WHA

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

  • Guideline ID
    GL-146918

  • Formulary
    premium

  • Effective date
    Jul 1, 2024

  • P&T approval date
    Jul 8, 2014

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

  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.
  • 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