ZYKADIA (ceritinib)

ZYKADIA (ceritinib)

SELF ADMINISTRATION - ORAL

Diagnosis considered for coverage:

• 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.

Coverage Criteria:

For diagnosis of non-small cell lung cancer (NSCLC):

• Dose does not exceed 450 mg per day, AND

• Prescribed by or in consultation with an oncologist, AND

• The patient has a diagnosis of non-small cell lung cancer (NSCLC), AND

• The disease is one of the following:

  • Metastatic

  • 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 (brugatinib), OR 

  • For continuation of prior therapy

Reauthorization Criteria:

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

Coverage Duration: 

• Initial: 12 months

• Reauthorization: 12 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosing:

  • Recommended dose: 450 mg Patient must have progressed on or are intolerant to Xalkori (crizotinib)

Policy Updates:

• 05/22/2023 – Updated indication, coverage criteria, and dosing 

References:

• Zykadia Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. August 2021. 

• The National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed April 28, 2022.