CurrentNeighborhood Health Plan of Rhode IslandPolicy 1683-A

Tafinlar 1683-A SGM P2024a

Defines covered indications, required documentation, authorization durations, and continuation criteria for dabrafenib (Tafinlar) including single-agent and combination use with trametinib across FDA-approved and compendial indications for BRAF V600 mutations. Applies to prior authorization review and limits use for non-covered/experimental indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTafinlar 1683-A SGM P2024a

Policy CodePolicy 1683-A

Change TypeClarified (no material change)

Effective DateJan 1, 2024

Next Review Date

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

POLICY UPDATE CHANGES

Policy effective 2024-01-01 with last review 2024-04-30; no material clinical policy changes indicated in document.

12Authorization months

>=1Minimum age for certain indications (years)

1Policy reference number (last digit grouping)

Coverage Summary

Coverage stance: covered_with_criteria for Tafinlar (dabrafenib) when specified FDA-approved and compendial criteria are met. Scope: defines covered indications, required documentation, authorization durations, and continuation criteria for dabrafenib including single-agent and combination use with trametinib across FDA-approved and compendial indications for BRAF V600 mutations. Policy subject: Tafinlar (dabrafenib). Policy number: 1683-A. Effective date: 2024-01-01. Last review: 2024-04-30.

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.
Adjuvant treatment of melanoma with BRAF V600E or V600K mutations with lymph node involvement following complete resection, in combination with trametinib.
Metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation in combination with trametinib.
Locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and no satisfactory locoregional treatment options in combination with trametinib.
Unresectable or metastatic solid tumors with BRAF V600E mutation in patients 1 year of age and older who have progressed following prior treatment and have no satisfactory alternative treatment options, in combination with trametinib.
Minimum age >= 1 year.
Pediatric patients 1 year of age and older with low-grade glioma (LGG) with BRAF V600E mutation who require systemic therapy, in combination with trametinib.
Minimum age >= 1 year.

Initial Therapy / Authorization Requirements

Documented Requirements for Prior Authorization (Documentation)

Submission requirement to initiate prior authorization review:

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

Authorization Duration and Setting-Specific Criteria

Authorization of 12 months may be granted for the following settings when criteria are met:

ANY of the following

Cutaneous Melanoma
- Unresectable or metastatic disease when used either as a single agent if BRAF/MEK inhibitor combination therapy is contraindicated, or in combination with trametinib (with or without pembrolizumab).
- Brain metastases from melanoma in combination with trametinib.
- Neoadjuvant therapy in combination with trametinib if immunotherapy is contraindicated.
- Adjuvant treatment of resected stage III cutaneous melanoma in combination with trametinib.
- Limited resectable local satellite/in-transit recurrent disease in combination with trametinib.
Non-Small Cell Lung Cancer (NSCLC)
- BRAF V600E mutation-positive recurrent, advanced, or metastatic NSCLC.
- Member has not experienced disease progression on BRAF-targeted therapy and requested drug will be used either as a single agent if dabrafenib plus trametinib is not tolerated, or in combination with trametinib.
Central Nervous System Cancer
- BRAF V600 mutation-positive gliomas, meningiomas, or astrocytomas.
Anaplastic Thyroid Cancer
- BRAF V600E mutation-positive locally advanced or stage IV anaplastic thyroid carcinoma in combination with trametinib and no satisfactory locoregional treatment options.
Biliary Tract Cancers
- Subsequent treatment of progressive BRAF V600E mutation-positive unresectable, resected gross residual (R2), or metastatic gallbladder cancer, extrahepatic cholangiocarcinoma, or intrahepatic cholangiocarcinoma in combination with trametinib.
Histiocytic Neoplasms
- BRAF V600E mutation-positive Erdheim-Chester disease or Langerhans cell histiocytosis as a single agent.
Solid Tumors (Tumor-Agnostic)
- Unresectable or metastatic solid tumors that are BRAF V600E mutation positive.
- Disease has progressed following prior treatment and there are no satisfactory alternative treatment options.
- Member is 1 year of age or older.
  Minimum age >= 1 year.
- 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
- Persistent or recurrent BRAF V600E mutation-positive epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, carcinosarcoma, clear cell carcinoma of the ovary, grade 1 endometrioid carcinoma, low-grade serous carcinoma/ovarian borderline epithelial tumor, or mucinous carcinoma of the ovary, in combination with trametinib.
GIST
- BRAF V600E mutation-positive GIST in combination with trametinib when used as neoadjuvant therapy or first-line therapy for gross residual disease (R2 resection), unresectable primary disease, tumor rupture or recurrent/metastatic disease.
Pancreatic Adenocarcinoma
- BRAF V600E mutation-positive recurrent, locally advanced, or metastatic disease in combination with trametinib.
Salivary Gland Tumors
- BRAF V600E mutation-positive recurrent salivary gland tumor in combination with trametinib.
Gastric / Esophageal / EGJ Cancer
- Subsequent treatment of BRAF V600E mutation-positive unresectable locally advanced, recurrent, or metastatic disease or for members who are not surgical candidates, in combination with trametinib.
Hairy Cell Leukemia
- Relapsed/refractory hairy cell leukemia in combination with trametinib if not previously treated with BRAF inhibitor therapy.
Small Bowel Adenocarcinoma
- BRAF V600E mutation-positive advanced or metastatic small bowel adenocarcinoma in combination with trametinib.

