ModifiedCignaPolicy IP0731

Hemophilia - Non-Factor Routine Prophylaxis Products - Hympavzi

Defines prior authorization, clinical eligibility, documentation requirements, covered indications, and exclusions for Hympavzi for routine prophylaxis to prevent/reduce bleeding in patients ≥12 years with hemophilia A or B without inhibitors.

Policy Summary

PayerCigna

PolicyHemophilia - Non-Factor Routine Prophylaxis Products - Hympavzi

Policy CodePolicy IP0731

Change TypeMultiple revisions (new policy; template and clinical updates)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document baseline Factor VIII/IX levels and inhibitor testing (within 30 days) and that prophylactic factor products will be discontinued while on Hympavzi.

SourceLink

POLICY UPDATE CHANGES

New policy created.

Preferred Product Criteria - Employer Plans updated; removed prior language about prescriber concern for drug-drug interaction and added documentation requirements throughout the policy.

Title updated to include 'Non-Factor Routine Prophylaxis Products' and hemophilia A severity threshold changed from <1% to ≤2%; wording changed regarding discontinuation of prophylactic factor products.

Hemophilia B wording standardized to 'moderately severe to severe' and prophylactic factor IX wording changed to 'will be discontinued'; Qfitlia added to concurrent-use exclusions; HCPCS coding table added.

Updated policy template and other administrative updates.

2Covered Indications (Hemophilia A and B)

>=12Minimum age (years)

≤2%

Baseline factor threshold for coverage

1Yearly approval duration (typical)

Coverage Summary

Overview: Hympavzi (marstacimab‑hncq) is a tissue factor pathway inhibitor antagonist indicated for routine prophylaxis to prevent or reduce bleeding in patients aged ≥ 12 years with hemophilia A or B without inhibitors. Coverage stance: covered with criteria. Policy number: IP0731.

Recommended dosing: a 300 mg loading dose (two 150 mg subcutaneous injections), then 150 mg once weekly maintenance subcutaneous injections on the same day each week. After proper training, the product may be self‑administered.

Threshold summary

Age>= 12 years

Baseline Factor VIII level<= 2% (without Factor VIII replacement therapy)

Baseline Factor IX level<= 2% (without Factor IX replacement therapy)

Inhibitor titer positivity threshold>= 1.0 Bethesda units/mL

Inhibitor test recencyWithin the past 30 days

Yearly approval duration1 year

Medically Necessary Criteria

Hympavzi is considered medically necessary when ONE of the following is met (1 or 2):

ANY of the following

A or B
- A) Initial Therapy
  - i: Patient is ≥ 12 years of age>= 12 years
  - ii: Patient is using Hympavzi for routine prophylaxis to prevent or reduce the frequency of bleeding episodes

Not Medically Necessary / Exclusions

Conditions Not Covered

Hympavzi for any other use is considered not medically necessary, including the following:

Concurrent use with Alhemo (concizumab-mtci), Hemlibra (emicizumab-kxwh), or Qfitlia (fitusiran) is not covered

No evidence supports concomitant use of Hympavzi with these non-factor prophylaxis products

Not covered: Hympavzi is considered not medically necessary for any uses other than the specified routine prophylaxis indications. Concurrent use of Hympavzi with other non‑factor routine prophylaxis products — specifically Alhemo (concizumab‑mtci), Hemlibra (emicizumab‑kxwh), or Qfitlia (fitusiran) — is not covered because there is no evidence to support concomitant use.

Coding

Covered HCPCSHCPCSCovered

J7172

Injection, marstacimab-hncq, 0.5 mg

Provider Actions / Requirements

Prior Authorization

Prior authorization required

Prior Authorization is required for benefit coverage of Hympavzi; approvals are provided for the duration noted in the criteria. Prescription must be by or in consultation with a hemophilia specialist.

J7172
Approval duration: 1 year

Documentation Required

Documentation of baseline factor levels and inhibitor testing

Document baseline (without replacement therapy) Factor VIII or Factor IX levels and, when applicable, perform inhibitor titer testing within 30 days. Documentation must show the inhibitor titer is below the positivity threshold or that the patient has not received prior factor therapy.

Baseline Factor VIII or Factor IX level (without replacement therapy)

Background & Evidence

Background: Hympavzi is indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients ≥ 12 years with hemophilia A (without Factor VIII inhibitors) or hemophilia B (without Factor IX inhibitors).

Dosing regimen: give a 300 mg loading dose by subcutaneous injection (two 150 mg injections), then start maintenance of 150 mg once weekly by subcutaneous injection one week after the loading dose, on the same day each week at any time of day.

Age and administration: indicated for patients ≥ 12 years; after proper training, Hympavzi may be self‑administered.

Evidence:

Prescribing information, Pfizer; October 2024

Definitions

Beneficial responseReduction in bleeding events, reduction in severity of bleeding episodes, reduction in number of bleeding events that required treatment, and/or reduction in number of spontaneous bleeds.

