Mekinist (trametinib)
Indications for Prior Authorization
Mekinist (trametinib)
-
For diagnosis of BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma
Indicated, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. -
For diagnosis of BRAF V600E mutation-positive metastatic non-small cell lung cancer
Indicated, in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer with BRAF V600E mutation as detected by an FDA-approved test. -
For diagnosis of Adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma
Indicated, in combination with dabrafenib, for the adjuvant treatment of 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. -
For diagnosis of BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer
Indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional options. -
For diagnosis of BRAF V600E mutation-positive unresectable or metastatic solid tumors
Indicated, in combination with dabrafenib, 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. -
For diagnosis of BRAF V600E mutation-positive low-grade glioma
Indicated, in combination with dabrafenib, 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. -
For diagnosis of Limitations of Use
MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.
Criteria
Mekinist
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
- Cancer is BRAF V600E 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]
Mekinist
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
Mekinist
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 Tafinlar (dabrafenib)
Mekinist
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
Mekinist
Prior Authorization
Length of Approval: 12 Month [A]
For diagnosis of Adjuvant 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 Tafinlar (dabrafenib)
Mekinist
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) [4] 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 Tafinlar (dabrafenib)
Mekinist
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
Mekinist
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
- 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 Tafinlar (dabrafenib)
Mekinist
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
Mekinist
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 Tafinlar (dabrafenib)
Mekinist
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
2024-03-07, 2023-10-02, 2023-06-15, 2022-08-04, 2022-03-08, 2021-09-27, 2021-05-21, 2021-03-02, 2020-02-27
References
- Mekinist Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. August 2023.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Melanoma v.3.2023. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf. Accessed February 11, 2024.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Non-Small Cell Lung Cancer v.2.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed February 11, 2024.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Thyroid Carcinoma v.1.2024. Available by subscription at: https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf. Accessed February 11 2024.
End Notes
- The recommended dosage of MEKINIST is 2 mg orally taken once daily in combination with dabrafenib until disease recurrence or unacceptable toxicity for up to 1 year for the adjuvant treatment of melanoma [1].
Revision History
- 2024-03-07: 2024 Annual Review. No criteria changes. Background updates.
- 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.
- 2022-08-04: Added new solid tumor indication. Updated background and references.
- 2022-03-08: Annual Review
- 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
- 2021-03-02: 2021 Annual Review
- 2020-02-27: Annual Review
HEALTHY LIVING