CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Gamifant (emapalumab-lzsg) coverage

Defines clinical indications, continuation, exclusions, and utilization management requirements for Gamifant (emapalumab-lzsg) for Neighborhood Health Plan of Rhode Island members; applies to UM department medication requests and ordering providers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGamifant (emapalumab-lzsg) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 26, 2024

Next Review DateJul 10, 2024

Key ActionObtain prior authorization from Evolent/Utilization Management; final approval is by the Utilization Management Committee.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmaximum treatment duration post-transplant

8 weeksmaximum treatment duration if transplant not performed

1 mg/kgsingle dose maximum

newborn+age range for HLH indication

2024-07-26policy effective date

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Coverage Criteria

Initial therapy — primary HLH

Covered when ALL of the following are met

Primary HLH indication: Member is adult or pediatric (newborn and older) with a diagnosis of primary hemophagocytic lymphohistiocytosis (HLH)

Supported by chunk 5

Position in therapy: Gamifant (emapalumab-lzsg) is used in combination with dexamethasone for disease that is recurrent, refractory, progressing on conventional therapy, or intolerant to conventional therapy (conventional/first-line therapy may include corticosteroids, etoposide, cyclosporine, and/or stem cell transplantation)

Supported by chunk 5

Supporting evidence: Use must be supported by FDA approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15

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Requests for Gamifant (emapalumab-lzsg) will be excluded when any of the following apply: use after disease progression on the same regimen; concurrent use with other biologics or live vaccines; the member has an active infection; dosing that exceeds the single dose limit of 1 mg/kg; treatment duration beyond the policy limits (more than 12 months post‑transplant or > 8 weeks if a transplant was not performed); or investigational/off‑label use that lacks sufficient evidence or is not generally accepted by the medical community (including reliance on abstracts without full peer‑reviewed articles).

When documenting requests, support for the clinical use of Gamifant must be consistent with accepted evidence standards; meeting abstracts without a full published article do not provide adequate evidence for coverage determinations and therefore are specifically noted as insufficient supporting evidence.

Initial Therapy — Primary HLH

Initial coverage — primary HLH

Initial coverage for primary HLH when criteria are met:

Diagnosis: Primary HLH diagnosis in an adult or pediatric patient (newborn and older)

chunk 5

Therapy context: Gamifant to be used in combination with dexamethasone for disease that is recurrent, refractory, progressing on conventional therapy, or intolerant to conventional therapy

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Documentation: Supportive documentation must align with FDA labeling, CMS-approved compendia, NCCN/ASCO clinical guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15

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Continuation Therapy Criteria

Continuation requests

Continuation requests for a previously used medication may be exempt from the policy when all conditions are met:

Continuation exemption: Requested medication was used within the last year AND the member has not experienced disease progression and/or intolerance to the requested medication AND no additional medications are being added to the continuation request

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Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required and processed by Evolent/Utilization Management. Final approval authority rests with the Utilization Management Committee.

Prior authorization required — all requests processed by Evolent/Utilization Management
Final approval decision made by the Utilization Management Committee

Note

Position in Therapy

Gamifant (emapalumab-lzsg) may be used in combination with dexamethasone for primary hemophagocytic lymphohistiocytosis (HLH) that is recurrent, refractory, progressing on, or intolerant to conventional/first-line therapy (e.g., corticosteroids, etoposide, cyclosporine, and/or stem cell transplantation).

Indication: primary HLH (adult and pediatric, newborn and older)
Use in combination with dexamethasone for recurrent/refractory/progressing/intolerant disease

Coding and Quantity Limits

inv-03: Single dose limit

Single dose limit1 mg/kg per dose

Applies toAll requests for Gamifant (emapalumab-lzsg)

Exclusion consequenceRequests with dosing >1 mg/kg will be excluded

inv-04: Maximum duration post-transplant

Maximum duration post-transplant12 months

Applies toMembers who have undergone transplant

Exclusion consequenceTreatment beyond 12 months post-transplant will be excluded

Step Therapy

Step	Requirement / Trigger	Notes
1	Use after failure, intolerance, or lack of response to conventional/first-line therapy	Conventional/first-line therapy examples include corticosteroids, etoposide, cyclosporine, and/or stem cell transplantation; Gamifant used in combination with dexamethasone for recurrent, refractory, progressing, or intolerant disease

Site of Care and Administration

Note

Infusion center — follow FDA label/package insert for administration and site‑of‑care

Refer to the FDA label/package insert for site‑of‑care details and administration guidance for infusion center use of Gamifant (emapalumab‑lzsg).

Background

Hemophagocytic lymphohistiocytosis (HLH) is a life‑threatening hyperinflammatory syndrome. Primary HLH refers to the genetic form and may present in adults and pediatrics (newborn and older). Gamifant (emapalumab‑lzsg), a monoclonal antibody targeting interferon‑gamma, is indicated for primary HLH and is typically used in combination with corticosteroids such as dexamethasone when disease is recurrent, refractory, progressing on conventional therapy, or the patient is intolerant to conventional regimens.

Use of Gamifant must align with the FDA label and be supported by recognized compendia or acceptable peer‑reviewed literature per coverage requirements; clinical context, dosing limits, and duration limits described elsewhere in this policy should be followed when initiating or continuing therapy.

Definitions

inv-11: Primary HLH

DefinitionPrimary hemophagocytic lymphohistiocytosis (HLH) is the genetic form of HLH for which Gamifant is indicated

Age applicabilityApplies to newborn and older (adult and pediatric)

Therapy contextGamifant may be used in combination with dexamethasone for recurrent, refractory, or progressing disease or when intolerant to conventional therapy