Pharmacy Prior Authorization Criteria

Unituxin (dinutuximab)

Indications for Prior Authorization

Unituxin (dinutuximab)

• For diagnosis of Neuroblastoma
  Indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.

Criteria

Unituxin

Prior Authorization

Length of Approval: 12 Month(s)
For diagnosis of Neuroblastoma

• Diagnosis of high-risk neuroblastoma
AND
• Used in combination with all of the following:
• Granulocyte-macrophage colony-stimulating factor (GM-CSF) [e.g., Leukine (sargramostim)]
• Interleukin-2 (IL-2) [e.g., Proleukin (aldesleukin)]
• 13-cis-retinoic acid (RA) [e.g., isotretinoin]
AND
• Patient responded to prior first-line multiagent, multimodality therapy (e.g., chemotherapy, surgery, stem cell transplant, radiation therapy)

P & T Revisions

2024-07-05, 2023-06-22, 2021-09-27, 2021-06-02, 2021-05-26, 2021-05-25, 2021-04-09, 2021-02-03, 2020-05-26

References

1. Unituxin Prescribing Information. United Therapeutics Corp. Research Triangle Park, NC. April 2024.

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Revision History

• 2024-07-05: 2024 annual review - No changes to criteria
• 2023-06-22: Removed specialist requirement
• 2021-09-27: 2021 Annual Review, no changes to criteria.
• 2021-06-02: 2021 Annual Review, no changes to criteria.
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-04-09: Updated GPIs
• 2021-02-03: Program Update
• 2020-05-26: 2020 Annual Review. Removed reference to drug name in reauth criteria, no changes to clinical criteria.

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