CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Alhemo

Policy governing coverage, dosing, dispensing, authorization length, renewal, and billing for Alhemo (concizumab-mtci) for Medicaid (pharmacy and medical listed) and Commercial/Medicare where specified, for prophylaxis of congenital Hemophilia A or B.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlhemo

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2025

Next Review Date

Key ActionInitial coverage provided for 8 weeks; may be renewed every 12 months thereafter contingent on renewal criteria including plasma concentration and clinical response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes identified in this update.

2Covered Indications (ICD-10 codes)

12Minimum age (years)

25 kgWeight threshold

200 ng/mLRenewal plasma concentration threshold

8Initial authorization (weeks)

Scope: Covered with criteria for Medicaid (pharmacy and medical) and Commercial/Medicare where specified for routine prophylaxis to prevent or reduce bleeding episodes in congenital Hemophilia A or B. Covered populations include Medicaid (pharmacy and medical) and Commercial/Medicare as specified in the policy. Indication: routine prophylaxis for congenital Hemophilia A or B. Dosing modality: subcutaneous, weight-based with a loading and maintenance regimen (see dosing details). Monitoring requirement: measurement of Alhemo (concizumab) plasma concentration for dose individualization and renewal decisions. Definitions: Routine prophylaxis = use to prevent or reduce the frequency of bleeding episodes; Breakthrough bleed = an acute bleeding episode that occurs despite prophylactic therapy (Alhemo is not for treatment of breakthrough bleeds).

Quick thresholds & facts

Minimum age12 years

Weight threshold>= 25 kg

Renewal plasma concentration threshold>= 200 ng/mL

Covered Indications (count)2

Covered ICD-10 codes (count)2

Initial Therapy Criteria

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

Patient is at least 12 years of age
Documentation that the patient weighs more than ≥ 25 kg>= 25 kg
weight threshold required for dosing
Will not be used for the treatment of breakthrough bleeds
Will not be used for breakthrough bleeds; bypassing agents may be administered as needed for breakthrough bleeds in patients treated with Alhemo
Female patients of reproductive potential are not pregnant prior to initiating therapy with Alhemo (concizumab)
Medicare 365-day exception: Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy Requirements
exception to step therapy for prior recent use
Universal Criteria: Will NOT be used in combination with another agent used as prophylactic therapy for Hemophilia A or B
See drug chart for prohibited combinations

Hemophilia diagnosis and prophylaxis requirements

Diagnosis: Patient has a diagnosis of Hemophilia A (congenital factor VIII deficiency) or Hemophilia B (congenital factor IX deficiency) as confirmed by blood coagulation testing
Diagnostic thresholds for non-inhibitor patients: Patients WITHOUT inhibitors must have a FVIII level < 1% or FIX level ≤ 2%FVIII <1% or FIX <=2%
Indication use: Must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
Prophylaxis intent: Used as treatment in one of the following: primary prophylaxis in patients with severe factor deficiency OR secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints

Prior therapy / inadequate response requirements (ONE of applies depending on subtype)

Hemophilia A without inhibitors: Patient has Hemophilia A without inhibitors; Patient has tried and had an inadequate response to Hemlibra (emicizumab) AND an antihemophilic Factor VIII agent product used for prophylaxis, unless contraindicated or not tolerated
Hemophilia A with inhibitors: Patient has Hemophilia A with inhibitors; Patient has tried and had an inadequate response to Hemlibra (emicizumab) and had previous prophylaxis therapy with an antihemophilic Factor VIII agent product with bypassing agent (i.e., Novoseven, FEIBA, etc.)
Hemophilia B without inhibitors: Patient has Hemophilia B without inhibitors; Patient has tried and had an inadequate response to an antihemophilic Factor IX agent prophylaxis, unless contraindicated or not tolerated
Hemophilia B with inhibitors: Patient has Hemophilia B with inhibitors; Patient has had previous prophylaxis therapy with an antihemophilic Factor IX agent with bypassing agents (i.e., Novoseven, FEIBA, etc.)

