Pharmacy Prior Authorization Criteria

Gamifant (emapalumab-lzsg)

Indications for Prior Authorization

Gamifant (emapalumab-lzsg)

• For diagnosis of Primary Hemophagocytic Lymphohistiocytosis (HLH)
  Indicated for the treatment of adult and pediatric (newborn and older) patients with primary HLH with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

Criteria

Gamifant

Prior Authorization (Initial Authorization)

Length of Approval: 6 Months [A]

• Diagnosis of primary hemophagocytic lymphohistiocytosis (HLH)
AND
• One of the following:
• Disease is one of the following:
• Refractory
• Recurrent
• Progressive
OR
• Trial and failure, contraindication, or intolerance to conventional HLH therapy (e.g., etoposide, dexamethasone, cyclosporine A, intrathecal methotrexate)
AND
• Prescribed by or in consultation with a hematologist/oncologist
AND
• Patient has not received hematopoietic stem cell transplantation (HSCT)

Gamifant

Prior Authorization (Reauthorization)

Length of Approval: 6 Months [A]

• Patient demonstrates positive clinical response to therapy (e.g., improvement in hemoglobin/lymphocyte/platelet counts, afebrile, normalization of inflammatory factors/markers)
AND
• Patient has not received HSCT

P & T Revisions

2024-01-26, 2023-09-29, 2023-01-15, 2022-02-18, 2021-09-27, 2021-05-19, 2021-02-03, 2020-02-19

References

1. Gamifant Prescribing Information. Sobi Inc. Waltham, MA. June 2020.
2. Per clinical consult with a pediatric hematologist/oncologist, January 18, 2019.

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End Notes

1. Per clinical consultation, it is appropriate to limit authorization duration to no more than 6 months at a time, given that the ultimate goal in therapy is to receive HSCT and treatment with Gamifant should be viewed as bridge therapy to HSCT. Pivotal trial data duration was also less than 3 months. [2]

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Revision History

• 2024-01-26: Annual Review, No criteria changes
• 2023-09-29: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-01-15: Annual Review - no criteria changes
• 2022-02-18: Annual review: no criteria changes.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
• 2021-02-03: Annual review: Added new product strength and updated reauthorization criteria.
• 2020-02-19: Annual Review: Background updated.

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