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.
Etranacogene dezaparvovec-drlb (Hemgenix) may be considered medically necessary when ALL of the following are met:
-
The individual has a diagnosis of congenital hemophilia B (also known as Factor IX deficiency, Christmas disease);
and
-
ONE of the following:
-
The individual's sex is male;
or
-
The prescriber has provided information that etranacogene dezaparvovec-drlb (Hemgenix) is medically appropriate for the individual's sex (medical records required);
and
-
The individual is 18 years of age or over;
and
-
The individual has been screened for Factor IX inhibitor titers AND ONE of the following (medical records required):
-
The individual tested negative for Factor IX inhibitor titers on the initial screening;
or
-
BOTH of the following:
-
The individual tested positive for Factor IX inhibitors on the initial screening;
and
-
The individual tested negative for Factor IX inhibitors within two (2) weeks of initial screening;
and
-
ONE of the following: (medical records required):
-
The individual is on prophylactic therapy with a Factor IX agent (e.g., AlphaNine SD, Alprolix, BeneFIX, Idelvion,Ixinity, Mononine, Profilnine SD, Rebinyn, Rixubis);
or
-
The individual has current or historical life-threatening hemorrhage;
or
-
The individual has had repeated, serious spontaneous bleeding episodes;
and
-
The prescriber has evaluated the individuals liver function and determined the patient has adequate liver function to receive etranacogene dezaparvovec-drlb (Hemgenix) based on the following assessments:
-
Liver enzyme testing (i.e., alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin);
and
-
Hepatic ultrasound and elastrography;
and
-
If the individual has sustained liver enzyme elevations and/or radiological liver abnormalities, the prescriber has considered consultation with a specialist (i.e., hepatologist);
and
- The individual has NOT had any previous gene therapy [including etranacogene dezaparvovec-drlb (Hemgenix)].
Length of Approval:
One (1) course per lifetime
The use of etranacogene dezaparvovec-drlb (Hemgenix) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
