Pharmacy Prior Authorization Criteria

Cotellic (cobimetinib)

Indications for Prior Authorization

Cotellic (cobimetinib)

• For diagnosis of Melanoma
  Indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib.

• For diagnosis of Histiocytic Neoplasms
  Indicated as a single agent for the treatment of adult patients with histiocytic neoplasms.

Criteria

Cotellic

*This product may require prior authorization.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Melanoma

• Diagnosis of unresectable or metastatic melanoma
AND
• One of the following: [A]
• Patient has a BRAF V600E mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., cobas 4800 BRAF V600 Mutation Test) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
OR
• Patient has a BRAF V600K mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test (e.g., cobas 4800 BRAF V600 Mutation Test) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Used in combination with Zelboraf (vemurafenib)*

Cotellic

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Histiocytic Neoplasms

• Diagnosis of histiocytic neoplasm
AND
• Used as monotherapy

Cotellic

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

• Patient has not experienced disease progression while on therapy

P & T Revisions

2024-07-03, 2023-07-06, 2022-11-30, 2022-06-29, 2021-09-27, 2021-05-20, 2020-06-18, 2019-07-01

References

1. Cotellic Prescribing Information. Genentech USA, Inc. South San Francisco, CA. May 2023.
2. Larkin J, Ascierto PA, Dréno B, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med. 2014;371(20):1867-76.
3. U.S. Food and Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm. Accessed May 23, 2024.

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End Notes

1. The cobas 4800 BRAF V600 Mutation Test is an FDA approved option and was used in the pivotal trial. [2, 3] The cobas 4800 BRAF V600 Mutation Test is also listed as the FDA approved companion diagnostic device for Zelboraf (vemurafenib). [3]

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Revision History

• 2024-07-03: Annual review: Background updates.
• 2023-07-06: Annual review: Updated criteria and background.
• 2022-11-30: Addition of new indication
• 2022-06-29: Annual Review
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2020-06-18: Annual Review
• 2019-07-01: Annual review: Updated FDA testing/CLIA verbiage, which was approved at the May P&T.

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