Currentharvard pilgrim health carePolicy N/A

Alhemo (concizumab-mtci)

Pharmacy medical necessity guideline governing coverage of Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce bleeding episodes in patients ≥12 years with hemophilia A or B who have inhibitors. Applies to specified commercial and Medicaid plans; does not apply to Medicare members.

Policy Summary

Payerharvard pilgrim health care

PolicyAlhemo (concizumab-mtci)

Policy CodePolicy N/A

Change Typeclarified

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionCoverage of Alhemo requires documentation meeting the Initial Authorization or Reauthorization criteria and will be authorized for up to 12 months; prescriber must be or consult a hematologist.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed by Pharmacy and Therapeutics Committee on May 13, 2025.

≥12Minimum age for coverage

12 moAuthorization duration

Hemophilia A/B w/ inhibitorsCovered indications

Coverage Summary

Pharmacy medical necessity guideline governing coverage of Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce bleeding episodes in patients 12 years and older with hemophilia A or B who have inhibitors. Applies to specified commercial and Medicaid plans; does not apply to Medicare members. Coverage stance: covered_with_criteria. Effective date: June 1, 2025. Status: CURRENT.

Initial Authorization Criteria

The plan may authorize coverage of Alhemo for Members when ALL of the following criteria are met:

ALL of the following

Documented diagnosis of hemophilia A or B
Documentation for use as prophylaxis to prevent or reduce the frequency of bleeding episodes
The patient is at least 12 years of age or older
Documentation the patient has inhibitors (hemophilia A: FVIII, hemophilia B: FIX)
Prescribed by or in consultation with a hematologist

Reauthorization / Continuation Criteria

Reauthorization Criteria

Coverage may be authorized at renewal when ALL of the following are met:

ALL of the following

Documented diagnosis of hemophilia A or B
The patient is at least 12 years of age or older
Prescribed by or in consultation with a hematologist
Documentation the patient has inhibitors (hemophilia A: FVIII, hemophilia B: FIX)
Documentation the Member has experienced a therapeutic response from Alhemo as defined by a reduction in the frequency of bleeds

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required per criteria

Coverage of Alhemo requires documentation meeting the Initial Authorization or Reauthorization criteria and will be authorized for up to 12 months. The prescriber must be or consult with a hematologist.

Duration: 12 months

Documentation Required

Documentation of inhibitors required

Submit documentation that the patient has factor VIII (FVIII) inhibitors for hemophilia A or factor IX (FIX) inhibitors for hemophilia B.

Documentation Required

Therapeutic response documentation for reauthorization

For reauthorization, provide documentation that the Member has experienced a therapeutic response from Alhemo, defined as a reduction in the frequency of bleeds while on therapy.

Billing Rule

Authorization duration

Coverage will be authorized for 12 months.

Background & Definitions

Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients 12 years and older with hemophilia A (with FVIII inhibitors) or hemophilia B (with FIX inhibitors). These guidelines apply to specified commercial and Medicaid plans and do not apply to Medicare members.

Inhibitors: Presence of neutralizing antibodies to factor VIII (FVIII) in hemophilia A or factor IX (FIX) in hemophilia B.

Revision History

May 13, 2025review

Policy reviewed by the Pharmacy and Therapeutics Committee; no material clinical policy change was stated.

June 1, 2025effective_dateLatest

Policy effective date for the Pharmacy Medical Necessity Guidelines: Alhemo (concizumab-mtci).