIST)
Disease is one of the following:
- Gross residual disease (R2 resection)
- Unresectable primary disease
- Tumor rupture
- Progressive
- Recurrent
- Metastatic
Used in combination with Mekinist (trametinib)

NCCN Recommended Regimens

NCCN Recommended Regimens: NCCN recognition (Category 1/2A/2B) is included as supporting guidance for coverage where applicable.

ANY of the following

NCCN-recommended regimens (Category 1, 2A, or 2B) may support coverage decisions for indications listed above as applicable
Providers should document NCCN-based rationale in the submission when relying on guideline-recommended regimens for off-label or less-common indications.

Billing Rule

Pediatric auto-processing under age 19

For members under age 19 the prescription will automatically process without a coverage review; when criteria are met an authorization will be issued for 12 months.

Step Therapy

Subsequent treatment requirement for select indications

For several tumor types (for example gallbladder cancer, extrahepatic or intrahepatic cholangiocarcinoma, and other solid tumors), Tafinlar is authorized when used as subsequent treatment after progression on or after systemic treatment.

Denial Risk

Reauthorization denial risk for progression

Reauthorization requires that the patient does not show evidence of progressive disease while on Tafinlar therapy; reauthorization may be denied if progressive disease is documented.

5/2015P&T approval

Annual review; updated coverage criteria and background with NCCN melanoma recommendation; added CNS cancer and NSCLC criteria; authorization increased to 12 months.

5/2016P&T approval

Annual review with updated background and references; no change to clinical criteria.

3/2017P&T approval

Annual review; editorial change from 'member' to 'patient' and updated references; no changes to coverage criteria.

3/2018P&T approval

Annual review; updated background to include new NSCLC indication and updated criteria to include NCCN adjuvant treatment recommendation in stage III disease; updated references.

3/2019P&T approval

Annual review; updated background and references.

3/2020P&T approval

Annual review; added general NCCN recommendations for use criteria and updated references.

3/2021P&T approval

Annual review; updated coverage criteria for CNS cancer per NCCN recommendations and updated references.

3/2022P&T approval

Annual review; per NCCN recommendations updated CNS cancer criteria and added criteria for hepatobiliary cancer and histiocytic neoplasms; updated background and references.

8/2022P&T approval

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

5/2023P&T approval

Updated background and coverage criteria with indication for pediatric patients with low-grade glioma per prescribing information; per NCCN recommendations updated CNS and thyroid cancer coverage and added ovarian, pancreatic, and ampullary cancer criteria.

5/2024P&T approval

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

5/2025P&T approvalLatest

Annual review with updated background and references; coverage criteria expanded over prior years to include new indications (solid tumors, pediatric LGG, hairy cell leukemia, salivary gland tumor, GIST) per package insert and NCCN. (Material change)

2025-08-01effective_dateLatest

Annual review with updated background and references; effective date 8/1/2025.

Patient has progressive disease

Disease is refractory to radioactive iodine treatment

Cancer is positive for BRAF V600 mutation