Nilotinib Products
Indications for Prior Authorization
Danziten (nilotinib tartrate), Nilotinib (nilotinib D-tartrate)
-
For diagnosis of Newly diagnosed Ph+ Chronic Myeloid Leukemia (CML)
Indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase. -
For diagnosis of Resistant or intolerant Ph+ CML
Indicated for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.
Tasigna (nilotinib hydrochloride)
-
For diagnosis of Newly diagnosed Ph+ Chronic Myeloid Leukemia (CML)
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 Ph+ CML
Indicated for the treatment of adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib. -
For diagnosis of Resistant or intolerant Ph+ CML
Indicated for the treatment of pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.
Criteria
Danziten
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 18 years of age or older AND
- One of the following:
- Disease is in the accelerated phase [B] OR
- Both of the following:
- Disease is in the chronic phase AND
- One of the following:
- Disease is high or intermediate risk [C] OR
- Both of the following:
- Disease is low risk AND
- One of the following:
- Trial and failure, contraindication, or intolerance to one of the following:
- generic dasatinib
- generic imatinib
- For continuation of prior therapy
Brand Nilotinib (by manufacturers Cipla and Exelan)
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 18 years of age or older AND
- One of the following:
- Disease is in the accelerated phase [B] OR
- Both of the following:
- Disease is in the chronic phase AND
- One of the following:
- Disease is high or intermediate risk [C] OR
- Both of the following:
- Disease is low risk AND
- One of the following:
- Trial and failure, contraindication, or intolerance to BOTH of the following:
- generic nilotinib hydrochloride
- generic imatinib
- For continuation of prior therapy
Brand Tasigna, generic nilotinib hydrochloride*
*If patient meets criteria above, please approve at GPI-12 level and with a MSC Y.
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 AND
- One of the following:
- Disease is in the accelerated phase [B] OR
- Both of the following:
- Disease is in the chronic phase AND
- One of the following:
- Disease is high or intermediate risk [C] OR
- Both of the following:
- Disease is low risk AND
- One of the following:
- Trial and failure, contraindication, or intolerance to generic imatinib OR
- For continuation of prior therapy
Danziten, Brand Nilotinib (by manufacturers Cipla and Exelan), Brand Tasigna, generic nilotinib hydrochloride*
*If patient meets criteria above, please approve at GPI-12 level and with a MSC Y.
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2025-12-04, 2025-12-02, 2025-11-19, 2025-07-07, 2025-07-03, 2025-07-03, 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
- Tasigna Prescribing Information. Novartis Pharmaceutical Corporation. East Hanover, NJ. February 2024.
- Nilotinib Prescribing Information. Apotex Inc. Toronto, Ontario Canada. April 2025.
- Danziten Prescribing Information. Azurity Pharmaceuticals, Inc. Woburn, MA. November 2024.
- Nilotinib Prescribing Information. Cipla USA, Inc. Warren, NJ. January 2025.
- National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Chronic Myelogenous Leukemia v.1.2026. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf. Accessed October 30, 2025.
End Notes
- 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.
- In accelerated phase CML (AP-CML), preferred agents include second-generation (e.g., nilotinib) or third-generation tyrosine kinase inhibitors (TKIs). Imatinib is considered a useful alternative for patients with AP-CML if second- or third-generation TKIs are contraindicated. [5]
- Prevention of disease progression to AP-CML or blast phase CML is the primary goal of TKI therapy in patients with chronic phase CML. Second-generation TKIs (e.g., nilotinib, dasatinib) are associated with a lower risk of disease progression than imatinib and are preferred for patients with an intermediate- or high-risk score. [5]
Revision History
- 2025-12-04: Operational note for generic nilotinib hydrochloride added (*If patient meets criteria above, please approve at GPI-12 level and with a MSC Y).
- 2025-12-02: Added manufacturer Exelan for Nilotinib D-tartrate products to guideline.
- 2025-11-19: Addition of Danziten and Nilotinib to guideline; update guideline name to Nilotinib products.
- 2025-07-07: Addition of new generic Tasigna as a target drug
- 2025-07-03: Correction to step in update due to the supply of generic imatinib being restored and the step through this product being reinstated, following temporary suspension.
- 2025-07-03: The supply of generic imatinib has been restored and so the step through this product will be reinstated, following temporary suspension.
- 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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