CurrentHealth NetPolicy CP PHAR.239

Clinical Policy: Dabrafenib (Tafinlar)

Defines medical necessity criteria, prior authorization expectations, dosing, approval durations, and coverage limits for dabrafenib (Tafinlar) across commercial, HIM, and Medicaid lines of business, including FDA-approved and NCCN-recommended off-label BRAF V600E/K mutation-positive indications and pediatric uses.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Dabrafenib (Tafinlar)

Policy CodePolicy CP PHAR.239

Change TypeAnnual reviews / revised criteria

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit documentation (chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria, including mutation status and prior treatment history.

POLICY UPDATE CHANGES

2025 annual review: consolidated biliary tract cancer types, added neuroglioma and glioneuronal tumor, added recurrent or progressive adult high-grade gliomas, clarified ovarian/fallopian/peritoneal cancers, consolidated gastric/esophageal group; updated FDA-approved ATC indication to include detection by an FDA-approved test.

2023-2024 updates: added pediatric LGG FDA approval and pediatric dosing/weight documentation; moved multiple cancer types between off-label and solid tumor criteria per NCCN; clarified thyroid cancer criteria to specify ATC per PI.

2021-2022 annual reviews: removed colorectal cancer off-label use, added generic redirection language, added 'limited resectable' melanoma classification, and other clarifications per NCCN.

MultipleCovered Indications (FDA + NCCN examples)

300 mg/dayAdult maximum dose

Minimum duration prior to continuation

1 yearPediatric age minimum for solid tumor indication

Coverage Summary

Policy stance: Covered with criteria — dabrafenib (Tafinlar) is covered when the policys medical necessity criteria are met, incorporating both FDA-approved indications and NCCN-recommended off-label uses as specified in the policy and compendium references.

Key thresholds & quick facts

Policy numberCP PHAR.239

Effective date11.16.16

Last review / P&T approval05.25 (last review date) / P&T Approval Date 05.25

Maximum adult daily dose300 mg per day

Maximum capsules per day4 capsules per day

Minimum therapy prior to continuation request≥ 30 days

Pediatric age minimum (solid tumor indication)1 year

Initial Therapy Criteria (by indication)

Initial Approval Criteria - Melanoma (BRAF V600E or V600K)

Tafinlar is medically necessary when ALL of the following are met:

ALL of the following

Disease status (one of)
- Diagnosis of melanoma with BRAF V600E or V600K mutation
  supporting detection by an FDA-approved test per PI
- Unresectable
- Limited resectable
- Metastatic

Continuation Therapy Criteria

Continued Therapy Criteria (All Indications)

For continued approval, ALL of the following must be met:

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Unapproved / Not Authorized Indications

Diagnoses/Indications Not Authorized

Coverage is NOT authorized when the indication is:

ALL of the following

Non-FDA approved indications that are not addressed in this policy and lack sufficient documentation of efficacy and safety per off-label use policies (CP.CPA.09 for commercial, HIM.PA.154 for HIM, CP.PMN.53 for Medicaid) or evidence of coverage documents
See referenced off-label policies

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Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Requests for Tafinlar require prior authorization. Combination use with trametinib (Mekinist) may require a separate prior authorization for Mekinist.

Documentation Required

Submit supporting documentation

Provider must submit documentation (chart notes, lab results, or other clinical information) demonstrating the member meets all approval criteria, including documented BRAF V600E/V600K mutation status and prior treatment history.

Mutation status (BRAF V600E or V600K) as detected by an FDA‑approved test
Prior treatment history
Relevant chart notes and lab results

Applicable Codes & Product Availability

Product Availability (NDC not specified in policy)mixed

Capsules: 50 mg, 75 mg	Available capsule strengths
Tablet for oral suspension: 10 mg	Available tablet for oral suspension strength

Clinical Evidence & References

Evidence summary: Coverage follows the Tafinlar Prescribing Information (Feb 2025) and the NCCN Drugs and Biologics Compendium and disease-specific NCCN guidelines (2024-2025). The policy adopts FDA-labeled indications and permits NCCN-recommended off-label uses where specified, requiring prescriber documentation and prior authorization as appropriate.

Background

Background and dosing: Dabrafenib is a kinase inhibitor. Indications covered include multiple BRAF V600E or V600K mutation-positive malignancies per FDA labeling and NCCN-compendium examples. Adult dosing for melanoma, NSCLC, and anaplastic thyroid cancer is 150 mg twice daily (300 mg/day maximum). Pediatric weight-based dosing (capsules and 10 mg oral suspension tablets) is detailed in the prescribing information for patients ≥1 year of age, with specific mg/kg-equivalent tablet/capsule regimens by weight band. Duration guidance: treat until disease progression or unacceptable toxicity (adjuvant melanoma has guidance up to 1 year where specified). Product availability includes capsules 50 mg and 75 mg and 10 mg oral suspension tablets.

Definitions

Glossary: BRAF — B-Raf proto-oncogene, serine/threonine kinase; LGG — Low-grade glioma; ATC — Anaplastic thyroid cancer; NSCLC — Non-small cell lung cancer.

