CurrentCignaPolicy IP0742

Hemophilia - Non-Factor Routine Prophylaxis Products - Qfitlia

Defines Cigna prior authorization and coverage criteria for Qfitlia (fitusiran) subcutaneous injection for routine prophylaxis to prevent/reduce bleeding in patients ≥ 12 years with hemophilia A or B, with or without inhibitors, including Employer Plan preferred product exceptions and dosing/monitoring notes.

Policy Summary

PayerCigna

PolicyHemophilia - Non-Factor Routine Prophylaxis Products - Qfitlia

Policy CodePolicy IP0742

Change TypeNew policy; multiple substantive and editorial revisions

Effective DateJul 15, 2025

Next Review Date

Key ActionPrior authorization is required; submit documentation (baseline factor levels, inhibitor titer testing within 30 days when required, prescriber attestation on discontinuation/non-use of prophylactic factor products or bypassing agents, and evidence of beneficial response) and ensure prescription is by or in consultation with a hemophilia specialist.

POLICY UPDATE CHANGES

New policy created for Non-Factor Routine Prophylaxis Products (Qfitlia).

Hemophilia A initial therapy severity criterion changed from Factor VIII < 1% to ≤ 2%.

Changed prophylactic use timing language to 'discontinued no later than 7 days following the initial Qfitlia dose' and made related wording edits.

Added requirement that patients with inhibitors not be undergoing immune tolerance induction therapy for approval.

Added Employer Plans preferred product table with required prior use of specific products (Hemlibra, Hympavzi, Alhemo) or existing Qfitlia therapy as exceptions.

Added HCPCS code J7174 (Injection, fitusiran, 0.04 mg) effective 10/01/2025.

Wording changes throughout: e.g., 'using' changed to 'receiving' and other editorial clarifications.

4Covered Indications (A/B for Hemophilia A/B with/without inhibitors)

1 yearTypical Approval Duration

>=12Minimum Age (years)

J7174New HCPCS Code Effective

Coverage Summary

Defines Cigna prior authorization and coverage criteria for Qfitlia (fitusiran) subcutaneous injection for routine prophylaxis to prevent or reduce bleeding in patients ≥ 12 years with hemophilia A or B, with or without inhibitors; the policy status is CURRENT and coverage stance is covered_with_criteria. Prior authorization is required, approvals are issued for 1 year, and prescribing must be by or in consultation with a hemophilia specialist.

Initial Therapy — Hemophilia A (no Factor VIII inhibitors)

FDA-Approved Indications - Hemophilia A without Factor VIII Inhibitors

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

ANY of the following

A) Initial Therapy
- i.: Patient is ≥ 12 years of age
- ii.: Patient is using Qfitlia 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%<= 2%
  [documentation required]
- iv. ONE of
  - a) BOTH
    (1): Factor VIII inhibitor titer testing has been performed 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 BU
    [documentation required]
  - 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.: Medication is prescribed by or in consultation with a hemophilia specialist
- vii.: Preferred product criteria is met for the product(s) as listed in the Employer Plans table
B) Patient is Currently Receiving Qfitlia
- i.: Patient is using Qfitlia 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 Qfitlia
  Use of Factor VIII products for treatment of breakthrough bleeding is permitted.
- iii.: 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, number requiring treatment, and/or number of spontaneous bleeds.

ref_index_or_null_if_missing_docId_note_title_placeholder_used_by_tooling_not_for_output_only_for_validation_purposes_DO_NOT_USE_THIS_FIELD_please_ignore_x0000_ref_x0000_b1_0_title_x0000_PLACEHOLDER_STRING_FIX_ME_TOO_x0000_DO_NOT_USE_THIS_FIELD_OR_CHANGE_it_please_keep_exactly_as_provided_in_prompt_ref_b1_0_title_FDA_Approved_Indications_Hemophilia_A_without_Factor_VIII_Inhibitors_and_rendering_instructions_about_nodes_and_intro_and_full_nested_nodes_A_Initial_Therapy_and_B_Currently_Receiving_Qfitlia_preserving_all_operator_logic_notes_and_documentation_annotations

ref”: “b1_0”

title”: “FDA-Approved Indications - Hemophilia A without Factor VIII Inhibitors”

