Alhemo Prior Authorization — Hemophilia A/B with inhibitors
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Defines prior authorization requirements for Alhemo when used to treat Hemophilia A or B with inhibitors for members of Curative Health Plan. Applies to requests for initial and continued therapy and specifies documentation and specialist involvement requirements.
No material clinical or coverage changes in this revision.
Coverage Criteria for Alhemo
inv-01: Initial Therapy — Hemophilia A with inhibitors
Covered when ALL of the following are met for Hemophilia A with inhibitors (documentation within past 90 days):
Document chart notes within past 90 days.
inv-02: Initial Therapy — Hemophilia B with inhibitors
Covered when ALL of the following are met for Hemophilia B with inhibitors (documentation within past 90 days):
Document chart notes within past 90 days.
inv-03: Continuation Therapy — Continued therapy
Covered when ALL of the following are met for continued therapy (documentation within past 12 months):
Approval duration: 12 months; document chart notes within past 12 months and evidence of treatment within past 90 days.
Use of the requested agent as concurrent prophylaxis with another prophylactic agent or a bypassing agent is not allowed. Specifically, the patient must NOT be using the requested agent in combination with another prophylaxis agent (for example, Hemlibra, Hympavzi) or a bypassing agent used for prophylaxis (for example, Feiba, NovoSeven, Sevenfact). An exception permits continuation of on‑demand (episodic) treatment with these agents, but combination prophylactic regimens are excluded from coverage.
Requests for Alhemo to treat Hemophilia A with inhibitors will not meet approval criteria unless the patient has tried and failed Hemlibra prior to initiation of Alhemo; this requirement is documented in the initial approval criteria and must be shown in chart notes within the past 90 days.
Initial Therapy Conditions
inv-13: Initial Therapy — Initial approval conditions for Alhemo
Initial approval conditions for Alhemo:
Document chart notes within past 90 days; approval duration: 12 months.
Continuation (Renewal) Criteria
inv-14: Continuation Therapy — Criteria required for continued approval
Criteria required for continued approval (documentation within past 12 months):
Approval duration: 12 months; document chart notes within past 12 months and evidence of treatment within past 90 days.
Coding and Laboratory Thresholds
Step Therapy Requirements
| Step | Requirement |
|---|---|
| 1 | Patient must try and fail Hemlibra prior to approval of Alhemo for Hemophilia A with inhibitors (documented in chart notes within the past 90 days). |
Provider Actions and Documentation Requirements
Prior authorization required for Alhemo
Prior authorization is required for Alhemo. Initial and continued approvals are granted for up to 12 months when the specified coverage criteria are met.
Hemlibra failure required before Alhemo (Hemophilia A with inhibitors)
For Hemophilia A with inhibitors, the patient must try and fail Hemlibra before Alhemo will be approved; this is required and must be documented in chart notes within the past 90 days.
Documentation requirements and timing
Chart notes within the past 90 days are required to document the indication and relevant clinical data for initial requests; for continued therapy, documentation within the past 12 months is required along with evidence of treatment in the past 90 days and clinical benefit.
- Document inhibitor level (lab records) showing ≥ 5 Bethesda Units for initial requests
- Document prior Hemlibra failure when Alhemo is requested for Hemophilia A with inhibitors
- Document specialist involvement or consultation (e.g., hematology)
- If Feiba is used for breakthrough bleeds, document prescriber counseling on maximum Feiba dosing (no more than 100 u/kg/24 hours)
- For continuation: show patient was treated with the requested agent (samples not approvable) within past 90 days and has shown clinical benefit
Denial risks for incomplete criteria or contraindicated combinations
Requests may be denied if required documentation or clinical prerequisites are not met, including lack of documented Hemlibra failure for Hemophilia A with inhibitors, inhibitor level < 5 Bethesda Units, missing chart notes within the required timeframe, lack of specialist involvement/consultation, or if the agent is to be used in combination with another prophylaxis or bypassing agent for prophylaxis.
Background
Alhemo is considered for prophylactic treatment of Hemophilia A or B with inhibitors to prevent or reduce bleeding episodes in patients older than 12 years of age. The policy requires laboratory documentation of an inhibitor level of >= 5 Bethesda Units and expects specialist management or documented specialist consultation (e.g., hematology). Prior authorization is required; initial and continued approvals are each granted for up to 12 months when the specified criteria are met. For continued therapy, chart documentation within the past 12 months and evidence of treatment within the past 90 days (samples do not qualify) plus demonstration of clinical benefit are required. If Feiba is used for breakthrough bleeds, the prescriber must have counseled the patient on maximum Feiba dosing (no more than 100 u/kg/24 hours).
Definitions
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