Pharmacy Prior Authorization Criteria

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.

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

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

AND

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

Tasigna Prescribing Information. Novartis Pharmaceutical Corporation. East Hanover, NJ. February 2024.
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Chronic Myelogenous Leukemia v.1.2023. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Accessed March 27, 2023.

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.

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.