WHA

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
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to generic imatinib
      • OR
    • Continuation of prior therapy
Tasigna

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to generic imatinib
      • OR
    • Continuation of prior therapy

  • Guideline ID
    GL-144839

  • Formulary
    EHB

  • Effective date
    Jun 1, 2024

  • P&T approval date
    Oct 3, 2006

P & T Revisions

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. 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.
  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.
  • 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.