Revision History

2025-02-12effective_document_dateLatest

2025 annual review — document effective date: policy updated to consolidate biliary tract cancer types; added neuroglioma and glioneuronal tumor; added recurrent or progressive adult high-grade gliomas; clarified ovarian/fallopian/peritoneal cancers; consolidated gastric/esophageal group; updated FDA-approved ATC indication to specify detection by an FDA‑approved test. Detailed revisions reflected in criteria and Appendix D examples.

2025-05-25P&T_approvalLatest

2025 annual review — P&T approval: revisions noted include the ATC FDA‑approved indication update (detection by an FDA‑approved test) and the consolidation/additions to NCCN off‑label solid tumor listings; P&T Approval Date recorded in revision log.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Dabrafenib (Tafinlar)

Policy CodePolicy CP PHAR.239

Change TypeAnnual reviews / revised criteria

Effective DateNov 16, 2016

Next Review Date

On This Page

Presence of lymph node(s) involvement following complete resection

adjuvant setting

Prescribed by or in consultation with an oncologist

Prescribed as

In combination with trametinib (Mekinist)
prior authorization for Mekinist may be required
As a single agent for unresectable or metastatic disease with BRAF V600E mutation

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

Dose requirement (one of)

300 mg per dayMaximum adult daily dose: 300 mg per day
Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)

Dose limits

Dose does not exceed 300 mg per dayMaximum adult daily dose: 300 mg per day
Dose does not exceed 4 capsules per dayMaximum capsules per day: 4 capsules per day

Prescribed regimen must be FDA-approved or recommended by NCCN

Initial Approval Criteria - Non-Small Cell Lung Cancer (NSCLC)

Tafinlar is medically necessary when ALL of the following are met:

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Initial Approval Criteria - Anaplastic Thyroid Cancer (ATC)

Tafinlar is medically necessary when ALL of the following are met:

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Initial Approval Criteria - BRAF V600E Mutation-Positive Solid Tumor (FDA-approved & NCCN off-label examples)

Tafinlar is medically necessary when ALL of the following are met:

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Initial Approval Criteria - Pediatric Low-Grade Glioma (LGG)

Tafinlar is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of low-grade glioma (WHO grade 1 or 2)
Age between 1 and 18 years
pediatric LGG FDA approval
Disease is positive for BRAF V600E mutation
Prescribed by or in consultation with an oncologist
Prescribed in combination with trametinib (Mekinist) when indicated (prior authorization for Mekinist may be required)
Member must use generic dabrafenib, if available, unless contraindicated or clinically significant adverse effects are experienced
Documentation of member's current body weight (kg) required for pediatric dosing
Dose requirement (one of)
- Dose does not exceed the FDA approved maximum recommended dose (see Section V)
  pediatric LGG: see dosing section
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN

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Off-Label NCCN Compendium Recommended Indications

For NCCN Compendium recommended off-label indications, ALL of the following must be met:

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Billing Rule

Generic use required when available

Member must use generic dabrafenib when available unless contraindicated or clinically significant adverse effects occur. Prescriber must attest or provide documentation supporting the contraindication or adverse effect when generic is not used.

Attestation or documentation of contraindication to generic dabrafenib or documented clinically significant adverse effects

Documentation Required

Pediatric weight documentation

For pediatric requests, documentation of the member's current body weight in kilograms (kg) is required to determine appropriate weight‑based dosing.

Current body weight (kg) must be provided for pediatric dosing calculations

Documentation Required

Dose justification for off-label or higher dosing

If the requested dose exceeds 300 mg/day or differs from FDA‑approved dosing, the prescriber must submit justification supported by practice guidelines or peer‑reviewed literature to support the off‑label or higher dosing.

If dose > 300 mg/day, submit practice guidelines or peer‑reviewed literature supporting the dose

Denial Risk

Non-covered uses

Non‑FDA approved indications that are not addressed in this policy may be denied if there is insufficient documentation of efficacy and safety per the referenced off‑label use policies.

Potential denial if lacking sufficient off‑label evidence per CP.CPA.09 (commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid)

2023-05-23revised

2023–2024 updates — pediatric dosing and age expansion: pediatric LGG added as FDA indication with dosing/weight documentation requirements and product availability updates (tablet/oral suspension); multiple cancer types reclassified between off‑label and solid tumor criteria per NCCN, and pediatric expansion to younger ages documented.

2023-09-21revised

2023 update (label expansion) — FDA pediatric expansion for BRAF V600E solid tumor indication: criteria updated to reflect pediatric expansion from older ages to 1 year and dosing/weight documentation requirement added.

2021-05-21annual_review

2021–2022 annual reviews — administrative and clinical alignment: removed colorectal cancer off‑label use per NCCN, added generic redirection language, revised references to HIM off‑label policy, added 'limited resectable' melanoma classification and other NCCN‑driven clarifications; P&T approval dates recorded in revision log.

2022-05-22annual_review

2021–2022 updates — clinical criteria refinements: per NCCN added limited resectable melanoma classification, allowances for NSCLC therapy without Tafinlar in certain contexts, clarified thyroid cancer staging/ATC-specific criteria, added radioactive iodine criterion for select thyroid carcinomas, and added CNS/hepatobiliary/histiocytic indications.