Medical Policy
Effective Date:04/01/2021 Title:Gamifant (emapalumab)
Revision Date: Document:BI683:00
CPT Code(s):J9210
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Gamifant (emapalumab) requires prior authorization.

2)    Gamifant is used to treat primary hemophagocytic lymphohistiocytosis (HLH) in adult and pediatric patients with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy.

3)    Gamifant is an injectable medication covered under the medical benefit as a specialty drug.
Medical Statement

Gamifant (emapalumab) is considered medically necessary for members meeting the following conditions:

1)    Diagnosis of primary HLH (i.e. familial (inherited) hemophagocytic lymphohistiocytosis (HLH)) AND

2)    Prescribed by or in consultation with a hematologist AND

3)    Failure of conventional HLH therapy that includes an etoposide- and dexamethasone-based regimen, unless contraindicated or clinically significant adverse effects are experienced AND

4)    Documentation of a scheduled bone marrow or hematopoietic stem cell transplantation (HSCT) or identification of a transplant donor is in process AND

5)    Dose does not exceed 10mg/kg per dose, two doses per week.

 

Initial Approval Duration is 2 months.

 

Reauthorization Criteria (for 6 months if approved)

Member is responding positively to therapy – including but not limited to improvement in ANY of the following parameters:
1) Fever reduction

1)    Splenomegaly

2)    Central nervous system symptoms

3)    Complete blood count

4)    Fibrinogen and/or D-dimer

5)    Ferritin

6)    Soluble CD25 (also referred to as soluble interleukin-2 receptor) levels

 

Codes Used In This BI:

1)    J9210 – Injection, emapalumab-lzsg, 1mg
Limits
Intentially left empty
Reference

1)    Gamifant Prescribing Information. Geneva, Switzerland: Novimmune; November 2019.

2)    Henter JI, Samuelsson-Horne AC, Arico M, et al. Treatment of hemophagocytic lymphohistiocytosis with HLH-94 immunochemotherapy and bone marrow transplantation. Blood 2002; 100 (7): 2367-72.

3)    Chesshyre E, Ramanan AV, Roderick MR. Hemophagocytic Lymphohistiocytosis and Infections: An update. The Pediatric Infectious Disease Journal March 2019; 38(3): e54-e56.

4)    Bergsten E, Horne AC, Arico M, et al. Confirmed efficacy of etoposide and dexamethasone in HLH treatment: long-term results of the cooperative HLH-2004 study. Blood 2017; 130 (25): 2728-38.
Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.