CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Alhemo (concizumab-mtci) coverage for hemophilia prophylaxis

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Defines pharmacy and medical coverage, dosing, authorization, and clinical criteria for Alhemo (concizumab-mtci) for members with hemophilia A or B (with or without inhibitors) aged 12 years and older under Neighborhood Health Plan of Rhode Island Medicaid/Commercial/Medicare where specified.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlhemo (concizumab-mtci) coverage for hemophilia prophylaxis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2025

Last ReviewSep 17, 2025

Next Review DateSep 17, 2025

Key ActionObtain prior authorization: initial approval provided for 8 weeks and renewable every 12 months under the Hemophilia Management Program.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Alhemo (concizumab-mtci) coverage for hemophilia prophylaxis

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Sign up for all Neighborhood Health Plan of Rhode Island policy alerts

Know when Neighborhood Health Plan of Rhode Island releases new policies or updates existing guidance.

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Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlhemo (concizumab-mtci) coverage for hemophilia prophylaxis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2025

Last ReviewSep 17, 2025

Next Review DateSep 17, 2025

Key ActionObtain prior authorization: initial approval provided for 8 weeks and renewable every 12 months under the Hemophilia Management Program.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

230 unitsloading dose

60 units/daymaintenance

Coverage Criteria for Alhemo (concizumab-mtci)

Initial Therapy

Covered when ALL of the following are met

Age and weight: Member is at least 12 years of age AND documentation that the member weighs more than 25 kg

Indication: Diagnosis of Hemophilia A (congenital factor VIII deficiency) or Hemophilia B (congenital factor IX deficiency) confirmed by blood coagulation testing (for members without inhibitors: FVIII level < 1% or FIX level ≤ 2%) AND used for routine prophylaxis to prevent or reduce frequency of bleeding episodes

Prophylaxis context: Used as primary prophylaxis for severe factor deficiency OR secondary prophylaxis for members with at least TWO documented spontaneous joint bleeds

Prior therapy - Hemophilia A without inhibitors: Member has tried and had an inadequate response to Hemlibra (emicizumab) AND an antihemophilic Factor VIII prophylaxis product unless contraindicated or not tolerated

Prior therapy - Hemophilia A with inhibitors: Member has tried and had an inadequate response to Hemlibra AND had previous prophylaxis with an antihemophilic Factor VIII product plus bypassing agent

Prior therapy - Hemophilia B without inhibitors: Member has tried and had an inadequate response to an antihemophilic Factor IX prophylaxis product unless contraindicated or not tolerated

Prior therapy - Hemophilia B with inhibitors: Member has had previous prophylaxis with an antihemophilic Factor IX product plus bypassing agents

Concomitant therapy: Will NOT be used in combination with another agent used as prophylactic therapy for Hemophilia A or B

Pregnancy: Female members of reproductive potential are not pregnant prior to initiating therapy

Renewal Therapy

Coverage can be renewed when ALL of the following are met

Ongoing indication: Member continues to meet the indication-specific relevant criteria from initial approval (including concomitant therapy requirements and other relevant clinical criteria)

Toxicity: Absence of unacceptable toxicity from the drug (examples include thromboembolic events, hypersensitivity)

Clinical benefit: Member has demonstrated a beneficial response to therapy (frequency of bleeding episodes has decreased from pre-treatment baseline)

Plasma concentration: Measurement of Alhemo (concizumab) plasma concentration is at least 200 ng/mL>= 200 ng/mL

Measurements below 200 ng/mL on two consecutive measurements will be reviewed on a case-by-case basis

General coverage criteria

Covered when use is consistent with FDA-approved labeling and plan clinical criteria as adopted by the P&T Committee; individual consideration will be given based on prescriber documentation.

Plan coverage general criteria: Use must align with FDA-approved labeling and relevant clinical literature; prescriber must provide clinical information to support the requested use; for Medicare members, National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs) take precedence where applicable.

This medication is not for the treatment of breakthrough bleeds. Bypassing agents may be administered on an as‑needed basis for management of breakthrough bleeds in members who are receiving Alhemo (concizumab). Additionally, the drug must not be used in combination with another agent used as prophylactic therapy for Hemophilia A or B.

For Medicare members, the criteria in this policy do not apply where a National Coverage Determination (NCD) or Local Coverage Determination (LCD) exists. Compliance with applicable NCDs/LCDs (and Local Coverage Articles where relevant) is required and will supersede plan criteria when applicable; use the CMS coverage search tools to identify applicable determinations.

Use of Alhemo in combination with another prophylactic hemophilia agent is prohibited. Concurrent prophylactic therapy with other agents for Hemophilia A or B would be considered not medically necessary and is not permitted under these coverage criteria.

Billing, HCPCS, NDC, and Diagnosis Codes

Billing/CPT/HCPCS CodesHCPCSCovered

J7173

Injection, concizumab-mtci, 0.5 mg

NDCNDC

00169-2084-xx	Alhemo 60 mg prefilled pen (brown)
00169-2080-xx	Alhemo 150 mg prefilled pen (gold)
00169-2081-xx	Alhemo 300 mg prefilled pen (white)

Covered Diagnosis CodesICD-10Covered

D66	Hereditary factor VIII deficiency

Covered Diagnosis CodesICD-10Covered

D67	Hereditary factor IX deficiency

Alhemo plasma concentration

Required plasma concentrationMaintain Alhemo (concizumab) plasma concentration >= 200 ng/mL

Consecutive low measurementsMeasurements <200 ng/mL on two consecutive tests will be reviewed on a case-by-case basis

Timing for measurementMeasure plasma concentration ~4 weeks after initiation for dose optimization and again after 8 weeks on the same maintenance dose to confirm steady-state

Dose adjustment guidanceIf <200 ng/mL adjust to 0.25 mg/kg once daily; if 200–4,000 ng/mL continue 0.2 mg/kg; if >4,000 ng/mL adjust to 0.15 mg/kg

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior authorization and dispensing requirements

Initial authorization is provided for 8 weeks and may be renewed every 12 months. Dispensing of Alhemo requires prior authorization through the Hemophilia Management Program and rendering providers must obtain authorization for each monthly dispensing prior to delivery.

