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.
Valoctocogene roxaparvovec-rvox (Roctavian) may be considered medically necessary as a one-time infusion for individuals with hemophilia A when
ALL
of the following criteria are met:
-
Individual is 18 to 70 years of age at the time of treatment decision;
and
-
Confirmed diagnosis of severe hemophilia A (i.e., less than 1 IU/dL clotting factor activity);
and
-
Prescribed by or in consultation with a hematologist or specialist with experience and expertise in the treatment of hemophilia A;
and
-
Individual has been on prophylactic FVIII replacement therapy and/or emicizumab (Hemlibra) for at least 12 months prior to receiving gene therapy;
and
-
Provider attestation that individual has been counseled regarding the risks of alcohol consumption and use of concomitant hepatotoxic medications after receiving valoctocogene roxaparvovec-rvox (Roctavian) and individual agrees to abstain from alcohol consumption for at least one (1) year following infusion;
and
-
Individual does not have
ANY
of the following:
-
Previous documented history of a detectable FVIII inhibitor (less than 0.6 Bethesda Units (BU), or less than 1.0 BU for laboratories with historical lower sensitivity cutoff for inhibitor detection of 1.0 BU);
or
-
Detectable AAV5 antibodies as determined by an FDA approved companion diagnostic;
or
-
Liver function levels (hepatic aminotransferases [ALT and AST], GGT, total bilirubin, and alkaline phosphatase) greater than 1.25 times the upper limit of normal or INR greater than 1.4;
or
-
Significant hepatic fibrosis or cirrhosis (stage 3 or 4 on the Batts-Ludwig scale or equivalent)
; or
-
Individual does not have a contraindication to receiving corticosteroids or immunosuppressive agents in the event that they experience elevated ALT levels post infusion
;or
- Note:
ALT levels should be monitored closely post-infusion; if ALT levels elevate >1.5 times the upper limit of normal, corticosteroids or alternative immunosuppressive agents should be initiated.
-
Positive HIV status;
or
-
Chronic or active hepatitis B infection;
or
-
Active hepatitis C infection;
or
-
Other active or controlled chronic infection;
or
-
History of arterial or recurrent or unprovoked venous thromboembolic events (e.g., non- hemorrhagic stroke, pulmonary embolism, myocardial infarction, arterial embolus);
and
-
Provider attestation of discontinuation of regular prophylactic therapy following appropriate time frame for FVIII levels to reach therapeutic levels after steady state, after individual has received gene therapy;
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 valoctocogene roxaparvovec-rvox (Roctavian) has not been evaluated. Therefore, coverage will be limited to once per lifetime.
The use of valoctocogene roxaparvovec-rvox (Roctavian) 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 Code