Initial Therapy — Hemophilia A (with Factor VIII inhibitors)

FDA-Approved Indications - Hemophilia A with Factor VIII Inhibitors

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

ANY of the following

A) Initial Therapy
- i.: Patient is ≥ 12 years of age
- ii.: Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- iii. BOTH
  - a):

Initial Therapy — Hemophilia B (no Factor IX inhibitors)

FDA-Approved Indications - Hemophilia B without Factor IX Inhibitors

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

ANY of the following

A) Initial Therapy
- i.: Patient is ≥ 12 years of age
- ii.: Patient is using Qfitlia 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%

Initial Therapy — Hemophilia B (with Factor IX inhibitors)

FDA-Approved Indications - Hemophilia B with Factor IX Inhibitors

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

ANY of the following

A) Initial Therapy
- i.: Patient is ≥ 12 years of age
- ii.: Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- iii. BOTH
  - a):

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Qfitlia. Use HCPCS code J7174 (Injection, fitusiran, 0.04 mg) for billing (code effective 10/01/2025). Approvals are provided for the duration noted in the policy (typically 1 year).

Prior authorization required for Qfitlia (fitusiran).
Bill using HCPCS J7174 (Injection, fitusiran, 0.04 mg) effective 10/01/2025.
Approvals provided for the duration noted (1 year in policy).

Documentation Required

Documentation Required for Lab and Clinical Criteria

Provide documentation as noted in the criteria (chart notes, laboratory tests, claims records) including baseline Factor levels, inhibitor titer testing within the past 30 days when required, and prescriber attestations. Documentation should show baseline (without replacement therapy) Factor VIII or IX levels as required, recent inhibitor titer testing results, and prescriber statements that prophylactic factor products or bypassing agents will be discontinued or are not being used as applicable; for continuing therapy include prescriber attestation of a beneficial response to Qfitlia.

Applicable Codes

Covered HCPCS for QfitliaHCPCSCovered

J7174

Injection, fitusiran, 0.04 mg (Code effective date 10/01/2025)

Clinical Evidence & Definitions

Evidence sources: Prescribing information: Qfitlia prescribing information (Genzyme/Sanofi; March 2025); Policy/coverage document: Cigna Coverage Policy IP0742 (Hemophilia - Non-Factor Routine Prophylaxis Products - Qfitlia); Employer Plans preferred product table (lists Hemlibra, Hympavzi, Alhemo and exceptions for patients already on Qfitlia).

Glossary: Beneficial response to therapy — reduction in bleeding events, reduction in severity of bleeding episodes, reduction in the number of bleeding events that required treatment, and/or reduction in the number of spontaneous bleeds; Bypassing agents — agents used to manage bleeding in patients with inhibitors (examples: NovoSeven RT, Sevenfact, FEIBA).

Background

Qfitlia (fitusiran) is an antithrombin‑directed small interfering RNA indicated for routine prophylaxis to prevent or reduce bleeding frequency in patients ≥ 12 years with hemophilia A or B, with or without Factor VIII or IX inhibitors; it is administered by subcutaneous injection with multiple approved dosing regimens including 50 mg SC Q2M (initial), 50 mg SC QM, 20 mg SC Q2M, 20 mg SC QM, 10 mg SC Q2M, and 10 mg SC QM, and may be self‑administered after training. Antithrombin activity must be monitored using an FDA‑cleared test and maintained between 15% to 35% by adjusting dose and/or frequency of administration.

Revision History

07/15/2025policy_created

New policy created for Non-Factor Routine Prophylaxis Products (Qfitlia).

07/15/2025material_change

Added Employer Plans preferred product table allowing approval if the patient has tried specified products (Hemlibra for Hemophilia A; Hympavzi for Hemophilia B without inhibitors; Alhemo for Hemophilia B with inhibitors) or if already started on Qfitlia.

07/15/2025material_change

Hemophilia A initial therapy severity criterion revised from Factor VIII < 1% to baseline Factor VIII level of ≤ 2% (moderately severe to severe).

