ModifiedBaylor Scott & White Health PlanPolicy 254

Emapalumab (Gamifant) Coverage Criteria

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Prior authorization and medical-necessity review for emapalumab-lzsg (Gamifant) for primary hemophagocytic lymphohistiocytosis and Still's disease-associated HLH/macrophage activation syndrome.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEmapalumab (Gamifant) Coverage Criteria

Policy CodePolicy 254

Change TypeModified

Effective DateNov 1, 2026

Last ReviewOct 22, 2026

Next Review DateOct 22, 2027

Key ActionSubmit prior authorization documentation showing that emapalumab is prescribed by or used in consultation with an HLH specialist and will be administered according to FDA-approved labeling.

SourceLink

POLICY UPDATE CHANGES

The policy was reformatted into universal, indication-specific initial, and renewal criteria.

The policy changed molecular diagnosis mutations to examples and added examples of conventional HLH treatment.

The requirement for concomitant dexamethasone administration was removed.

Examples of tuberculosis tests were removed.

Specific coverage criteria were added for HLH/macrophage activation syndrome associated with Still's disease.

The renewal authorization duration was changed to 12 months.

RequiredPrior authorization

12 months

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ModifiedBaylor Scott & White Health PlanPolicy 254

Emapalumab (Gamifant) Coverage Criteria

Customize your policy alerts

Sign up for baylor_scott_and_white_health_plan Policy 254 alerts

Get alerted when Policy 254 changes without checking for updates manually.

Monitor payer policy activity

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Prior authorization and medical-necessity review for emapalumab-lzsg (Gamifant) for primary hemophagocytic lymphohistiocytosis and Still's disease-associated HLH/macrophage activation syndrome.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEmapalumab (Gamifant) Coverage Criteria

Policy CodePolicy 254

Change TypeModified

Effective DateNov 1, 2026

Last ReviewOct 22, 2026

Next Review DateOct 22, 2027

Key ActionSubmit prior authorization documentation showing that emapalumab is prescribed by or used in consultation with an HLH specialist and will be administered according to FDA-approved labeling.

SourceLink

POLICY UPDATE CHANGES

The policy was reformatted into universal, indication-specific initial, and renewal criteria.

The policy changed molecular diagnosis mutations to examples and added examples of conventional HLH treatment.

The requirement for concomitant dexamethasone administration was removed.

Examples of tuberculosis tests were removed.

Specific coverage criteria were added for HLH/macrophage activation syndrome associated with Still's disease.

The renewal authorization duration was changed to 12 months.

RequiredPrior authorization

12 months

Authorization duration

5 of 8Primary HLH diagnostic pathway

2 of 4HLH/MAS laboratory abnormalities

2Covered indications

Coverage Criteria

Universal criteria

Covered when all universal criteria are met.

Specialist oversight: Emapalumab is prescribed by or in consultation with a specialist with expertise in the treatment of hemophagocytic lymphohistiocytosis (HLH).
Administration: Emapalumab is dosed and administered according to FDA-approved labeling.

Primary HLH initial therapy

Initial primary HLH requests are covered when all criteria are met.

Universal criteria: The member meets all universal criteria.
Primary HLH diagnosis
- Molecular diagnosis: A molecular diagnosis of primary HLH is documented.
  Examples include PRF1, UNC13D, STX11, and STXBP2.
- Clinical and laboratory findings
  - Fever
  - Splenomegaly
  - Cytopenias affecting 2 of 3 peripheral-blood lineages.Hemoglobin < 9 g/dL; platelets < 100,000/microliter; neutrophils < 1,000/microliter
  - Hypertriglyceridemia and/or hypofibrinogenemia.Fasting triglycerides > 3 mmol/L or ≥ 265 mg/dL and/or fibrinogen ≤ 1.5 g/L
Disease and prior therapy: The member has refractory, recurrent, or progressive disease, or intolerance to conventional HLH therapy, such as etoposide or dexamethasone.
Transplant candidacy: The member is a candidate for stem cell transplant.
Transplant phase: Emapalumab is used during the induction or maintenance phase of stem cell transplant and will be discontinued when conditioning for stem cell transplant begins.
Tuberculosis evaluation: The member has been evaluated for tuberculosis risk factors and has undergone pretreatment screening for latent tuberculosis.
Tuberculosis prophylaxis: When the member has a positive tuberculosis test result or is at risk for tuberculosis, prophylactic tuberculosis treatment has been initiated before emapalumab therapy begins.

