CurrentNeighborhood Health Plan of Rhode IslandPolicy 1683-A

Dabrafenib (Tafinlar) coverage

Defines coverage criteria and authorization requirements for dabrafenib (Tafinlar), alone or with trametinib, for BRAF V600–mutant malignancies for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDabrafenib (Tafinlar) coverage

Policy CodePolicy 1683-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit documentation confirming a BRAF V600 mutation (FDA‑approved test) to initiate prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

BRAF V600E/V600Kmutations specified for coverage

colorectal excludedexplicit limitation of use

12 monthsadjuvant melanoma limit

Coverage Criteria for Dabrafenib (Tafinlar)

inv-01: FDA-Approved Indications

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Covered when ALL of the following FDA-approved indications criteria are met (per indication details elsewhere in the document):

FDA indications general: Indication corresponds to an FDA-approved use for dabrafenib (Tafinlar) as a single agent or in combination with trametinib (Mekinist) for specified malignancies (including unresectable or metastatic melanoma, metastatic NSCLC, anaplastic thyroid cancer, unresectable/metastatic solid tumors in patients ≥1 year, and pediatric low-grade glioma) as detected by an FDA-approved test

As detected by an FDA-approved test

Mutation requirement: Tumor must be BRAF V600 mutation-positive (e.g., V600E or V600K) as specified per FDA indication

BRAF mutation documentation required (FDA‑approved test)

inv-02: Tumor-agnostic/solid tumors

Covered when ALL of the following are met for unresectable or metastatic solid tumors (tumor-agnostic) in combination with trametinib:

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; patient is 1 year of age or older; the requested medication will not be used for treatment of colorectal cancer; the requested medication will be used in combination with trametinib (Mekinist)

Authorization of 12 months may be granted

inv-03: Compendial and other tumor-specific coverage

Covered compendial and other specified tumor types when listed criteria are met (examples below):

Cutaneous melanoma: BRAF V600 mutation-positive melanoma (e.g., V600E or V600K); allowed for unresectable or metastatic disease as single agent only if combination therapy is contraindicated or in combination with trametinib; also authorized for neoadjuvant (if immunotherapy contraindicated), adjuvant, and limited resectable local recurrent disease

Authorization of 12 months may be granted

Non-small cell lung cancer (NSCLC): BRAF V600E mutation-positive recurrent, advanced, or metastatic NSCLC when the member has not experienced disease progression on prior BRAF-targeted therapy; can be used as single agent if combination with trametinib is not tolerated or in combination with trametinib

Authorization of 12 months may be granted

Follicular, oncocytic, and papillary thyroid carcinoma: BRAF V600E mutation-positive follicular, oncocytic, or papillary thyroid carcinoma in combination with trametinib for unresectable or metastatic disease not amenable to radioactive iodine or as first-line for high‑risk disease not appropriate for VEGF inhibitors

Authorization of 12 months may be granted

Biliary tract cancers: Progressive BRAF V600E mutation-positive unresectable, resected gross residual (R2), or metastatic gallbladder cancer, extrahepatic or intrahepatic cholangiocarcinoma in combination with trametinib

Authorization of 12 months may be granted

Histiocytic neoplasms: BRAF V600E mutation-positive Erdheim–Chester disease or Langerhans cell histiocytosis; single‑agent dabrafenib may be authorized

Authorization of 12 months may be granted

Ovarian, fallopian tube, primary peritoneal and related gynecologic tumors: Persistent or recurrent BRAF V600E mutation‑positive epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer and related histologies in combination with trametinib

Authorization of 12 months may be granted

Gastrointestinal stromal tumor (GIST): BRAF V600E mutation-positive GIST in combination with trametinib for neoadjuvant or first‑line contexts (gross residual disease, unresectable primary disease, tumor rupture, or recurrent/metastatic disease)

Authorization of 12 months may be granted

Pancreatic adenocarcinoma: BRAF V600E mutation-positive recurrent, locally advanced, or metastatic pancreatic adenocarcinoma in combination with trametinib

Authorization of 12 months may be granted

Salivary gland, gastric/esophageal, small bowel adenocarcinoma, and other listed tumors: Various BRAF V600E mutation-positive malignancies listed in compendia (including salivary gland tumors, gastric/esophageal cancers, small bowel adenocarcinoma and others) in combination with trametinib as specified

Authorization of 12 months may be granted

inv-04: Salivary Gland Tumors

Covered when ALL of the following are met for salivary gland tumors:

Salivary Gland Tumors: Member has a BRAF V600E mutation‑positive recurrent, unresectable, or metastatic salivary gland tumor

Authorization of 12 months may be granted; treatment in combination with trametinib (Mekinist) is specified.

inv-05: Gastric, Esophageal and Esophagogastric Junction Cancer

Covered when ALL of the following are met for gastric/esophageal cancers:

Gastric/Esophageal/Esophagogastric Junction Cancer: Member has BRAF V600E mutation‑positive unresectable locally advanced, recurrent, or metastatic disease or is not a surgical candidate

