Does J9210 require prior authorization?

Yes, J9210 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J9210?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J9210`, Injection, emapalumab-lzsg, 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires prior authorization (high confidence)

Medicare Pricing

Work RVU

0.00

Facility

N/A

Non-Facility

N/A

Documentation Required

For Primary HLH: documentation of either a molecular genetic diagnosis consistent with primary HLH OR documentation that the patient meets at least five of the specified diagnostic criteria at baseline (list and values required): Fever ≥38.5°C; Splenomegaly; Cytopenias (Hgb <9 g/dL or <10 g/dL in infants <4 weeks; Platelets <100 × 10^9/L; Neutrophils <1.0 × 10^9/L); Fasting triglycerides ≥265 mg/dL OR fibrinogen ≤1.5 g/L; Hemophagocytosis in bone marrow, spleen, or lymph nodes; Low or absent natural killer cell activity (with local lab reference); Ferritin ≥500 mcg/L; Soluble CD25 ≥2,400 U/mL.

For HLH/MAS: documentation of confirmed or suspected systemic juvenile idiopathic arthritis or adult-onset Still's disease; baseline ferritin value (>684 ng/mL) and documentation that at least two of: Platelets ≤181 × 10^9/L; AST >48 U/L; Fasting triglyceride >156 mg/dL; Fibrinogen ≤360 mg/dL, are present.

Documentation of prior therapies and response: records showing trial of at least one conventional therapy (examples given: etoposide, cyclosporine A, anti-thymocyte globulin) and documentation of refractory, recurrent, progressive disease during conventional therapy OR documentation of intolerance to conventional therapy for Primary HLH.

For HLH/MAS: documentation of inadequate response or intolerance to high dose IV corticosteroids OR documentation of prior Gamifant therapy if used as qualifying reason.

Clinical notes indicating prescribing or consultation with appropriate specialist (hematologist, oncologist, immunologist, transplant specialist, rheumatologist, or physician specializing in HLH/related disorders).

Baseline labs and diagnostic test results: ferritin, triglycerides (fasting), fibrinogen, AST, platelets, hemoglobin, neutrophil count, NK cell activity (if available), soluble CD25 (sIL-2R) (if available), bone marrow/splen/lymph node pathology if hemophagocytosis documented.

Key Coverage Criteria

Primary hemophagocytic lymphohistiocytosis (HLH) in adult and pediatric patients with refractory, recurrent, or progressive disease, or intolerance with conventional HLH therapy.
Hemophagocytic Lymphohistiocytosis / Macrophage Activation Syndrome (HLH/MAS) in adult and pediatric patients with known or suspected Still's disease including systemic juvenile idiopathic arthritis (sJIA), with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS.
For Primary HLH: Diagnosis has been determined by at least one of the following: Has a molecular genetic diagnosis consistent with primary hemophagocytic lymphohistiocytosis; OR prior to treatment, the patient meets at least FIVE of the following diagnostic criteria at baseline: Fever ≥ 38.5°C; Splenomegaly; Cytopenias defined as at least TWO of the following: Hemoglobin <9 g/dL (or <10 g/dL in infants less than 4 weeks of age); Platelets <100 × 10^9/L; Neutrophils <1.0 × 10^9/L; Fasting triglyc [...]
For Primary HLH: Patient has tried at least one conventional therapy (e.g., etoposide, cyclosporine A, or antithymocyte globulin) and has experienced refractory, recurrent, or progressive disease during conventional therapy OR intolerance to conventional therapy.
For HLH/MAS (secondary HLH related to Still's disease/sJIA): Has a confirmed or suspected diagnosis of systemic juvenile idiopathic arthritis or Still's disease, adult onset; prior to treatment patient has a ferritin level >684 ng/mL and at least TWO of the following diagnostic criteria at baseline: Platelets ≤181 × 10^9/L; AST >48 U/L; Fasting triglyceride >156 mg/dL; Fibrinogen ≤360 mg/dL.
For HLH/MAS: Meets one of the following: Has had an inadequate response or intolerance to high dose intravenous corticosteroids; Has previously received therapy with Gamifant.

20 Active Policies

ARKBLUE-EMAPALUMAB-LZSG-E-G-GAMIFANT-108F2CB9AB, Emapalumab-LZSG (e.g., Gamifant)

FLORIDA_BLUE-FLBLUE-EMAPALUMAB-LZSG-GAMIFANT-35DB3E2F48, Emapalumab-lzsg (Gamifant)

BCBSLA-00678-EC4FEB6E97, 00678 emapalumab-lzsg (Gamifant)

BCBSM-2202281-443984595B, GAMIFANT (EMAPALUMAB-LZSG)

HEALTHPARTNERS-CC-ENTRY-210222, Oncology - emapalumab-lzsg (Gamifant)

MULTI

BCBSND-EMAPALUMAB-LZSG-GAMIFANT-892713DDC1, Emapalumab Lzsg Gamifant

BCBSNJ-DRUGS-187-D20745B7A0, Emapalumab-lzsg (Gamifant)

MODA-GAMIFANT-5E572F01BC, Gamifant (emapalumab-lzsg)

HEALTHNET_OR-HNOR-EMAPALUMAB-LZSG-GAMIFANT-CP-PHAR-402-1373C06506, Emapalumab-lzsg (Gamifant); CP.PHAR.402

HIGHMARK_WHOLECARE-HMWC-MEDICAID-MEDICATIO-XJLI23UVQKOCELBGVQYU2W-4D105E16C5, Gamifant

IBX-MEDICARE-ADVANTAGE-MA08-104C-4D8ED89FCB, Emapalumab-lzsg (Gamifant)

IBX-COMMERCIAL-08-01-54D-EABD40FA32, Emapalumab-lzsg (Gamifant)

SUREST-POL-SUREST-gamifant-emapalumab-lzsg, Gamifant (Emapalumab-Lzsg)

AMERIHEALTH-MEDICARE-ADVANTAGE-MA08-104C-7B54994ACE, Emapalumab-lzsg (Gamifant)

BCBSTN-d135b257d6, Emapalumab-lzsg (Gamifant)

EVICORE-MEDICAL_DRUG-127DB8B7113A, Gamifant (emapalumab-lzsg)

UHC-COMM-MD-GAMIFANT-EMAPALUMAB-LZSG-COMMUNITY-PLAN-CB3961C96A, Gamifant (Emapalumab-Lzsg) – Community Plan Medical Benefit Drug Policy

UHC-EXCH-MD-GAMIFANT-EMAPALUMAB-LZSG-INDIVIDUAL-EXCH-3BD4AE168E, Gamifant (Emapalumab-Lzsg) – Individual Exchange Medical Benefit Drug Policy

UHC-POL-gamifant-emapalumab-lzsg, Gamifant (Emapalumab-Lzsg)

UMR-POL-UMR-gamifant-emapalumab-lzsg, Gamifant (Emapalumab-Lzsg)

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J9210, Injection, emapalumab-lzsg, 1 mg