CurrentNeighborhood Health Plan of Rhode IslandPolicy 1683-A

Dabrafenib (Tafinlar) — Clinical Coverage and Prior Authorization Criteria

Clinical coverage and prior authorization guidance for dabrafenib (Tafinlar) across FDA‑approved and compendial oncology indications, including combination use with trametinib where specified.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDabrafenib (Tafinlar) — Clinical Coverage and Prior Authorization Criteria

Policy CodePolicy 1683-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation proving BRAF mutation to initiate prior authorization; approvals typically granted for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

BRAF V600E/V600Kmutation indications referenced

manycompendial uses listed

1683-Adocument identifier

Coverage Criteria for Dabrafenib (Tafinlar)

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Melanoma coverage: Member has unresectable or metastatic cutaneous melanoma with a BRAF V600 activating mutation (e.g., V600E or V600K) detected by an FDA‑approved test; therapy may be given as single‑agent dabrafenib only if BRAF/MEK combination therapy is contraindicated, otherwise dabrafenib is used in combination with trametinib; included settings: neoadjuvant therapy, adjuvant treatment of resected stage III disease, limited resectable local satellite/in‑transit recurrent disease, and unresectable/metastatic disease.

Authorization duration: 12 months

NSCLC — covered with criteria

Covered when the following are met for NSCLC:

NSCLC coverage: Member has recurrent, advanced, or metastatic non‑small cell lung cancer (NSCLC) with a BRAF V600E mutation detected by an FDA‑approved test; member has not experienced disease progression on prior BRAF‑targeted therapy; dabrafenib may be used as a single agent only if the combination of dabrafenib plus trametinib is not tolerated, otherwise use in combination with trametinib.

Authorization duration: 12 months

Tumor-agnostic solid tumors — covered with criteria

Covered when the following are met for tumor-agnostic solid tumors:

Solid tumor (tumor-agnostic) coverage: Tumor is BRAF V600E mutation‑positive; disease has progressed following prior treatment and there are no satisfactory alternative treatment options; member is ≥1 year of age; request is not for colorectal cancer; dabrafenib will be used in combination with trametinib.

Authorization duration: 12 months

Compendial uses — covered with criteria

Covered compendial indications (each with 12-month authorization unless otherwise noted) when BRAF V600 mutation positive:

Compendial indications: Includes compendial tumor types such as anaplastic thyroid cancer; follicular/oncocytic/papillary thyroid carcinoma (per specific criteria); biliary tract cancers; histiocytic neoplasms (Erdheim‑Chester disease, Langerhans cell histiocytosis); ovarian/fallopian tube/primary peritoneal cancers; GIST; pancreatic adenocarcinoma; salivary gland tumors; gastric/esophageal/EGJ cancers; and others listed in compendial uses. Many entries specify combination use with trametinib; some specify single‑agent use where noted.

Authorization duration: 12 months for listed compendial uses

Salivary Gland Tumors

Authorization may be granted when ALL of the following are met for salivary gland tumors:

Salivary gland tumors (with trametinib): Treatment of BRAF V600E mutation‑positive recurrent, unresectable, or metastatic salivary gland tumor in combination with trametinib (Mekinist).12 months authorization

See compendial entry for salivary gland tumors

Gastric, Esophageal and Esophagogastric Junction Cancer

Authorization may be granted when ALL of the following are met for gastric, esophageal, and EGJ cancers:

Gastric/Esophageal/EGJ cancers (with trametinib): Subsequent treatment of BRAF V600E mutation‑positive unresectable locally advanced, recurrent, or metastatic gastric, esophageal, or esophagogastric junction cancer, or for members who are not surgical candidates, in combination with trametinib (Mekinist).12 months authorization

See compendial entry for gastric/esophageal/EGJ cancers

Hairy Cell Leukemia

Authorization may be granted when ALL of the following are met for hairy cell leukemia:

Hairy cell leukemia (with trametinib): Treatment of relapsed or refractory hairy cell leukemia that is BRAF V600E mutation‑positive in combination with trametinib (Mekinist) provided the member has not been previously treated with a BRAF inhibitor.12 months authorization

