Scemblix (asciminib)

Indications for Prior Authorization

Scemblix
  • For diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia
    Indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). Scemblix is also indicated for the treatment of Ph+CML in CP with the T315I mutation.

Criteria

Scemblix

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of chronic myelogenous/myeloid leukemia (CML) [1, 2]
  • AND
  • Disease is Philadelphia chromosome-positive (Ph+)
  • AND
  • Disease is in chronic phase
  • AND
  • One of the following:
    • Both of the following:
      • Patient has been previously treated with two or more alternative tyrosine kinase inhibitors (TKI) [e.g., Bosulif (bosutinib), imatinib, Sprycel (dasatinib), Tasigna (nilotinib), Iclusig (ponatinib)]
      • AND
      • Prescribed medication will be dosed at a maximum of 80 mg per day
      OR
    • Both of the following:
      • Disease is T315I mutation positive
      • AND
      • Prescribed medication will be dosed at a maximum of 400 mg per day
Scemblix

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Patient does not show evidence of progressive disease while on therapy
P & T Revisions

2024-07-31, 2024-01-16, 2023-06-05, 2023-01-04, 2022-08-04, 2021-12-06

  1. Scemblix [prescribing information]. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation. November 2023.
  2. Scemblix. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed December 3, 2021. http://www.micromedexsolutions.com.

  • 2024-07-31: Added new GPI
  • 2024-01-16: 2024 Annual Review - updated references
  • 2023-06-05: Removed prescriber requirement.
  • 2023-01-04: Annual Review. No changes to criteria. Updated references
  • 2022-08-04: Update to add dosing criteria to guideline
  • 2021-12-06: New program for Scemblix

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