ModifiedCignaPolicy IP0742

Hemophilia - Non-Factor Routine Prophylaxis Products - Qfitlia

Defines Cigna's prior authorization and medical necessity criteria for coverage of Qfitlia (fitusiran) as routine prophylaxis to prevent or reduce bleeding episodes in patients ≥12 years with hemophilia A or B, with or without inhibitors; includes employer-plan preferred product requirements and dosing/monitoring notes.

Policy Summary

PayerCigna

PolicyHemophilia - Non-Factor Routine Prophylaxis Products - Qfitlia

Policy CodePolicy IP0742

Change TypeClinical threshold and operational clarifications

Effective DateJul 15, 2025

Next Review Date

Key ActionObtain prior authorization and document baseline Factor VIII or IX levels and plan to discontinue prophylactic factor or bypassing agents no later than 7 days after the initial Qfitlia dose.

SourceLink

POLICY UPDATE CHANGES

Requirement for hemophilia A initial therapy changed from Factor VIII level <1% to baseline Factor VIII level ≤2%.

Language changed regarding discontinuation timing of prophylactic Factor VIII/IX or bypassing agents to 'will be discontinued no later than 7 days following the initial Qfitlia dose'.

A requirement was added that patients are not undergoing immune tolerance induction therapy.

Non-Factor Routine Prophylaxis Products was added to the policy title.

Non-Factor Routine Prophylaxis Products was added to the title of the Policy.

A requirement was added that patients receiving Qfitlia must not be undergoing immune tolerance induction therapy.

Concurrent use of non-factor routine prophylaxis products are now listed together in one criterion.

HCPCS code J7174 was added to the coding table with an effective date of 10/01/2025.

A preferred product table for Employer Plans was added.

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≥12minimum patient age

1 yearapproval duration

≤2%baseline Factor threshold

7 daysmax time to stop prophylaxis

J7174HCPCS code (fitusiran)

Coverage Criteria for Qfitlia (fitusiran)

Initial Therapy — Hemophilia A without Factor VIII Inhibitors

Covered when ALL of the following are met

Hemophilia A initial therapy criteria: 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]Factor VIII ≤ 2%

Severity threshold revised from <1% to ≤2%

Concurrent Prophylactic Factor/Bypassing Agent Management

Requirement regarding prophylactic use of factor or bypassing agents

Discontinue prophylactic factor/bypassing agents: Prophylactic use of Factor VIII or Factor IX products or bypassing agents will be discontinued no later than 7 days following the initial Qfitlia dose≤ 7 days

Replaces prior wording regarding timing of discontinuation

Initial Therapy & Current Receipt — Patients with Factor VIII or IX Inhibitors

Covered when ALL of the following are met

No immune tolerance induction: Patient is not undergoing immune tolerance induction therapy while receiving Qfitlianone

Requirement added to approval criteria (previously listed under Conditions Not Recommended for Approval)

Concurrent use of Qfitlia with other non-factor routine prophylaxis products is considered not medically necessary. Specifically, concomitant administration with Alhemo (concizumab), Hemlibra (emicizumab), or Hympavzi (marstacimab) is not supported by the evidence and is excluded from coverage.

The policy was revised to move the prior exclusion for patients undergoing immune tolerance induction into the approval criteria for patients with inhibitors. As a result, patients receiving immune tolerance induction therapy must not be undergoing that therapy while receiving Qfitlia, and this requirement is now part of the initial and continuation eligibility criteria rather than listed as a condition not recommended for approval.

Use of Qfitlia for indications other than the FDA-approved routine prophylaxis indications listed in this policy is considered not medically necessary. Requests for Qfitlia for unapproved uses should be denied as not covered.

The policy consolidates restrictions on concurrent use of non-factor routine prophylaxis products into a single criterion. Concurrent administration of Qfitlia with other non-factor routine prophylaxis agents (listed together in the policy) is restricted; the policy explicitly consolidates these agents into one concurrent-use exclusion to simplify and clarify the coverage stance.

Coding and Billing Codes

Covered HCPCS CodesHCPCSCovered

J7174

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

HCPCS Coding TableHCPCSCovered

J7174

HCPCS code added for Qfitlia (effective 10/01/2025)

Baseline Factor VIII or IX level — clinical threshold value

Baseline Factor VIII or IX level≤ 2%

Use for Hemophilia A initial therapy evidenceBaseline (without replacement therapy) Factor VIII level of ≤ 2% [documentation required]

Use for Hemophilia B initial therapy evidenceBaseline (without replacement therapy) Factor IX level of ≤ 2% [documentation required]

Target antithrombin activity — monitoring target

Target antithrombin activityMaintain antithrombin activity between 15% to 35% using an FDA-cleared test

Monitoring methodAdjust dose and/or frequency of Qfitlia to keep antithrombin activity within target range

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Qfitlia. Approvals are provided for 1 year when criteria are met. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Qfitlia, the medication must be prescribed by or in consultation with a hemophilia specialist.

