J9210 — Injection, emapalumab-lzsg, 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Submission of medical records (e.g., chart notes, laboratory values) confirming either: Confirmation of a gene mutation known to cause primary HLH (e.g., PRF1, UNC13D, RAB27A, STX11, STXBP2); OR confirmation that five of the following clinical characteristics are present: Fever; Splenomegaly; Two of the following cytopenias in the peripheral blood: Hemoglobin <9 g/dL; or Platelet count <100 x 10^9/L; or Neutrophils <1 x 10^9/L; One of the following: Hypertriglyceridemia (fasting triglycerides ≥3 mmol/L or ≥265 mg/dL) or Hypofibrinogenemia (fibrinogen ≤1.5 g/L); Hemophagocytosis in bone marrow, spleen, or lymph nodes with no evidence of malignancy; Low or absent natural killer cell activity; Ferritin ≥500 mcg/L; Soluble CD25 (soluble IL-2 receptor) ≥2,400 U/mL.
- For HLH/MAS (Initial Therapy): submission of medical records confirming: Confirmed or suspected diagnosis of systemic juvenile idiopathic arthritis (sJIA) or adult onset Still's disease (AOSD); Diagnosis of active MAS with ferritin > 684 ng/mL AND two of the following laboratory criteria: Platelet count ≤ 181 x 10^9/L; AST > 48 U/L; Triglycerides > 156 mg/dL; Fibrinogen level ≤ 360 mg/dL; AND documentation that the patient has had an inadequate response to high-dose intravenous glucocorticoids.
- For Continuation/Reauthorization: documentation of a positive clinical response to Gamifant and that dosing remains in accordance with FDA approved labeling.
Key Coverage Criteria
- Treatment of primary hemophagocytic lymphohistiocytosis (HLH) in patients who meet all of the following criteria: Diagnosis of primary hemophagocytic lymphohistiocytosis; and Patient has refractory, recurrent or progressive disease, or intolerance with conventional HLH therapy (e.g., etoposide, corticosteroids, cyclosporine, anti-thymocyte globulin, methotrexate); and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Authorization will be for no m [...]
- Gamifant is medically necessary for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) when submission of medical records (e.g., chart notes, laboratory values) confirming one of the following: Confirmation of a gene mutation known to cause primary HLH (e.g., PRF1, UNC13D, RAB27A, STX11, STXBP2); or Confirmation that five of the following clinical characteristics are present: Fever; Splenomegaly; Two of the following cytopenias in the peripheral blood: Hemoglobin <9 g/dL; or Plate [...]
- Treatment of hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in patients with known or suspected Still's disease, including systemic juvenile idiopathic arthritis (sJIA) or adult onset Still's disease (AOSD), with an inadequate response or intolerance to glucocorticoids (Initial Therapy): Diagnosis of HLH/MAS; Known or suspected diagnosis of Still's disease, including sJIA; Inadequate response or intolerance to glucocorticoids; Dosing in accordance with FDA labeling [...]
- Gamifant is medically necessary for treatment of HLH/MAS (Initial Therapy) when submission of medical records confirming: Confirmed or suspected diagnosis of sJIA or AOSD; Diagnosis of active MAS with both of the following: Ferritin > 684 ng/mL; Two of the following laboratory criteria: Platelet count ≤ 181 x 10^9/L; or AST > 48 U/L; Triglycerides > 156 mg/dL; Fibrinogen level ≤ 360 mg/dL; Patient has had an inadequate response to high-dose intravenous glucocorticoids; Dosing is in accordance wi [...]
- Continuation of Therapy for HLH/MAS: Documentation of a positive clinical response to Gamifant; Dosing in accordance with FDA labeling; Reauthorization for no more than 12 months.
3 Active Policies
UHC-POL-gamifant-emapalumab-lzsg — Gamifant (Emapalumab-Lzsg)
UMR-POL-UMR-gamifant-emapalumab-lzsg — Gamifant (Emapalumab-Lzsg)
SUREST-POL-SUREST-gamifant-emapalumab-lzsg — Gamifant (Emapalumab-Lzsg)
Related Codes
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