Last Review Date: 02/04/2025

Date of Origin: 02/04/2025

Dates Reviewed: 02/2025

1. Length of Authorization

Coverage will be provided for 8 weeks initially and may be renewed every 12 months thereafter.

2. Dosing Limits

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

• Load: 115 mg
• Maintenance: 30 mg daily

3. Initial Approval Criteria ^1-3,8,10-11

Coverage 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: 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 any of the following (Note: bypassing agents can be administered for the treatment of breakthrough bleeds while receiving concizumab):
  • hemophilia bypassing agent prophylaxis (i.e., factor VIIa or anti-inhibitor coagulant complex); AND
  • Immune tolerance induction with clotting factor products (i.e., factor VIII or factor IX concentrates) as prophylactic therapy; AND
  • Emicizumab for hemophilia A with inhibitors; AND

Hemophilia A (congenital factor VIII deficiency) with inhibitors † Ф

• Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing; AND
• Patient has inhibitors to Factor VIII with a current or historical titer of ≥ 5 Bethesda Units (BU)**; 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 VIII deficiency (factor VIII level of <1%); OR
    • Secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints;

Hemophilia B (congenital factor IX deficiency aka Christmas Disease) with inhibitors † Ф

• Diagnosis of congenital factor IX deficiency has been confirmed by blood coagulation testing; AND
• Patient has inhibitors to Factor IX with a current or historical titer of ≥ 5 Bethesda Units (BU)**; 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 IX deficiency (factor IX level of <1%); OR
    • Secondary prophylaxis in patients with at least TWO documented episodes of spontaneous bleeding into joints;

**Note: Patients with inhibitor titer levels >0.6 BU to <5 BU who are not responding to or are not a candidate for standard factor replacement, will be evaluated on a case-by-case basis.

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

4. Renewal Criteria ^1-3,8

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the 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, 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:

• J3590 – Unclassified biologic

NDC:

• 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. December 2024. Accessed January 2025.
2. MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Selected Disorders of the Coagulation System. Revised April 11, 2024. National Hemophilia Foundation. MASAC Document #284; April 2024. Available at: https://www.bleeding.org. Accessed May 2024.
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 2024.
4. Annual Review of Factor Replacement Products. Oklahoma Health Care Authority Review Board. Updated Dec 2020. Accessed May 2024.
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; April 2022. Available at: https://www.bleeding.org. Accessed May 2024.
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. Accessed May 2024.
10. Hoots, WK. (2024). Hemophilia A and B: Routine management including prophylaxis. In Leung LLK, Tirnauer JS (Eds.), UptoDate. Last updated: April 16, 2024. Accessed May 13, 2024. Available from https://www.uptodate.com/contents/hemophilia-a-and-b-routine-management-including-prophylaxis?search=hemophilia%20a&source=search_result&selectedTitle=2~150&usage_type=default&display_rank=2#H978189854.
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. doi: https://doi.org/10.1182/blood-2022-166522.

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.