ModifiedCignaPolicy IP0742

Hemophilia - Non-Factor Routine Prophylaxis Products - Qfitlia

Cigna coverage policy for prior authorization, medical necessity, and utilization requirements for Qfitlia (fitusiran) as routine prophylaxis to prevent or reduce bleeding in patients ≥12 years with hemophilia A or B, with or without inhibitors; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyQfitlia (fitusiran) for routine prophylaxis in hemophilia

Policy CodePolicy IP0742

Change TypeCriteria revision and coding update

Effective Date10/01/2025

Next Review Date08/15/2025

Key ActionSubmit prior authorization with documentation of baseline Factor VIII/IX level (≤2% for eligibility), inhibitor testing, and prescriber attestation that prophylactic factor or bypassing agents will be discontinued within 7 days of the initial Qfitlia dose.

SourceLink

POLICY UPDATE CHANGES

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

Prophylactic use of factor products language changed to require discontinuation no later than 7 days following initial Qfitlia dose (instead of 'will not occur 7 days after initiation').

Requirement added that patients are not undergoing immune tolerance induction therapy for certain indications.

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

HCPCS coding table added with HCPCS code J7174 effective 10/01/2025.

Preferred product table added for Employer Plans.

≥12minimum patient age for coverage

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≤2%baseline factor level threshold

1 yearapproval duration

Deniedconcurrent non-factor agents

Coverage Criteria for Qfitlia (fitusiran)

FDA-Approved Indications and Criteria

Qfitlia is considered medically necessary when ONE of the following is met (1, 2, 3, or 4):

Overall indications: One of: Hemophilia A without inhibitors; Hemophilia A with inhibitors; Hemophilia B without inhibitors; Hemophilia B with inhibitors (see respective subcriteria).

Approvals provided for 1 year; prescriber must be or in consultation with a hemophilia specialist; documentation required as noted.

Hemophilia A without Factor VIII inhibitors - Initial Therapy: i. Patient is ≥ 12 years of age; AND ii. Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND iii. Patient has moderately severe to severe hemophilia A as evidenced by a baseline (without Factor VIII replacement therapy) Factor VIII level of ≤ 2%; AND iv. Either (a) Factor VIII inhibitor titer testing performed within the past 30 days and no positive test for Factor VIII inhibitors ≥ 1.0 BU OR (b) patient has not received Factor VIII therapy in the past; AND v. According to the prescriber, prophylactic use of Factor VIII products will be discontinued; AND vi. Medication prescribed by or in consultation with a hemophilia specialist; AND vii. Preferred product criteria met for Employer Plans.≤ 2%

Documentation required for baseline factor level and inhibitor testing.

Hemophilia A with Factor VIII inhibitors - Initial Therapy: i. Patient is ≥ 12 years of age; AND ii. Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND iii. Factor VIII inhibitor titer testing performed within the past 30 days with a positive test for Factor VIII inhibitors of ≥ 0.6 BU; AND iv. According to the prescriber, prophylactic use of bypassing agents will be discontinued no later than 7 days following the initial Qfitlia dose; AND v. Patient is not undergoing immune tolerance induction therapy; AND vi. Medication prescribed by or in consultation with a hemophilia specialist; AND vii. Preferred product criteria met for Employer Plans.

Bypassing agents may be used for breakthrough bleeding; documentation required.

Hemophilia B without Factor IX inhibitors - Initial Therapy: i. Patient is ≥ 12 years of age; AND ii. Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND iii. Patient has moderately severe to severe hemophilia B as evidenced by a baseline (without Factor IX replacement therapy) Factor IX level of ≤ 2%; AND iv. Either (a) Factor IX inhibitor titer testing performed within the past 30 days and no positive test for Factor IX inhibitors ≥ 1.0 BU OR (b) patient has not received Factor IX therapy in the past; AND v. According to the prescriber, prophylactic use of Factor IX products will be discontinued no later than 7 days following the initial Qfitlia dose; AND vi. Medication prescribed by or in consultation with a hemophilia specialist; AND vii. Preferred product criteria met for Employer Plans.≤ 2%

Breakthrough use of Factor IX products permitted; documentation required.

Hemophilia B with Factor IX inhibitors - Initial Therapy: i. Patient is ≥ 12 years of age; AND ii. Patient is using Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND iii. Factor IX inhibitor titer testing performed within the past 30 days with a positive test for Factor IX inhibitors of ≥ 0.6 BU; AND iv. According to the prescriber, prophylactic use of bypassing agents will be discontinued no later than 7 days following the initial Qfitlia dose; AND v. Patient is not undergoing immune tolerance induction therapy; AND vi. Medication prescribed by or in consultation with a hemophilia specialist; AND vii. Preferred product criteria met for Employer Plans.

