Cigna Hympavzi Coverage & Prior Auth Update

Medical Necessity and Coverage Rules

Hemophilia A - Medical Necessity

Hympavzi is considered medically necessary when ONE of the following is met (A or B). For Hemophilia A without Factor VIII inhibitors, approve for 1 year if the patient meets ONE of the following (A or B):

Hemophilia A: initial or current therapy

Initial Therapy criteria (A): i. Patient is ≥ 12 years of age; ii. Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; iii. Patient has moderately severe to severe hemophilia A as evidenced by a baseline (without Factor VIII replacement therapy) Factor VIII level of ≤ 2% [documentation required]; iv. Patient meets ONE of the following: (a) Factor VIII inhibitor titer testing has been performed within the past 30 days [documentation required] AND patient does not have a positive test for Factor VIII inhibitors of ≥ 1.0 Bethesda units/mL [documentation required]; OR (b) patient has not received Factor VIII therapy in the past; v. According to the prescriber, prophylactic use of Factor VIII products will be discontinued (use of Factor VIII products for treatment of breakthrough bleeding is permitted); vi. The medication is prescribed by or in consultation with a hemophilia specialist.Factor VIII ≤ 2%
Documentation required for baseline level and inhibitor testing
Currently Receiving (B): i. Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; ii. According to the prescriber, prophylactic use of Factor VIII products will not occur while receiving Hympavzi (use of Factor VIII products for treatment of breakthrough bleeding is permitted); iii. The medication is prescribed by or in consultation with a hemophilia specialist; iv. According to the prescriber, patient experienced a beneficial response to therapy (examples include reduction in bleeding events, severity, need for treatment, and/or spontaneous bleeds).
Documentation required

Hemophilia B - Medical Necessity

For Hemophilia B without Factor IX inhibitors, approve for 1 year if the patient meets ONE of the following (A or B):

Hemophilia B: initial or current therapy

Initial Therapy criteria (A): i. Patient is ≥ 12 years of age; ii. Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; iii. Patient has moderately severe to severe hemophilia B as evidenced by a baseline (without Factor IX replacement therapy) Factor IX level of ≤ 2% [documentation required]; iv. Patient meets ONE of the following: (a) Factor IX inhibitor titer testing has been performed within the past 30 days [documentation required] AND patient does not have a positive test for Factor IX inhibitors of ≥ 1.0 Bethesda units/mL [documentation required]; OR (b) patient has not received Factor IX therapy in the past; v. According to the prescriber, prophylactic use of Factor IX products will be discontinued (use of Factor IX products for treatment of breakthrough bleeding is permitted); vi. The medication is prescribed by or in consultation with a hemophilia specialist.Factor IX ≤ 2%
Documentation required for baseline level and inhibitor testing
Currently Receiving (B): i. Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; ii. According to the prescriber, prophylactic use of Factor IX products will not occur while receiving Hympavzi (use of Factor IX products for treatment of breakthrough bleeding is permitted); iii. The medication is prescribed by or in consultation with a hemophilia specialist; iv. According to the prescriber, patient experienced a beneficial response to therapy (examples include reduction in bleeding events, severity, need for treatment, and/or spontaneous bleeds).

Hympavzi is considered not medically necessary for any use not explicitly described in the medical necessity criteria for routine prophylaxis in hemophilia A or B. Concurrent administration with other non‑factor routine prophylaxis agents is specifically addressed below and is prohibited. Documentation supporting medical necessity (as required in the criteria) must be provided; lack of appropriate documentation or use outside the stated indications will result in denial as not medically necessary.

Concurrent use of Hympavzi with other non‑factor routine prophylaxis products is not medically necessary and will not be approved. This explicitly includes Alhemo (concizumab), Hemlibra (emicizumab), and Qfitlia (fitusiran), as there is no evidence to support concomitant use of these agents with Hympavzi.

