Lanreotide (Somatuline® Depot, generic) Injection

Lanreotide (Somatuline Depot, generic) is covered only for the FDA‑approved, non‑oncology indication of long‑term treatment of acromegaly; non‑acromegaly or oncology uses are excluded. Approval (12 months) requires documentation of inadequate response to or ineligibility for surgery/radiotherapy (or tumor mass effects), a baseline IGF‑1 above the lab‑specific ULN, prescription by or consultation with an endocrinologist, an initial 90 mg deep subcutaneous dose every 4 weeks for 3 months, and GH/IGF‑1/symptom‑guided dose adjustments (including limited 120 mg every 6–8 weeks extension only for patients already controlled on 60 or 90 mg with GH/IGF‑1 testing 6 weeks after the change).

"Policy applies to non-oncology indications only; treatment must be for the FDA-approved non-oncology indication (acromegaly)."

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