Surface thresholds and quick facts

Authorization duration12 months

Minimum age (where applicable)>= 1 year

Adjuvant melanoma limitAdjuvant cutaneous melanoma: only 12 months total therapy will be approved

Settings with 12-month authUnresectable/metastatic melanoma, NSCLC, CNS tumors, ATC, biliary, histiocytic neoplasms, tumor-agnostic solid tumors, ovarian/GIST/pancreatic/salivary/gastric/hairy cell/small bowel cancers

Continuation Therapy (Reauthorization) Criteria

Continuation of Therapy (Reauthorization)

Criteria for reauthorization for indications listed above:

No evidence of unacceptable toxicity while on current regimen.

No evidence of disease progression or recurrence while on current regimen.

For adjuvant treatment of cutaneous melanoma, only 12 months of therapy total will be approved.12 months

Documentation Required

Reauthorization requirements

For reauthorization, documentation must show there is no evidence of unacceptable toxicity while on the current regimen and no evidence of disease progression or recurrence. For adjuvant treatment of cutaneous melanoma, only a total of 12 months of therapy will be approved.

Evidence of no unacceptable toxicity on current regimen
Evidence of no disease progression or recurrence on current regimen
If adjuvant cutaneous melanoma: documentation that total therapy will not exceed 12 months

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required with 12-month approvals

Prior authorization review is required to request coverage for Tafinlar, and approvals may be granted for a duration of 12 months when criteria are met.

Documentation Required

Submit BRAF mutation documentation

Submission of documentation demonstrating the presence of a BRAF V600 mutation (e.g., V600E or V600K) is required to initiate prior authorization review.

Laboratory or pathology report demonstrating presence of BRAF V600 mutation (e.g., V600E or V600K) detected by an FDA-approved test

Documentation Required

Reauthorization evidence

For continuation of therapy, submit documentation showing no unacceptable toxicity while on the current regimen and no evidence of disease progression or recurrence. For adjuvant treatment of cutaneous melanoma, reauthorization is limited to a total of 12 months of therapy.

Documentation of no unacceptable toxicity on current regimen
Documentation of no disease progression or recurrence on current regimen
For adjuvant cutaneous melanoma: documentation that total therapy duration is 12 months

Background

Tafinlar (dabrafenib) is a BRAF inhibitor approved for BRAF V600 mutation-positive malignancies including unresectable or metastatic melanoma and BRAF V600E NSCLC, and is used in combination with trametinib for multiple tumor types. It is FDA-approved as single agent for unresectable or metastatic melanoma with BRAF V600E and in combination with trametinib for melanoma (V600E or V600K), adjuvant melanoma with lymph node involvement, metastatic NSCLC (BRAF V600E), anaplastic thyroid cancer with BRAF V600E and for certain unresectable or metastatic solid tumors and pediatric low-grade glioma in patients ≥1 year of age. Limitations include lack of activity in colorectal cancer and lack of indication for wild-type BRAF tumors. Compendial uses extend to multiple tumor types with BRAF V600 activating mutations (e.g., brain metastases from melanoma, glioma, meningioma, biliary tract cancers, histiocytic neoplasms, ovarian and gastrointestinal malignancies).

Quick reference

Policy number1683-A

Effective date2024-01-01

Last review2024-04-30

PayerNeighborhood Health Plan of Rhode Island

SubjectTafinlar (dabrafenib) coverage policy

OpenPayer

Tafinlar 1683-A SGM P2024a

Coverage Summary

Initial Therapy / Authorization Requirements

Continuation Therapy (Reauthorization) Criteria

Not Covered / Exclusions

Provider Actions & Prior Authorization

Applicable Codes & Policy Identifiers

Clinical Evidence & References

Background

Definitions

Revision History