Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Fidanacogene elaparvovec-dzkt (Beqvez) may be considered medically necessary when ALL the following criteria are met:
- Individual is 18 of age or older at time of treatment decision; and
- Documented diagnosis of moderate-severe or severe hemophilia B (ex. FIX levels less than 2 IU/dL); and
- Prescribed by or in consultation with a hematologist or specialist with experience and expertise in the treatment of hemophilia B; and
- Individual has been on prophylactic FIX replacement therapy for at least six (6) months prior to receiving gene therapy; and
- Provider attestation of discontinuation of regular prophylactic FIX replacement therapy following appropriate timeframe for FIX levels to reach steady state after individual has received gene therapy; and
- Individual has a current or historical life-threatening hemorrhage; or
- Individual has repeated, serious spontaneous bleeding episodes; and
- Individual has been tested for anti-AAVRh74var antibodies and is deemed a suitable candidate for treatment; and
- Individual does not have ANYof the following:
- No previous documented history of neutralizing antibodies to exogenous FIX including the use of bypassing agents (such as recombinant FVIIa and activated prothrombin complex concentrate [aPCC]); or
- Active infection with hepatitis B or C; or
- History of hepatitis B or C exposure currently controlled by antiviral therapy; or
- Diagnosis of HIV not currently controlled by antiviral therapy; or
- Liver function levels (hepatic aminotransferases [AST and ALT], total bilirubin, and alkaline phosphatase) greater than or equal to two (2) times upper limit of normal; or
- History of arterial or recurrent or unprovoked venous thromboembolic events (e.g., non- hemorrhagic stroke, pulmonary embolism, myocardial infarction, arterial embolus); and
- Acute factor product utilized prior to receiving gene therapy to be maintained for treatment of on-demand bleeds or perioperative management.
Note: The safety and effectiveness of repeat administration of fidanacogene elaparvovec-dzkt (Beqvez) has not been evaluated. Therefore, coverage will be limited to once per lifetime.
The use of fidanacogene elaparvovec-dzkt (Beqvez)for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.
Procedure Codes
