CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tafinlar (dabrafenib) coverage for BRAF V600 mutations

Defines medical coverage, prior authorization requirements, and approved indications for Tafinlar (dabrafenib) for members with BRAF V600–positive tumors, including FDA‑approved and compendial uses, and conditions for authorization and continuation of therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTafinlar (dabrafenib) coverage for BRAF V600 mutations

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of a BRAF V600E or V600K mutation; prior authorization of up to 12 months may be granted when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization length

V600E/V600Kmutations specified

≥6 yrsminimum age (selected)

colorectalexplicit exclusion

Coverage Criteria for Tafinlar (dabrafenib)

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Initial Coverage Criteria

Covered when ALL of the following are met for FDA‑approved and certain compendial indications:

Mutation requirement: Tumor is positive for a BRAF V600E or V600K mutation as detected by an FDA‑approved test

Required for all covered indications

Indication-specific settings: Treatment is for an indication listed as FDA‑approved or compendial (examples include: unresectable or metastatic cutaneous melanoma [single agent or with trametinib], adjuvant resected stage III melanoma with trametinib, melanoma brain metastases with trametinib, anaplastic thyroid cancer with trametinib, metastatic NSCLC with BRAF V600E, certain pediatric or other unresectable/metastatic solid tumors age ≥6 in combination with trametinib after prior therapy failure, histiocytic neoplasms, selected ovarian/fallopian/primary peritoneal cancers)

See Sections III A–G for full list of covered indications; authorization of 12 months may be granted

Exclusions and prior therapy: Requested use is not for colorectal cancer and, where specified for unresectable or metastatic solid tumors, disease has progressed following prior treatment and there are no satisfactory alternative treatment options

Colorectal cancer is explicitly excluded; pediatric/solid tumor indication requires prior progression and age ≥6 when specified

Continuation / Reauthorization

Continuation of therapy covered when ALL of the following are met:

Response or toxicity: There is no evidence of unacceptable toxicity or disease progression or recurrence while on the current regimen

For adjuvant cutaneous melanoma only 12 months total therapy will be approved

Tafinlar (dabrafenib) is not indicated for the treatment of patients with colorectal cancer due to known intrinsic resistance to BRAF inhibition. Requests where the medication will be used to treat colorectal cancer will not be approved.

Tafinlar is also not indicated for treatment of patients with wild‑type BRAF solid tumors; coverage requires the presence of an activating BRAF V600 mutation (e.g., V600E or V600K) as detected by an FDA‑approved test.

Indication	Regimen / notes	Coverage status
Unresectable or metastatic cutaneous melanoma (including brain metastases)
Dabrafenib as a single agent or in combination with trametinib (Mekinist) as specified per setting (single‑agent or combo for unresectable/metastatic; combination for brain metastases)
Authorization of up to 12 months may be granted when criteria are met (BRAF V600E or V600K mutation documented)
Adjuvant treatment of resected stage III cutaneous melanoma
Dabrafenib in combination with trametinib (Mekinist) for adjuvant therapy following complete resection
Approval limited to 12 months total therapy for adjuvant cutaneous melanoma
Anaplastic thyroid cancer (locally advanced or metastatic) with BRAF V600E mutation
Dabrafenib in combination with trametinib (Mekinist); used when no satisfactory locoregional treatment options exist
Metastatic non‑small cell lung cancer (NSCLC) with BRAF V600E mutation
Dabrafenib in combination with trametinib (Mekinist)
Unresectable or metastatic solid tumors (pediatric and adult) with BRAF V600E mutation, age ≥ 6 years, after prior therapy
Dabrafenib in combination with trametinib (Mekinist); authorization requires disease progression after prior treatment and no satisfactory alternatives
Limitations / exclusions
Not indicated for colorectal cancer (requests for colorectal cancer will not be approved); not for wild‑type BRAF tumors

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization of up to 12 months may be granted for listed indications when all applicable criteria are met.

Authorization may be granted for up to 12 months when criteria are satisfied.
Applies to the indications listed in the policy (cutaneous melanoma, NSCLC, CNS cancers, thyroid, hepatobiliary, histiocytic neoplasms, unresectable/metastatic solid tumors, ovarian/fallopian tube/primary peritoneal cancers).

