Pharmacy Prior Authorization Criteria

Tafinlar (dabrafenib)

Indications for Prior Authorization

Tafinlar (dabrafenib)

• For diagnosis of BRAF V600E mutation-positive unresectable or metastatic melanoma
  Indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.

  Limitation of use: Tafinlar is not indicated for treatment of patients with wild-type BRAF solid tumors. Tafinlar is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Indication BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

• For diagnosis of BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma
  Indicated in combination with trametinib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test.

  Limitation of use: Tafinlar is not indicated for treatment of patients with wild-type BRAF solid tumors. Tafinlar is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Indication BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

• For diagnosis of BRAF V600E mutation-positive metastatic non-small cell lung cancer
  Indicated in combination with trametinib for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.

  Limitation of use: Tafinlar is not indicated for treatment of patients with wild-type BRAF solid tumors. Tafinlar is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Indication BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

• For diagnosis of BRAF V600E or V600K mutation-positive adjunctive treatment for melanoma
  Indicated for adjuvant treatment in combination with trametinib for patients with melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.

  Limitation of use: Tafinlar is not indicated for treatment of patients with wild-type BRAF solid tumors. Tafinlar is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Indication BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

• For diagnosis of Anaplastic thyroid cancer (ATC) with BRAF V600E mutation
  Indicated in combination with trametinib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.

  Limitation of use: Tafinlar is not indicated for treatment of patients with wild-type BRAF solid tumors. Tafinlar is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Indication BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

• For diagnosis of BRAF V600E mutation-positive unresectable or metastatic solid tumors
  Indicated, in combination with trametinib, for the treatment of adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.

  Limitation of use: Tafinlar is not indicated for treatment of patients with wild-type BRAF solid tumors. Tafinlar is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Indication BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

• For diagnosis of BRAF V600E mutation-positive low-grade glioma
  Indicated, in combination with trametinib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

  Limitation of use: Tafinlar is not indicated for treatment of patients with wild-type BRAF solid tumors. Tafinlar is not indicated for the treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Indication BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma.

Criteria

Tafinlar

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Unresectable or metastatic melanoma

• One of the following diagnoses: [2]
• Unresectable melanoma
• Metastatic melanoma
AND
• One of the following:
• Cancer is BRAFV600E mutant type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2]
OR
• Both of the following:
• Cancer is BRAFV600E or V600K mutant type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2]
AND
• Medication is used in combination with Mekinist (trametinib)

Tafinlar

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Unresectable or metastatic melanoma

• Patient does not show evidence of progressive disease while on therapy

Tafinlar

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-small cell lung cancer

• Diagnosis of metastatic non-small cell lung cancer
AND
• Cancer is BRAF V600E mutant type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [2]
AND
• Medication is used in combination with Mekinist (trametinib)

Tafinlar

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-small cell lung cancer

• Patient does not show evidence of progressive disease while on therapy

Tafinlar

Prior Authorization

Length of Approval: 12 Month [A]
For diagnosis of Adjunctive treatment for melanoma

• Diagnosis of melanoma
AND
• Cancer is BRAF V600E mutation or V600K mutation type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Involvement of lymph nodes following complete resection [2]
AND
• Used as adjunctive therapy
AND
• Medication is used in combination with Mekinist (trametinib)

Tafinlar

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Anaplastic thyroid cancer (ATC)

• Diagnosis of locally advanced or metastatic anaplastic thyroid cancer (ATC) [2]
AND
• Cancer is BRAF V600E mutation type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Cancer may not be treated with standard locoregional treatment options
AND
• Medication is used in combination with Mekinist (trametinib)

Tafinlar

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Anaplastic thyroid cancer (ATC)

• Patient does not show evidence of progressive disease while on therapy

Tafinlar

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Unresectable or metastatic solid tumors

• Diagnosis of solid tumors
AND
• Patient is 1 year of age or older
AND
• Disease is one of the following:
• unresectable
• metastatic
AND
• Patient has progressed on or following prior treatment and have no satisfactory alternative treatment options
AND
• Cancer is BRAF V600E mutation type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Medication is used in combination with Mekinist (trametinib)

Tafinlar

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Unresectable or metastatic solid tumors

• Patient does not show evidence of progressive disease while on therapy

Tafinlar

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Low-grade glioma

• Diagnosis of low-grade glioma
AND
• Patient is 1 year of age or older
AND
• Patient requires systemic therapy
AND
• Cancer is BRAF V600E mutation type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Medication is used in combination with Mekinist (trametinib)

Tafinlar

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Low-grade glioma

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-02-22, 2023-10-02, 2023-06-15, 2023-03-15, 2022-08-04, 2022-03-02, 2021-09-27, 2021-05-26, 2021-05-25, 2021-03-04, 2020-02-17

References

1. Tafinlar Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. August 2023.
2. National Comprehensive Cancer (NCCN) Drugs & Biologics Compendium [internet database]. Updated periodically. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed February 12, 2024.

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End Notes

1. The recommended dosage of TAFINLAR is 150 mg orally taken twice daily in combination with trametinib until disease recurrence or unacceptable toxicity for up to 1 year for the adjuvant treatment of melanoma [1].

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Revision History

• 2024-02-22: 2024 Annual Review. Updated references.
• 2023-10-02: update guideline
• 2023-06-15: Added new indication for low grade glioma. Added new tablet for oral suspension. Removed prescriber requirement for all indications. Updated background and references.
• 2023-03-15: Annual review - updated references.
• 2022-08-04: Added new solid tumor indication. Updated background and references.
• 2022-03-02: Annual review - updated references.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-04: Annual review - updated references.
• 2020-02-17: Annual review - updated criterion to "test performed a facility approved by CLIA" to align with med D verbiage for clarity. Also removed drug name from reauth criteria. Updated background and references.

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