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
