Pharmacy Prior Authorization Criteria

Koselugo (selumetinib)

Indications for Prior Authorization

Koselugo (selumetinib)

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

Criteria

Koselugo Capsules

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)

Koselugo Oral Granules

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 greater than or equal to 1 year of age and less than 2 years of age
OR
• All of the following:
• Patient is greater than or equal to 2 years of age
AND
• Patient is unable to swallow a solid dosage form (e.g., oral capsule) due to one of the following:
• Age
• Physical Impairment e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube
AND
• Trial and failure, contraindication, or intolerance to Gomekli dispersible tablets

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
AND
• For Koselugo oral granules only, one of the following:
• 2.1 Patient is greater than or equal to 1 year of age and less than 2 years of age
OR
• All of the following:
• Patient is greater than or equal to 2 years of age
AND
• Patient is unable to swallow a solid dosage form (e.g., oral capsule) due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube
AND
• Trial and failure, contraindication, or intolerance to Gomekli dispersible tablets

P & T Revisions

2026-03-02, 2026-01-07, 2025-10-13, 2025-07-02, 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. November 2025. Accessed February 2026
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].

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Revision History

• 2026-03-02: Addition of criteria to Koselugo Oral Granules product.
• 2026-01-07: Updated criteria as latest FDA indication update includes adult patients. Background updates.
• 2025-10-13: Criteria and background updates due to expanded indication and addition of Koselugo granules.
• 2025-07-02: 2025 Annual Review. No criteria changes.
• 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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