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.
Emicizumab-kxwh (Hemlibra) may be considered medically necessary when the following criteria are met:
-
ONE (1) of the following:
-
There is information that the individual has been treated with emicizumab-kxwh (Hemlibra) (starting on samples is not approvable) within the past 90 days;
or
-
The prescriber states the individual has been treated with emicizumab-kxwh (Hemlibra) (starting on samples is not approvable) within the past 90 days and is at risk if therapy is changed;
or
-
The individual has a diagnosis of hemophilia A with or without inhibitors;
and
-
Emicizumab-kxwh (Hemlibra) will be used as prophylaxis to prevent or reduce the frequency of bleeding episodes;
and
-
The prescriber is a specialist in the area of the individual's diagnosis [e.g., prescriber working in a hemophilia treatment center (HTC), hematologist with hemophilia experience] or the prescriber has consulted with a specialist in the area of the individual's diagnosis;
and
-
Beyond the first week of starting emicizumab-kxwh (Hemlibra), the individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with a Factor VIIa product (e.g., NovoSeven RT), a Factor VIII product (e.g., Advate, Adynovate, Eloctate, Nuwiq, Recombinate, Xyntha) or a bypassing agent (e.g., Feiba, NovoSeven) used for prophylaxis treatment or immune tolerance therapy (ITT) (immune tolerance induction [ITI]) (on-demand treatment is acceptable to continue);
and
-
If the individual is receiving Feiba [activated prothrombin complex concentrate (aPCC)] for breakthrough bleeds, BOTH of the following:
-
The individual will be monitored for thrombotic microangiopathy and thromboembolism;
and
-
The prescriber has counseled the individual on the maximum dosages of Feiba to be used (i.e., no more than 100 u/kg/24 hours);
and
-
ONE (1) of the following:
-
The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with a nonsteroidal anti-inflammatory agent (NSAID) (e.g., aspirin, ibuprofen) other than cyclooxygenase-2 (COX-2) inhibitors (e.g., celecoxib) NOTE: for the purposes of this criteria COX-2 inhibitors will be accepted for concomitant use;
or
-
The prescriber has provided information in support of using an NSAID for this individual;
and
- The individual does NOT have any FDA labeled contraindications to emicizumab-kxwh (Hemlibra).
Reauthorization Criteria
Reauthorization of
emicizumab-kxwh (Hemlibra)
may be considered medically necessary when the following criteria are met:
-
The individual has been previously approved for emicizumab-kxwh (Hemlibra) through Blue Cross Blue Shield of North Dakota's Prior Authorization process;
and
-
ONE (1) of the following:
-
The individual has shown clinical benefit since starting emicizumab-kxwh (Hemlibra) (i.e., less breakthrough bleeds as reported in the treatment log and/or chart notes) (medical records including treatment log and/or chart notes required);
or
-
The prescriber has submitted information supporting the continued use of emicizumab-kxwh (Hemlibra) (medical record required);
and
-
If the individual is receiving Feiba [activated prothrombin complex concentrate (aPCC)] for breakthrough bleeds, the individual will be monitored for thrombotic microangiopathy and thromboembolism;
and
-
The prescriber is a specialist in the area of the individual's diagnosis [e.g., prescriber working in a hemophilia treatment center (HTC), hematologist with hemophilia experience] or the prescriber has consulted with a specialist in the area of the individual's diagnosis;
and
-
The individual will NOT use emicizumab-kxwh (Hemlibra) in combination with a Factor VIIa product (e.g., NovoSeven RT), a Factor VIII product (e.g., Advate, Adynovate, Eloctate, Nuwiq, Recombinate, Xyntha) or a bypassing agent (e.g., Feiba, NovoSeven) used for prophylaxis treatment or immune tolerance therapy (ITT) (immune tolerance induction [ITI]) (on-demand treatment is acceptable to continue);
and
-
ONE (1) of the following:
-
The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with a nonsteroidal anti-inflammatory agent (NSAID) (e.g., aspirin, ibuprofen) other than cyclooxygenase-2 (COX-2) inhibitors (e.g., celecoxib) NOTE: for the purposes of this criteria COX-2 inhibitors will be accepted for concomitant use;
or
-
The prescriber has provided information in support of using an NSAID for this individual;
and
- The individual does NOT have any FDA labeled contraindications to emicizumab-kxwh (Hemlibra).
The use of emicizumab-kxwh (Hemlibra)
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