Prior BRAF inhibitor therapy excludes approval; see documentation requirements

Small Bowel Adenocarcinoma

Authorization may be granted when ALL of the following are met for small bowel adenocarcinoma:

Small bowel adenocarcinoma (with trametinib): Treatment of BRAF V600E mutation‑positive advanced or metastatic small bowel adenocarcinoma in combination with trametinib (Mekinist).12 months authorization

See compendial entry for small bowel adenocarcinoma

Gastrointestinal Stromal Tumor (GIST) - Reauthorization

Authorization may be granted for continued treatment when ALL of the following are met for GIST:

GIST reauthorization: Continued treatment for BRAF V600E mutation‑positive GIST when there is no evidence of unacceptable toxicity while on the current regimen.12 months authorization

Reauthorization contingent on absence of unacceptable toxicity

All Other Indications / Reauthorization

Authorization may be granted for continued treatment for other listed indications when ALL of the following are met:

Other indications reauthorization: Continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression or recurrence while on the current regimen.12 months authorization (general)

Adjuvant cutaneous melanoma limited to 12 months total therapy

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization and Reauthorization Requirements

Prior authorization is required for requests. Approvals are generally issued for up to 12 months for the indications listed below; reauthorization requires documentation that there is no unacceptable toxicity and no disease progression or recurrence while on therapy. For adjuvant treatment of cutaneous melanoma, a total maximum of 12 months of therapy will be approved; requests exceeding the 12‑month adjuvant limit may be denied.

Prior authorization: typical approval duration = 12 months for listed indications and reauthorizations.
Reauthorization requires documentation of no unacceptable toxicity and no disease progression or recurrence while on the current regimen.
Adjuvant cutaneous melanoma: maximum total duration = 12 months (denial risk for requests beyond this limit).

Prior Authorization

Thyroid Cancer Therapy Sequencing

Authorization for follicular, oncocytic, or papillary thyroid carcinoma (BRAF V600E mutation‑positive) in combination with trametinib (Mekinist) will be granted for 12 months when either the disease is unresectable or metastatic and not amenable to radioactive iodine (RAI) therapy, or when the medication is being used as first‑line therapy for high‑risk disease in patients who are not appropriate for VEGF inhibitors.

Thyroid cancer sequencing: approval contingent on meeting sequencing/setting criteria (unresectable/metastatic disease not amenable to RAI OR first‑line for high‑risk disease not appropriate for VEGF inhibitors).
Authorization duration = 12 months.

Prior Authorization

Hairy Cell Leukemia — Prior Therapy Requirement

For relapsed/refractory hairy cell leukemia, authorization of 12 months may be granted when the disease is BRAF V600E mutation‑positive and the member has not been previously treated with a BRAF inhibitor.

Hairy cell leukemia prior therapy requirement: no prior BRAF inhibitor therapy for approval.
Authorization duration = 12 months.

Permitted Regimens and Combination Therapy

Regimen	Indications / Notes	Authorization duration	Coverage status
Dabrafenib (single-agent)
Unresectable or metastatic cutaneous melanoma when BRAF/MEK combination therapy is contraindicated; recurrent/advanced/metastatic NSCLC only if combination with trametinib is not tolerated
Typically up to 12 months (per indication)
Covered when criteria met

Regimen	Indications / Notes	Authorization duration	Coverage status
Dabrafenib + trametinib (combination)
FDA‑approved and compendial indications for BRAF V600E (and where specified V600K) mutation-positive tumors including unresectable/metastatic melanoma, NSCLC, anaplastic thyroid cancer, tumor-agnostic solid tumors in patients ≥1 year, and multiple compendial uses (salivary gland, gastric/esophageal/EGJ, hairy cell leukemia, small bowel adenocarcinoma, etc.)
Typically up to 12 months per authorization; adjuvant melanoma limited to 12 months total
Covered when criteria met

Scenario	Reauthorization criteria	Authorization duration on reauthorization	Coverage status
Continued treatment for ongoing therapy (general)
Member has no evidence of unacceptable toxicity or disease progression/recurrence while on the current regimen
Typically up to 12 months per reauthorization
Covered when criteria met

Line of Therapy Specifications

first-line — 1 top-level node

First-line GIST settings: Allowed as neoadjuvant or first‑line therapy for gross residual disease (R2), unresectable primary disease, tumor rupture, or recurrent/metastatic disease.