Prior authorization required — approvals for 1 year when criteria met
Prescribed by or in consultation with a hemophilia specialist

Documentation Required

Required Documentation

Documentation is required where noted in the criteria. Acceptable documentation may include, but is not limited to: chart notes, laboratory test results (including baseline Factor VIII/IX levels and inhibitor titers where applicable), and other clinical records that support the indication and that prophylactic Factor replacement will be discontinued when required.

Background

Hemophilia A and B are hereditary bleeding disorders caused by deficiency or dysfunction of coagulation Factor VIII (Hemophilia A) or Factor IX (Hemophilia B). These conditions lead to prolonged or spontaneous bleeding and increase the risk of joint damage (hemophilic arthropathy). Development of inhibitor antibodies to replacement factor products can occur and renders factor replacement ineffective, increasing bleeding risk and complicating management.

Definitions

Hemophilia A — definition

DefinitionHemophilia A is a genetic bleeding disorder caused by dysfunction or deficiency of coagulation Factor VIII.

Clinical consequenceLeads to impaired clot formation with prolonged or spontaneous bleeding; risk of hemophilic arthropathy.

Population impactHemophilia A accounts for approximately 80% of hemophilia cases in the US.

Hemophilia B — definition

DefinitionHemophilia B is a genetic bleeding disorder caused by dysfunction or deficiency of coagulation Factor IX.

Clinical consequenceResults in impaired clot formation with prolonged or spontaneous bleeding and potential hemophilic arthropathy.

Policy Summary

PayerCigna

PolicyHemophilia - Non-Factor Routine Prophylaxis Products - Qfitlia

Policy CodePolicy IP0742

Change TypeClinical threshold and operational clarifications

Effective DateJul 15, 2025

Next Review Date

SourceLink

On This Page

Initial dosing contextMonitor after initiation and with subsequent dosing regimens (Q2M, QM, or alternate doses) to maintain 15%–35%

Baseline Factor VIII level — revised threshold for Hemophilia A

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

Change from prior criterionRequirement changed from Factor VIII level <1% to ≤2% (effective 07/15/2025)

DocumentationBaseline (without replacement therapy) Factor VIII level is documentation required for initial therapy

Discontinue prophylactic factor/bypassing agents — operational limit (timeframe)

Maximum time to discontinue prophylactic factor/bypassing agentsDiscontinue prophylactic Factor VIII, Factor IX, or bypassing agents no later than 7 days following the initial Qfitlia dose

Operational wordingReplaces prior phrasing 'will not occur 7 days after initiation' with 'will be discontinued no later than 7 days following the initial Qfitlia dose'

Exception for breakthrough bleedingUse of factor or bypassing agents for treatment of breakthrough bleeding is permitted

Chart notes supporting diagnosis and treatment plan

Baseline (without Factor replacement) Factor VIII/IX level documentation where required

Factor VIII inhibitor titer testing results when applicable (performed within past 30 days)

Documentation that prophylactic use of Factor products will be discontinued (timing as required by criteria)

Step Therapy

Preferred Product / Step Requirement (Employer Plans)

Employer plans may require trial of a plan-preferred product prior to approval of Qfitlia. For Employer Plans, coverage of Qfitlia is subject to meeting the preferred product / step requirement as shown below.

Employer Plans: Qfitlia (fitusiran) — Patient must meet ONE of the following: A) Hemophilia A without Factor VIII inhibitors: prior trial of Hemlibra (documentation required) OR already started on Qfitlia; B) Hemophilia A with Factor VIII inhibitors: prior trial of Hemlibra (documentation required) OR clinical justification for why Hemlibra is not appropriate (e.g., drug‑drug interaction) OR already started on Qfitlia; C) Hemophilia B without Factor IX inhibitors: prior trial of Hympavzi (documentation required) OR already started on Qfitlia; D) Hemophilia B with Factor IX inhibitors: prior trial of Alhemo (documentation required) OR already started on Qfitlia.

Denial Risk

Coding, Billing, and Denial Triggers

Claims lacking covered diagnosis/procedure codes or not meeting the policy criteria will be denied. Failure to meet baseline severity criteria or to discontinue prophylactic agents as required in the criteria are triggers for denial.

Claims without covered diagnosis/procedure codes will be denied
Denial triggers include: failure to meet baseline severity criteria (e.g., baseline Factor level thresholds) and failure to discontinue prophylactic Factor or bypassing agents per policy timing requirements

PrevalenceHemophilia B comprises about 20% of hemophilia cases in the US.

Baseline (without Factor VIII replacement therapy) Factor VIII level — definition/term usage

Term usage'Baseline Factor VIII level' refers to the Factor VIII level measured without Factor VIII replacement therapy.

PurposeUsed to document disease severity for eligibility (e.g., ≤ 2% for moderately severe to severe disease).

Documentation requirementBaseline (without replacement therapy) Factor VIII level is documentation required for initial therapy criteria.

moderately severe to severe hemophilia B — classification definition

Classification'Moderately severe to severe hemophilia B' is used as the severity classification for eligibility (baseline Factor IX level ≤ 2%).

Eligibility markerDetermined by baseline (without replacement therapy) Factor IX level ≤ 2% for initial therapy consideration.

DocumentationBaseline Factor IX level measurement is documentation required for initial therapy criteria for hemophilia B.