CurrentBlue Cross Blue Shield - IowaPolicy 05.05.85

Alhemo (concizumab-mtci) coverage for prophylaxis in hemophilia A and B

Defines prior authorization criteria, documentation, dosing/quantity limits, prescriber specialty, and billing codes for Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce bleeding in patients age 6ge;12 years with hemophilia A or B.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAlhemo (concizumab-mtci) coverage for prophylaxis in hemophilia A and B

Policy CodePolicy 05.05.85

Change TypeRevised; HCPCS code added

Effective DateOct 14, 2025

Next Review Date

Key ActionSubmit chart notes and labs (including inhibitor status and baseline hematologic/hepatic/renal assessments) to initiate prior authorization review for initial and continuation requests.

POLICY UPDATE CHANGES

HCPCS code J7173 effective 10/1/25 listed for concizumab-mtci

Policy reviewed and revised August 2025; current effective date October 14, 2025.

2Covered Indications

12 moAuthorization Duration

4 pens/28 dQuantity Limit

Coverage Summary

Alhemo (concizumab-mtci) is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A or hemophilia B, with or without inhibitors. Coverage is covered_with_criteria and intended to align with FDA-approved labeling, prescribing information, and the clinical evidence base. Prior authorization requirements, documentation, dosing/quantity limits, prescriber specialty, and monitoring requirements are specified to reflect FDA labeling and evidence-based practice. The policy includes the HCPCS billing code J7173 for concizumab-mtci and standard quantity limits (e.g., 4 pens per 28 days), and approvals/dosing are to follow FDA-recommended dosing and therapeutic monitoring guidance.

Continuation of Therapy (12 months)

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

ALL of the following

Member is experiencing benefit from therapy (e.g., reduced frequency or severity of bleeds)
Member is not using Alhemo in combination with bypassing agents, factor VIII products (e.g., Advate, Adynovate, Eloctate) or factor IX products (e.g., Alprolix, Ixinity, Rebinyn) for prophylactic use
Other criteria set forth above remain met (e.g., labs, contraindications, prior gene therapy, Hemlibra avoidance, monitoring)

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Unapproved Uses and Exclusions

The criteria exclude members who have previously received gene therapy for hemophilia (e.g., Beqvez, Hemgenix, Roctavian) and prohibit concurrent use with Hemlibra. Prophylactic use of bypassing agents and prophylactic use of factor VIII or factor IX replacement products must be discontinued prior to initiating Alhemo. The criteria also require absence of current or high risk for thromboembolic events and exclude members undergoing or planning immune tolerance treatment.

Provider Actions / Billing Requirements

Prior Authorization

Prior authorization required with documentation

Submit chart notes and labs (including inhibitor status and baseline hematologic/hepatic/renal assessments) to initiate prior authorization review for initial and continuation requests.

Affected code: J7173

Documentation Required

Prescriber specialty requirement

Medication must be prescribed by or in consultation with a hematologist.

Documentation Required

Baseline laboratory documentation

Provide lab results showing platelets, ALT/AST, total bilirubin, fibrinogen, eGFR and inhibitor testing as applicable.

Billing Rule

Quantity limits

Limit of 4 pens per 28 days for Alhemo formulations; dosing approvals may be subject to FDA labeling and monitoring-based dose adjustments.

Affected code: J7173

Documentation Required

Therapeutic monitoring attestation

Provider must attest that concizumab-mtci plasma concentrations will be monitored per prescribing information and adjust dosing per specified plasma concentration ranges.

Clinical Evidence

Evidence sources cited for reviewers include the Alhemo package insert (Novo Nordisk; December 2024) and the Phase 3 trial of concizumab in hemophilia with inhibitors (Matsushita et al., N Engl J Med. 2023;389(9):783-794).

Monitoring specifics

Plasma concizumab monitoring timingMeasured at 4 weeks after treatment initiation

Maintenance dose calculation timingMaintenance dose calculated no later than 8 weeks after treatment initiation

Dose adjustment guidanceAdjust dosing based on plasma concizumab concentration per labeling (examples: <200 ng/mL → 0.25 mg/kg; 200–4000 ng/mL → 0.2 mg/kg; >4000 ng/mL → 0.15 mg/kg)

Background & Definitions

Alhemo is indicated for routine prophylaxis in adults and pediatric patients aged 12 years and older with hemophilia A or B, with or without inhibitors, consistent with FDA labeling and prescribing information. Prescribers must be a hematologist or consult a hematologist, and required baseline documentation includes inhibitor testing and hematologic/hepatic/renal assessments. Definition: Bypassing agent — therapies such as FEIBA or NovoSeven used to treat bleeding in patients with inhibitors.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAlhemo (concizumab-mtci) coverage for prophylaxis in hemophilia A and B

Policy CodePolicy 05.05.85

Change TypeRevised; HCPCS code added

Effective DateOct 14, 2025

Next Review Date

Key ActionSubmit chart notes and labs (including inhibitor status and baseline hematologic/hepatic/renal assessments) to initiate prior authorization review for initial and continuation requests.

On This Page

OpenPayer

Alhemo (concizumab-mtci) coverage for prophylaxis in hemophilia A and B

Coverage Summary

Initial Therapy (12 months)

Continuation of Therapy (12 months)

Unapproved Uses and Exclusions

Provider Actions / Billing Requirements

Applicable Codes

Clinical Evidence

Background & Definitions

Revision History