CurrentAvMedPolicy Pub. 100-2

Gamifant (emapalumab-lzsg) prior authorization for HLH/MAS

Defines prior authorization and step-edit requirements for Gamifant (emapalumab-lzsg) when used to treat Hemophagocytic Lymphohistiocytosis (HLH) or Macrophage Activation Syndrome (MAS), including in the context of Still's disease, for AvMed members and providers completing the PA form.

Policy Summary

PayerAvMed

PolicyGamifant (emapalumab-lzsg) prior authorization for HLH/MAS

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the AvMed prior authorization form and attach supporting clinical documentation including labs and chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30 daysInitial authorization length

9250Max billable HCPCS units per 30 days

>684 ng/mLRequired ferritin threshold

Coverage Criteria for Gamifant (emapalumab-lzsg)

Initial Authorization

Covered when ALL of the following are met

Policy Summary

PayerAvMed

PolicyGamifant (emapalumab-lzsg) prior authorization for HLH/MAS

Policy CodePolicy Pub. 100-2

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the AvMed prior authorization form and attach supporting clinical documentation including labs and chart notes.

SourceLink

On This Page

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Infection screening and monitoring: Member has been evaluated and screened for latent tuberculosis (TB) prior to initiating treatment and will receive ongoing TB monitoring; providers will monitor and consider prophylaxis for Herpes Zoster, Pneumocystis jirovecii, and fungal infections; member does NOT have an active infection favored by interferon-gamma neutralization (e.g., mycobacteria, Histoplasma capsulatum)

Medication must not be administered concurrently with live or live attenuated vaccines.

Reauthorization / Continuation Therapy

Covered when ALL of the following are met

Continuing need: Member continues to require therapy for treatment of HLH/MAS

Documentation must support ongoing clinical need.

Response or dose escalation: Member meets ONE of: complete response as evidenced by clinical resolution of MAS signs/symptoms (VAS ≤1 cm) AND laboratory endpoints (WBC and platelets >LLN; LDH, AST, ALT <1.5×ULN; fibrinogen >100 mg/dL; ferritin decreased ≥80% from baseline or <2000 ng/mL) OR member has had unsatisfactory improvement and requires dose escalation up to the maximum specified dose/frequencyferritin decrease ≥80% from baseline or ferritin <2000 ng/mL

Dose escalation permitted up to cumulative 10 mg/kg over 3 days and increased frequency per dosing guidance; monitor for toxicity.

Safety monitoring: Member has absence of unacceptable toxicity (e.g., serious infections) and is receiving ongoing monitoring for adenovirus, EBV, and CMV as clinically indicated

If unacceptable toxicity occurs, consider discontinuation; continue routine infection surveillance.

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Gamifant (J9210). The prescribing physician must sign and clearly print their name on AvMed's prior authorization form (preprinted stamps are not valid). The prescriber must complete and submit the AvMed PA form with all required attachments and supporting documentation (labs, diagnostics, chart notes). Fax completed form and documents to 1-877-535-1391.

Affected code: J9210 (Gamifant, emapalumab-lzsg)
Fax: 1-877-535-1391

Note

Clinical Prerequisites

Member must have had an inadequate response or intolerance to high‑dose intravenous (IV) glucocorticoids (currently or within the last 30 days), OR have recurrent MAS, and meet the diagnostic and laboratory criteria specified for HLH/MAS. All required documentation supporting these clinical prerequisites (including ferritin, platelet count, AST, triglycerides, fibrinogen, and evidence of Still's disease when applicable) must be submitted.

Ferritin >684 ng/mL
At least 2 of: platelet count ≤181×10^9/L; AST >48 U/L; triglycerides >156 mg/dL; fibrinogen ≤360 mg/dL
Member has known or suspected Still's disease (sJIA or AOSD) — when applicable

Documentation Required

Documentation Requirements

Prescriber must sign and clearly print name on the PA request (preprinted stamps are not valid). Submit all supporting documentation — lab results, diagnostics, and chart notes — with the PA form. Incomplete, illegible, or missing documentation may result in denial or delay of the authorization.

Prescriber signature and printed name required (no preprinted stamps)
Include labs, diagnostics, and chart notes with submission
Fax to 1-877-535-1391

Denial Risk

Denial / Delay Risk

Authorizations may be delayed or denied if the PA form or supporting documentation is incomplete, incorrect, illegible, or does not clearly support the requested therapy. Ensure phone and fax numbers on the form are correct and provide clear, complete evidence for each criterion checked to avoid processing delays or denial.

Authorization can be delayed or denied if PA form or supporting documentation is incomplete, incorrect, or illegible
Provide clear documentation for inadequate response to high‑dose IV glucocorticoids or evidence of recurrent MAS

Background

Hemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) are severe hyperinflammatory syndromes that can occur in the setting of systemic juvenile idiopathic arthritis or Adult Onset Still's disease. These conditions are characterized by excessive immune activation leading to marked elevation of inflammatory markers (for example, ferritin >684 ng/mL) and clinical/laboratory abnormalities such as cytopenias, elevated transaminases, hypertriglyceridemia, and hypofibrinogenemia. Targeted therapy, including interferon-gamma neutralization with emapalumab, is used for refractory or recurrent cases where high-dose glucocorticoids are inadequate or not tolerated.

OpenPayer

Gamifant (emapalumab-lzsg) prior authorization for HLH/MAS

Coverage Criteria for Gamifant (emapalumab-lzsg)

Coding and Billing

Provider Requirements and Submission Instructions

Diagnostic Thresholds and Definitions

Background