Authorization of 12 months may be granted; use in combination with trametinib (Mekinist) is specified.

inv-06: Hairy Cell Leukemia

Covered when ALL of the following are met for hairy cell leukemia:

Hairy Cell Leukemia: Member has relapsed or refractory hairy cell leukemia

Authorization of 12 months may be granted in combination with trametinib (Mekinist) if the member has not previously been treated with a BRAF inhibitor.

inv-07: Small Bowel Adenocarcinoma

Covered when ALL of the following are met for small bowel adenocarcinoma:

Small Bowel Adenocarcinoma: Member has BRAF V600E mutation‑positive advanced or metastatic small bowel adenocarcinoma

Authorization of 12 months may be granted in combination with trametinib (Mekinist).

inv-08: GIST Continued Treatment

Covered when ALL of the following are met for GIST reauthorization:

Gastrointestinal Stromal Tumor (GIST): Member requests reauthorization for continued treatment with a dabrafenib-containing regimen

Authorization of 12 months may be granted when there is no evidence of unacceptable toxicity while on the current regimen.

inv-09: All Other Indications / Reauthorization Limits

Covered when ALL of the following are met for other listed indications:

All Other Indications: Member requests reauthorization for an indication listed in the coverage criteria section

Authorization of 12 months may be granted when there is no evidence of unacceptable toxicity or disease progression or recurrence while on the current regimen; for adjuvant treatment of cutaneous melanoma, only 12 months of therapy total will be approved.

Tafinlar (dabrafenib) is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. In addition, Tafinlar is not indicated for treatment of patients with wild‑type BRAF solid tumors. Use for indications outside the FDA‑approved and specified compendial uses listed in this policy (see compendial list such as melanoma, NSCLC, glioma, histiocytic neoplasms, biliary tract, ovarian, GIST, pancreatic, salivary, gastric/esophageal, hairy cell leukemia, small bowel adenocarcinoma) should be avoided unless supported by the policy criteria and prior authorization documentation.

Adjuvant treatment of cutaneous melanoma with Tafinlar is limited to a maximum total duration of 12 months of therapy; prior authorization and reauthorization requests must reflect this explicit time limit.

All indications not specifically listed in the FDA‑approved indications or the compendial uses in this policy are considered experimental/investigational and not medically necessary. Requests for use outside the listed indications are therefore not supported by this coverage policy.

Permitted Drug Regimens and Scenarios

Regimen	Indications / Notes	Coverage status
Dabrafenib (single-agent)
Indicated for unresectable or metastatic melanoma with BRAF V600E mutation; permitted as single agent when combination therapy is contraindicated or not tolerated (includes neoadjuvant/adjuvant contexts per policy).
Covered when criteria met (see policy)

Regimen	Indications / Notes	Coverage status
Dabrafenib in combination with trametinib
Indicated for multiple BRAF V600E or V600K mutation–positive cancers including unresectable/metastatic melanoma, metastatic NSCLC (BRAF V600E), anaplastic thyroid cancer (BRAF V600E), tumor-agnostic unresectable/metastatic solid tumors in patients ≥1 year with BRAF V600E, salivary gland, gastric/esophageal, small bowel adenocarcinoma, hairy cell leukemia (in combination), and other compendial uses as specified; authorization typically up to 12 months.
Covered when criteria met (mutation documentation and indication-specific requirements)

Regimen	Reauthorization conditions	Coverage status
Continued dabrafenib-containing regimens (single agent or with trametinib)
{"text":"Reauthorization may be granted for up to 12 months when there is no evidence of unacceptable toxicity and no disease progression or recurrence while on the current regimen; for adjuvant cutaneous melanoma, total therapy limited to 12 months."","status":""}
Covered when reauthorization conditions met

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tafinlar. Typical authorization durations are 12 months for covered indications; approvals will be limited to the scope and indication reviewed at the time of authorization.

Authorization period: typically 12 months for initial and continued therapy where allowed.
Scope: approval limited to the specific indication and combination/single-agent use requested.

Prior Authorization

Authorization Period and Reauthorization Requirements

Authorization is typically granted for a 12-month period for the listed indications. Reauthorization requests must document continued clinical benefit and absence of unacceptable toxicity or disease progression on the current regimen.

Typical authorization period: 12 months.
Reauthorization requires documentation of no unacceptable toxicity and no disease progression or recurrence while on therapy.
Adjuvant cutaneous melanoma: only 12 months total will be approved.

Documentation Required

Single-agent vs Combination Therapy

Single-agent dabrafenib may be authorized only when combination therapy with trametinib is contraindicated or not tolerated. For most indications the drug is expected to be used in combination with trametinib; request must state clinical reason for single-agent use.

Single-agent use allowed when combination with trametinib is contraindicated or not tolerated (e.g., due to toxicity or drug interaction).
For indications where combination therapy is specified (most solid tumors, NSCLC, thyroid, biliary, ovarian, GIST, pancreatic, salivary, gastric/esophageal, small bowel, etc.), documentation should justify single-agent use if requested.

