ModifiedmhnPolicy CP.PHAR.625

Clinical Policy: Concizumab-mtci (Alhemo)

Clinical coverage policy governing prior authorization and medical necessity criteria for Alhemo (concizumab-mtci) used for routine prophylaxis to prevent or reduce bleeding episodes in patients ≥12 years with hemophilia A or B, with or without inhibitors. Affects providers seeking coverage through the payer lines of business listed.

Policy Summary

Payermhn

PolicyClinical Policy: Concizumab-mtci (Alhemo)

Policy CodePolicy CP.PHAR.625

Change TypeMaterial updates to coding, product presentations, and approval/monitoring history

Effective DateDec 20, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes, lab results, weight in kg, hematologist consultation, and documentation of prior therapy failures when required.

SourceLink

POLICY UPDATE CHANGES

Single-patient-use prefilled pens available in 60 mg/1.5 mL, 150 mg/1.5 mL, and 300 mg/3 mL presentations.

HCPCS code J7173 (Injection, concizumab-mtci, 0.5 mg) was added and miscellaneous codes (C9399, J3590) were removed.

Initial and continued approval durations adjusted for Medicaid/HIM and Commercial lines; provider attestation and monitoring requirements for Concizumab ELISA were added then later removed in 2Q2026.

≥12minimum age for coverage

≤0.25 mg/kg/daymaximum maintenance dose

>200 ng/mLtarget plasma concentration

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12 moapproval duration (Medicaid/HIM)

3prefilled pen strengths

Coverage Criteria for Alhemo (concizumab-mtci)

Initial Approval — Congenital Hemophilia A or B Without Inhibitors

Covered when ALL of the following are met

Initial criteria group: 1) Diagnosis: congenital hemophilia A (FVIII deficiency) without inhibitors OR congenital hemophilia B (FIX deficiency) without inhibitors; 2) Prescribed by or in consultation with a hematologist; 3) Age ≥ 12 years; 4) For members new to Alhemo who have not previously used FVIII or FIX products for routine prophylaxis, member meets ONE of: (a) hemophilia A with FVIII level < 1%; (b) hemophilia B with FIX level ≤ 2%; or (c) has experienced at least one serious spontaneous bleed; 5) Step therapy: For hemophilia A both (i) failure of a FVIII product used for routine prophylaxis as assessed and documented by prescriber AND (ii) failure of Hemlibra as assessed and documented by prescriber, unless contraindicated or clinically significant adverse effects are experienced; For hemophilia B: failure of a FIX product used for routine prophylaxis as assessed and documented by prescriber, unless contraindicated or clinically significant adverse effects are experienced (note: for Illinois HIM requests the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395); 6) Provider confirms discontinuation of any use of FVIII or FIX products as prophylactic therapy while on Alhemo (on-demand usage may continue); 7) Documentation of member's current body weight (in kg); 8) Dose limits: one loading dose of 1 mg/kg AND maintenance dose not to exceed 0.25 mg/kg per day.

Initial Approval — Congenital Hemophilia A or B With Inhibitors

Covered when ALL of the following are met

Initial with inhibitors: 1) Diagnosis: congenital hemophilia A (FVIII deficiency) with inhibitors OR congenital hemophilia B (FIX deficiency) with inhibitors; 2) Prescribed by or in consultation with a hematologist; 3) Age ≥ 12 years; 4) Inhibitor level ≥ 5 Bethesda units (BU); 5) For hemophilia A: failure of Hemlibra as assessed and documented by prescriber, unless contraindicated or clinically significant adverse effects are experienced (note: for Illinois HIM requests the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395); 6) Provider confirms discontinuation of Hemlibra, bypassing agents, FVIII products, or FIX products as prophylactic therapy while on Alhemo (on-demand usage may continue); 7) Documentation of member's current body weight (in kg); 8) Dose limits: one loading dose of 1 mg/kg AND maintenance dose not to exceed 0.25 mg/kg per day.

