Pharmacy Prior Authorization Criteria

Koselugo (selumetinib)

Indications for Prior Authorization

Koselugo (selumetinib)

• For diagnosis of Neurofibromatosis Type 1
  Indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)

Criteria

Koselugo

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s) [A]
For diagnosis of Neurofibromatosis Type 1

• Diagnosis of neurofibromatosis type 1
AND
• Patient has plexiform neurofibromas that are both of the following:
• Inoperable [B]
• Causing significant morbidity (e.g., disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment)
AND
• One of the following:
• Patient is less than 18 years of age
OR
• Both of the following:
• Patient is 18 years of age or older
• Patient is continuing therapy [C]
AND
• Patient is able to swallow a capsule whole

Koselugo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Neurofibromatosis Type 1

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

P & T Revisions

2024-06-05, 2023-08-21, 2023-05-31, 2022-06-08, 2021-09-27, 2021-05-11, 2020-06-04

References

1. Koselugo Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. January 2024.
2. Per clinical consult with oncologist, May 27, 2020.

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End Notes

1. The initial authorization duration of 6 months is to allow for assessment of adverse reactions (e.g., cardiomyopathy) without interruption of therapy [1,2].
2. Inoperable plexiform neurofibromas are defined as those that could not be completely removed without risk for substantial morbidity due to encasement of, or close proximity to, vital structures, invasiveness, or high vascularity of the PN [1].
3. It is the recommendation of the consultant that the medication should not be discontinued due to patient's age [2].

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Revision History

• 2024-06-05: 2024 Annual Review. No criteria changes. Background updates.
• 2023-08-21: Removed prescriber requirement
• 2023-05-31: Annual Review
• 2022-06-08: Annual Review
• 2021-09-27: Annual Review
• 2021-05-11: Annual Review
• 2020-06-04: New Program

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