Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Elivaldogene autotemcel (Skysona) may be considered medically necessary when the following criteria are met:
- The individual has a diagnosis of active cerebral adrenoleukodystrophy (ALD) as defined by BOTH of the following:
- Elevated very long chain fatty acids (VLCFA) values; and
- Active central nervous system (CNS) disease established by central radiographic review of brain magnetic resonance imaging (MRI) demonstrating:
- Loes score between 0.5 and 9 (inclusive) on the 34-point scale; and
- Gadolinuim enhancement on MRI of demyelinating lesions; and
- The individual has a Neurologic Function Score (NFS) less than or equal to 1; and
- ONE of the following:
- The individual's sex is male; or
- The prescriber has provided information that the requested agent is medically appropriate for the patient's sex; and
- The individual is 4 to 17 years of age; and
- The individual has NOT had an allogeneic hematopoietic stem cell transplant; and
- The individual does NOT have availability of a willing 10/10 HLA-matched sibling donor (excluding female heterozygotes) AND
- The individual does NOT have any of the following indicators of hematological compromise:
- Peripheral blood absolute neutrophil count (ANC) less than 1500 cells/mm^3
- Platelet count less than 100,000 cells/mm^3
- Hemoglobin less than 10 g/dL
- Uncorrected bleeding disorder; and
- The individual does NOT have any of the following indicators of hepatic compromise:
- Aspartate transaminase (AST) value greater than 2.5 X the upper limit of normal (ULN)
- Alanine transaminase (ALT) value greater than 2.5 X ULN
- Total bilirubin value greater than 3.0 mg/dL unless the patient has a diagnosis of Gilbert's Syndrome and is otherwise stable; and
- The individual does NOT have hepatitis B; and
- The individual is NOT HIV positive; and
- ONE of the following:
- The individual's hepatitis C virus (HCV) antibody is negative; or
- The individual's HCV antibody is positive AND the patient's HCV RNA is negative; and
- The individual does NOT have another active infection; and
- The individual has NOT had previous gene therapy for any diagnosis.
Length of Approval: One (1) course per lifetime
Elivaldogene autotemcel (Skysona) for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence does not support its use for any other indication.
Procedure Codes
