CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Gamifant (emapalumab-lzsg) — coverage criteria for primary HLH

Defines accepted indications, coverage criteria, coding, exclusions, and administrative requirements for Gamifant (emapalumab-lzsg) for members of Neighborhood Health Plan of Rhode Island processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGamifant (emapalumab-lzsg) — coverage criteria for primary HLH

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization via Evolent; continuation requests may be allowed if no disease progression, prior use within last year without >30‑day lapse, and no additional drugs are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 mgsingle dose limit reported

12 momax duration post-transplant

8 wkmax duration if no transplant

J9210HCPCS code

Commercial/Exchange/Medicaidlines of business

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Coverage Criteria for Gamifant (emapalumab-lzsg)

Approved Indications for Gamifant

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)

Disease status and prior therapy: Used for recurrent, refractory, or progressive disease, or for intolerance to conventional/first-line therapy

Can be used in combination with dexamethasone

Coverage is not approved when any of the following exclusion criteria apply: Gamifant (emapalumab-lzsg) is being used after disease progression with the same regimen; there is concurrent use with other biologics or live vaccines; the member has a diagnosis of active infections; dosing exceeds the single dose limit of 1 mg/kg; or treatment exceeds the maximum duration limit of 12 months post-transplant or 8 weeks if transplant was not performed.

Requests for Gamifant that fall under these exclusions will be excluded and are likely to be denied. Providers should ensure dosing and duration limits are followed and avoid concurrent administration with other biologics or live vaccines, and should not request therapy for members with active infections or for use after documented progression on the same regimen.

Investigational or off‑label use of Gamifant (emapalumab-lzsg) that is not supported by sufficient evidence is considered not medically necessary. Sufficient evidence is defined by standard criteria including representation of the patient population and regimen in published evidence, clinically meaningful outcomes (for example ASCO‑recommended thresholds such as hazard ratios <0.80 and survival benefits of at least 3 months for OS/PFS), appropriate study design, and reliance on adequate clinical trial data rather than uncontrolled case reports or abstracts without full peer‑reviewed publication.

Uses lacking support in CMS‑recognized compendia or acceptable peer‑reviewed literature — including indications supported only by anecdotal case reports or meeting abstracts without full articles — will be excluded from coverage.

Provider Requirements, Authorization, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for Gamifant (emapalumab-lzsg). Requests must document the diagnosis of primary hemophagocytic lymphohistiocytosis (HLH) and meet the medical necessity criteria in this policy. Continuation (re-authorization) requests for a medication that would otherwise be considered not-approvable are exempt from denial when ALL of the following are met: the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days from an active authorization; and no additional medications are being added to the continuation request.

Prior authorization required for initial and continuation requests
Continuation requests exempt when: no disease progression; prior use within last year with ≤30 day lapse; no added medications

Note

Position Relative to Conventional Therapy

Gamifant is intended for use in primary HLH and may be used in combination with dexamethasone for recurrent, refractory, or progressive disease or intolerance to conventional/first-line therapy (for example corticosteroids, etoposide, cyclosporine, and/or stem cell transplantation). Documentation should show that conventional therapy was considered or attempted unless there is a documented contraindication or intolerance.

Used for primary HLH (adult and pediatric)
May be combined with dexamethasone for recurrent/refractory/progressive disease or intolerance to conventional therapy
Document trials of or contraindications to conventional/first-line therapies

Documentation Required

Evidence and Documentation Requirements

Include clinical notes and supporting evidence with all requests. Required documentation includes: diagnosis and clinical status, prior treatments and responses (including dates and duration), rationale for Gamifant (including intolerance or failure of conventional therapy if applicable), dosing plan and intended duration, and absence of active infection or contraindicated concurrent biologics/live vaccines. For continuation requests, include evidence of no disease progression and prior authorization history (dates showing ≤30 day lapse).

Diagnosis and clinical course, including prior therapies and response
Rationale for use and dosing plan with intended duration (≤12 months post‑transplant or ≤8 weeks if no transplant)
Documentation excluding active infections and concurrent biologic or live vaccine use
For continuation: evidence of no progression and prior authorization within past year (≤30 day lapse)

Denial Risk

Exclusion-Based Denial Triggers

Denial or exclusion may occur for use after documented disease progression on the same regimen, concurrent administration with other biologics or live vaccines, presence of active infections, dosing above the single dose limit of 1 mg/kg, treatment exceeding the maximum duration limits, or investigational/off-label uses lacking adequate supporting evidence (per CMS compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature).

Use after disease progression on same regimen — exclusion trigger
Concurrent use with other biologics or live vaccines — exclusion trigger
Active infection present — exclusion trigger
Dosing > single dose limit of 1 mg/kg — exclusion trigger
Treatment beyond maximum duration (12 months post‑transplant; 8 weeks if no transplant) — exclusion trigger
Off‑label/ investigational use without sufficient evidence per CMS compendia or accepted literature — exclusion trigger

Regimen	Indication / Positioning	Notes (conventional/first-line options)
Gamifant (emapalumab-lzsg) ± dexamethasone	Recurrent, refractory, or progressive primary hemophagocytic lymphohistiocytosis (HLH) or intolerance to conventional therapy	Conventional/first-line therapy may include corticosteroids, etoposide, cyclosporine, and/or stem cell transplantation

Background and Definitions

Hemophagocytic lymphohistiocytosis (HLH) is a severe hyperinflammatory syndrome that may occur as a primary (inherited) or secondary condition. Gamifant (emapalumab-lzsg) is indicated for treatment of primary HLH, particularly for patients with recurrent, refractory, or progressive disease or when conventional therapy is not tolerated. Conventional/first‑line therapies include corticosteroids, etoposide, cyclosporine, and hematopoietic stem cell transplantation.

Because HLH can be rapidly progressive and life‑threatening, therapy selection should consider prior response to conventional regimens and transplantation status; coverage and continuation of Gamifant are subject to dosing, duration, and exclusion criteria described elsewhere in this policy.

Primary HLH definition

DefinitionPrimary hemophagocytic lymphohistiocytosis (HLH): inherited form of HLH affecting pediatric and adult patients.

PopulationApplies to adult and pediatric members (newborn and older).

Therapeutic contextGamifant (emapalumab-lzsg) may be used for recurrent, refractory, or progressive disease or when conventional therapy is not tolerated.

Conventional/first‑line therapiesIncludes corticosteroids, etoposide, cyclosporine, and/or stem cell transplantation.

OpenPayer

Gamifant (emapalumab-lzsg) — coverage criteria for primary HLH

Coverage Criteria for Gamifant (emapalumab-lzsg)

Coding and Quantity Limits

Provider Requirements, Authorization, and Denials

Regimens and Line of Therapy

Background and Definitions