CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tafinlar 1683 A Sgm P2023

Defines covered indications, documentation and prior-authorization criteria, duration limits, continuation criteria, and compendial uses for Tafinlar (dabrafenib), including as single agent and in combination with trametinib across multiple tumor types with BRAF V600 mutations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTafinlar 1683 A Sgm P2023

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit documentation of BRAF V600 mutation (e.g., V600E or V600K) detected by an FDA-approved test to initiate prior authorization review; authorizations generally granted for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

12 monthsTypical authorization duration

>=6Minimum age for tumor-agnostic

1Adjuvant melanoma limit (years)

Covered w/ criteriaCoverage stance

Coverage Summary

This policy adopts a covered_with_criteria stance for Tafinlar (dabrafenib), defining coverage for BRAF V600 mutation-positive malignancies per the FDA label and NCCN compendia when the specified prior‑authorization and documentation criteria are met; it covers single‑agent and combination (with trametinib) FDA‑approved indications and additional compendial uses as outlined in the policy scope.

Covered Indications (FDA-approved)

Tafinlar is covered for the following FDA-approved indications when approval criteria are met and member has no exclusions:

ANY of the following

Tafinlar as a single agent for unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Tafinlar in combination with trametinib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
Tafinlar in combination with trametinib for adjuvant treatment of melanoma with BRAF V600E or V600K mutations and lymph node involvement following complete resection.
Tafinlar in combination with trametinib for metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
Tafinlar in combination with trametinib for locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and no satisfactory locoregional treatment options.
Tafinlar in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation in adult and pediatric patients 6 years of age and older who have progressed following prior treatment and have no satisfactory alternative treatment options.Age >= 6 years

Compendial Uses (considered covered when approval criteria met)

ANY of the following

Melanoma, BRAF V600 activating mutation-positive.
Brain metastases from melanoma.
NSCLC, BRAF V600E.
Glioma, BRAF V600 activating mutation-positive.
Meningioma, BRAF V600 activating mutation-positive.
Astrocytoma, BRAF V600 activating mutation-positive.

Initial Therapy Criteria

Documentation and Prior Authorization Requirements

Submission of BRAF mutation documentation is necessary to initiate prior authorization review. Authorization of 12 months may be granted when criteria below are met for each disease category:

General

Submission of documentation of BRAF V600 mutation (e.g., V600E or V600K) detected by an FDA-approved test.
Member must have no exclusions to the prescribed therapy.

Cutaneous Melanoma settings (authorization 12 months)

Unresectable or metastatic cutaneous melanoma as a single agent or in combination with trametinib.
Brain metastases from melanoma in combination with trametinib.
Adjuvant treatment of resected stage III cutaneous melanoma in combination with trametinib.
Limited resectable local satellite/in-transit recurrent disease in combination with trametinib.

NSCLC (authorization 12 months)

BRAF V600E mutation-positive advanced or metastatic NSCLC as a single agent or in combination with trametinib.

Central Nervous System Cancers (authorization 12 months)

BRAF V600 mutation-positive gliomas, meningiomas, or astrocytomas.

Thyroid Cancer (authorization 12 months)

Progressive and/or symptomatic BRAF-positive follicular, Hürthle cell, or papillary thyroid carcinoma not amenable to radioactive iodine (RAI) therapy.
BRAF V600E mutation-positive locally advanced, metastatic, or borderline resectable anaplastic thyroid carcinoma when used in combination with trametinib.

Hepatobiliary Cancers (authorization 12 months)

Subsequent treatment of progressive BRAF-V600E mutated unresectable or metastatic gallbladder cancer, extrahepatic cholangiocarcinoma, or intrahepatic cholangiocarcinoma in combination with trametinib.

Histiocytic Neoplasms (authorization 12 months)

BRAF V600E mutation-positive Erdheim-Chester disease or Langerhans cell histiocytosis as a single agent.

Solid Tumors (tumor-agnostic) (authorization 12 months)

Tumors are BRAF V600E mutation positive.Age >= 6 years
Disease has progressed following prior treatment and there are no satisfactory alternative treatment options.
Member is 6 years of age or older.>= 6 years
Requested medication will not be used for the treatment of colorectal cancer.
Requested medication will be used in combination with trametinib.

Ovarian/Fallopian Tube/Primary Peritoneal Cancer (authorization 12 months)

Persistent or recurrent BRAF-V600E positive epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, carcinosarcoma (malignant mixed Mullerian tumors), clear cell carcinoma of the ovary, grade 1 endometrioid carcinoma, low-grade serous carcinoma/ovarian borderline epithelial tumor (low malignant potential), or mucinous carcinoma of the ovary, in combination with trametinib.

Continuation Therapy Criteria

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment when reauthorization criteria met:

ALL of the following

No evidence of unacceptable toxicity while on the current regimen.
No evidence of disease progression or recurrence while on the current regimen.
For adjuvant treatment of cutaneous melanoma, only 12 months total therapy will be approved.12 months

Key thresholds

Minimum age (tumor-agnostic)>= 6 years for unresectable or metastatic BRAF V600E solid tumors when used in combination with trametinib

Standard authorization duration12 months for initial approval and for continuation when reauthorization criteria are met

Adjuvant melanoma duration limitAdjuvant (resected stage III) cutaneous melanoma limited to 12 months total therapy when used in combination with trametinib

Provider Actions

Prior Authorization

Prior authorization required with BRAF documentation

Submit documentation of a BRAF V600 activating mutation (e.g., V600E or V600K) detected by an FDA-approved test to initiate prior authorization review. When approval criteria are met, authorizations are generally granted for 12 months.

Documentation Required

Mutation test documentation

Provide evidence of BRAF mutation testing using an FDA‑approved test specific to the requested indication. For melanoma and other listed indications, document the relevant BRAF V600 activating mutation (for example V600E or V600K).

Denial Risk

Excluded colorectal cancer use

Requests for Tafinlar to treat colorectal cancer should be denied or considered not covered because Tafinlar is not indicated for colorectal cancer due to known intrinsic resistance to BRAF inhibition.

Documentation Required

Continuation reauthorization requirements

For reauthorization, document that the member has no unacceptable toxicity and no evidence of disease progression or recurrence while on the current regimen. Note that adjuvant treatment of cutaneous melanoma is limited to a total of 12 months of therapy.

Document absence of unacceptable toxicity on current regimen.
Document absence of disease progression or recurrence on current regimen.
Adjuvant melanoma: maximum of 12 months total therapy.

OpenPayer

Tafinlar 1683 A Sgm P2023

Coverage Summary

Limitations of Use

Initial Therapy Criteria

Continuation Therapy Criteria

Not Medically Necessary / Experimental

Provider Actions

Applicable Codes

Clinical Evidence & References

Definitions

Revision History