Primary HLH renewal therapy

Renewal primary HLH requests are covered when all criteria are met.

The member meets all universal criteria.
The member has improvement or stabilization of disease.
The member has manageable or no side effects.
The member continues to require therapy for HLH.
The member has not received a hematopoietic stem cell transplant and has not started conditioning for stem cell transplant.

HLH/MAS initial therapy

Initial HLH/MAS requests are covered when all criteria are met.

The member meets all universal criteria.
The member has a documented diagnosis of HLH/MAS.
The member has known or suspected Still's disease, including systemic juvenile idiopathic arthritis or adult-onset Still's disease.
Ferritin requirement: Ferritin is greater than 684 ng/mL.> 684 ng/mL
Laboratory abnormalities

HLH/MAS renewal therapy

Renewal HLH/MAS requests are covered when all criteria are met.

The member meets all universal criteria.
The member has improvement or stabilization of disease.
The member has manageable or no side effects.
The member continues to require therapy for HLH/MAS.

Other indications

The following use is not covered under this policy.

Other indications: Emapalumab for indications other than the covered primary HLH or HLH/MAS indications is considered experimental and investigational because effectiveness has not been established.

Emapalumab is considered experimental and investigational for indications other than the covered uses for primary hemophagocytic lymphohistiocytosis (HLH) and HLH/macrophage activation syndrome (MAS) associated with known or suspected Still’s disease, because effectiveness for other indications has not been established.

For primary HLH, emapalumab must be used during the induction or maintenance phase of stem-cell transplant and discontinued when conditioning begins. Renewal is not supported after the member has received a hematopoietic stem-cell transplant or started conditioning for transplant.

Initial Therapy Criteria

HLH/MAS initial therapy

Covered when all HLH/MAS initial-therapy criteria are met.

Universal criteria: The member meets all universal criteria.
HLH/MAS diagnosis: The member has a documented diagnosis of HLH/MAS.
Still's disease association: The member has known or suspected Still's disease, including systemic juvenile idiopathic arthritis or adult-onset Still's disease.
Ferritin is greater than 684 ng/mL.> 684 ng/mL

Renewal and Continuation Criteria

Renewal therapy

Renewal is covered when the applicable criteria for the member's indication are met.

Universal criteria: The member meets all universal criteria.
Clinical response: The member has improvement or stabilization of disease.
Tolerability: The member has manageable or no side effects.
Continued need
- Applicable indication

Required Prior Treatment

Step	Indication	Requirement	Coverage
1	Primary hemophagocytic lymphohistiocytosis (HLH)	Failure or intolerance of conventional HLH therapy, such as etoposide or dexamethasone.	Covered when applicable criteria are met

Step	Indication	Requirement	Coverage
1	HLH/macrophage activation syndrome (MAS) associated with Still's disease	Inadequate response or intolerance to high-dose glucocorticosteroids.	Covered when applicable criteria are met

Coding and Clinical Thresholds

HCPCS CodesHCPCS

J9210

Injection, emapalumab-lzsg, 1 mg

Primary HLH cytopenias

HemoglobinLess than 9 g/dL

PlateletsLess than 100,000/microliter

NeutrophilsLess than 1,000/microliter

Lineage requirementCytopenias must affect 2 of 3 peripheral-blood lineages

Primary HLH hypertriglyceridemia

TestFasting triglycerides

ThresholdGreater than 3 mmol/L or greater than or equal to 265 mg/dL

Provider Submission and Review Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for all emapalumab-lzsg (Gamifant) requests submitted to Baylor Scott & White Health Plan.

Submit the request before treatment is initiated.

Note

Clinical Review

All requests are reviewed by a clinical pharmacist and medical director.

Clinical review applies to both initial and renewal requests.

