Sargramostim (Leukine)

Sargramostim (Leukine) is covered only for compendial non‑oncology off‑label uses—specifically chronic neutropenic disorders (e.g., congenital, cyclic, idiopathic) and zidovudine‑associated neutropenia in HIV—and there is no FDA‑approved non‑oncology indication. Coverage requires documentation of the compendial diagnosis, absence of serious allergy to yeast‑derived products or any product component, exclusion of other causes of neutropenia for chronic cases, and supports 12‑month initial and renewal approvals (policy gives no dosing guidance).

"When requesting Leukine (sargramostim) for non-oncology indications, the individual requiring treatment must be diagnosed with an approved compendial use and meet the specific coverage guidelines a..."

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