CurrentMass General Brigham Health PlanPolicy N/A

Alhemo (conicizumab) prior authorization and coverage for hemophilia with inhibitors

Governs prior authorization, continuation, and quantity/benefit limits for Alhemo (conicizumab) for Mass General Brigham Health Plan members, affecting commercial/exchange and pharmacy specialty benefit prescribers and specialty pharmacies.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAlhemo (conicizumab) prior authorization and coverage for hemophilia with inhibitors

Policy CodePolicy N/A

Change TypeCriteria updated

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document that the member will discontinue other prophylactic Factor VIII or IX therapies when initiating Alhemo.

SourceLink

POLICY UPDATE CHANGES

Updated criteria to require that member will discontinue prophylactic therapies when starting Alhemo.

Hemophilia A/B w inhibitorsindications covered

>=12minimum age for coverage

12 monthsapproval duration

Specialty pharmacydispense requirement

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Initial Authorization

Covered when ALL of the following are met

Initial Authorization: Member has congenital hemophilia A (factor VIII deficiency) with factor VIII inhibitors OR congenital hemophilia B (factor IX deficiency) with factor IX inhibitors; requested medication will be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; member is 12 years of age or older; requested medication is prescribed by or in consultation with a hematologist; member will discontinue use of other prophylactic therapies.

Authorization may also be granted for members new to the plan within the past 90 days who are currently receiving the medication (excluding samples or manufacturer patient assistance program supply).

Continuation of Therapy

Reauthorization when ALL of the following are met

Continuation: Requested medication continues to be used for prophylaxis to prevent or reduce the frequency of bleeding episodes; member demonstrates a positive clinical response to therapy (e.g., reduced frequency or severity of bleeds); member is not using the requested medication in combination with prophylactic Factor VIII or Factor IX therapies.

Approvals (initial and reauthorization) will be granted for 12 months.

Coverage for Alhemo (conicizumab) is limited to patients with congenital hemophilia A with factor VIII inhibitors or congenital hemophilia B with factor IX inhibitors. Use of Alhemo for indications other than hemophilia A or B with inhibitors is not supported by the criteria in this policy.

Use of Alhemo in combination with prophylactic Factor VIII or Factor IX therapies is not permitted for authorization or continuation. Members receiving Alhemo must not be maintained on concurrent prophylactic factor replacement therapy.

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required; may be granted for members new to the plan within the past 90 days who are currently receiving the medication (excludes samples or manufacturer patient assistance programs).

Prior authorization required
May be granted for members new to the plan within past 90 days who are currently receiving the medication (excluding samples or manufacturer patient assistance programs)

Step Therapy

Step Therapy / Sequencing

Step therapy / sequencing: Member must discontinue other prophylactic therapies when initiating Alhemo. No additional step therapy specified.

Member will discontinue use of other prophylactic therapies when starting Alhemo
No other step requirements specified

Documentation Required

Required Documentation

Required documentation: Documentation must show the member has congenital hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors; that the medication will be used for prophylaxis to prevent or reduce bleeding episodes; member is 12 years of age or older; the drug is prescribed by or in consultation with a hematologist; member will discontinue other prophylactic Factor VIII or Factor IX therapies; for continuation, documentation of positive clinical response (reduced frequency or severity of bleeds) and that the member is not using the medication in combination with prophylactic Factor VIII or Factor IX therapies.

Diagnosis: congenital hemophilia A (factor VIII deficiency) with factor VIII inhibitors OR congenital hemophilia B (factor IX deficiency) with factor IX inhibitors
Intended use: prophylaxis to prevent or reduce frequency of bleeding episodes
Age: member is 12 years of age or older
Prescriber: prescribed by or in consultation with a hematologist
Therapy discontinuation: member will discontinue other prophylactic therapies (including prophylactic Factor VIII or Factor IX) when using Alhemo
Continuation evidence: documentation of positive clinical response (e.g., reduced frequency or severity of bleeds) and not using in combination with prophylactic Factor VIII or Factor IX therapies

Denial Risk

Denial Triggers

Denial triggers: Failure to demonstrate the required diagnosis (hemophilia A or B with inhibitors), age ≥ 12 years, prophylactic intended use, hematology involvement, discontinuation of other prophylactic therapies, or lack of clinical response on continuation requests.

Missing documentation of hemophilia A or B with inhibitors
Member is < 12 years of age
Requested use is not prophylaxis
No documentation the drug is prescribed by or in consultation with a hematologist
Member has not discontinued other prophylactic therapies
For reauthorization: failure to demonstrate positive clinical response or concurrent use with prophylactic Factor VIII or Factor IX

Background and Clinical Overview

Conicizumab (Alhemo) is a tissue factor pathway inhibitor antagonist indicated for routine prophylaxis to prevent and reduce bleeding frequency in patients with inhibitors to factor VIII or IX. This policy supports coverage when the member meets the specified criteria — including diagnosis of hemophilia A or B with inhibitors, use for prophylaxis, being 12 years of age or older, hematology prescriber involvement, and discontinuation of other prophylactic therapies; reauthorization requires evidence of a positive clinical response and absence of concurrent prophylactic Factor VIII or IX therapy.

OpenPayer

Alhemo (conicizumab) prior authorization and coverage for hemophilia with inhibitors

Coverage Criteria for Alhemo (conicizumab)

Provider Requirements and Operational Notes

Background and Clinical Overview

Key Definitions