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 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 Factor VIII inhibitors (hemophilia A with inhibitors) AND ALL of the following:
- The individual’s inhibitor level is greater than or equal to 5 BU (medical records required); and
- ONE of the following:
- The individual has tried and had an inadequate response to Immune Tolerance Induction (ITI) [Immune Tolerance Therapy (ITT)]; or
- The individual has an inhibitor level greater than or equal to 200 BU (lab records required); or
- Information has been provided indicating why the individual is not a candidate for ITI; 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); or
- The individual has a diagnosis of hemophilia A without Factor VIII inhibitors (hemophilia A) or the individual has an inhibitor level less than 5 AND ONE of the following:
- The individual has severe hemophilia (i.e., residual Factor VIII level of less than 1%) (medical records required); or
- The individual is under two (2) years of age; or
- The individual has poor venous access (medical records required); or
- The prescriber has determined that the individual has had an adequate trial and cannot be sufficiently controlled on prophylaxis with a Factor VIII clotting factor agent (e.g., Advate, Adynovate, Eloctate, Nuwiq, Recombinate, Xyntha); or
- The individual failed to achieve an adequate trough level while on clinically optimal dose and frequency of a Factor VIII clotting factor agent (medical record required); or
- The individual has had a least two (2) episodes of spontaneous bleeding into the joints (medical records required); or
- The individual has had one (1) or more episodes of bleeding into the central nervous system or other serious life-threatening bleed (medical records required); and
- Emicizumab-kxwh (Hemlibra) will be used as prophylaxis to prevent or reduce the frequency of bleeding episodes; and
- The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with ITI/ITT; 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 (on-demand treatment is acceptable to continue); and
- The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with nonsteroidal anti-inflammatory agents (NSAIDS) (e.g., aspirin, ibuprofen); and
- The individual does NOT have any FDA labeled contraindications to emicizumab-kxwh (Hemlibra).
Length of initial approval: one (1) month for induction therapy; six (6) months for maintenance therapy (or remainder of six (6) months if requesting induction therapy and maintenance therapy)
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 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 (on-demand treatment is acceptable to continue); and
- The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with nonsteroidal anti-inflammatory agents (NSAIDS) (e.g., aspirin, ibuprofen); and
- The individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with immune tolerance induction (ITI) [immune tolerance therapy (ITT)]; and
- The individual does NOT have any FDA labeled contraindications to emicizumab-kxwh (Hemlibra).
Length of approval: 12 months
Emicizumab-kxwh (Hemlibra) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
