CurrentAvMedPolicy N/A

Alhemo (Pharmacy)

This is a pharmacy prior authorization form and coverage criteria for Alhemo (concizumab) for treatment of Hemophilia A or B; it specifies initial and reauthorization clinical criteria, dosing/monitoring guidance, restrictions on concomitant therapies, duration of approval, and specialty pharmacy requirement.

Policy Summary

PayerAvMed

PolicyAlhemo (Pharmacy)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the pharmacy prior authorization form, provide supporting documentation (labs, diagnostics, chart notes) and fax to 1-305-671-0200.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

12+Minimum age (years)

25+Minimum weight (kg)

12 moApproval length

3Plasma concentration bands

Coverage Summary

Alhemo (concizumab) is covered with criteria as a pharmacy prior authorization for prophylaxis of congenital Hemophilia A or B. Approval requires that the medication be prescribed by a specialist experienced in treating hemophilia, documentation supporting each criterion be submitted, and initial/reauthorization approvals are for 12 months. The policy prohibits concurrent prophylactic use of certain hemophilia therapies (including bypassing agent prophylaxis, immune tolerance induction with clotting factor concentrates, Hemlibra/emicizumab, Hympavzi/marstacimab, and Qfitlia/fitusiran) and enforces exclusions on using concizumab to treat breakthrough bleeds (bypassing agents may be used as needed for breakthrough bleeds).

Initial Authorization / Medically Necessary

All criteria must be met for approval. To support each line checked, documentation (labs, diagnostics, chart notes) must be provided.

ALL of the following

Initial Authorization duration is 12 months
Member is ≥ 12 years of age
checkbox on form
Member's weight is ≥ 25 kg
checkbox on form
Medication prescribed by a specialist familiar with treating patients with hemophilia (factor VIII or IX deficiency)
Female patients of reproductive potential are NOT pregnant prior to initiating therapy with concizumab
checkbox on form
Requested medication concizumab will NOT be used in combination with hemophilia bypassing agent prophylaxis (i.e., factor VIIa or anti-inhibitor coagulant complex), immune tolerance induction with clotting factor products (i.e., factor VIII or factor IX concentrates) as prophylactic therapy, Hemlibra (emicizumab-kxwh) in those with hemophilia A as prophylactic therapy, and Hympavzi (marstacimab-hncq) or Qfitlia (fitusiran) in those with hemophilia A or hemophilia B as prophylactic therapy
concizumab monotherapy for prophylaxis required
Concizumab will NOT be used for the treatment of breakthrough bleeds
bypassing agents may be used as needed for breakthrough bleeds
Member does NOT have a history of, or is on current treatment for inherited or acquired coagulation disorder other than congenital hemophilia
ONE of the following diagnosis conditions
- Hemophilia A (congenital factor VIII deficiency) specific requirements
  - Diagnosis of congenital factor VIII deficiency has been confirmed by blood coagulation testing
  - Member has NOT received prior gene therapy for hemophilia A (e.g., Roctavian (valoctocogene roxaparvovec-rvox))
  - ONE of
    Member has a history of life-threatening hemorrhage requiring on-demand use of factor replacement therapy
    Member has a history of repeated, serious spontaneous bleeding episodes requiring on-demand use of Factor VIII therapy
- Hemophilia B (congenital factor IX deficiency) specific requirements

Reauthorization / Continued Medical Necessity

All criteria must be met for approval. Documentation including lab results and quantitative assessment of bleeding events must be submitted.

ALL of the following

Reauthorization duration is 12 months
Member continues to meet the indication-specific relevant criteria identified in the initial criteria section (not including prerequisite therapy)
Member has NOT experienced any unacceptable toxicity from the drug (e.g., thromboembolic events, hypersensitivity)
Member has demonstrated a beneficial response to therapy (i.e., frequency and/or severity and/or number of spontaneous bleeding events has decreased from pre-treatment baseline)
providers must submit well-documented, quantitative assessment of bleeding events since initiating concizumab therapy
Plasma concentration-based dosing adjustments (select one as applicable)
- Less than 200 ng/mL: adjust to a once-daily dose of 0.25 mg/kg
- 200 to 4,000 ng/mL: continue once-daily dose of 0.2 mg/kg
- Greater than 4,000 ng/mL: adjust to once-daily dose of 0.15 mg/kg

Recommended Dosing / Loading and Maintenance

Dosing recommendations provided for initiation and adjustment based on trough plasma concentration

ALL of the following

Subcutaneous: 1 mg/kg once on day 1 (loading dose) then 0.2 mg/kg once daily starting on day 2; continue for 4 to 8 weeks, then maintenance dosage is based on plasma concentrations
loading dose
ALL of the following
- Trough plasma concentration ranges: <200 ng/mL: Increase dose to 0.25 mg/kg once daily
- Trough plasma concentration ranges: 200 to 4,000 ng/mL: Continue 0.2 mg/kg once daily
- Trough plasma concentration ranges: >4,000 ng/mL: Decrease dose to 0.15 mg/kg once daily

Dosing initiation includes a loading dose followed by once-daily maintenance; dosing is guided by trough plasma concentrations with monitoring required for dose adjustments. Maintenance dosing begins after 4 to 8 weeks and subsequent dose changes are made based on measured concizumab trough levels.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prescriber must complete and sign the pharmacy prior authorization form, supply documentation (labs, diagnostics, chart notes) to support each checked criterion, and fax the completed form to 1-305-671-0200. If information provided is incomplete, incorrect, or illegible the authorization process can be delayed or the request may be denied.

Documentation Required

Diagnostic confirmation and monitoring documentation

Provide blood coagulation testing confirming congenital factor VIII or IX deficiency, documentation that the member has not received prior gene therapy for hemophilia A or B when applicable, submit a quantitative assessment of bleeding events since initiating therapy, and include concizumab trough plasma concentration laboratory results for reauthorization and for dose adjustment decisions.

Billing Rule

Specialty pharmacy dispensing

This medication must be provided by the Specialty Pharmacy - Proprium Rx.

Denial Risk

Use of samples does not meet criteria

Use of samples to initiate therapy does not meet the step-edit/preauthorization criteria and may result in denial.

Background

Alhemo (concizumab) is administered subcutaneously for prophylaxis in patients with congenital hemophilia A or B. The recommended regimen is a 1 mg/kg subcutaneous loading dose on day 1 followed by 0.2 mg/kg once daily starting on day 2; after 4 to 8 weeks the maintenance dose is adjusted based on trough plasma concentrations. The policy requires prescribing by a hemophilia specialist and excludes concurrent prophylactic use of certain hemophilia therapies as specified in the authorization criteria.

Breakthrough bleeds are bleeding episodes that occur despite prophylactic therapy; concizumab is not to be used for treatment of breakthrough bleeds, though bypassing agents may be administered as needed for those breakthrough events.

Policy Summary

PayerAvMed

PolicyAlhemo (Pharmacy)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must complete and sign the pharmacy prior authorization form, provide supporting documentation (labs, diagnostics, chart notes) and fax to 1-305-671-0200.

SourceLink

On This Page

OpenPayer

Alhemo (Pharmacy)

Coverage Summary

Initial Authorization / Medically Necessary

Reauthorization / Continued Medical Necessity

Recommended Dosing / Loading and Maintenance

Provider Actions & Prior Authorization

Applicable Codes

Background

Revision History