Initial coverage period = 8 weeks; renewals available every 12 months.
Monthly dispensing requires prior authorization from the rendering provider as part of the Hemophilia Management Program.

Prior Authorization

Prior authorization follows plan clinical criteria and FDA labeling

Prior authorization decisions are made using the plan's clinical coverage criteria based on FDA-approved labeling and relevant clinical literature. For Medicare members, applicable NCDs/LCDs supersede plan criteria where present.

Decisions reference FDA labeling, clinical literature, and P&T-adopted criteria.
Medicare members: follow NCD/LCD when applicable.

Background on Alhemo

Alhemo (concizumab‑mtci) is a subcutaneous tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce bleeding frequency in patients with hemophilia A or B. The plan’s initial approval criteria require members to be ≥12 years of age and to weigh > 25 kg, and specify that the agent is not to be used for treatment of breakthrough bleeds. Clinical review by the plan (including review of prior prophylaxis history and reproductive status for females of reproductive potential) and enrollment in the Hemophilia Management processes are components of the coverage pathway.

Definitions and Diagnostic Criteria

Hemophilia A / B — Definitions

Hemophilia A definition (ICD-10)Congenital factor VIII deficiency — D66 (Hereditary factor VIII deficiency)

Hemophilia B definition (ICD-10)Congenital factor IX deficiency — D67 (Hereditary factor IX deficiency)

Diagnostic confirmationDiagnosis must be confirmed by blood coagulation testing (for members WITHOUT inhibitors: FVIII <1% or FIX ≤2%)

Policy Revision History

2025-11-01policy_effectiveLatest

Policy effective date for Alhemo (concizumab-mtci) coverage criteria adopted following P&T Committee review.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlhemo (concizumab-mtci) coverage for hemophilia prophylaxis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNov 1, 2025

Last ReviewSep 17, 2025

Next Review DateSep 17, 2025

Key ActionObtain prior authorization: initial approval provided for 8 weeks and renewable every 12 months under the Hemophilia Management Program.

SourceLink

On This Page

Step Therapy

Step therapy requirements and Medicare exemption

Medicare members who have received Alhemo within the prior 365 days are exempt from step therapy. All other members must have documented trials and inadequate response to the specified prior prophylactic agents (e.g., emicizumab, anti-FVIII or anti-FIX products, and bypassing agents where applicable) unless contraindicated or not tolerated.

Medicare exemption: prior Alhemo within 365 days removes step therapy requirement.
Required prior trials vary by diagnosis and inhibitor status (Hemlibra/emicizumab, anti-FVIII products, anti-FIX products, and bypassing agents as specified).

Note

Consideration of cost‑effective alternatives before approval

The policy directs prescribers and reviewers to ensure more cost-effective options are used first when appropriate; the P&T-adopted criteria and plan processes may require consideration of these alternatives before approving Alhemo.

Coverage criteria are intended to minimize risk and ensure cost-effective options are used first when applicable and appropriate.
Individual consideration may be given if documentation justifies use of Alhemo over alternatives.

Documentation Required

Required documentation for authorization and dispensing

Documentation submitted with prior authorization requests must confirm patient age (≥12 years), weight (>25 kg), diagnosis of Hemophilia A or B confirmed by coagulation testing (for those without inhibitors: FVIII <1% or FIX ≤2%), and prior treatment history when step therapy is applicable. Rendering providers must also document dispensing needs under the Hemophilia Management Program.

Age ≥12 years and weight >25 kg must be documented.
Diagnosis confirmation by blood coagulation testing (FVIII <1% or FIX ≤2% for members without inhibitors).
Prior therapy history demonstrating trials/inadequate response to required agents when step therapy applies.
Dispensing authorization and consideration of on‑hand medication quantities per Hemophilia Management Program.

Documentation Required

Documentation expectations and individualized review

Prescriber-submitted clinical information will be individually considered to support the requested use; documentation should demonstrate alignment with FDA-approved labeling or referenced clinical literature and justify medical necessity.

Plan will review clinical information submitted by the prescriber on a case-by-case basis.
Documentation should support requested use and alignment with FDA labeling or clinical literature.

Denial Risk

Denial triggers: age, weight, pregnancy, and concomitant prophylaxis

Requests may be denied if the member is under 12 years of age, weighs ≤25 kg, is pregnant, or if Alhemo is being used in combination with another prophylactic agent for hemophilia.

Age <12 years or weight ≤25 kg are exclusionary triggers.
Female members who are pregnant at initiation are not eligible.
Use in combination with another prophylactic hemophilia agent is not permitted and may result in denial.

Denial Risk

Denial risk when request is inconsistent with FDA labeling or plan criteria

Requests inconsistent with FDA labeling, relevant clinical literature, or the plan-established clinical criteria may be denied. For Medicare members, NCDs/LCDs take precedence and may override plan criteria.

Non-alignment with FDA labeling or referenced clinical literature is grounds for denial.
Medicare determinations must comply with NCD/LCD where applicable; plan criteria apply only in their absence.