CurrentBaylor Scott & White Health PlanPolicy 254

MEDICAL COVERAGE POLICY

Defines medical necessity criteria, prior authorization requirements, initial and renewal authorization durations, and coding guidance for emapalumab (Gamifant®) for treatment of primary hemophagocytic lymphohistiocytosis (HLH) across Baylor Scott & White Health Plan lines of business.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyMEDICAL COVERAGE POLICY

Policy CodePolicy 254

Change TypeRenewal duration and specialist requirement updates

Effective Date03/01/2026

Next Review Date02/26/2027

Key ActionSubmit prior authorization with documentation that all clinical criteria are met, including diagnostic evidence and specialist consultation.

SourceLink

POLICY UPDATE CHANGES

Adjusted renewal authorization duration to 12 months (02/26/2026).

Added specialist requirement (06/09/2025).

Added HCPCS code J9210 and renewal criteria/authorization durations (07/30/2020 and earlier history).

Removed Medicare NCD/LCD Interqual statement for clarity (08/11/2025).

Applied new format and layout, updated background information (07/24/2024).

1Covered Indication (primary HLH)

8HLH diagnostic criteria listed

J9210Primary HCPCS code

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8w / 12mInitial / Renewal durations

Coverage Summary

coverage_stance: covered_with_criteria; subject: Emapalumab (Gamifant®); scope_summary: Defines medical necessity criteria, prior authorization requirements, initial and renewal authorization durations, and coding guidance for emapalumab (Gamifant®) for treatment of primary hemophagocytic lymphohistiocytosis (HLH) across Baylor Scott & White Health Plan lines of business. Policy number: 254; effective date: 03/01/2026. One-line indication summary: Emapalumab (emapalumab-lzsg) is covered with criteria for adult and pediatric patients with primary HLH as bridge/induction/maintenance therapy for stem cell transplant candidates (to be discontinued at initiation of conditioning) when refractory, recurrent, progressive disease or intolerance to conventional therapy is documented.

Thresholds and Authorization Durations

Ferritin>= 500 mcg/L

Soluble CD25>= 2400 U/mL

Hemoglobin< 9 g/dL

Platelets< 100,000/microliter

Neutrophils< 1,000/microliter

Triglycerides> 3 mmol/L or >= 265 mg/dL (fasting)

Fibrinogen<= 1.5 g/L

Initial authorization duration8 weeks

Renewal authorization duration12 months (as of 02/26/2026)

Universal criteria (all required)

Emapalumab-lzsg may be considered medically necessary when ALL of the following are met:

ALL of the following

ANY of the following
- When HLH diagnosis is based on clinical criteria, at least 5 of the following 8 must be present: Fever
- Splenomegaly
- Cytopenias affecting 2 of 3 lineages in the peripheral blood: hemoglobin < 9 g/dL; platelets < 100,000/microliter; neutrophils < 1,000/microliterHemoglobin < 9 g/dL; Platelets < 100,000/microliter; Neutrophils < 1,000/microliter

Initial authorization criteria

All of the following must be met for initial approval:

ALL of the following

Member meets all Universal criteria
Member is a candidate for stem cell transplant
Emapalumab is being used as part of the induction or maintenance phase of stem cell transplant and is to be discontinued at the initiation of conditioning for stem cell transplant
Member has been evaluated for tuberculosis (TB) risk factors and has undergone pretreatment screening for latent TB with PPD skin test or interferon gamma release assay

Renewal authorization criteria

All of the following must be met for renewal:

ALL of the following

Member meets all Universal criteria
Member has improvement or stabilization of disease
Member has manageable or no side effects

ALL of the following

Prior Authorization

Authorization durations and renewal documentation

Not covered / Experimental

Emapalumab is considered experimental/investigational for:

ALL of the following

Treatment of all other indications not listed in this policy because effectiveness has not been established

ALL of the following

Denial Risk

Denial risk for non‑covered indications

Requests for indications other than primary HLH with refractory, recurrent, progressive disease or intolerance to conventional therapy may be denied as experimental/investigational.

Applicable Codes

HCPCS (drug)HCPCSCovered

J9210

Injection, emapalumab-lzsg, 1 mg

CPTCPT

No codes listed

ICD-10 (applicable diagnosis codes)ICD-10

No codes listed

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for emapalumab. Submit documentation showing all applicable clinical criteria are met.

J9210
Submit documentation demonstrating all applicable clinical criteria are met

Documentation Required

Diagnostic evidence for HLH

Provide molecular diagnostic results for primary HLH OR documentation that at least 5 of the 8 specified clinical criteria are present (fever; splenomegaly; cytopenias affecting ≥2 lineages: hemoglobin <9 g/dL, platelets <100,000/µL, neutrophils <1,000/µL; hypertriglyceridemia and/or hypofibrinogenemia; hemophagocytosis in marrow/spleen/lymph nodes; low/absent NK‑cell activity; ferritin ≥500 mcg/L; soluble CD25 ≥2400 U/mL).