Policy Summary

PayerCigna

PolicyHemophilia - Non-Factor Routine Prophylaxis Products - Qfitlia

Policy CodePolicy IP0742

Change TypeNew policy; multiple substantive and editorial revisions

Effective DateJul 15, 2025

Next Review Date

On This Page

Factor VIII inhibitor titer testing has been performed within the past 30 days

[documentation required]

b): Patient has a positive test for Factor VIII inhibitors of ≥ 0.6 Bethesda units/mL>= 0.6 BU

[documentation required]

iv.: According to the prescriber, prophylactic use of bypassing agents will be discontinued no later than 7 days following the initial Qfitlia dose

Use of bypassing agents for the treatment of breakthrough bleeding is permitted.

v.: Patient is not undergoing immune tolerance induction therapy

vi.: Medication is prescribed by or in consultation with a hemophilia specialist

vii.: Preferred product criteria is met for the product(s) as listed in the Employer Plans table

B) Patient is Currently Receiving Qfitlia

i.: Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
ii.: According to the prescriber, prophylactic use of bypassing agents will not occur while receiving Qfitlia
Use of bypassing agents for the treatment of breakthrough bleeding is permitted.
iii.: Patient is not undergoing immune tolerance induction therapy
iv.: Medication is prescribed by or in consultation with a hemophilia specialist
v.: According to the prescriber, patient experienced a beneficial response to therapy
Examples include reduction in bleeding events, severity, number requiring treatment, and/or number of spontaneous bleeds.

ref_index_or_null_if_missing_docId_note_title_placeholder_used_by_tooling_not_for_output_only_for_validation_purposes_DO_NOT_USE_THIS_FIELD_please_ignore_x0000_ref_x0000_b2_0_title_x0000_PLACEHOLDER_STRING_FIX_ME_TOO_x0000_DO_NOT_USE_THIS_FIELD_OR_CHANGE_it_please_keep_exactly_as_provided_in_prompt_ref_b2_0_title_FDA_Approved_Indications_Hemophilia_A_with_Factor_VIII_Inhibitors_and_rendering_instructions_about_nodes_and_intro_and_full_nested_nodes_A_Initial_Therapy_and_B_Currently_Receiving_Qfitlia_with_not_undergoing_immune_tolerance_induction_requirement_and_7_day_discontinuation_language

title”: “FDA-Approved Indications - Hemophilia A with Factor VIII Inhibitors”

[documentation required]

iv. ONE of

a) BOTH
- (1): Factor IX inhibitor titer testing has been performed 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 BU
  [documentation required]
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 no later than 7 days following the initial Qfitlia dose

Use of Factor IX products for treatment of breakthrough bleeding is permitted.

vi.: Medication is prescribed by or in consultation with a hemophilia specialist

vii.: Preferred product criteria is met for the product(s) as listed in the Employer Plans table

B) Patient is Currently Receiving Qfitlia

i.: Patient is using Qfitlia 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 Qfitlia
Use of Factor IX products for treatment of breakthrough bleeding is permitted.
iii.: 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, number requiring treatment, and/or number of spontaneous bleeds.

ref_index_or_null_if_missing_docId_note_title_placeholder_used_by_tooling_not_for_output_only_for_validation_purposes_DO_NOT_USE_THIS_FIELD_please_ignore_x0000_ref_x0000_b3_0_title_x0000_PLACEHOLDER_STRING_FIX_ME_TOO_x0000_DO_NOT_USE_THIS_FIELD_OR_CHANGE_it_please_keep_exactly_as_provided_in_prompt_ref_b3_0_title_FDA_Approved_Indications_Hemophilia_B_without_Factor_IX_Inhibitors_and_rendering_instructions_about_nodes_and_intro_and_full_nested_nodes_A_Initial_Therapy_and_B_Currently_Receiving_Qfitlia_preserving_all_nested_logic_and_notes

title”: “FDA-Approved Indications - Hemophilia B without Factor IX Inhibitors”

Factor IX inhibitor titer testing has been performed within the past 30 days

[documentation required]

b): Patient has a positive test for Factor IX inhibitors of ≥ 0.6 Bethesda units/mL>= 0.6 BU

[documentation required]

iv.: According to the prescriber, prophylactic use of bypassing agents will be discontinued no later than 7 days following the initial Qfitlia dose

Use of bypassing agents for the treatment of breakthrough bleeding is permitted.