Documentation Required

Clinical Background

Hemophagocytic lymphohistiocytosis (HLH) is a life-threatening hyperinflammatory syndrome caused by overactivation of the immune system. Primary HLH is hereditary, whereas secondary HLH may occur with infection, malignancy, autoimmune disease, post-allogeneic hematopoietic cell transplantation, or drug hypersensitivity. Macrophage activation syndrome (MAS) is a form of HLH associated with rheumatic disease and frequently occurs with Still’s disease. Emapalumab is an intravenous monoclonal antibody that inhibits interferon-gamma. Allogeneic hematopoietic stem-cell transplantation is described as the only curative therapy for HLH.

Key Definitions

Primary HLH

DefinitionPrimary HLH is a hereditary form of hemophagocytic lymphohistiocytosis

Also known asFamilial HLH

Disease typeA hereditary disorder

Macrophage activation syndrome (MAS)

DefinitionMacrophage activation syndrome is a subtype of hemophagocytic lymphohistiocytosis

AssociationIt is associated with underlying rheumatic disease

Frequent occurrenceIt frequently occurs with Still's disease

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEmapalumab (Gamifant) Coverage Criteria

Policy CodePolicy 254

Change TypeModified

Effective DateNov 1, 2026

Last ReviewOct 22, 2026

Next Review DateOct 22, 2027

Key ActionSubmit prior authorization documentation showing that emapalumab is prescribed by or used in consultation with an HLH specialist and will be administered according to FDA-approved labeling.

SourceLink

On This Page

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

Low or absent natural killer-cell activity.

Ferritin.≥ 500 mcg/L

Soluble CD25.≥ 2400 U/mL

Triglycerides.> 156 mg/dL

Fibrinogen levels.≤ 360 mg/dL

The member has an inadequate response or intolerance to high-dose glucocorticosteroids.

Laboratory abnormalities

Platelet count.≤ 181 × 10^9/L
AST.> 48 U/L
Triglycerides.> 156 mg/dL
Fibrinogen levels.≤ 360 mg/dL

Treatment response: The member has an inadequate response or intolerance to high-dose glucocorticosteroids.

This is the required prior-treatment response criterion.

Primary HLH: The member continues to require therapy for HLH.

HLH/MAS: The member continues to require therapy for HLH/MAS.

Primary HLH transplant status: For primary HLH, the member has not received a hematopoietic stem cell transplant and has not started conditioning for stem cell transplant.

This criterion applies to primary HLH renewals.

Authorization duration: Authorization is provided for 12 months.12 months

Criteria roleHypertriglyceridemia is one of the specified primary HLH diagnostic findings

Primary HLH hypofibrinogenemia

TestFibrinogen

ThresholdLess than or equal to 1.5 g/L

Criteria roleHypofibrinogenemia is one of the specified primary HLH diagnostic findings

Primary HLH ferritin

TestFerritin

ThresholdGreater than or equal to 500 mcg/L

Criteria roleFerritin is one of the specified primary HLH diagnostic findings

Primary HLH soluble CD25

TestSoluble CD25

ThresholdGreater than or equal to 2400 U/mL

Criteria roleSoluble CD25 is one of the specified primary HLH diagnostic findings

HLH/MAS ferritin

TestFerritin

ThresholdGreater than 684 ng/mL

Criteria roleThis threshold is required separately for HLH/MAS initial requests

HLH/MAS platelet count

TestPlatelet count

ThresholdLess than or equal to 181 × 10^9/L

Criteria rolePlatelet count is one of the 4 laboratory abnormalities; any 2 are required

HLH/MAS AST

TestAST

ThresholdGreater than 48 U/L

Criteria roleAST is one of the 4 laboratory abnormalities; any 2 are required

HLH/MAS triglycerides

TestTriglycerides

ThresholdGreater than 156 mg/dL

Criteria roleTriglycerides are one of the 4 laboratory abnormalities; any 2 are required

HLH/MAS fibrinogen

TestFibrinogen levels

ThresholdLess than or equal to 360 mg/dL

Criteria roleFibrinogen is one of the 4 laboratory abnormalities; any 2 are required

Universal Documentation Required

Submit documentation showing that emapalumab is prescribed by, or provided in consultation with, a specialist experienced in treating HLH and that dosing and administration follow FDA-approved labeling.

