CurrentmhnPolicy CP.PHAR.239

Clinical Policy: Dabrafenib (Tafinlar)

Clinical coverage policy defining medical necessity criteria for initiation and continuation of dabrafenib (Tafinlar) across FDA-approved and selected NCCN-recommended off-label indications, dosing limits, duration of approval, pediatric dosing and documentation requirements, and product availability for commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Dabrafenib (Tafinlar)

Policy CodePolicy CP.PHAR.239

Change TypeMultiple annual reviews; revised and clarified indications

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit documentation that the tumor is BRAF V600E or V600K mutation-positive as required by the selected indication (detection by FDA-approved test required for ATC).

POLICY UPDATE CHANGES

RT4: revised criteria to include new FDA-approved indication of BRAF V600E mutation-positive solid tumors (pediatric expansion to age ≥1 year) and updated dosing and availability.

2Q 2024 annual review: specified only ATC for thyroid cancer per PI and added radioactive iodine therapy requirement for certain thyroid carcinomas in solid tumor section.

2Q 2021 annual review: removed colorectal cancer off-label use and added generic redirection language.

RT4: updated FDA-approved indication for ATC to include detection by an FDA-approved test.

7Covered Indication Sections (A-G)

300 mg/dayAdult maximum dose

1 yrMinimum pediatric age for solid tumor FDA approval

Coverage Summary

This policy covers dabrafenib (Tafinlar) as medically necessary with criteria for FDA‑approved indications and selected NCCN‑recommended off‑label uses for BRAF V600 mutation‑positive malignancies. Coverage requirements include diagnosis‑specific criteria (e.g., melanoma, NSCLC, ATC, BRAF V600E mutation‑positive solid tumors, pediatric LGG, hematologic/histiocytic neoplasms), prescriber consultation with an oncologist or hematologist as applicable, and documentation of mutation status. The policy directs use of generic dabrafenib if available unless contraindicated or clinically significant adverse effects occur. Product availability includes capsules (50 mg, 75 mg) and a 10 mg tablet for oral suspension.

Quick Facts and Thresholds

Maximum adult dose300 mg/day

Max capsules/day4 capsules/day

Minimum pediatric age (solid tumor FDA approval)1 year

Covered Indication Sections7

Initial Therapy Criteria

Continuation Therapy Criteria

Unproven / Exclusions

Denials or coverage risk may occur when requests exceed stated dosing limits—specifically doses above 300 mg per day or more than 4 capsules per day—unless the prescriber submits supporting practice guideline or peer‑reviewed literature evidence. Requests for brand Tafinlar instead of available generic dabrafenib may be subject to noncoverage or require justification unless there is a documented contraindication or clinically significant adverse event to the generic. Providers must submit required clinical documentation (e.g., mutation testing, chart notes) to support approval; failure to provide supporting documentation may result in denial per policy.

Provider Actions and Requirements

Documentation Required

Mutation status documentation

Submit documentation that the tumor is BRAF V600E or V600K mutation-positive as required by the selected indication. For ATC, detection by an FDA-approved test is required.

Prior Authorization

Prior authorization for Mekinist may be required

When prescribed in combination with trametinib (Mekinist), prior authorization for Mekinist may be required; prescriber should obtain PA as applicable.

Applicable Codes and Product Availability

Product Availability (NDC not specified)mixed

Capsules: 50 mg, 75 mg	Capsule strengths available
Tablet for oral suspension: 10 mg	Tablet for oral suspension strength available

Clinical Evidence & References

Key evidence sources informing the policy include the primary reference Tafinlar Prescribing Information (Novartis), February 2025 and guideline sources from the NCCN Drugs & Biologics Compendium and disease‑specific NCCN guidelines (multiple 2024–2025 versions). FDA approvals and NCCN‑supported off‑label uses were used to define covered indications and criteria. Policy revisions reflect recent FDA label changes including the pediatric expansion of the BRAF V600E solid tumor indication to patients aged ≥1 year.

Background

Dabrafenib is a kinase inhibitor indicated for BRAF V600 mutation‑positive malignancies and may be used as a single agent or in combination with trametinib (Mekinist) depending on the specific FDA‑approved indication. The policy incorporates FDA approvals and NCCN‑recommended off‑label uses and directs use of generic dabrafenib when available unless contraindicated or clinically significant adverse effects are experienced.

Definitions

ATCanaplastic thyroid cancer

BRAFB-Raf proto-oncogene, serine/threonine kinase

LGGlow grade glioma

NSCLCnon-small cell lung cancer

Revision History

07.08.22revised

RT4: revised criteria to include new FDA-approved indication of BRAF V600E mutation-positive solid tumors (pediatric expansion noted in later RT4 entries); marked as material change in policy history.

04.04.23revised

RT4: added newly FDA approved indication of pediatric low-grade glioma (LGG) and updated dosing (including requirement for documentation of body weight for all pediatric requests) and product availability to include tablet; moved several tumor types between sections per NCCN updates.

09.21.23revised

RT4: updated V600E mutation-positive unresectable or metastatic solid tumors indication to reflect pediatric expansion from patients aged ≥6 years to patients aged ≥1 year.

Policy Summary

Payermhn

PolicyClinical Policy: Dabrafenib (Tafinlar)

Policy CodePolicy CP.PHAR.239

Change TypeMultiple annual reviews; revised and clarified indications

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit documentation that the tumor is BRAF V600E or V600K mutation-positive as required by the selected indication (detection by FDA-approved test required for ATC).

On This Page

Documentation Required

Oncologist consultation requirement

Prescriptions must be by or in consultation with an oncologist (or hematologist for specified hematologic indications).

Documentation Required

Pediatric weight documentation

For pediatric members, provide current body weight (kg) for dosing verification.

Billing Rule

Generic use requirement

Member must use generic dabrafenib if available unless contraindicated or clinically significant adverse effects are experienced.

Denial Risk

Dose limit denial risk

Requests exceeding 300 mg/day or >4 capsules/day without supporting guideline or literature evidence may be denied.

Documentation Required

Initial documentation required

Provider must submit office chart notes, lab results or other clinical information supporting that member has met all approval criteria.

02.07.24revised

2Q 2024 annual review: for thyroid cancer, specified only ATC per prescribing information; revised solid tumor criteria to include off-label indications for resectable disease, removed 'as subsequent treatment' restriction for thyroid carcinomas to allow first-line use in some cases, and clarified adult LGG specification.

02.21.22revised

2Q 2022 annual review: added 'limited resectable' melanoma classification, clarified NSCLC and thyroid criteria, added radioactive iodine therapy requirement for certain thyroid carcinomas, and added multiple off-label indications including CNS and hepatobiliary cancers; commercial approval duration revised.

05.21revised

2Q 2021 annual review: removed colorectal cancer off-label use and added generic redirection language and updated HIM off-label policy reference.

02.12.25clarified

RT4: for anaplastic thyroid cancer (ATC), updated FDA-approved indication to require detection by an FDA-approved test (clarification of required test type).

05.25revisedLatest

RT4 / Feb 2025: revised criteria to include the FDA-approved indication for BRAF V600E mutation-positive solid tumors (pediatric expansion to age ≥1 year), updated dosing and pediatric weight documentation requirements, added tablet product availability, and consolidated/clarified multiple NCCN off-label solid tumor listings (is_material: true).