Pharmacy Prior Authorization Criteria

Gomekli (mirdametinib)

Indications for Prior Authorization

Gomekli (mirdametinib)

• For diagnosis of Neurofibromatosis Type 1
  Indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection

Criteria

Gomekli

Prior Authorization (Initial Authorization)

Length of Approval: 0 6 Months [A]

• 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
• Patient is 2 years of age or older

Gomekli

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

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

P & T Revisions

2025-03-20

References

1. Gomekli Prescribing Information. SpringWorks Therapeutics, Inc. Stamford, CT 06902. February 2025.
2. Moertel CL, Hirbe AC, Shuhaiber HH, et al. ReNeu: A Pivotal, Phase IIb Trial of Mirdametinib in Adults and Children With Symptomatic Neurofibromatosis Type 1-Associated Plexiform Neurofibroma. J Clin Oncol. 2025;43(6):716-729. doi:10.1200/JCO.24.01034

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End Notes

1. The initial authorization duration of 6 months is to allow for assessment of adverse reactions (e.g., ocular toxicity, left ventricular dysfunction) without interruption of therapy [1].
2. Inoperable plexiform neurofibromas are defined as those that cannot 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

• 2025-03-20: New program.

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