Koselugo (selumetinib) — Medica

Initial criteria

• Patient meets ONE of the following (i, ii, iii, iv, or v): i. Patient meets BOTH of the following (a and b): a) Patient has multisystem Langerhans cell histiocytosis; AND b) Patient has symptomatic disease or impending organ dysfunction; OR ii. Patient has single system lung Langerhans cell histiocytosis; OR iii. Patient meets BOTH of the following (a and b): a) Patient has single system bone disease; AND b) Patient has not responded to treatment with a bisphosphonate; OR iv. Patient has central nervous system disease; OR v. Patient has relapsed or refractory disease
• The medication is used as a single agent

Approval duration

1 year