Continuation (Renewal) Therapy — With or Without Inhibitors

Covered when ALL of the following are met

Continuation criteria: 1) Member is currently receiving medication via the benefit or previously met initial approval criteria, or is enrolled in continuity of care where applicable; 2) Member is responding positively to therapy (e.g., reduction in number of bleeds); 3) Provider confirms discontinuation of Hemlibra, bypassing agents, FVIII, or FIX products as prophylactic therapy while on Alhemo (on-demand usage may continue); 4) Documentation of member's current body weight (in kg); 5) Member has not had 2 consecutive Alhemo plasma concentrations < 200 ng/mL; 6) New dose adjusted per Alhemo plasma concentration and does not exceed: if < 200 ng/mL then 0.25 mg/kg/day; if 200–4,000 ng/mL then 0.2 mg/kg/day; if > 4,000 ng/mL then 0.15 mg/kg/day.

Non‑FDA approved indications not addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid, or unless coverage is supported by the member’s evidence of coverage documents.

Continued‑therapy criteria historically included an exclusion when a member had 2 consecutive Alhemo plasma concentrations < 200 ng/mL; this requirement was part of prior monitoring and attestation expectations tied to Concizumab ELISA testing. During the 2Q2026 policy review these ELISA documentation and provider attestation requirements were removed from the policy.

Uses for indications not explicitly listed in this policy are considered not medically necessary unless the provider supplies adequate off‑label justification and supporting documentation per the referenced off‑label policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53) or the member’s evidence of coverage.

Coding and Laboratory Thresholds

Covered HCPCS CodesHCPCSCovered

J7173

Injection, concizumab-mtci, 0.5 mg

Removed HCPCS CodesHCPCSNot Covered

C9399	Not specified (removed)
J3590	Not specified (removed)

inv-09: Alhemo plasma concentration — thresholds and ranges

Alhemo plasma concentration ranges≤ 200 ng/mL; 200–4,000 ng/mL; > 4,000 ng/mL

Action when ≤ 200 ng/mLIncrease maintenance dose to 0.25 mg/kg SC once daily

Action when 200–4,000 ng/mLUse maintenance dose 0.2 mg/kg SC once daily

Action when > 4,000 ng/mLUse maintenance dose 0.15 mg/kg SC once daily

inv-10: FVIII level (hemophilia A severe) — threshold detail

Severe hemophilia A thresholdFVIII level of < 1%

Provider Requirements, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. The provider must demonstrate that all initial or continuation criteria are met and submit necessary supporting documentation to obtain approval prior to shipment or administration.

Prior authorization required for initial and continuation requests; prior auth may also be required for FVIII products, FIX products, and Hemlibra where noted.
Use HCPCS J7173 (Injection, concizumab-mtci, 0.5 mg) for billing; coding inclusion does not guarantee coverage.
Initial approval durations and continued approval durations vary by line of business per policy effective dates and revisions.

Documentation Required

Documentation Required — Noncompliance May Result in Denial

Providers must submit documentation (such as office chart notes, laboratory results, specialty consultation notes, and other clinical information) that supports the member meets all applicable approval criteria. Failure to provide requested supporting documentation or to meet clinical criteria may result in denial of the request.

Clinical Background

Concizumab (Alhemo) is a tissue factor pathway inhibitor antagonist approved for routine prophylaxis to reduce bleeding episodes in patients aged ≥12 years with hemophilia A or B, with or without inhibitors. Clinical guidance in this policy emphasizes maintaining Alhemo plasma concentrations above 200 ng/mL to reduce bleeding risk, dosing limits of a single loading dose of 1 mg/kg and maintenance dosing ≤ 0.25 mg/kg/day, and that monitoring and prior ELISA‑based concentration attestations were removed in the 2Q2026 update.

Definitions and Units

inv-23: BU — Bethesda unit definition

Bethesda unit (BU)BU: Bethesda unit, used to quantify inhibitor levels.

Appendix referenceDefined in Appendix A: Abbreviation/Acronym Key

Clinical useUsed to determine eligibility threshold for members with inhibitors (≥ 5 BU)

inv-24: Spontaneous bleed — definition

Spontaneous bleed definitionA bleeding episode that occurs without apparent cause and is not the result of trauma.

Examples of serious bleedsIntracranial; neck/throat; gastrointestinal; joints (hemarthrosis); muscles (deep compartments); mucous membranes of mouth, nose, genitourinary tract

Policy Summary

Payermhn

PolicyClinical Policy: Concizumab-mtci (Alhemo)

Policy CodePolicy CP.PHAR.625

Change TypeMaterial updates to coding, product presentations, and approval/monitoring history

Effective DateDec 20, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes, lab results, weight in kg, hematologist consultation, and documentation of prior therapy failures when required.