Prior Authorization

Prior Treatment / No Acceptable Alternatives

For unresectable or metastatic solid tumors, prior authorization requires documented disease progression following prior treatment and that there are no satisfactory alternative treatment options.

Applies to unresectable or metastatic solid tumors only.
Requested medication must be used in combination with trametinib when specified by the indication.

Documentation Required

BRAF Mutation Documentation Required

Submission of BRAF mutation documentation is required to initiate prior authorization review.

Provide documentation showing BRAF V600 activating mutation (e.g., V600E or V600K) as applicable to the requested indication.

Denial Risk

Documentation and Exclusion — Denial Risk

Lack of submitted BRAF mutation documentation or requests for use in colorectal cancer will result in denial of the prior authorization request.

Requests without BRAF mutation documentation will not be reviewed.
Use of the requested medication for colorectal cancer is excluded and will be denied.

Permitted Lines of Therapy

first-line

First-line FDA‑approved indications: Treatment is for an FDA‑approved indication such as unresectable or metastatic cutaneous melanoma (single agent or with trametinib), adjuvant resected stage III cutaneous melanoma with trametinib, melanoma brain metastases with trametinib, anaplastic thyroid cancer with trametinib, metastatic NSCLC with BRAF V600E (single agent or with trametinib)

Covered as listed; authorization of 12 months may be granted

subsequent

Subsequent-line requirement: Disease has progressed following prior treatment and there are no satisfactory alternative treatment options

Applies to unresectable or metastatic solid tumors (member must be ≥ 6 years of age and treatment is in combination with trametinib for this indication)

Required Biomarker Testing

inv-13: BRAF V600E or V600K — Requirement for activating BRAF V600 mutations (V600E or V600K).

Required mutationTumor is positive for an activating BRAF V600 mutation (V600E or V600K) as detected by an FDA‑approved test

Test typeMutation must be identified by an FDA‑approved test (per FDA‑approved indications)

ApplicabilityThis mutation requirement applies to all covered indications listed (melanoma, NSCLC, ATC, select pediatric/solid tumors, etc.)

inv-10: BRAF V600E or V600K mutation — Activating BRAF V600 mutations detected by an FDA‑approved test; required for covered indications.

Activating mutations specifiedBRAF V600E or V600K mutation (activating BRAF V600 mutations)

Detection standardMust be detected by an FDA‑approved test as stated in FDA‑approved indications

Use for solid tumorsFor unresectable/metastatic solid tumors (age ≥6), BRAF V600E positivity required and treatment is given in combination with trametinib after prior therapy failure

Coding and Billing Notes

Billing Rule

Obtain prior authorization — include duration and supporting details

Prior authorization must be obtained before therapy; when criteria are met, authorizations of up to 12 months may be granted — include the indication-specific authorization length in the request.

For solid tumors, confirm age ≥ 6 years and that trametinib will be used when required.
For adjuvant cutaneous melanoma, note that 12 months total therapy may be approved.

Background on Dabrafenib (Tafinlar)

Dabrafenib (Tafinlar) is a selective BRAF inhibitor indicated for treatment of malignancies that harbor activating BRAF V600 mutations. FDA‑approved uses include treatment of unresectable or metastatic melanoma (as monotherapy for BRAF V600E and in combination with trametinib for V600E or V600K), adjuvant therapy for resected melanoma in combination with trametinib, treatment of anaplastic thyroid cancer and metastatic non‑small cell lung cancer with BRAF V600E in combination with trametinib, and treatment of unresectable or metastatic solid tumors with BRAF V600E in patients aged ≥6 years in combination with trametinib after progression on prior therapy.

Authorization criteria require documentation of a BRAF V600E or V600K mutation detected by an FDA‑approved test and, for unresectable or metastatic solid tumors, evidence of disease progression following prior treatment with no satisfactory alternative options; the agent must not be used for colorectal cancer and, where specified, is given in combination with trametinib. Authorization of up to 12 months may be granted for covered indications when criteria are met.