CurrentUnitedHealthcarePolicy 2025 P 2369-2

Alhemo (concizumab-mtci) prior authorization and medical necessity

Criteria and authorization rules for coverage of Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce bleeding episodes in patients age 12 and older with hemophilia A or B, with or without inhibitors; applies to UnitedHealthcare pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicyAlhemo (concizumab-mtci) prior authorization and medical necessity

Policy CodePolicy 2025 P 2369-2

Change TypeNew prior authorization programcriteria added and clarified

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization per UnitedHealthcare Program 2025 P 2369-2 and document diagnosis, age (>=12), inhibitor status, and indication to support approval.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program created for Alhemo (concizumab-mtci).

Added coverage criteria for hemophilia A or B without inhibitors per updated FDA label.

Clarified high titer inhibitor criteria (>= 5 Bethesda units).

Updated references, including package insert and phase 3 trial citation.

>=12Min patient age

>=5 BUHigh-titer inhibitor threshold

12 monthsAuth duration

3/2025, 8/2025

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Coverage Criteria for Alhemo (concizumab‑mtci)

Initial Authorization — Hemophilia A with inhibitors

Covered when ALL of the following are met for hemophilia A with high-titer FVIII inhibitors:

Hemophilia A with inhibitors - Initial: 1) Diagnosis of hemophilia A; AND 2) Patient has developed high-titer factor VIII inhibitors (>= 5 Bethesda units [BU]); AND 3) Patient is 12 years of age or older; AND 4) Alhemo is prescribed for routine prophylaxis to prevent bleeding episodes.>= 5 Bethesda units (BU); age >= 12 years

Authorization will be issued for 12 months.

Initial Authorization — Hemophilia A without inhibitors

Covered when ALL of the following are met for hemophilia A without high-titer FVIII inhibitors:

Hemophilia A without inhibitors - Initial: 1) Diagnosis of hemophilia A; AND 2) Patient has NOT developed high-titer factor VIII inhibitors (< 5 Bethesda units [BU]); AND 3) Patient is 12 years of age or older; AND 4) Alhemo is prescribed for the prevention of bleeding episodes (routine prophylaxis).< 5 Bethesda units (BU); age >= 12 years

Authorization will be issued for 12 months.

Initial Authorization — Hemophilia B with inhibitors

Covered when ALL of the following are met for hemophilia B with high-titer FIX inhibitors:

Hemophilia B with inhibitors - Initial: 1) Diagnosis of hemophilia B; AND 2) Patient has developed high-titer factor IX inhibitors (>= 5 Bethesda units [BU]); AND 3) Patient is 12 years of age or older; AND 4) Prescribed for the prevention of bleeding episodes (routine prophylaxis).>= 5 Bethesda units (BU); age >= 12 years

Authorization will be issued for 12 months.

Initial Authorization — Hemophilia B without inhibitors

Covered when ALL of the following are met for hemophilia B without high-titer FIX inhibitors:

Hemophilia B without inhibitors - Initial: 1) Diagnosis of hemophilia B; AND 2) Patient has NOT developed high-titer factor IX inhibitors (< 5 Bethesda units [BU]); AND 3) Patient is 12 years of age or older; AND 4) Alhemo is prescribed for the prevention of bleeding episodes (routine prophylaxis).< 5 Bethesda units (BU); age >= 12 years

Authorization will be issued for 12 months.

Reauthorization

Reauthorization covered when the following criterion is met:

Reauthorization: Documentation of positive clinical response to Alhemo therapy.

Authorization will be issued for 12 months upon approval.

Coverage for Alhemo may be limited or impacted by state mandates, federal regulatory requirements, or member-specific benefit plan terms. Other UnitedHealthcare medical or pharmacy policies and utilization management programs (for example, supply limits or automated approval rules) may also affect coverage or approval decisions. Providers should confirm benefits and any applicable state or federal requirements when submitting prior authorization requests.

Initial Therapy Criteria

Initial therapy

Initial authorization criteria vary by hemophilia type and inhibitor status

Initial - general: Diagnosis of hemophilia A or B as specified in the sections above; patient age >= 12 years; inhibitor status per indication (high-titer >= 5 BU or not high-titer < 5 BU); and prescribed for routine prophylaxis to prevent bleeding episodes.Age >= 12 years; high-titer threshold >= 5 BU

Authorizations are issued for 12 months.

Reauthorization / Continuation Criteria

Reauthorization / Continuation

Reauthorization requirement

Continuation: Documentation of positive clinical response to Alhemo therapy is required for reauthorization.

Approvals for reauthorization will be issued for 12 months.

Key Coding and Clinical Thresholds

inv-07: High-titer inhibitor threshold

High-titer inhibitor threshold>= 5 Bethesda units (BU)

Measurement unitsBethesda units (BU)

Applies toHigh-titer FVIII or FIX inhibitors per indication-specific criteria

inv-08: Minimum patient age for coverage

Minimum patient age for coverage>= 12 years

Age applies toAdult and pediatric patients 12 years of age and older for hemophilia A and B

Authorization duration

Provider Actions and Requirements

Prior Authorization

Prior authorization required (Program 2025 P 2369-2)

Prior authorization is required under UnitedHealthcare Pharmacy Clinical Pharmacy Programs (Program Number 2025 P 2369-2). Approval is contingent on meeting the diagnosis-, age-, inhibitor-status-, and indication-specific criteria detailed for hemophilia A and B.

Program number: 2025 P 2369-2
Approval contingent on meeting the applicable criteria for diagnosis, age (>=12 years), inhibitor status, and indication (routine prophylaxis)

Billing Rule

Utilization management — supply limits and automated approvals possible

Supply limits and other utilization management may apply; automated approval or reauthorization based on prior claim/medication history, diagnosis codes, or claim logic may be used depending on program and therapeutic class.

Background

Alhemo (concizumab-mtci) is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients aged 12 years and older with hemophilia A or B, with or without inhibitors. The recommendation and supporting evidence cited include the product labeling and phase 3 trial data referenced in the FDA package insert.

Definitions

inv-14: High-titer inhibitor definition (>= 5 Bethesda units)

DefinitionHigh-titer inhibitors are defined as inhibitors greater than or equal to 5 Bethesda units (BU)

Applies toFactor VIII (FVIII) and factor IX (FIX) inhibitor assessments as referenced in indication-specific criteria

Use in criteriaUsed to determine ‘with inhibitors’ vs ‘without inhibitors’ eligibility for Alhemo coverage