Pharmacy Prior Authorization Criteria

Zykadia (ceritinib)

Indications for Prior Authorization

Zykadia (ceritinib)

• For diagnosis of Non-small Cell Lung Cancer (NSCLC)
  Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Criteria

Zykadia

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• One of the following: [2]
• Disease is metastatic
• Disease is recurrent
AND
• Tumor is anaplastic lymphoma kinase (ALK)-positive as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• One of the following:
• Patient has had disease progression on, contraindication or intolerance to, or is not a candidate for one of the following:
• Alecensa (alectinib)
• Alunbrig (brigatinib)
OR
• For continuation of prior therapy

Zykadia

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2024-05-02, 2023-06-26, 2023-05-03, 2022-04-28, 2021-08-02, 2021-06-15, 2021-04-08, 2021-02-04, 2020-05-27

References

1. Zykadia Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. June 2022.
2. The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed April 10, 2024.

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Revision History

• 2024-05-02: 2024 Annual review. No criteria changes. Background updates.
• 2023-06-26: Removed specialist requirement.
• 2023-05-03: Annual review, no criteria changes.
• 2022-04-28: Annual review - No criteria changes, updated background
• 2021-08-02: Annual review - updated CLIA verbiage to align with standard language for consistency. Updated references.
• 2021-06-15: Annual review - updated CLIA verbiage to align with standard language for consistency. Updated references.
• 2021-04-08: Updated GPI
• 2021-02-04: Added embedded step through Alecensa and Alunbrig. Removed drug name from reauth criteria.
• 2020-05-27: Annual review, no changes to clinical criteria updated references

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