SourceLink

On This Page

Applies for members new to Alhemo who have not previously used FVIII products for routine prophylaxis

DocumentationHemophilia severity associated with factor level is taken at baseline prior to use of factor products for routine prophylaxis

inv-11: FIX level (hemophilia B moderately severe to severe) — threshold detail

Moderately severe to severe hemophilia B thresholdFIX level of ≤ 2%

Use contextApplies for members new to Alhemo who have not previously used FIX products for routine prophylaxis

DocumentationHemophilia severity associated with factor level is taken at baseline prior to use of factor products for routine prophylaxis

inv-12: Inhibitor level (with inhibitors) — Bethesda unit threshold

Inhibitor level threshold≥ 5 Bethesda units (BU)

Use contextRequired for initial approval when member has congenital hemophilia A or B with inhibitors

Definition referenceBU defined as Bethesda unit (see Appendix A)

inv-13: Alhemo plasma concentration (historical exclusion note; ELISA monitoring removed 2Q2026)

Historical exclusion for low concentrationsPreviously excluded members with 2 consecutive Alhemo plasma concentrations < 200 ng/mL

Policy changeELISA documentation and provider attestation requirements for Concizumab were removed in 2Q2026

ImplicationPrior continued-therapy criteria referencing ELISA monitoring are no longer required as of 2Q2026

Required supporting documentation includes but is not limited to: hematology consult notes, body weight (kg), prior therapy history and reason for discontinuation/failure, and objective laboratory data where applicable.
If requested documentation is not received or criteria are not met, the prior authorization may be denied.

Note

Lab Monitoring & Attestations (historical then removed)

Historical policy iterations required documentation of Alhemo plasma concentration by Concizumab ELISA within 4–8 weeks of initiation and routine monitoring attestations thereafter; these ELISA documentation and attestation requirements have been removed in the 2Q 2026 update.

Earlier versions: provider attestation that Concizumab ELISA would be completed 4 weeks post-initiation and documentation of Alhemo plasma concentration within 4–8 weeks for continued therapy.
Current policy (2Q 2026): requirements for Concizumab ELISA documentation and provider attestations have been removed.

Step Therapy

Step Therapy Requirements

Step therapy requirements apply for certain indications and lines of business. Providers must document failure of prior products (FVIII, FIX, or Hemlibra as specified) unless contraindicated or clinically significant adverse effects are experienced. Some state-specific exemptions (e.g., Illinois HIM per IL HB 5395) provide step therapy bypasses.

For hemophilia A without inhibitors: documented failure of an FVIII product and failure of Hemlibra are required unless contraindicated; for hemophilia B without inhibitors: documented failure of a FIX product is required.
Prior authorization may be required for FVIII, FIX, and Hemlibra products; prescriber must document rationale for failure or contraindication.
State-specific exceptions (for example IL HIM per IL HB 5395) may exempt members from step therapy requirements — verify applicable state rules.

Step Therapy

Step Therapy / Product Discontinuation Requirements

When step therapy or product discontinuation is required, the provider must confirm member will discontinue specified prophylactic therapies while on Alhemo and document ongoing management. Providers may request step therapy bypass where allowed and must supply documentation supporting continued therapy.

Provider confirmation required that member will discontinue use of FVIII or FIX products (for without inhibitors indication) or discontinue Hemlibra, bypassing agents, FVIII, or FIX products (for with inhibitors indication) as prophylactic therapy while on Alhemo; on-demand use may continue.
Continued therapy approvals require documentation the member is responding to therapy and has not had two consecutive Alhemo plasma concentrations < 200 ng/mL (where applicable per legacy criteria prior to removal of specific ELISA attestations).
Step therapy bypass requests must include supporting clinical rationale and any state-mandated exemptions; continued therapy requests must include provider confirmation and relevant documentation of response.

One serious spontaneous bleed can meet initial-approval criteria for members new to Alhemo who have not used factor products

inv-25: Alhemo PI — reference to prescribing information

Alhemo Prescribing Information (PI)Alhemo Prescribing Information. Novo Nordisk; July 2025. Available at: https://www.novo-pi.com/alhemo.pdf

RoleReferenced for dosing, administration, and product information in the policy's references section

AccessedAccessed January 13, 2026 (per references listing)