CurrentCignaPolicy N/A

Oncology (Oral - BRAF Inhibitor) - Tafinlar Prior Authorization Policy

This policy governs prior authorization and medical necessity criteria for coverage of Tafinlar (dabrafenib) for Cigna-administered health benefit plans; it applies to prescribers and payers making coverage determinations under those plans.

Policy Summary

PayerCigna

PolicyOncology (Oral - BRAF Inhibitor) - Tafinlar Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMultiple material and minor revisions

Effective DateN/A

Next Review DateAug 27, 2025

Key ActionObtain prior authorization; approvals are provided for 1 year when specified clinical criteria for the indicated condition are met.

SourceLink

POLICY UPDATE CHANGES

Age requirements (e.g., ≥ 6 years and ≥ 1 year) were removed for multiple indications and pediatric age language was updated.

Hairy Cell Leukemia was added as a new indication under Other Uses with Supportive Evidence.

Solid tumors note updated to add 'occult primary' and examples adjusted (small bowel adenocarcinoma added in earlier revision history).

1 yearapproval duration

BRAF V600required biomarker

colorectal cancernot covered

with trametinib

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Coverage Criteria for Tafinlar (dabrafenib)

inv-01: FDA-Approved Indications

Covered when ALL of the following are met for each indication as specified

Glioma (FDA): Approve for 1 year if BOTH A and B are met: A) Patient has BRAF V600 mutation-positive disease; AND B) The medication will be taken in combination with Mekinist (trametinib).

FDA indication for glioma; age minimum language removed.

Melanoma (FDA): Approve for 1 year if BOTH A and B are met: A) Patient has unresectable, advanced (including Stage III or Stage IV disease) or metastatic melanoma (includes adjuvant Stage III with no evidence of disease post-surgery); AND B) Patient has BRAF V600 mutation-positive disease.

May be single agent or combination per overview; policy requires mutation positive.

Non-Small Cell Lung Cancer (FDA): Approve for 1 year if BOTH A and B are met: A) Patient has recurrent, advanced, or metastatic disease; AND B) Patient has BRAF V600 mutation-positive disease.

Combination with trametinib is the expected regimen for this indication.

Solid Tumors (accelerated approval): Approve for 1 year if BOTH A and B are met: A) Patient has BRAF V600 mutation-positive disease; AND B) The medication will be taken in combination with Mekinist (trametinib).

Accelerated approval for unresectable or metastatic solid tumors (examples listed in policy).

Thyroid Carcinoma, Anaplastic (FDA): Approve for 1 year if ALL A, B, and C are met: A) Patient has locally advanced or metastatic anaplastic disease; AND B) Patient has BRAF V600 mutation-positive disease; AND C) The medication will be taken in combination with Mekinist (trametinib).

No age minimum in current criteria.

inv-02: Other Uses with Supportive Evidence

Other uses with supportive evidence (approve for 1 year if criteria met):

Hairy Cell Leukemia: Approve for 1 year if ALL A, B, and C are met: A) Patient has not been previously treated with a BRAF inhibitor therapy; AND B) The medication will be used for relapsed/refractory disease; AND C) The medication will be taken in combination with Mekinist (trametinib).

Added based on compendium recommendations.

Histiocytic Neoplasm: Approve for 1 year if BOTH: A) Patient has Langerhans cell histiocytosis OR Erdheim-Chester disease; AND B) Patient has BRAF V600–mutation positive disease.

Compendium-supported indication; prior multisystem requirement removed.

Thyroid Carcinoma, Differentiated: Approve for 1 year if ALL A, B, and C are met: A) Patient has differentiated thyroid carcinoma (e.g., papillary, follicular, oncocytic); AND B) Patient has recurrent or metastatic disease; AND C) Patient has BRAF V600 mutation-positive disease.

Listed under Other Uses with Supportive Evidence.