Authorization of 12 months

salvage — 1 top-level node

Salvage (tumor-agnostic): Disease has progressed following prior treatment and there are no satisfactory alternative treatment options; member is ≥1 year of age; request is not for colorectal cancer; therapy given in combination with trametinib.

Authorization of 12 months

second-line | subsequent — 1 top-level node

Second-line / subsequent treatment: Used for subsequent treatment of BRAF V600E mutation‑positive unresectable locally advanced, recurrent, or metastatic gastric, esophageal, or EGJ disease, or for members who are not surgical candidates, in combination with trametinib.

Authorization of 12 months

salvage — 1 top-level node

Salvage (hairy cell leukemia): Relapsed or refractory hairy cell leukemia when the member has not been previously treated with a BRAF inhibitor; therapy given in combination with trametinib.

Authorization of 12 months

Required Biomarker Documentation

BRAF V600E / V600K detection requirement by an FDA‑approved test

RequirementBRAF V600E or V600K must be detected by an FDA‑approved test prior to use of dabrafenib (single agent or in combination with trametinib) for indicated melanoma and other FDA‑approved settings.

Test typeDetection must be by an FDA‑approved diagnostic test as specified in FDA labeling.

Applicable indicationsRequired for unresectable or metastatic melanoma (single agent and combination regimens), adjuvant melanoma when indicated, and other FDA‑approved BRAF V600E/V600K indications.

BRAF V600E mutation-positive — biomarker for several indications

DefinitionTumors confirmed to harbor the BRAF V600E variant — the biomarker required for multiple FDA‑approved and compendial dabrafenib indications.

Representative indicationsIncluded: unresectable/metastatic melanoma; metastatic NSCLC (BRAF V600E); anaplastic thyroid cancer; pediatric and adult unresectable/metastatic solid tumors with BRAF V600E; salivary gland, gastric/esophageal/EGJ, small bowel adenocarcinoma and others as listed.

Use with trametinibMany listed indications require dabrafenib in combination with trametinib when indicated by FDA labeling or compendial guidance.

Key Definitions

Definition of BRAF V600E / V600K mutation and testing requirement

Mutation definitionActivating BRAF mutations V600E or V600K (amino acid substitution at codon 600).

Testing requirementDetection of BRAF V600E or V600K must be documented by an FDA‑approved test to meet coverage criteria for indicated uses of dabrafenib.

Clinical relevancePresence of these activating mutations is required for many FDA‑approved and compendial dabrafenib indications including melanoma and select solid tumors.

BRAF V600E mutation-positive definition (biomarker)

Biomarker termBRAF V600E mutation-positive = tumor confirmed to harbor the BRAF V600E variant.

Indication linkageRequired biomarker for approved indications including melanoma, NSCLC (BRAF V600E), anaplastic thyroid cancer, and for many compendial tumor types listed in policy.

Treatment implicationDocumentation of BRAF V600E positivity is necessary for prior authorization review and to meet coverage criteria for dabrafenib (often with trametinib).

Background on Dabrafenib (Tafinlar)

Dabrafenib (Tafinlar) is a selective BRAF inhibitor indicated for tumors harboring activating BRAF V600 mutations (commonly V600E and in some settings V600K). It may be used as monotherapy when combination with a MEK inhibitor is contraindicated, but many covered indications—including tumor‑agnostic BRAF V600E settings—specifically require use in combination with trametinib (Mekinist). Standard authorizations for listed indications are generally for 12 months when coverage criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDabrafenib (Tafinlar) — Clinical Coverage and Prior Authorization Criteria

Policy CodePolicy 1683-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit documentation proving BRAF mutation to initiate prior authorization; approvals typically granted for up to 12 months when criteria are met.

SourceLink

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Dabrafenib (Tafinlar) — Clinical Coverage and Prior Authorization Criteria

Coverage Criteria for Dabrafenib (Tafinlar)

Authorization, Documentation, and Provider Requirements

Permitted Regimens and Combination Therapy

Line of Therapy Specifications

Required Biomarker Documentation

Key Definitions

Background on Dabrafenib (Tafinlar)

Policy Revision History