CurrentUnitedHealthcarePolicy CSLA2O24DOO77H

Gamifant (Emapalumab-Lzsg) (for Louisiana Only)

UnitedHealthcare Medical Benefit Drug Policy applicable only to Louisiana members covering use of emapalumab (Gamifant) for primary hemophagocytic lymphohistiocytosis (HLH) with specified clinical criteria, dosing limits, and coding guidance. Includes FDA indication, clinical evidence summary, and applicable HCPCS and ICD-10 codes.

Policy Summary

PayerUnitedHealthcare

PolicyGamifant (Emapalumab-Lzsg) (for Louisiana Only)

Policy CodePolicy CSLA2O24DOO77H

Change TypeSupporting information and references updated

Effective DateDec 1, 2024

Next Review Date

Key ActionSubmit medical records (chart notes, laboratory values) confirming diagnostic criteria (five of listed characteristics) and other coverage criteria for prior authorization and coverage determination.

POLICY UPDATE CHANGES

Supporting information updated; References section updated.

1Covered Indications (primary HLH)

6 monthsMaximum approval duration

J9210Primary HCPCS drug code

Coverage Summary

Coverage stance: covered_with_criteria — emapalumab (Gamifant) is covered when the policy’s specified criteria are met for primary hemophagocytic lymphohistiocytosis (HLH). Scope: This UnitedHealthcare Medical Benefit Drug Policy applies only to Louisiana members. FDA indication summary: Gamifant is indicated for treatment of adult and pediatric patients with primary HLH with refractory, recurrent, or progressive disease or intolerance to conventional HLH therapy. Payer/geographic applicability: UnitedHealthcare — Louisiana only. High-level approval limits: approval duration is limited to no more than 6 months, and dosing must follow the FDA-approved labeling.

Medically Necessary (Initial) Coverage Criteria

Emapalumab is proven and medically necessary for treatment of primary HLH when ALL of the following are met:

Refractory or intolerant to conventional therapy: Patient has refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy (e.g., etoposide and dexamethasone)

Candidate for transplant: Patient is a candidate for stem cell transplant

Administered with dexamethasone: Emapalumab will be administered with dexamethasone

Use during induction/maintenance phase: Emapalumab is being used in the induction or maintenance phase related to stem cell transplant and is to be discontinued at the initiation of conditioning for stem cell transplant

Approval duration is for no more than 6 months≤ 6 months

Dosing per FDA label: Dosing is in accordance with the FDA-approved labeling

Dosing must follow FDA-approved labeling

Ferritin threshold: Ferritin ≥ 500 mg/L≥ 500 mg/L

Continuation / Treatment Duration

Emapalumab is authorized for use in the induction or maintenance phase related to hematopoietic stem cell transplant (HSCT) and must be discontinued at the initiation of conditioning for HSCT. Approval duration for therapy in this context is limited to a maximum of 6 months. Dosing and administration must follow the FDA-approved labeling.

Prior Authorization, Documentation & Billing

Prior Authorization

Prior authorization and documentation required

Submission of medical records (chart notes, laboratory values) confirming diagnostic criteria (five of listed characteristics) and other coverage criteria is required for coverage determination.

Affected codes: J9210, D76.1
Medical records confirming diagnostic criteria are required

Documentation Required

Document NK cell activity and soluble CD25 if used

Provide local laboratory reference results for NK cell activity and soluble CD25 (sIL-2R) when these criteria are used to meet diagnostic threshold.

NK cell activity (according to local laboratory reference)
Soluble CD25 (sIL-2R) — threshold: ≥ 2,400 U/mL

Billing Rule

Dosing per FDA label

Dosing must follow the FDA-approved labeling. Approval is limited to a maximum of 6 months. Emapalumab must be discontinued at the initiation of conditioning for hematopoietic stem cell transplant.

Affected code: J9210
Emapalumab discontinued at initiation of conditioning for stem cell transplant
Approval duration limit: no more than 6 months

Clinical Evidence Summary

64.7%Study NI-0501-04 overall response at end of treatment

88.2%Study NI-0501-04 overall response (any time); median time to first response 8 days

65%Underwent hematopoietic stem cell transplantation (HSCT)

86.4%HSCT engraftment rate

81.8%Post-HSCT event-free survival

56%Infections reported during pre-conditioning (bacterial, fungal, or viral)

Background and clinical evidence: Emapalumab is a monoclonal antibody that neutralizes interferon gamma (IFNγ); nonclinical data indicate IFNγ is hypersecreted in HLH and emapalumab decreases plasma concentrations of the IFNγ-induced chemokine CXCL9. In study NI-0501-04, overall response at end of treatment was 64.7% and overall response rate was 88.2%, with a median time to first response of 8 days. Approximately 65% of patients underwent HSCT with an engraftment rate of 86.4% and post-HSCT event-free survival of 81.8%. Notable safety signals during the pre-conditioning period included infections (bacterial, fungal, or viral) reported in 56% of patients, along with infusion-related reactions and other events.

Background & Definitions

Emapalumab is a monoclonal antibody that binds to and neutralizes interferon gamma (IFNγ). Nonclinical data suggest IFNγ is hypersecreted in HLH and treatment with emapalumab decreases plasma concentrations of CXCL9, a chemokine induced by IFNγ.

Primary HLH — familial or genetic form of HLH typically requiring hematopoietic stem cell transplant (HSCT).

Induction/maintenance phase — phases of treatment in relation to HSCT; emapalumab is used during induction or maintenance and is discontinued at the initiation of conditioning for HSCT.