WHA
 

Nilotinib Products- PA, NF

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
              OR
            • For continuation of prior therapy
Brand Nilotinib (by manufacturer 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
              OR
            • For continuation of prior therapy
Brand Tasigna, generic nilotinib hydrochloride*

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
    AND
  • Trial and failure, or intolerance to generic nilotinib hydrochloride (applies to Brand Tasigna only)
Danziten, Brand Nilotinib (by manufacturer Cipla and Exelan), Brand Tasigna, generic nilotinib hydrochloride*

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy
    • AND
  • Trial and failure, or intolerance to generic nilotinib hydrochloride (applies to Brand Tasigna only)
Brand Tasigna

Non Formulary

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) confirming 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:
            • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to generic imatinib
              • OR
            • Both of the following:
              • Submission of medical records (e.g., chart notes) or paid claims confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy for continuation of therapy
              • Patient does not show evidence of progressive disease while on therapy
    AND
  • Both of the following:
    • Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with generic nilotinib hydrochloride that has the same active ingredient
      • AND
    • Submission of medical records confirming generic nilotinib hydrochloride has not been effective AND valid clinical justification provided explaining how Brand Tasigna is expected to provide benefit when generic nilotinib hydrochloride has not been shown to be effective despite having the same active ingredient

  • Guideline ID
    GL-491202

  • Formulary
    ehb

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Oct 3, 2006

P & T Revisions

2026-01-09, 2025-12-09, 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

  1. Tasigna Prescribing Information. Novartis Pharmaceutical Corporation. East Hanover, NJ. February 2024.
  2. Nilotinib Prescribing Information. Apotex Inc. Toronto, Ontario Canada. April 2025.
  3. Danziten Prescribing Information. Azurity Pharmaceuticals, Inc. Woburn, MA. November 2024.
  4. Nilotinib Prescribing Information. Cipla USA, Inc. Warren, NJ. January 2025.
  5. 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.
  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.
  2. 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]
  3. 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]
  • 2026-01-09: Update to NF criteria
  • 2025-12-09: Added step requirement and NF criteria for Brand Tasigna and operational note update
  • 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.