Inhibitor positivity (Bethesda unit definition)A Bethesda unit titer of >= 1.0 Bethesda units/mL

Revision History

05/15/2025added

New policy created.

07/15/2025revised

Preferred Product Criteria - Employer Plans updated: removed prior language about prescriber concern for drug-drug interaction and added documentation requirements throughout the policy.

08/15/2025revised

Annual Revision: title updated to include 'Non-Factor Routine Prophylaxis Products'; Hemophilia A severity threshold changed from <1% to ≤2%; wording updated regarding discontinuation of prophylactic Factor VIII products.

Policy Summary

PayerCigna

PolicyHemophilia - Non-Factor Routine Prophylaxis Products - Hympavzi

Policy CodePolicy IP0731

Change TypeMultiple revisions (new policy; template and clinical updates)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document baseline Factor VIII/IX levels and inhibitor testing (within 30 days) and that prophylactic factor products will be discontinued while on Hympavzi.

SourceLink

On This Page

Patient has moderately severe to severe hemophilia A as evidenced by a baseline (without Factor VIII replacement therapy) Factor VIII level of ≤ 2%

<= 2% (without Factor VIII replacement therapy)

[documentation required]

iv) ONE of the following (a or b)

a) Prior Factor VIII recipients
- (1): Factor VIII inhibitor titer testing has been performed within the past 30 daysinhibitor test within the past 30 days
  [documentation required]
- (2): Patient does not have a positive test for Factor VIII inhibitors of ≥ 1.0 Bethesda units/mL>= 1.0 Bethesda units/mL is inhibitor positivity
  [documentation required]
b) No prior Factor VIII therapy: 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

[documentation required]

B) Patient is 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 products will not occur while receiving Hympavzi
Use of Factor VIII products for the treatment of breakthrough bleeding is permitted
iii: The medication is prescribed by or in consultation with a hemophilia specialist
[documentation required]
iv: According to the prescriber, patient experienced a beneficial response to therapy
Examples include reduction in bleeding events, severity, number of events that required treatment, and/or number of spontaneous bleeds

ANY of the following

A or B
- A) Initial Therapy
  - i: Patient is ≥ 12 years of age>= 12 years
  - 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 ≤ 2%<= 2% (without Factor IX replacement therapy)
    [documentation required]
  - iv) ONE of the following (a or b)
    a) Prior Factor IX recipients
    (1): Factor IX inhibitor titer testing has been performed within the past 30 daysinhibitor test within the past 30 days
    [documentation required]
    (2): Patient does not have a positive test for Factor IX inhibitors of ≥ 1.0 Bethesda units/mL>= 1.0 Bethesda units/mL is inhibitor positivity
    [documentation required]
    b) No prior Factor IX therapy: 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
    [documentation required]
- B) Patient is 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 IX products will not occur while receiving Hympavzi
    Use of Factor IX products for the treatment of breakthrough bleeding is permitted
  - iii: The medication is prescribed by or in consultation with a hemophilia specialist
    [documentation required]
  - iv: According to the prescriber, patient experienced a beneficial response to therapy
    Examples include reduction in bleeding events, severity, number of events that required treatment, and/or number of spontaneous bleeds

Inhibitor titer testing performed within the past 30 days

Inhibitor threshold for positivity: ≥ 1.0 Bethesda units/mL (must be < 1.0 BU/mL for coverage)

Documentation Required

Prescriber attestation regarding discontinuation of prophylactic factor products

Prescriber must attest that prophylactic use of Factor VIII (for hemophilia A) or Factor IX (for hemophilia B) products will be discontinued while the patient is receiving Hympavzi.

Use of factor products for treatment of breakthrough bleeding is permitted

Documentation Required

Document beneficial response for continuation

For patients currently receiving Hympavzi, the prescriber must document that the patient experienced a beneficial response to therapy to support continued approval.

Examples of beneficial response include reduction in bleeding events, reduction in severity of bleeding episodes, reduction in number of bleeding events that required treatment, and reduction in number of spontaneous bleeds

Denial Risk

Not medically necessary for other uses

Hympavzi is considered not medically necessary for indications other than routine prophylaxis in hemophilia A or B without inhibitors. Claims for concurrent use with specified non-factor prophylaxis products will be denied.

Concurrent use with Alhemo (concizumab), Hemlibra (emicizumab), or Qfitlia (fitusiran) is excluded
Claims for uses outside the specified hemophilia A/B without inhibitors prophylaxis criteria will be denied as not medically necessary

10/01/2025revised

Non-material administrative update: updated policy template and other administrative updates.

10/15/2025revisedLatest

Revisions through 10/15/2025: Hemophilia B wording standardized to 'moderately severe to severe' and prophylactic Factor IX wording changed to 'will be discontinued'; Qfitlia added to concurrent-use exclusions; HCPCS coding table added.