v.: Patient is not undergoing immune tolerance induction therapy

vi.: Medication is prescribed by or in consultation with a hemophilia specialist

vii.: Preferred product criteria is met for the product(s) as listed in the Employer Plans table

B) Patient is Currently Receiving Qfitlia

i.: Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes
ii.: According to the prescriber, prophylactic use of bypassing agents will not occur while receiving Qfitlia
Use of bypassing agents for treatment of breakthrough bleeding is permitted.
iii.: Patient is not undergoing immune tolerance induction therapy
iv.: Medication is prescribed by or in consultation with a hemophilia specialist
v.: According to the prescriber, patient experienced a beneficial response to therapy
Examples include reduction in bleeding events, severity, number requiring treatment, and/or number of spontaneous bleeds.

ref_index_or_null_if_missing_docId_note_title_placeholder_used_by_tooling_not_for_output_only_for_validation_purposes_DO_NOT_USE_THIS_FIELD_please_ignore_x0000_ref_x0000_b4_0_title_x0000_PLACEHOLDER_STRING_FIX_ME_TOO_x0000_DO_NOT_USE_THIS_FIELD_OR_CHANGE_it_please_keep_exactly_as_provided_in_prompt_ref_b4_0_title_FDA_Approved_Indications_Hemophilia_B_with_Factor_IX_Inhibitors_and_rendering_instructions_about_nodes_and_intro_and_full_nested_nodes_A_Initial_Therapy_and_B_Currently_Receiving_Qfitlia_with_not_undergoing_immune_tolerance_induction_requirement_and_7_day_discontinuation_language

title”: “FDA-Approved Indications - Hemophilia B with Factor IX Inhibitors”

Baseline Factor VIII or IX levels (without replacement therapy) as specified in criteria.
Factor inhibitor titer testing performed within the past 30 days when required and results (per thresholds in policy).
Prescriber attestation that prophylactic factor products or bypassing agents will be discontinued (or are not being used) as required.
For patients currently receiving Qfitlia, prescriber attestation of beneficial response to therapy.

Documentation Required

Specialist Prescriber Requirement

Qfitlia must be prescribed by or in consultation with a hemophilia specialist as required for approval; this specialty prescriber requirement applies across initial and continuing therapy criteria.

Billing Rule

Dosing and Monitoring Notes

Follow dosing regimens described in the policy (including initial 50 mg SC Q2M and other approved regimens) and monitor antithrombin activity using an FDA-cleared test. Maintain antithrombin activity between 15% and 35% by adjusting dose and/or frequency per the policy. The policy references initial dosing regimens and other dose options to guide billing and monitoring.

Initial dose example: 50 mg SC once every 2 months (Q2M); other regimens listed (50 mg QM; 20 mg Q2M; 20 mg QM; 10 mg Q2M; 10 mg QM).
Monitor antithrombin activity with an FDA-cleared test and maintain activity between 15%–35% by dose/frequency adjustment.

Denial Risk

Not Medically Necessary Uses

Use outside the approved routine prophylaxis indications is considered not medically necessary. Concurrent (concomitant non-factor routine prophylaxis) use of Qfitlia with Alhemo, Hemlibra, or Hympavzi is specifically listed as not medically necessary. Employer Plan language allows exceptions when the patient has tried the listed preferred product or is already on Qfitlia per the Employer Plans table.

Concurrent use of Qfitlia with Alhemo, Hemlibra, or Hympavzi is considered not medically necessary.
Employer Plans may permit approval if prior trial of the specified agent is documented or if the patient is already receiving Qfitlia (per Employer Plans table).

07/15/2025material_change

Changed timing language so prophylactic use of factor/bypassing agents for initial therapy will be discontinued no later than 7 days following the initial Qfitlia dose; similar wording edits for 'receiving' vs 'using' throughout policy.

07/15/2025material_change

Requirement moved from Conditions Not Recommended to approval criteria: patients with inhibitors must not be undergoing immune tolerance induction therapy to qualify for approval.

10/01/2025coding_update

Added HCPCS code J7174 (Injection, fitusiran, 0.04 mg) effective 10/01/2025.

08/15/2025annual_revisionLatest

Annual revision noting title addition 'Non-Factor Routine Prophylaxis Products' and multiple wording/clarifying edits; policy last reviewed 08/15/2025.