CurrentCignaPolicy N/A

Hemophilia - Non-Factor Routine Prophylaxis Products - Hympavzi Prior Authorization Policy

Prior authorization policy for Cigna-administered health benefit plans governing medical (prescription) coverage of Hympavzi for routine prophylaxis to prevent or reduce bleeding episodes in patients ≥12 years with hemophilia A or B without respective factor inhibitors; includes initial and continuation therapy criteria, prescriber requirements, duration of approval, and exclusions for concurrent use with other non-factor prophylactic products.

Policy Summary

PayerCigna

PolicyHemophilia - Non-Factor Routine Prophylaxis Products - Hympavzi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeMaterial and administrative revisions (inhibitor thresholds, severity threshold, exclusions, wording updates)

Effective DateN/A

Next Review DateN/A

Key ActionPrior Authorization is recommended; document baseline Factor VIII/IX level (≤2%) and inhibitor testing within 30 days or document lack of prior factor therapy; ensure prescription is by or in consultation with a hemophilia specialist and discontinue prophylactic factor products while on Hympavzi.

POLICY UPDATE CHANGES

Threshold for positive inhibitor test changed; added allowance that patients who have not received prior factor therapy are not required to meet inhibitor testing requirements.

Severity threshold for Hemophilia A changed from <1% to ≤2% baseline Factor VIII level (wording changed from 'severe' to 'moderate to severe').

Minor wording changes across Hemophilia A and B criteria for clarity, including wording adjustments from 'using' to 'receiving' for continuation criteria.

Conditions Not Covered section updated to add Qfitlia to the list of non-factor prophylaxis products that should not be used concurrently with Hympavzi.

Administrative/content clarification: policy title updated to include 'Non-Factor Routine Prophylaxis Products'.

Coverage Summary

Prior authorization policy for Cigna-administered health benefit plans governing medical (prescription) coverage of Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce bleeding episodes in patients ≥12 years with hemophilia A or B without respective factor inhibitors; includes initial and continuation therapy criteria, prescriber requirements, duration of approval, and exclusions for concurrent use with other non-factor prophylactic products.

Policy Thresholds

Age≥ 12 years

Baseline Factor VIII level (Hemophilia A)≤ 2% (baseline, without Factor VIII replacement therapy)

Baseline Factor IX level (Hemophilia B)≤ 2% (baseline, without Factor IX replacement therapy)

Positive inhibitor test threshold≥ 1.0 Bethesda units/mL (Factor VIII or Factor IX)

Inhibitor testing recencyPerformed within the past 30 days (unless patient has not received prior factor therapy)

Medical-Necessity Criteria

FDA-Approved Indications - Hemophilia A without Factor VIII Inhibitors

Approve for 1 year if the patient meets ONE of the following (A or B):

A or B

A) Initial Therapy
- Patient is ≥ 12 years of age
- Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- Patient has moderately severe to severe hemophilia A as evidenced by a baseline (without Factor VIII replacement therapy) Factor VIII level of ≤ 2%≤ 2%
- iv. ONE of

Not Medically Necessary / Exclusions

Conditions Not Covered (Not Medically Necessary)

Hympavzi is considered not medically necessary for ANY other use(s) including:

Concurrent use with Alhemo (concizumab-mtci), Hemlibra (emicizumab-kxwh), or Qfitlia (fitusiran) - no evidence to support concomitant use with these non-factor routine prophylaxis products

Coding

Drugs mentioned (policy context / exclusions)mixed

marstacimab-hncq	Hympavzi (marstacimab-hncq) subcutaneous injection - Pfizer
concizumab-mtci	Alhemo (concizumab-mtci) subcutaneous injection - Novo Nordisk
emicizumab-kxwh	Hemlibra (emicizumab-kxwh) subcutaneous injection - Genentech/Roche/Chugai
fitusiran	Qfitlia (fitusiran) subcutaneous injection - Genzyme/Sanofi

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Hympavzi; approvals are provided for 1 year for eligible patients.

Documentation Required

Baseline factor level and inhibitor testing documentation

Document baseline (without replacement therapy) Factor VIII or IX level (≤ 2%) and, if applicable, inhibitor titer testing performed within the past 30 days showing < 1.0 Bethesda units/mL; alternatively document lack of prior factor therapy if inhibitor testing not required.

Background, Evidence & Definitions

Hympavzi is a tissue factor pathway inhibitor antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years of age with hemophilia A (congenital Factor VIII deficiency) or hemophilia B (congenital Factor IX deficiency) without respective factor inhibitors. Typical dosing is a 300 mg loading dose given as two 150 mg subcutaneous injections, followed one week later by 150 mg once weekly maintenance subcutaneous injections on the same day each week; after proper training, Hympavzi may be self-administered.

Revision History

2024-11-22revised

Threshold for positive inhibitor test changed to ≥ 1.0 Bethesda units/mL for Hemophilia A (previously >0.6 BU) and Hemophilia B (previously ≥0.3 BU). Detail: It was added that a patient who has not received prior Factor VIII or Factor IX therapy is not required to meet inhibitor testing requirements. Flagged as material change.

2024-12-04revised

Severity threshold for Hemophilia A changed from <1% to ≤2% baseline Factor VIII level and wording changed from 'severe' to 'moderate to severe'. Detail: Similar wording adjustments made for Hemophilia B ('moderately severe or severe' to 'moderately severe to severe'). Prophylactic factor product language changed from 'will not occur while using/receiving Hympavzi' to 'will be discontinued' (and 'using' changed to 'receiving' in continuity criteria). Flagged as material change.

2025-06-11