Sogroya (somapacitan-beco) — Medica

Initial criteria

• Approve for 1 year if ANY of the following (A or B) are met:
• A) Initial Therapy with any Growth Hormone Agent. Approve if ANY of the following (i, ii, iii, iv, or v) are met:
• i. Patient meets BOTH of the following (a and b):
• a) Patient meets ONE of the following [(1) or (2)]:
• (1) Patient has had ≥ 2 growth hormone stimulation tests (levodopa, insulin-induced hypoglycemia, arginine, clonidine, or glucagon) AND peak GH response to both tests < 10 ng/mL; OR
• (2) Patient has had ≥ 1 growth hormone stimulation test (same agents) with peak GH response < 10 ng/mL AND has ≥ 1 risk factor for growth hormone deficiency (e.g., downward deviation across ≥ 2 height percentiles, growth rate < expected normal, low IGF-1/IGFBP-3, low peak GH per prescriber, growth velocity <10th percentile, post craniopharyngioma resection, optic nerve hypoplasia, GH gene deletion); AND
• b) Medication prescribed by or in consultation with an endocrinologist; OR
• ii. Patient has undergone brain radiation or tumor resection AND meets BOTH:
• a) Patient meets ONE of the following [(1) or (2)]: (1) Has had ≥ 1 growth hormone stimulation test (same agents) AND peak GH response < 10 ng/mL; OR (2) Has deficiency in ≥ 1 other pituitary hormone (ACTH, TSH, gonadotropin, or prolactin); AND
• b) Medication prescribed by or in consultation with an endocrinologist; OR
• iii. Patient has congenital hypopituitarism AND meets BOTH:
• a) Patient meets ONE of the following [(1), (2), or (3)]: (1) Has had ≥ 1 GH stimulation test (same agents) AND peak GH response < 10 ng/mL; OR (2) Has deficiency in ≥ 1 other pituitary hormone (ACTH, TSH, gonadotropin, or prolactin); OR (3) —continuation criteria on next page—; AND
• b) Medication prescribed by or in consultation with an endocrinologist.

Approval duration

1 year