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) is 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
- ONE of the following:
- The individual has a diagnosis of hemophilia A with Factor VIII inhibitors (hemophilia A with inhibitors) AND ALL of the following:
- Emicizumab-kxwh (Hemlibra) is prescribed for prophylactic use; and
- ONE of the following:
- The individual’s inhibitor level is ≥ 5 BU (medical records required); or
- The individual has tried and had an inadequate response to Immune Tolerance Therapy (ITT) [Immune Tolerance Induction (ITI)]; or
- The individual is using a bypassing agent (Feiba, NovoSeven) for on-demand treatment and is not adequately controlled (treatment log and/or chart notes required); or
- The individual is using a bypassing agent for prophylaxis and had an inadequate response (documentation including treatment log and/or chart notes required); or
- The individual is using more than 5 doses per week of a bypassing agent (documentation including treatment log and/or chart notes required); or
- The individual is under 2 years of age; or
- The individual has poor venous access (documentation including chart notes required); or
- The individual has an intolerance or hypersensitivity to a bypassing agent; or
- The individual has an FDA labeled contraindication to a bypassing agent; 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) AND BOTH of the following:
- Emicizumab-kxwh (Hemlibra) is being prescribed for prophylactic use; and
- ONE of the following:
- The prescriber has determined that the individual has had an adequate trial and failed to be sufficiently controlled on prophylaxis with a Factor VIII clotting factor agent (e.g., Advate, Adynovate, Eloctate, Nuwiq, Recombinate, Xyntha); or
- The individual is under 2 years of age; or
- The individual has poor venous access (documentation including chart notes required); 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 an intolerance or hypersensitivity to prophylaxis with a Factor VIII clotting factor agent; or
- The individual has an FDA labeled contraindication to prophylaxis with a Factor VIII clotting factor agent; and
- The prescriber has discussed with the individual that a treatment log, documenting at least 6 months of bleeds prior to starting emicizumab-kxwh (Hemlibra) , and which includes ALL of the following must be maintained and a copy will be submitted (via prescriber or pharmacy) for renewal purposes *note if a historical bleed log is unavailable, a new log must be started and submitted for renewal
- Date of the bleed; and
- The treatment used (include the brand name and number of units administered); and
- The number of doses required to treat the bleed; 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 temicizumab-kxwh (Hemlibra), the individual will NOT be using emicizumab-kxwh (Hemlibra) in combination with 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 does NOT have any FDA labeled contraindications to emicizumab-kxwh (Hemlibra).
Length of initial approval: 1 month for induction therapy; 6 months for maintenance therapy (or remainder of 6 months if requesting induction therapy and maintenance therapy)
Reauthorization of emicizumab-kxwh (Hemlibra) is 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
- The prescriber or pharmacy has provided a copy of the individual’s treatment logs for bleeds that includes ALL of the following: (documentation including treatment log required)
- Date of bleed; and
- The treatment used (include the brand name and number of units administered); and
- The number of doses required to treat the bleed; and
- ONE of the following:
- The individual has shown clinical benefit since starting emicizumab-kxwh (Hemlibra) (i.e., less breakthrough bleeds as documented in the treatment log and/or chart notes) (documentation 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 useemicizumab-kxwh (Hemlibra) in combination with 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 does NOT have any FDA labeled contraindications to emicizumab-kxwh (Hemlibra).
Length of approval: 12 months
The use of emicizumab-kxwh (Hemlibra) for any indication not mentioned within this policy is considered experimental/investigational and therefore, non-covered. The scientific evidence has not established the safety and efficacy for use in other indications.
Procedure Codes