Bypassing agents may be used for breakthrough bleeding; documentation required.

Currently Receiving Qfitlia - Hemophilia A or B (with or without inhibitors): i. Patient is receiving Qfitlia for routine prophylaxis to prevent or reduce the frequency of bleeding episodes; AND ii. According to the prescriber, prophylactic use of factor products or bypassing agents will not occur while receiving Qfitlia (use for breakthrough bleeding permitted as noted); AND iii. Medication prescribed by or in consultation with a hemophilia specialist; AND iv. According to the prescriber, patient experienced a beneficial response to therapy (examples include reduction in bleeding events, severity, or spontaneous bleeds).

Documentation required for response to therapy and prior factor/inhibitor testing as applicable.

Revised Approval Criteria Highlights

Revisions to approval criteria include updated severity thresholds, prophylactic product discontinuation timing, and exclusion for immune tolerance induction therapy.

Hemophilia A (without inhibitors) - eligibility change: Patient must have moderately severe to severe hemophilia A as evidenced by baseline (without Factor VIII replacement therapy) Factor VIII level of ≤ 2%.≤2%

Chunk 18

Prophylactic Factor or Bypassing Agents: Prophylactic use of Factor VIII/IX products or bypassing agents must be discontinued no later than 7 days following the initial Qfitlia dose.7 days

Chunks 18,19

Immune Tolerance Induction (ITI): Patients receiving Qfitlia who have inhibitors must not be undergoing immune tolerance induction therapy while receiving Qfitlia.

Qfitlia for any use not explicitly meeting the policy's approval criteria is considered not medically necessary. This includes concurrent use with non-factor routine prophylaxis agents Alhemo, Hemlibra, or Hympavzi, for which the policy states there is no evidence to support concomitant use and such combinations will be denied.

The condition "Patient Receiving Immune Tolerance Induction Therapy" was removed from the list of Conditions Not Recommended for Approval because it has been incorporated into the approval criteria for patients with inhibitors; the policy now requires that patients receiving Qfitlia who have inhibitors must not be undergoing immune tolerance induction therapy while receiving Qfitlia.

The policy explicitly states that concurrent use of Qfitlia with other non-factor routine prophylaxis products (Alhemo, Hemlibra, Hympavzi) is not medically necessary and is managed as a consolidated criterion addressing all listed non-factor prophylaxis agents together.

A previously listed condition ("Patient Receiving Immune Tolerance Induction Therapy") has been moved out of the Conditions Not Recommended section and repurposed into the approval criteria for inhibitor indications; operationally this means the policy now addresses ITI status as an explicit requirement within the applicable coverage criteria rather than as a standalone exclusion.

Coding and Baseline Thresholds

Considered Medically Necessary when criteria metHCPCSCovered

J7174

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

HCPCS CodingHCPCS

J7174

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

inv-09: Baseline Factor level

Baseline Factor level (general)≤ 2% for Factor VIII or Factor IX depending on hemophilia type

Evidence requiredBaseline factor level must be measured without replacement therapy (documentation required)

Applies to eligibilityUsed to define moderately severe to severe hemophilia for initial therapy approval and ongoing treatment criteria

inv-10: Factor VIII baseline level

Factor VIII baseline threshold≤ 2%

Measurement conditionBaseline Factor VIII level must be measured without Factor VIII replacement therapy

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required for Qfitlia. Approvals are provided for 1 year. Qfitlia must be prescribed by or in consultation with a hemophilia specialist due to required evaluation and monitoring.

All approvals provided for 1 year.
Prescriber specialty: hemophilia specialist required (or consultation).

Billing Rule

Prior Authorization and Coding

Prior authorization and coding — Prior authorization is required for Qfitlia. For billing, HCPCS code J7174 was added effective 2025-10-01; include appropriate documentation with the prior authorization request and claims.

Definitions and Key Terms

inv-22: Qfitlia (fitusiran)

Drug class and mechanismFitusiran is an antithrombin-directed small interfering RNA (siRNA) administered subcutaneously

Indication summaryIndicated for routine prophylaxis to prevent or reduce bleeding in patients ≥ 12 years with hemophilia A or B, with or without Factor VIII/IX inhibitors

Monitoring noteMonitor antithrombin activity using an FDA-cleared test and maintain activity between 15% and 35% by dose/frequency adjustment

inv-23: Hemophilia severity

Severity definition (eligibility)Moderately severe to severe hemophilia is defined by baseline Factor level ≤ 2% for initial therapy eligibility

Documentation requirementBaseline factor level must be documented without replacement therapy to demonstrate severity

Background

Hemophilia A and B are X-linked bleeding disorders caused by deficiency or dysfunction of coagulation factors that result in prolonged bleeding and spontaneous bleeds. Severe disease and the development of factor inhibitors increase bleeding risk and can limit the effectiveness of factor replacement. Qfitlia (fitusiran) is an antithrombin-directed small interfering RNA administered by subcutaneous injection for routine prophylaxis to reduce bleeding in patients aged ≥ 12 years with hemophilia A or B, with or without inhibitors; monitoring of antithrombin activity is part of clinical management to maintain therapeutic levels.