Tafinlar (dabrafenib) is not medically necessary for the treatment of colon or rectal cancer (colorectal cancer). This exclusion is based on evidence of known intrinsic resistance to BRAF inhibition in colorectal tumors, and the drug is not indicated for this disease.

Any use of Tafinlar that is not listed among the policy’s FDA‑approved indications or the listed Other Uses with Supportive Evidence is considered not medically necessary. As an explicit example, Tafinlar is not covered for colorectal cancer because of intrinsic resistance to BRAF inhibition; providers should not expect authorization for unlisted or unsupported indications.

Regimen	Indication / Note	Coverage status
Dabrafenib in combination with trametinib (Mekinist)
Most FDA‑approved indications (glioma, solid tumors, non‑small cell lung cancer, anaplastic thyroid carcinoma) specify or expect use in combination with trametinib; see individual indication criteria for details.
Covered when criteria are met (see FDA‑Approved Indications)

Coding and Billing

Covered Codesmixed

No specific CPT/HCPCS/ICD-10/NDC codes listed in policy document

Approval duration

Typical approval duration1 year for covered indications (approvals provided for 1 year when specified clinical criteria are met)

Reauthorization expectationRenewal/reauthorization required after 1 year if continued therapy is clinically indicated and criteria remain met

Applies toAll FDA‑approved and Other Uses with Supportive Evidence entries that meet policy criteria

Provider Actions and Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization recommended for Tafinlar (dabrafenib). Approvals are provided for 1 year when specified clinical criteria are met.

Applies to Tafinlar (dabrafenib capsules and tablets for oral suspension, Novartis).
Approvals: approve for 1 year when FDA‑approved indication criteria are met (see FDA‑Approved Indications).

Step Therapy

No explicit step therapy sequence or prerequisite therapies are specified in this policy for Tafinlar. Providers should not assume a required trial of another agent is mandated by this policy unless specified in a member’s benefit plan.

Background

Tafinlar (dabrafenib) is a targeted BRAF inhibitor used for malignancies driven by BRAF V600 mutations. It is indicated for several BRAF V600 mutation–positive cancers (often in combination with the MEK inhibitor trametinib) but is not indicated for colorectal cancer due to intrinsic resistance of colorectal tumors to BRAF inhibition.

Definitions

BRAF V600 mutation‑positive — definition / key concept

DefinitionBRAF V600 mutation‑positive = presence of a BRAF V600 mutation (e.g., V600E, V600K) as detected by an FDA‑approved test

Clinical relevanceRequired biomarker for covered indications including glioma, melanoma, NSCLC, anaplastic thyroid, and certain solid tumors

Test requirementMutation must be detected by an FDA‑approved test when specified in the indication language

Line of Therapy

inv-13: salvage

Salvage: Hairy Cell Leukemia: Medication will be used for relapsed/refractory disease; patient has not been previously treated with a BRAF inhibitor therapy; and therapy will be given in combination with Mekinist (trametinib).

Approve for 1 year when criteria met (see Other Uses with Supportive Evidence).

inv-14: second-line

Second-line: NSCLC: For recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC).

Approve for 1 year when BRAF V600 mutation-positive disease is present (see FDA-Approved Indications).

Biomarker Requirements

BRAF V600 (e.g., V600E, V600K) — biomarker requirement for coverage

Required biomarkerBRAF V600 (examples: V600E, V600K) — must be present for coverage of the listed indications

Examples included in policyV600E and V600K explicitly noted for melanoma and other indications; policy examples cite BRAF V600 mutation‑positive disease

Detection methodMutation should be identified using an FDA‑approved test as specified in the FDA indication language

Covered Regimens and Combinations

Regimen	When required / expected	Coverage status
Dabrafenib plus trametinib (Mekinist)
Required or expected for glioma, solid tumors (accelerated approval), non‑small cell lung cancer, and anaplastic thyroid carcinoma per policy and product overview; melanoma may be single‑agent or combination depending on setting but mutation requirement applies.
Covered when clinical criteria are met (approve for 1 year)