Pharmacy Prior Authorization Criteria

Danziten (nilotinib)

Indications for Prior Authorization

Danziten (nilotinib)

• For diagnosis of Chronic myeloid leukemia
  Indicated for the treatment of: 1) Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. 2) Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.

Criteria

Danziten

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic myeloid leukemia

• Diagnosis of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)
AND
• Patient is 18 years of age or older
AND
• One of the following:
• Disease is in the accelerated phase
OR
• Both of the following:
• Disease is in the chronic phase
AND
• One of the following:
• Disease is high or intermediate risk
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

Danziten

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic myeloid leukemia

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

P & T Revisions

2025-07-03, 2025-05-07, 2025-05-07, 2025-01-15

References

1. Danziten Prescribing Information. Azurity Pharmaceuticals, Inc. Woburn, MA 0180. November 2024

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Revision History

• 2025-07-03: The supply of generic imatinib has been restored and so the step through this product will be reinstated, following temporary suspension. The updated step is a single step for patients in Chronic Phase with low risk disease, through generic dasatinib/ generic imatinib. Attached is discussion with IR and DT teams confirming 8/1/25 effective date. Pushed to active and brought to July P&T as an FYI. CJ 7/3/2025
• 2025-05-07: updating effective date for previous update to 5/9.
• 2025-05-07: Temporary removal of step through generic imatinib due to drug shortages.
• 2025-01-15: New program

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