Pharmacy Prior Authorization Criteria

Tasigna (nilotinib)

Indications for Prior Authorization

Tasigna (nilotinib)

• For diagnosis of Newly diagnosed Ph+ Chronic Myeloid Leukemia
  Indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

• For diagnosis of Resistant or intolerant CML in chronic phase (CP) and accelerated phase (AP)
  Indicated for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant to or intolerant to prior therapy that included imatinib.

• For diagnosis of Resistant or intolerant CML in chronic phase (CP) and accelerated phase (AP), Pediatric
  Indicated for pediatric patients greater than or equal to 1 year of age with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy.

Criteria

Tasigna

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of Philadelphia chromosome-positive/BCR ABL positive (Ph+/BCR ABL) chronic myelogenous/myeloid leukemia (CML) (A)
AND
• Patient is 1 year of age or older

Tasigna

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2025-05-08, 2025-04-03, 2024-04-03, 2023-06-20, 2023-04-10, 2022-04-07, 2022-03-11, 2021-10-22, 2021-09-27, 2021-05-25, 2021-03-04, 2020-03-16, 2019-11-04, 2019-07-30

References

1. Tasigna Prescribing Information. Novartis Pharmaceutical Corporation. East Hanover, NJ. February 2024.
2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Chronic Myelogenous Leukemia v.3.2025. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Accessed March 24, 2025.

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End Notes

1. BCR-ABL1 refers to a gene sequence found in an abnormal chromosome 22. The cause of chronic myelogenous leukemia (CML) can be traced to a single, specific genetic abnormality in one chromosome. The presence of the gene sequence known as BCR-ABL1 confirms the diagnosis of CML.

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Revision History

• 2025-05-08: Temporary removal of step through generic imatinib due to drug shortages.
• 2025-04-03: 2025 Annual Review -Removed step requirement w/COT bypass in reauth criteria and updated references
• 2024-04-03: 2024 Annual Review - t/f requirement added to reauth criteria and updated references
• 2023-06-20: Removal of specialist requirement
• 2023-04-10: 2023 Annual Review
• 2022-04-07: 2022 Annual Review - added age restriction per FDA label
• 2022-03-11: Updated GPI list
• 2021-10-22: Background update to Pediatric indication
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-04: 2021 Annual Review: Updated ST criteria to reflect standard trial and failure language. Updated references.
• 2020-03-16: Annual Review; No changes
• 2019-11-04: Added embedded step through generic imatinib for Brand Tasigna and allow current users to bypass the step per form strategy update
• 2019-07-30: Removal of criteria 2 Patient does not have the T315I mutation based on consultant feedback (Dr Sinha and Dr Gandhi) that this is not routinely done in practice as first line.

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