CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Hympavzi (marstacimab) — Coverage Criteria for Routine Prophylaxis in Hemophilia A and B

Policy governs authorization, dosing, and renewal criteria for Hympavzi (marstacimab-hncq) for Medicaid, Commercial, and MMP members age 12 and older with hemophilia A or B without inhibitors at Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyHympavzi (marstacimab) — Coverage Criteria for Routine Prophylaxis in Hemophilia A and B

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documenting age ≥12, hematology prescriber or consultation, diagnosis without inhibitors, initiation dosing (300 mg load then 150 mg weekly), and supporting treatment history or bleeding frequency.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization period

300 mgloading dose

150 mg weeklymaintenance dose

max 300 mgmaximum weekly dose

≥12 yrsminimum patient age

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Hympavzi (marstacimab-hncq)

Initial Approval Criteria

Covered when ALL of the following are met:

Age and prescriber: Patient is at least 12 years of age; Hympavzi must be prescribed by, or in consultation with, a hematologist.

Diagnosis of congenital factor VIII (hemophilia A) or factor IX (hemophilia B) deficiency without inhibitors confirmed by blood coagulation testing.

See ICD-10 D66/D67

Indication qualifiers: Patient meets ONE of the following: (1) inadequate response, intolerance, or contraindication to compliant use of a factor VIII product (for A) or factor IX product (for B) — and for hemophilia A this may include Hemlibra; OR (2) at least 6 acute bleeding episodes in the previous 6 months; OR (3) primary prophylaxis for severe deficiency (factor level <1% for A; analogous severe deficiency for B) OR secondary prophylaxis with documented spontaneous joint bleeds.

Dosing initiation and use: Initiate with a loading dose of 300 mg (two 150 mg subcutaneous injections) followed by maintenance 150 mg weekly for routine prophylaxis; not authorized for treatment of breakthrough bleeds (factor VIII or IX products may be used as needed for breakthrough bleeds while on therapy).loading:300 mg; maintenance:150 mg weekly; max weekly:300 mg

If multiple injections are required to deliver a dose, administer each injection at a different site.

Contraindications and safety: Female patients of reproductive potential are not pregnant at initiation; patient has no history of coronary artery disease, venous or arterial thrombosis, or ischemic disease.

Gene therapy exclusion: Patient has not previously received gene therapy for hemophilia.

Renewal Criteria

Renewal coverage when ALL of the following are met:

Continued indication and safety: Patient continues to meet the original indication-specific criteria in Section IV and has no unacceptable toxicity (examples include thromboembolic events or hypersensitivity).

Clinical benefit: Patient has demonstrated benefit (reduction in frequency of bleeding episodes from pre-treatment baseline) OR requires dose escalation per policy criteria.

ref":"b0_1","title":"Renewal Criteria"}]}]}]}]}

Hympavzi (marstacimab) must not be used in combination with clotting factor concentrates (e.g., factor VIII or factor IX products) or with Hemlibra for prophylactic therapy. Per policy, prophylactic combination is prohibited and therapy may be initiated only after discontinuing clotting factor concentrates. Factor VIII or IX products may still be administered on an as‑needed basis for treatment of breakthrough bleeds while the patient is receiving marstacimab.

Initiation of maintenance therapy should begin at the lower maintenance dose: 150 mg every week following the loading regimen. Patients must meet baseline eligibility (including being at least 12 years of age and not pregnant) and have hematology prescriber involvement or consultation prior to initiation.

Use of Hympavzi for treatment of breakthrough bleeds is not an authorized indication; the policy specifically covers Hympavzi for routine prophylaxis to prevent or reduce bleeding frequency. For management of acute bleeds, factor VIII or factor IX products may be used as needed while the patient remains on marstacimab, but prophylactic co‑administration with clotting factor concentrates or Hemlibra is not medically necessary.

Requests should document that prophylactic combination therapy is not being used and that any prior clotting factor concentrate therapy has been discontinued before initiating marstacimab. Patients who have previously received hemophilia gene therapy (e.g., Roctavian) are excluded from coverage.

Coding – HCPCS, NDC, and Diagnosis Codes

HCPCSHCPCS

J3590

Unclassified biologic

NDCNDC

00069-1510-xx	Hympavzi single-dose prefilled syringe NDC
00069-2151-XX	Hympavzi single-dose prefilled pen NDC

Covered Diagnosis Codes (ICD-10)ICD-10Covered

D66	Hereditary factor VIII deficiency
D67	Hereditary factor IX deficiency

inv-08: Weight threshold for dose escalation — >= 50 kg

Weight threshold for dose escalation>= 50 kg

Dose escalation maximum weekly doseUp to 300 mg weekly if weight >= 50 kg and inadequate control on lower dose

Condition for escalationRequires inadequate control of bleeding events judged by provider despite adherence to maintenance dosing

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hympavzi (marstacimab-hncq).

Applies to pharmacy and medical benefit per scope.
Patient must be >= 12 years of age.

Step Therapy

Prerequisite Therapy or Bleeding Frequency

Hympavzi is intended for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in congenital hemophilia A or B without inhibitors. Prior authorization will require documentation that the patient meets prerequisite therapy or bleeding frequency criteria.

Documentation of one of the following is required: inadequate response, intolerance, or contraindication to compliant use of an appropriate factor VIII (for Hemophilia A) or factor IX (for Hemophilia B) product (examples: Advate, Koate, Hemofil, etc.) and/or Hemlibra when clinically appropriate; OR
At least 6 acute bleeding episodes in the previous 6 months.

Background and Indication

Hympavzi (marstacimab) is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients aged 12 years and older with hemophilia A (congenital factor VIII deficiency) or hemophilia B (congenital factor IX deficiency) without factor inhibitors. Approval is based on clinical trial evidence demonstrating a reduction in bleeding rates compared with on‑demand factor replacement and comparable rates to prophylactic factor replacement.

In the policy context, initiation follows a loading regimen then maintenance dosing for prophylaxis; Hympavzi is not authorized for treatment of breakthrough bleeds and is intended for routine, ongoing bleed prevention in eligible patients.

Definitions

inv-14: Hemophilia A / Hemophilia B definitions — Hemophilia A: factor VIII deficiency; Hemophilia B: factor IX deficiency

Hemophilia ACongenital factor VIII (FVIII) deficiency

Indication age groupIndicated for patients age >= 12 years with hemophilia A or B without inhibitors

inv-15: Without inhibitors — inhibitors defined as neutralizing antibodies; policy applies to patients without inhibitors

Definition of inhibitorsNeutralizing antibodies to factor VIII or factor IX

Policy applicabilityPolicy applies only to patients without factor VIII or IX inhibitors

Clinical confirmationDiagnosis without inhibitors should be confirmed by blood coagulation testing