Last Review Date: 09/04/2025

Date of Origin: 02/04/2025

Dates Reviewed: 02/2025, 07/2025, 09/2025

1. Length of Authorization

• Initial: Prior authorization validity will be provided initially for 8 weeks.
• Renewal: Prior authorization validity may be renewed every 12 months thereafter.

2. Dosing Limits

     Max Units (per dose and over time) [HCPCS Unit]:

• Load: 230 billable units
• Maintenance: 60 billable units daily

3. Initial Approval Criteria ^1-3,8,10-13

Prior authorization validity is provided in the following conditions:

• Patient is at least 12 years of age; AND
• Will not be used for the treatment of breakthrough bleeds (Note: On-demand factor concentrates or bypassing agents may be administered on an as needed basis for the treatment of breakthrough bleeds in patients being treated with concizumab); AND
• Female patients of reproductive potential are not pregnant prior to initiating therapy with concizumab; AND

Universal Criteria

• Will NOT be used in combination with another agent used as prophylactic therapy for Hemophilia A or B; AND

Hemophilia (with or without factor VIII or IX inhibitors) † Ф

• Patient has a diagnosis of Hemophilia A (congenital factor VIII deficiency) or Hemophilia B (congenital factor IX deficiency aka Christmas Disease) as confirmed by blood coagulation testing (Note: Patients WITHOUT inhibitors must have a FVIII level < 1% or FIX level ≤ 2%); AND
• Must be used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND
• 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; AND
• One of the following apply:
  • • Patient has Hemophilia A without inhibitors; AND

• • • Patient has tried and had an inadequate response to emicizumab AND an antihemophilic Factor VIII agent, that are used for prophylaxis, unless contraindicated or not tolerated; OR

• • • Patient has Hemophilia A with inhibitors; AND

• • • Patient has had previous prophylaxis therapy; OR

• • • Patient has Hemophilia B without inhibitors; AND

• • • Patient has tried and had an inadequate response to an antihemophilic Factor IX agent used for prophylaxis, unless contraindicated or not tolerated; OR

• • • Patient has Hemophilia B with inhibitors; AND

• • • Patient has had previous prophylaxis therapy

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1-3,8

Prior authorization validity can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: thromboembolic events, hypersensitivity reactions, etc.; AND
• Patient has demonstrated a beneficial response to therapy (i.e., the frequency of bleeding episodes has decreased from pre-treatment baseline); AND
• Patient measurement of concizumab plasma concentrations at least 200 ng/mL*

*Note: Requests for patients with measurements of concizumab plasma concentrations that remain below 200 ng/mL at two consecutive measurements, will be reviewed on a case-by-case basis.

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code(s):

• J7173 – Injection, concizumab-mtci, 0.5 mg; 1 billable unit = 0.5 mg (Effective 10/01/2025)
• J3590 – Unclassified biologic (Discontinue use on 10/01/2025)
• C9399 – Unclassified drugs or biologicals (Discontinue use on 10/01/2025)

NDC(s):

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

7. References

1. Alhemo [package insert]. Plainsboro, NJ; Novo Nordisk, Inc. July 2025. Accessed August 2025.
2. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Selected Disorders of the Coagulation System. Revised October 2, 2024. National Hemophilia Foundation. MASAC Document #290. Available at: https://www.bleeding.org. Accessed May 2025.
3. Guidelines for the Management of Hemophilia. 3^rd Edition. World Federation of Hemophilia 2020. Available at: https://www1.wfh.org/publications/files/pdf-1863.pdf. Accessed May 2025.
4. Annual Review of Factor Replacement Products. Oklahoma Health Care Authority Review Board. Updated Dec 2020.
5. Graham A1, Jaworski K. Pharmacokinetic analysis of anti-hemophilic factor in the obese patient. Haemophilia. 2014 Mar;20(2):226-9.
6. Croteau SE1, Neufeld EJ. Transition considerations for extended half-life factor products. Haemophilia. 2015 May;21(3):285-8.
7. Mingot-Castellano, et al. Application of Pharmacokinetics Programs in Optimization of Haemostatic Treatment in Severe Hemophilia a Patients: Changes in Consumption, Clinical Outcomes and Quality of Life. Blood. 2014 December; 124 (21).
8. MASAC Recommendation Concerning Prophylaxis for Hemophilia A and B with and without Inhibitors. Revised April 27, 2022. National Hemophilia Foundation.  MASAC Document #267; Available at: https://www.bleeding.org. Accessed May 2025.
9. UKHCDO protocol for first line immune tolerance induction for children with severe haemophilia A: A protocol from the UKHCDO Inhibitor and Paediatric Working Parties. 2017. Available at: http://www.ukhcdo.org/guidelines.
10. Malec L. (2025). Hemophilia A and B: Routine management including prophylaxis. In Leung LLK, Tirnauer JS (Eds.), UptoDate. Last updated: April 29, 2025. Accessed May 1, 2025. Available from https://www.uptodate.com/contents/hemophilia-a-and-b-routine-management-including-prophylaxis
11. Frei-Jones M,  Cepo K,  d'Oiron R, et al. Subcutaneous Concizumab Prophylaxis in Patients with Hemophilia A or B with Inhibitors: Efficacy and Safety Results By Hemophilia Subtype from the Phase 3 Explorer7 Trial. Blood 2022; 140 (Supplement 1): 466–468. https://doi.org/10.1182/blood-2022-166522.
12. Castaman G, Abraham A, Angchaisuksiri P, et al. The Effect of Concizumab Prophylaxis on Target Joints, Resolution and Joint Bleeds in Patients With Hemophilia A or B With or Without Inhibitors in Phase 3 Clinical Trials. Blood, Volume 142, Supplement 1, 2023, Page 284, ISSN 0006-4971. https://doi.org/10.1182/blood-2023-180790.
13. Chowdary P, Angchaisuksiri P, Apte S, et al. Concizumab prophylaxis in people with haemophilia A or haemophilia B without inhibitors (explorer8): a prospective, multicentre, open-label, randomised, phase 3a trial. Lancet Haematol. 2024;11(12):e891-e904. doi:10.1016/S2352-3026(24)00307-7

Appendix A – Non-Quantitative Treatment Limitations (NQTL) Factor Checklist

Non-quantitative treatment limitations (NQTLs) refer to the methods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan. These may include things like utilization review or prior authorization. The utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder (MH/SUD) Medical Benefit Prescription Drugs and medical/surgical (M/S) Medical Benefit Prescription Drugs. The table below lists the factors that were considered in designing and applying prior authorization to this drug/drug group, and a summary of the conclusions that Prime’s assessment led to for each.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): N/A