Denial Risk

Prior BRAF Inhibitor Exposure — Hairy Cell Leukemia

For hairy cell leukemia, prior exposure to a BRAF inhibitor excludes authorization for retreatment with BRAF inhibitor therapy.

Hairy cell leukemia: not authorized if previously treated with a BRAF inhibitor.

Documentation Required

BRAF Mutation Documentation Required

Submit documentation confirming the presence of a qualifying BRAF V600 mutation detected by an FDA-approved or validated test to initiate prior authorization review.

Required: documentation of BRAF V600 mutation (e.g., V600E or V600K) by an FDA-approved test or equivalent report.
Missing mutation documentation will be a trigger for denial.

Denial Risk

Denial and Reauthorization Denial Triggers

Denials may be issued for missing BRAF mutation documentation or use for excluded indications (for example, colorectal cancer or wild-type BRAF tumors). Reauthorization may be denied for unacceptable toxicity, disease progression, or recurrence while on the current regimen.

Denial triggers: absence of documented BRAF V600 mutation, use for colorectal cancer, or use for wild-type BRAF solid tumors.
Reauthorization denial triggers: evidence of unacceptable toxicity, disease progression, or recurrence on the current regimen.

Specified Line-of-Therapy Uses

inv-25: subsequent

Subsequent-line use: Disease has progressed following prior treatment and there are no satisfactory alternative treatment options (applies to tumor‑agnostic solid tumor coverage and other subsequent‑line contexts)

Authorization of 12 months may be granted

inv-26: first-line

First-line contexts: Allowed as neoadjuvant or first-line for GIST when used for gross residual disease (R2), unresectable primary disease, tumor rupture, or recurrent/metastatic disease

Authorization of 12 months may be granted

inv-27: salvage

Salvage-line (Hairy cell leukemia): Relapsed/refractory hairy cell leukemia and member has not been previously treated with a BRAF inhibitor

Authorization of 12 months may be granted in combination with trametinib (Mekinist)

Mutation and Test Requirements

BRAF V600 (e.g., V600E or V600K) — mutation-positive requirement

Required mutationBRAF V600 (e.g., V600E or V600K) — tumor must be mutation‑positive as detected by an FDA‑approved test

Assay requirementMutation must be documented by an FDA‑approved test (submission of documentation required for prior authorization)

Applicable indicationsRequired for most covered indications including melanoma, NSCLC, anaplastic thyroid cancer, pediatric solid tumors and tumor‑agnostic uses per policy

Age noteFor tumor‑agnostic unresectable/metastatic solid tumors, patient must be ≥1 year of age

Exclusion reminderNot indicated for colorectal cancer or BRAF wild‑type tumors — requests for these uses may be denied

BRAF V600E — mutation specification for multiple indications

Required mutationBRAF V600E — tumor must harbor the activating V600E mutation (mutation‑positive)

Indication examplesSpecified for salivary gland tumors, gastric/esophageal/esophagogastric junction cancer, small bowel adenocarcinoma and other listed indications in combination with trametinib

Authorization periodAuthorization of 12 months may be granted for listed BRAF V600E indications when criteria are met

Combination therapyPolicy specifies use in combination with trametinib (Mekinist) for these BRAF V600E indications

Prior treatment/age criteriaFor tumor‑agnostic solid tumors with BRAF V600E, prior progression and age ≥1 year apply where specified

Drug and Billing Codes

Covered drug(s)NDCCovered

dabrafenib

Tafinlar, Generic Name = dabrafenib

Background and Drug Information

Dabrafenib (Tafinlar) is a targeted BRAF inhibitor directed at tumors that harbor activating BRAF V600 mutations (for example, V600E or V600K). It is authorized in this policy as either monotherapy when combination therapy is contraindicated or intolerable, or in combination with the MEK inhibitor trametinib (Mekinist) for multiple BRAF V600 mutation–positive malignancies. Coverage is aligned to FDA‑approved indications and selected compendial uses and requires documentation of the qualifying BRAF mutation prior to authorization.

BRAF V600E or V600K mutation — concise definition

DefinitionBRAF V600E or V600K — activating substitutions at codon 600 of BRAF; mutation‑positive tumors are eligible where specified in policy

Primary actionable variantBRAF V600E — specified across multiple tumor types and tumor‑agnostic indications

Alternate actionable variantBRAF V600K — included among BRAF V600 variants for certain melanoma indications

Testing requirementDetection must be by an FDA‑approved test; documentation required for prior authorization

Clinical notePresence of BRAF V600 mutations underpins eligibility for dabrafenib ± trametinib per the policy's coverage criteria

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDabrafenib (Tafinlar) coverage

Policy CodePolicy 1683-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit documentation confirming a BRAF V600 mutation (FDA‑approved test) to initiate prior authorization.

SourceLink

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