Document the qualified specialist's involvement.
Include the planned dose and administration schedule.

Documentation Required

Document Primary HLH Diagnosis

For initial primary HLH requests, document a diagnosis based on either a qualifying molecular diagnosis or at least 5 of the 8 specified diagnostic criteria.

Molecular diagnosis examples include PRF1, UNC13D, STX11, and STXBP2.
Alternative diagnostic criteria: fever; splenomegaly; cytopenias affecting 2 of 3 lineages (hemoglobin <9 g/dL, platelets <100,000/microliter, or neutrophils <1,000/microliter); hypertriglyceridemia (fasting triglycerides >3 mmol/L or ≥265 mg/dL) and/or hypofibrinogenemia (≤1.5 g/L); hemophagocytosis in bone marrow, spleen, or lymph nodes without malignancy; low or absent NK-cell activity; ferritin ≥500 mcg/L; or soluble CD25 ≥2,400 U/mL.

Documentation Required

Primary HLH Treatment and Transplant Documentation

For initial primary HLH treatment, document refractory, recurrent, or progressive disease, or intolerance to conventional HLH therapy, and establish transplant-related treatment intent.

Document conventional therapy history, such as etoposide or dexamethasone.
Document that the member is a candidate for stem cell transplant.
Emapalumab must be used during induction or maintenance of stem cell transplant and discontinued when conditioning begins.

Documentation Required

Renewal Documentation

For renewal requests, document ongoing universal-criteria compliance, clinical improvement or stabilization, manageable or absent side effects, and continued need for emapalumab therapy.

For HLH, document that the member has not received a hematopoietic stem cell transplant or started transplant conditioning.
Authorization duration is 12 months.

Documentation Required

HLH/MAS Documentation

For HLH/MAS requests, document HLH/MAS, known or suspected Still's disease, the required laboratory findings, and inadequate response or intolerance to high-dose glucocorticosteroids.

Still's disease includes systemic juvenile idiopathic arthritis or adult-onset Still's disease.
Document ferritin >684 ng/mL plus any 2 of: platelets ≤181×10⁹/L, AST >48 U/L, triglycerides >156 mg/dL, or fibrinogen ≤360 mg/dL.
For renewal, document improvement or stabilization, manageable or absent side effects, and continued need for HLH/MAS therapy.

Denial Risk

Other Indications Not Established

Emapalumab use for indications outside the covered primary HLH and HLH/MAS criteria is considered experimental and investigational because effectiveness has not been established.

Requests for other indications may be denied as experimental and investigational.

Denial Risk

Criteria Not Met

Requests may be denied when required universal, initial-treatment, or renewal documentation is missing or when any applicable criterion is not satisfied.

Initial primary HLH: denial risk includes failure to document the diagnosis, refractory/recurrent/progressive disease or intolerance to conventional therapy, transplant candidacy, or qualifying transplant-phase use.
Initial HLH/MAS: denial risk includes failure to document HLH/MAS, Still's disease, required laboratory findings, or inadequate response/intolerance to high-dose glucocorticosteroids.
Renewal: denial risk includes lack of improvement or stabilization, unmanageable side effects, or no continued treatment need; for primary HLH, denial also applies after stem cell transplant or initiation of conditioning.
Any request may be denied if specialist involvement or FDA-labeled dosing and administration is not documented.

Documentation Required

Tuberculosis Requirements

Before starting emapalumab for primary HLH, document evaluation of tuberculosis risk factors and pretreatment screening for latent TB. If testing is positive or the member is at risk, initiate prophylactic TB treatment before therapy begins.

Submit TB risk evaluation and latent-TB screening documentation.
Document initiation of prophylaxis when indicated.

Interferon-gamma

DefinitionInterferon-gamma is a cytokine secreted by cells of the immune system

FunctionIt helps regulate immune functions

Emapalumab actionEmapalumab is a potent inhibitor of interferon-gamma