Koselugo (selumetinib) — Medica

Initial criteria

• Patient meets ONE of the following (i or ii): i. Patient is 3 to 21 years of age; OR ii. Patient meets BOTH of the following (a and b): a) Patient is > 21 years of age; AND b) Patient has been previously started on therapy with Koselugo prior to becoming 21 years of age
• Patient has recurrent, refractory, or progressive disease
• Tumor meets ONE of the following (i, ii, or iii): i. Tumor is BRAF fusion positive; OR ii. Tumor is BRAF V600E activating mutation positive; OR iii. Patient has neurofibromatosis type 1 mutated glioma
• The medication will be used as a single agent

Approval duration

1 year