KOSELUGO (selumetinib)

KOSELUGO (selumetinib)

SELF ADMINISTRATION - Oral

Indications for Prior Authorization:

• The treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

Patients must meet the following criteria for the indication(s) above:

• Chart note documentation must confirm diagnosis of neurofibromatosis type 1, AND
• Prescribed by or in consultation with an oncologist or neurologist, AND
• Patient has plexiform neurofibromas that are BOTH of the following:
  • Inoperable
  • Causing significant morbidity (e.g., disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment), AND
• Patient is able to swallow a capsule whole, AND
• Body surface area (BSA) is provided (dosing is based on BSA). (Patient must have a BSA of at least 0.55 m²), AND
• ONE of the following:
  • Patient is 2 years old to 17 years old, OR
  • Both of the following:
    • Patient is 18 years of age or older, and
    • Patient is continuing therapy

Reauthorization criteria:

• Specialist chart note documentation provided shows a clinical response to therapy

Dosing:

• Recommended dosage: 25 mg/m² orally twice daily (approximately every 12 hours) without food on empty stomach until disease progression or unacceptable toxicity
• Do not consume food 2 hours before each dose or 1 hour after each dose
• Dosing reductions are recommended for toxicities, hepatic impairment, and drug interactions.

Approval:

• Initial: 6 months
• Renewal: 1 year