Skytrofa — Cigna

Initial criteria

• Endocrinologist must certify that growth hormone therapy is not being prescribed for anti-aging therapy, athletic ability enhancement, or body building; AND
• Patient has diagnosis of growth hormone deficiency that is ONE of the following:
• i. Childhood onset; OR
• ii. Adult onset resulting from growth hormone deficiency alone or multiple hormone deficiencies (hypopituitarism) due to pituitary disease, hypothalamic disease, pituitary surgery, cranial radiation therapy, tumor treatment, traumatic brain injury, or subarachnoid hemorrhage; AND
• Patient meets at least ONE of the following (i, ii, or iii):
• i. Patient (adult or transition adolescent) has known perinatal insults OR congenital or genetic defects; OR
• ii. Patient meets ALL of the following:
• a) Has or had ≥ 3 pituitary hormone deficiencies prior to hormone replacement therapy (ACTH, TSH, gonadotropin deficiency, and prolactin); AND
• b) Serum insulin-like growth factor-1 below lower limit of normal for age and gender prior to growth hormone therapy; AND
• c) Other causes of low IGF-1 excluded (malnutrition, prolonged fasting, poorly controlled diabetes mellitus, hypothyroidism, hepatic insufficiency, oral estrogen therapy); OR
• iii. Patient meets ONE of the following (a or b):
• a) Adult: has negative response to at least ONE standard growth hormone stimulation test (Insulin tolerance test ≤5.0 mcg/L; OR Glucagon stimulation test ≤3.0 mcg/L depending on BMI thresholds as specified; OR Macrilen test <2.8 ng/mL [BMI ≤40]); OR
• b) Transition adolescent: off growth hormone therapy ≥1 month prior to retesting AND has negative response to stimulation test (Insulin tolerance ≤5.0 mcg/L OR Glucagon stimulation ≤3.0 mcg/L depending on BMI thresholds OR Arginine test ≤0.4 mcg/L if ITT/Glucagon contraindicated); AND
• Medication prescribed by or in consultation with an endocrinologist

Approval duration

1 year