In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.
Lower risk defined as IPSS-R (Very Low, Low, Intermediate), IPSS (Low/Intermediate-1), and WPSS (Very Low, Low, Intermediate).
Filgrastim (Neupogen), J1442, excludes biosimilar reference in its definition and should therefore be reported with code Q5101 or Q5110 to report the biosimilarity of filgrastim. Pegfilgrastim (Neulasta), J2506, excludes biosimilar reference in its definition and should therefore be reported with code Q5108, Q5111, Q5120, or Q5122 to report the biosimilarity of pegfilgrastim.
The safety and efficacy of sargramostim (Leukine) have not been assessed in individuals with AML less than 55 years of age.
Liquid solutions containing benzyl alcohol (including liquid sargramostim or lyophilized Leukine reconstituted with bacteriostatic water for injection, USP (0.9% benzyl alcohol)) should not be administered to neonates.