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UnitedHealthcare Pennsylvania medical benefit drug policy defining medical necessity criteria, initiation and continuation requirements, and applicable billing codes for Gamifant (emapalumab-lzsg) for primary HLH and HLH/MAS in Still's disease (sJIA/AOSD). Applies only to Pennsylvania.
Revised coverage criteria; added criterion requiring the provider does not request a planned inpatient admission for the sole purpose of administering Gamifant.
Coverage stance: Covered with criteria — Gamifant (emapalumab-lzsg) is covered by UnitedHealthcare Pennsylvania for the FDA‑approved indications of primary hemophagocytic lymphohistiocytosis (HLH) and HLH/macrophage activation syndrome (MAS) in Still's disease (sJIA/AOSD). Policy number CSPA2026D0077K, effective 2026-04-01 (Pennsylvania only).
Authorization durations: for primary HLH authorization will be limited to no more than 6 months per request (applies to initial and renewal requests); for HLH/MAS in Still's disease initial authorization and reauthorization are limited to no more than 12 months.
Limitations and exclusions: the policy includes specific medical necessity criteria and documentation requirements and states that Gamifant is not proven or medically necessary for secondary HLH; additional limitations and exclusions apply (see Not Medically Necessary / Exclusions in the policy).
Primary HLH (FDA indication) — Initiation & Continuation Criteria
ALL of the following
ONE of
HLH/MAS in Still's disease (sJIA/AOSD) - Initial Therapy
Gamifant is medically necessary for HLH/MAS in known or suspected Still's disease when ALL of the following are met for initiation:
ALL of the following
ALL of the following
ALL of the following
Two of the following laboratory criteria
HLH/MAS in Still's disease (sJIA/AOSD) - Continuation of Therapy
Reauthorization is allowed when ALL of the following are met:
ALL of the following
Not Medically Necessary / Exclusions
Gamifant is not proven or medically necessary for the following:
ALL of the following
| J9210 | Injection, emapalumab-lzsg, 1 mg |
| D76.1 | Hemophagocytic lymphohistiocytosis |
| D76.2 | Hemophagocytic syndrome, infection-associated |
| D76.3 | Other histiocytosis syndromes |
HSCT candidacy documentation for primary HLH
For primary HLH coverage, documentation must show the patient is a candidate for hematopoietic stem cell transplant and, if applicable, that Gamifant is being used as induction or maintenance prior to conditioning for transplant.
Clinical evidence: Phase 2–3 trial data showed meaningful responses in primary HLH enabling proceeding to hematopoietic stem cell transplantation (HSCT) — overall response at end of treatment was 64.7%, and 88.2% of patients responded to emapalumab with a median time to first response of 8 days; 65% of treated patients underwent HSCT with an engraftment rate of 86.4% and post‑HSCT event‑free survival of 81.8%.
Safety signals observed in clinical programs included infections (bacterial, fungal, and viral, including CMV), infusion reactions, and events described as aggravated HLH or HLH reactivation/flare; in HLH/MAS studies the most common adverse reactions (≥20%) included viral infections (including CMV) and rash.
Background/mechanism and indications: Emapalumab is an antibody that binds and neutralizes interferon gamma (IFNγ). It is indicated for primary HLH (adult and pediatric) and for HLH/MAS in known or suspected Still's disease (including sJIA and AOSD) in patients with inadequate response or intolerance to standard therapies.
Disease context: Primary HLH is a rare disorder (estimated incidence ~1:50,000 live births), typically presenting in infancy and associated with high mortality. MAS is a severe form of HLH that occurs as a complication of rheumatic diseases, most frequently in Still's disease (sJIA/AOSD).
| Term | Definition |
|---|---|
| Primary HLH | |
| Familial or genetically-defined hemophagocytic lymphohistiocytosis requiring 5 of 8 diagnostic criteria or molecular confirmation. | |
| MAS | |
| Macrophage activation syndrome, a form of HLH associated with rheumatic disease (eg, sJIA/AOSD). |
Archived previous policy version CSPA2025D0077J. Revised coverage criteria; added criterion requiring the provider does not request a planned inpatient admission for the sole purpose of administering Gamifant.
Policy effective date updated to April 1, 2026 (Policy Number: CSPA2026D0077K).
ALL of the following
Planned inpatient admission solely for administration may result in denial
Dosing must follow FDA labeling
Prior Authorization Required
Prior authorization is required for Gamifant. Submit a PA request before initiating therapy to avoid delays.
HSCT candidacy documentation and diagnostic records required
Submit medical records (e.g., chart notes, laboratory values, genetic testing reports, pathology reports) to support the diagnosis of primary HLH and fulfillment of diagnostic criteria or confirmatory gene mutation. Records must document the criteria used to establish diagnosis and candidacy for HSCT.
Dosing must follow FDA labeling
Dosing and administration must follow FDA approved labeling for emapalumab-lzsg, including co-administration with dexamethasone as indicated in the label. Ensure billing uses HCPCS code J9210 for emapalumab-lzsg.
Denial risk for planned inpatient admission solely for administration
Planned inpatient admission for the sole purpose of administering Gamifant may result in denial of coverage. Providers should arrange outpatient administration when clinically appropriate and document the medical necessity for inpatient care if admission is requested.
Denial risk for planned inpatient admission solely for administration
Requests will not meet criteria if the provider requests a planned inpatient admission for the sole purpose of administering Gamifant.
Denial risk for planned inpatient admission solely for administration
Reauthorization will not be approved if the provider requests a planned inpatient admission solely to administer Gamifant.
Last review date: 2026-04-01.