Pharmacy Prior Authorization Criteria

Scemblix (asciminib)

Indications for Prior Authorization

Scemblix

• For diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia
  Indicated for the treatment of adult patients with 1) Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is approved under accelerated approval based on major molecular response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s) 2) Previously treated Ph+ CML in CP. 3) 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

Scemblix

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2025-01-15, 2024-07-31, 2024-01-16, 2023-06-05, 2023-01-04, 2022-08-04, 2021-12-06

References

1. Scemblix [prescribing information]. East Hanover, New Jersey: Novartis Pharmaceuticals Corporation. October 2024.
2. Scemblix. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed December 3, 2021. http://www.micromedexsolutions.com.

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Revision History

• 2025-01-15: 2025 Annual Review. Update to reflect expanded indication for use as first line therapy. Removal of criterion for dosing in patients with T315I mutation
• 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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