Molecular diagnostic results (e.g., PRF1, UNC13D, STX11, STXBP2) OR
Documentation of ≥5 of the 8 HLH clinical criteria (listed in policy)

Clinical Evidence

63%Overall response rate (ORR) in NI-0501-04 (17/27)

26% / 30%Complete response (CR) 26% and partial response (PR) 30% in NI-0501-04

Key evidence sources include the multicenter open-label single-arm trial NI-0501-04 (NCT01818492) and the Gamifant (emapalumab-lzsg) FDA Prescribing Information (May 2022). Background clinical rationale is summarized in the Background section of the policy.

Background

Background: Emapalumab is a fully human monoclonal antibody that is a potent inhibitor of interferon-gamma. It is indicated for adult and pediatric (newborn and older) patients with primary HLH who have refractory, recurrent, or progressive disease, or intolerance to conventional HLH therapy. In practice within this policy, emapalumab is used as a bridge, induction, or maintenance therapy for patients who are candidates for allogeneic hematopoietic cell transplant (HCT), with HCT being the only curative therapy for primary HLH.

Definitions

Primary HLHHereditary/familial hemophagocytic lymphohistiocytosis caused by mutations (e.g., PRF1, UNC13D, STX11, STXBP2) leading to immune overactivation.

Refractory/recurring/progressive diseaseDisease that does not respond to, returns after, or worsens despite conventional HLH therapy.

Revision History

07/30/2020coding/authorization

Added HCPCS code J9210 (Injection, emapalumab-lzsg, 1 mg) and added renewal criteria and authorization duration.

06/09/2025clinical requirement

Added requirement that emapalumab be prescribed by or in consultation with a specialist experienced in the treatment of HLH; renewal authorization duration was changed to 6 months (material change).

08/11/2025clarification

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyMEDICAL COVERAGE POLICY

Policy CodePolicy 254

Change TypeRenewal duration and specialist requirement updates

Effective Date03/01/2026

Next Review Date02/26/2027

Key ActionSubmit prior authorization with documentation that all clinical criteria are met, including diagnostic evidence and specialist consultation.

SourceLink

On This Page

Hypertriglyceridemia (fasting triglycerides > 3 mmol/L or >= 265 mg/dL) and/or hypofibrinogenemia (<= 1.5 g/L)Fasting triglycerides > 3 mmol/L or >= 265 mg/dL; Fibrinogen <= 1.5 g/L

Hemophagocytosis in bone marrow, spleen, or lymph nodes with no evidence of malignancy

Low or absent NK-cell activity

Ferritin >= 500 mcg/LFerritin >= 500 mcg/L

Soluble CD25 >= 2400 U/mLSoluble CD25 >= 2400 U/mL

Member has refractory, recurrent, or progressive disease OR intolerance with conventional HLH therapy

Emapalumab is prescribed by or in consultation with a specialist that has expertise in the treatment of HLH

Dexamethasone will be administered concomitantly with emapalumab

ALL of the following

If member has a positive TB test result or is at risk for TB, prophylactic treatment for TB has been initiated before starting therapy

ALL of the following

Prior Authorization

Prior authorization required

Prior authorization is required for emapalumab. Submit documentation showing all applicable clinical criteria are met.

J9210

Initial authorization duration is 8 weeks. Renewal authorization duration is 12 months (as of 02/26/2026). For renewal requests, document disease response (improvement or stabilization) and manageable or no side effects.

Documentation Required

Specialist involvement required

Emapalumab must be prescribed by or in consultation with a specialist experienced in the treatment of HLH. Include consult notes or documentation of the prescriber’s specialty with the request.

Include consult notes or prescriber specialty documentation

Documentation Required

Concomitant steroid therapy

Document that dexamethasone will be administered concomitantly with emapalumab.

Include plan for concomitant dexamethasone administration

Documentation Required

Stem cell transplant candidacy and timing

For initial requests, document that the member is a candidate for stem cell transplant, that emapalumab is being used as part of induction or maintenance for transplant, and that therapy will be discontinued at the initiation of conditioning for transplant.

Document transplant candidacy and plan to discontinue emapalumab at initiation of conditioning

Documentation Required

TB screening and prophylaxis

Document pretreatment TB screening with PPD skin test or interferon gamma release assay (IGRA). If the test is positive or the member is at risk for TB, document that prophylactic TB treatment has been initiated prior to starting emapalumab.

PPD or IGRA test results
Documentation of TB prophylaxis if indicated

Prior Authorization

Authorization durations

Initial authorization duration: 8 weeks. Renewal authorization duration: 12 months (as of 02/26/2026).

Denial Risk

Experimental/Investigational denials

Requests for indications other than primary HLH with refractory, recurrent, or progressive disease or intolerance to conventional therapy may be denied as experimental/investigational.

Removed Medicare NCD/LCD Interqual statement for clarity (non-material clarification).

07/24/2024formatting/background

Applied new format and layout and updated background information (non-material clarification).

02/26/2026authorization durationLatest

Adjusted renewal authorization duration back to 12 months (material change).