Dispensing program notes: Prescriptions cannot be auto-filled; rendering providers must submit monthly authorization prior to dispensing; cumulative on-hand amounts should be considered

See hemophilia management program dispensing requirements

Continuation (Renewal) Criteria

Renewal Criteria

Coverage renewal every 12 months is provided when ALL of the following are met:

Patient continues to meet the indication-specific relevant criteria identified in Initial Approval (e.g., concomitant therapy requirements, performance status)

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

Patient has demonstrated a beneficial response to therapy (frequency of bleeding episodes has decreased from pre-treatment baseline)

Plasma concentration for renewal: Patient measurement of Alhemo (concizumab) plasma concentrations is at least 200 ng/mL>= 200 ng/mL

Requests with two consecutive measurements below 200 ng/mL will be reviewed case-by-case

Applicable Codes

Covered HCPCSHCPCSCovered

J7173

Injection, concizumab-mtci, 0.5 mg

Covered ICD-10 Diagnosis CodesICD-10Covered

D66	Hereditary factor VIII deficiency
D67	Hereditary factor IX deficiency

NDCs (product identifiers)NDC

00169-2084-xx	Alhemo 60 mg single-patient use multi-dose prefilled pen (brown)
00169-2080-xx	Alhemo 150 mg single-patient use multi-dose prefilled pen (gold)
00169-2081-xx	Alhemo 300 mg single-patient use multi-dose prefilled pen (white)

Referenced Hemophilia product HCPCS mappingHCPCS

J7189	Novoseven RT (Factor VIIa)
J7212	Sevenfact
J7198	Feiba (Anti-Inhibitor Coagulant Complex)
J7192	Various Factor VIII products (Advate, Kogenate FS, Helixate FS, Recombinate)
J7211	Kovaltry
J7205	Eloctate
J7190	Koate / Koate-DVI; Hemofil M
J7182	Novoeight
J7209	Nuwiq
J7188	Obizur

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Provider Actions & Billing Rules

Prior Authorization

Initial authorization length and renewal

Initial coverage is provided for 8 weeks. Coverage may be renewed every 12 months thereafter if renewal criteria are met, including maintenance of target plasma concentration and demonstration of clinical response.

Documentation Required

Diagnosis and laboratory documentation

Provide blood coagulation testing confirming Hemophilia A or B, including FVIII or FIX levels as applicable. Include documentation of prior therapies and inadequate responses or contraindications to those therapies.

Documentation Required

Pregnancy status

Document that female patients of reproductive potential are not pregnant prior to initiating Alhemo (concizumab).

Billing Rule

Max units per dose and daily

Billing units: Loading dose billed as 230 billable units; maintenance billed as 60 billable units daily.

J7173

Documentation Required

Plasma concentration monitoring

Measure concizumab-mtci plasma concentration by ELISA 4 weeks after initiation and at routine follow-ups. For renewal, maintain a plasma concentration of at least 200 ng/mL; requests with two consecutive measurements below 200 ng/mL will be reviewed case-by-case.

Billing Rule

Dispensing authorization for rendering providers

Rendering providers must submit monthly authorization for the dispensing quantity prior to delivering product; prescriptions cannot be auto-filled and the cumulative on-hand amount should be considered when dispensing.

Background

Background: Alhemo (concizumab-mtci) is a subcutaneous agent indicated for routine prophylaxis in congenital Hemophilia A or B. Dosing is weight-based with a loading dose followed by once-daily maintenance regimens individualized by measured plasma concentration. Providers must measure concizumab-mtci plasma concentration (ELISA) for dose individualization and to guide maintenance dosing; maintenance dosing is adjusted based on plasma concentration bands. Alhemo is not indicated for treatment of breakthrough bleeds. Billing and product identifiers: HCPCS code J7173 (Injection, concizumab-mtci, 0.5 mg) and NDCs for 60 mg, 150 mg, and 300 mg prefilled pens are listed.

Routine prophylaxis: Use to prevent or reduce the frequency of bleeding episodes in patients with Hemophilia A or B. Routine prophylaxis is required as the indication for Alhemo coverage in this policy.

Breakthrough bleed: An acute bleeding episode that occurs despite prophylactic therapy; Alhemo is not for treatment of breakthrough bleeds (bypassing agents may be used as needed for breakthrough bleeds).

OpenPayer

Alhemo

Coverage Summary

Initial Therapy Criteria

Continuation (Renewal) Criteria

Applicable Codes

Provider Actions & Billing Rules

Clinical Evidence & References

Background

Revision History