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:
-
The individual has a diagnosis of hemophilia A (also known as Factor VIII deficiency, or classic hemophilia);
and
-
ONE of the following:
-
The individual has a Factor VIII baseline residual level less than or equal to one (1) IU/dL (lab test required);
or
-
The individual has a Factor VIII baseline residual level greater than one (1) IU/dL and less than or equal to five (5) IU/dL AND the prescriber has determined that the individual has a bleed history that simulates severe hemophilia A (medical records including lab test and bleed history required);
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 individual's sex (medical records required);
and
-
The individual is 18 years of age or over;
and
-
The individual does NOT have active inhibitors to Factor VIII;
and
-
The individual has a modified Nijmegen Bethesda assay of less than 0.6 Bethesda Units (BU) on two (2) consecutive occasions at least one week apart within the past 12 months (test results required);
and
-
The individual is NOT on any bypassing agents (i.e., Feiba, NovoSeven);
and
-
ONE of the following: (medical records required)
-
The individual is on prophylactic therapy with a Factor VIII agent (e.g., Advate, Eloctate, Recombinate) AND has had a minimum of 150 exposure days;
or
-
The prescriber has determined that the individual requires improved protection than they are receiving from their current therapy (e.g., individuals with increased bleeding due to severely damaged joints, individuals with increased bleeding due to need for anticoagulation, elderly individuals with risk for falls);
and
-
ONE of the following:
-
The individual is NOT HIV positive (medical records including lab tests within the past three (3) months required);
or
-
The individual is HIV positive AND is well controlled (i.e. viral load within the past 12 months less than 1000 copies/mL) (lab results within the past 12 months required);
and
-
The individual does NOT have another immunosuppressive disorder;
and
-
The individual's hepatitis B surface antigen is negative (medical records including lab tests within the past three (3) months required);
and
-
ONE of the following:
-
The individual's hepatitis C virus (HCV) antibody is negative (medical records including lab tests within the past three (3) months required);
or
-
The individual's HCV antibody is positive AND the individual's HCV RNA is negative (medical records including lab tests within the past three (3) months required);
and
-
The individual does NOT have another active infection;
and
-
The individual does NOT have significant liver dysfunction as defined by abnormal elevation of any of the following: (lab results within the past three (3) months required)
-
ALT (alanine transaminase) three (3) times the upper limit of normal;
or
-
Bilirubin above three (3) times the upper limit of normal;
or
-
Alkaline phosphatase above three (3) times the upper limit of normal;
or
-
INR (international normalized ratio) greater than or equal to 1.4;
and
-
The individual does NOT have creatinine greater than or equal to 1.5 mg/dL (lab results within the past three (3) months required);
and
-
The individual does NOT have evidence of any bleeding disorder not related to hemophilia A;
and
-
The individual does not have anti-AAV antibodies (e.g., AAV-5) titers that exceed labeling administration instructions (test results within the past three (3) months required) see Viral Vector Table;
and
- The individual has NOT had previous gene therapy for hemophilia A (including requested agent).
Viral vector Table
Agent | Vector |
Roctavian (valoctocogene roxaparvovec) | AAV-5 |
Length of Approval:
1 course 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
