Pharmacy Prior Authorization Criteria

Iclusig (ponatinib)

Indications for Prior Authorization

Iclusig (ponatinib)

• For diagnosis of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
  1) Newly diagnosed Ph+ ALL in combination with chemotherapy.

  This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

  2) As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.

• For diagnosis of Chronic Myeloid Leukemia (CML)
  1) Indicated for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.

  2) Indicated for the treatment of adult patients with Accelerated phase (AP) or blast phase (BP) Chronic Myeloid Leukemia (CML) for whom no other kinase inhibitors are indicated.

  3) Indicated for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase)

  Limitations of Use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML

Criteria

Iclusig

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Myelogenous Leukemia

• Diagnosis of chronic myelogenous leukemia (CML)

Iclusig

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

• Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
AND
• One of the following [1]:
• Used in combination with chemotherapy up to 20 cycles
OR
• Used as monotherapy in patients where one of the following applies:
• No other kinase inhibitors are indicated
• Disease is T315I-positive Ph+ ALL

Iclusig

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

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

P & T Revisions

2024-09-27, 2024-04-23, 2023-12-01, 2023-07-06, 2023-04-28, 2022-11-02, 2021-10-25, 2021-09-27, 2021-05-19, 2021-04-07, 2021-02-03, 2020-10-26, 2019-09-26, 2019-07-30

References

1. Iclusig Prescribing Information. ARIAD Pharmaceuticals, Inc. Cambridge, MA. March 2024.

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End Notes

1. Resistance in CP-CML while on prior TKI therapy, was defined as failure to achieve either a complete hematologic response (by 3 months), a minor cytogenetic response (by 6 months), or a major cytogenetic response (by 12 months). Patients with CP-CML who experienced a loss of response or development of a kinase domain mutation in the absence of a complete cytogenetic response or progression to AP-CML or BP-CML at any time on prior TKI therapy were also considered resistant. Resistance in AP-CML, BP-CML, and Ph+ALL was defined as failure to achieve either a major hematologic response (by 3 months in AP-CML, and by 1 month in BP-CML and Ph+ALL), loss of major hematologic response (at any time), or development of a kinase domain mutation in the absence of a complete major hematologic response while on prior TKI therapy. Intolerance was defined as the discontinuation of prior TKI therapy due to toxicities despite optimal management in the absence of a complete cytogenetic response in patients with CP-CML or major hematologic response for patients with APCML, BP-CML, or Ph+ALL. [1]

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Revision History

• 2024-09-27: 2024 Annual Review. No updates
• 2024-04-23: Addition of criteria for new indication in combination with chemotherapy, for treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. Background updates.
• 2023-12-01: Annual review - updated indications to include limitations to use; updated references.
• 2023-07-06: Removed specialist requirement
• 2023-04-28: Program update to remove trial requirement of 2 TKI's or confirmation of T315I mutation status.
• 2022-11-02: Annual Review - No criteria changes
• 2021-10-25: Annual Review - no clinical criteria changes
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-07: Updated GPI'S
• 2021-02-03: new indication and added new 10mg and 30mg strengths to guideline
• 2020-10-26: annual review no updates to clinical criteria
• 2019-09-26: annual review no updates
• 2019-07-30: Removed all of the following and changed to two of the following TKI's for CML indication based on consultant feedback (Dr Sinha and Dr Gandhi) Dr Sinha wanted removal of confirmation of mutation but dr Gandhi feedback that would allow for patient to try or fail a drug and then get a genetic test (which is what is done in his practice area) then patient can still get drug. Added two examples of TKIs in indication for acute lymphoblastic leukemia Updated reference date updated reauth criteria to remove "while on Iclusig" just stating patient does not show evidence of progressive disease so no need to update guideline when generic approved

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