Policy governs long-acting granulocyte colony stimulating factors (LA-GCSF) — pegfilgrastim and long-acting G-CSF analogs — for medical benefit use, including branded and biosimilar products such as Fulphila®, Fylnetra®, Neulasta®, Nyvepria™, Pegfilgrastim-fpgk (Stimufend®/unbranded), Rolvedon®, Ryzneuta®, Udenyca®, and Ziextenzo®. (Product list and document ID IC-0234).
Utilization management: prior authorization is required for these LA-GCSF products. Initial prior authorization validity is generally 4 months for most products; specific indications have shorter, single- or two-dose validity (e.g., BMT failure/engraftment delay and PBPC mobilization/transplant: 1 dose; H-ARS: 2 doses for most products; Rolvedon H-ARS: 2 doses; see product-specific exceptions). Renewals may be provided every 4 months when renewal criteria are met, except where renewal is prohibited for listed indications.
Age limits and product sequencing: Rolvedon and Ryzneuta have an adult-only requirement (≥18 years). Prior authorization requires prerequisite therapy sequencing for certain products: patients must have a documented contraindication, intolerance, or failure to Fulphila® AND Udenyca® before consideration of several pegfilgrastim products (Fylnetra®, Neulasta®, Nyvepria™, Stimufend®/pegfilgrastim-fpgk, or Ziextenzo®), OR a contraindication/intolerance/failure to Rolvedon® before consideration of Ryzneuta.
Billing and dosing limits: HCPCS billing units and maximum units are product- and indication-specific. Typical pegfilgrastim 6 mg products use 12 billable units (0.5 mg units) per dose with limits such as 12 units weekly x 2 doses for acute radiation exposure, 12 units x 1 dose for BMT/PBPC indications, and 12 units per 14 days for other indications. Rolvedon uses 132 billable units per dose under analogous limits; Ryzneuta uses 40 billable units per dose. Providers must document regimen-specific febrile neutropenia risk, patient risk factors when applicable, prior neutropenic complications, and prerequisite treatment failures/intolerances for coverage consideration.
Timing note: these agents should not be administered within 14 days before and 24 hours after cytotoxic chemotherapy; prophylactic dosing is typically given ~24 hours after chemotherapy.