Initial Therapy — Approval Conditions

Initial Therapy

Initial therapy approval criteria (approve for 1 year) for Hemophilia A and B:

Initial Therapy: i. Patient is ≥ 12 years; ii. Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; iii. Baseline factor level ≤ 2% (Factor VIII for Hemophilia A; Factor IX for Hemophilia B) measured without replacement therapy [documentation required]; iv. Either (a) inhibitor testing within the past 30 days with titer < 1.0 Bethesda units/mL [documentation required] OR (b) patient has not received factor therapy in the past; v. According to the prescriber, prophylactic use of factor products will be discontinued while on Hympavzi (use for breakthrough bleeding permitted); vi. Prescribed by or in consultation with a hemophilia specialist.Factor level ≤ 2%

Documentation required for baseline factor level and inhibitor testing

Continuation Therapy — Ongoing Use Requirements

Continuation Therapy

Criteria for patients currently receiving Hympavzi to continue therapy (approve for 1 year):

Currently Receiving Hympavzi: i. Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; ii. According to the prescriber, prophylactic use of Factor VIII/IX products will not occur while receiving Hympavzi (use of factor products for treatment of breakthrough bleeding is permitted); iii. The medication is prescribed by or in consultation with a hemophilia specialist; iv. According to the prescriber, patient experienced a beneficial response to therapy (examples include reduction in bleeding events, severity, need for treatment, and/or spontaneous bleeds).

Documentation required

Billing Codes and Clinical Thresholds

Covered HCPCS CodesHCPCSCovered

J7172

Injection, marstacimab-hncq, 0.5 mg

inv-06: Baseline Factor Level

Baseline factor level threshold≤ 2% (Factor VIII for Hemophilia A; Factor IX for Hemophilia B), measured without replacement therapy

Disease severity indicatedModerately severe to severe hemophilia (evidenced by baseline factor ≤ 2%)

Measurement contextBaseline level must be measured without Factor VIII/IX replacement therapy

Prescriber Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Hympavzi. All approvals are provided for the duration noted in the policy (typically 1 year for approved indications). Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Hympavzi, approval requires the medication to be prescribed by or in consultation with a hemophilia specialist.

Prior authorization required for Hympavzi
Approval duration: typically 1 year for FDA‑approved indications
Prescriber requirement: prescribed by or in consultation with a hemophilia specialist

Documentation Required

Documentation is required where noted in the clinical criteria as [documentation required]. Examples of acceptable documentation include chart notes, laboratory test results (e.g., baseline Factor VIII or IX levels, inhibitor titers), and claims records. Specific documentation items called for in the criteria include recent (within 30 days) inhibitor titer testing and baseline factor level measurements.

Key Terms and Definitions

inv-12: Routine prophylaxis

DefinitionRoutine prophylaxis: use of Hympavzi to prevent or reduce the frequency of bleeding episodes

Indication age groupPatients ≥ 12 years of age

Use contextApplied as ongoing preventive therapy (initial or continuation) rather than for on-demand/breakthrough bleeding

Step Therapy / Treatment Sequence Constraints

Restriction	Agents	Coverage Status	Notes
Concurrent use with other non-factor routine prophylaxis agents	Alhemo (concizumab), Hemlibra (emicizumab), Qfitlia (fitusiran)	Not medically necessary	These are non-factor products used for routine prophylaxis; there is no evidence to support concomitant use with Hympavzi.

Dosing and Quantity Limits

inv-16: Hympavzi (marstacimab-hncq) — dosing schedule

Loading dose300 mg total given as two 150 mg subcutaneous injections (single administration)

Maintenance dose150 mg subcutaneously once weekly starting one week after the loading dose

Administration route and timingSubcutaneous injections; maintenance on same day each week at any time of day

Self-administrationMay be self-administered after proper training

Administration Setting

Note

Self‑administration permitted after training; specialist oversight required

After proper training, Hympavzi may be self‑administered subcutaneously at home; the prescription must be by or in consultation with a hemophilia specialist.

Ensure patient training on subcutaneous self‑administration before authorizing home use.
Prescriber must be a hemophilia specialist or have consulted one.

Background and Indication

Hympavzi (marstacimab‑hncq) is a tissue factor pathway inhibitor antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding in patients aged ≥ 12 years with hemophilia A or B without inhibitors. The policy notes that Hympavzi is not to be used concurrently with other non‑factor routine prophylaxis agents, and Qfitlia was recently added to the list of products that must not be used concomitantly.