Revision History and Policy Changes

07/15/2025New policy / Annual revision

Policy created/updated: title expanded to include 'Non-Factor Routine Prophylaxis Products' and Hemophilia A severity threshold changed from Factor VIII <1% to ≤2%; prophylactic product discontinuation wording updated to discontinue no later than 7 days after initial Qfitlia dose; immune tolerance induction therapy requirement added for patients with inhibitors.

08/15/2025Annual revision

Annual revision entry notes additional wording refinements and confirms changes to prophylactic product discontinuation timing and Hemophilia B phrasing; documents ongoing revision activity.

10/01/2025Coding update (HCPCS addition)

Policy Summary

PayerCigna

PolicyQfitlia (fitusiran) for routine prophylaxis in hemophilia

Policy CodePolicy IP0742

Change TypeCriteria revision and coding update

Effective Date10/01/2025

Next Review Date08/15/2025

SourceLink

On This Page

Concurrent Non-Factor Routine Prophylaxis: All non-factor routine prophylaxis agents are listed together in one criterion governing concurrent use (concurrent use of Qfitlia with Alhemo, Hemlibra, or Hympavzi is considered not medically necessary).

Chunk 20

PurposeDefines moderately severe to severe hemophilia A for eligibility for initial Qfitlia therapy

inv-11: Prophylactic product discontinuation window

Discontinuation deadlineProphylactic Factor VIII/IX products or bypassing agents must be discontinued no later than 7 days following the initial Qfitlia dose

Treatment allowanceUse of factor products for treatment of breakthrough bleeding is permitted (not for routine prophylaxis)

DocumentationPrescriber must indicate prophylactic products will be discontinued and documentation is required

HCPCS J7174 effective 2025-10-01.
Include prior authorization approval when submitting claims.

Denial Risk

Concurrent Non‑Factor Prophylaxis

Concurrent non-factor prophylaxis — Concurrent routine prophylactic use of non-factor agents with Qfitlia is not medically necessary. Concomitant use with Alhemo, Hemlibra, or Hympavzi (and other non-factor routine prophylaxis products) will be denied.

Concurrent use with Alhemo, Hemlibra, or Hympavzi is not medically necessary.
All non-factor routine prophylaxis agents are consolidated into a single denial criterion.

Denial Risk

Prophylactic Product Discontinuation Timing

Prophylactic product discontinuation timing — For initial therapy, prescriber must confirm prophylactic Factor VIII/IX products or bypassing agents will be discontinued no later than 7 days following the initial Qfitlia dose. Failure to discontinue prophylactic Factor products or bypassing agents within this timeframe may result in denial or requirement to discontinue.

Factor VIII/IX products: discontinue no later than 7 days after initial Qfitlia dose.
Bypassing agents: discontinue no later than 7 days after initial Qfitlia dose.
Use of factor products or bypassing agents for treatment of breakthrough bleeding is permitted.

Documentation Required

Baseline Factor Level and ITI Status (Documentation)

Baseline factor level and ITI status — Documentation must include baseline Factor VIII or IX level measured without replacement therapy (e.g., ≤ 2% for moderately severe to severe disease) and recent inhibitor titer testing per criteria. For patients with inhibitors, document inhibitor titers (testing within past 30 days) and that the patient is not undergoing immune tolerance induction (ITI) therapy when applicable.

Baseline Factor VIII or IX level (without replacement therapy) — e.g., ≤ 2% where specified.
Factor inhibitor titer testing performed within past 30 days and documented results.
Patients with inhibitors: document not undergoing immune tolerance induction therapy when required.

Step Therapy

Preferred Product Trial (Employer Plans)

Preferred product trial (Employer Plans) — Employer plan-specific step requirements apply: prior trial of the listed preferred non-factor or alternative products is required before Qfitlia in certain indications per the Employer Plans table. Exceptions include patients already receiving Qfitlia or prescriber-documented contraindication or drug‑drug interaction (where specified).

Hemophilia A without inhibitors: trial of Hemlibra required (or already started on Qfitlia).
Hemophilia A with inhibitors: trial of Hemlibra required unless documented drug‑drug interaction (e.g., with FEIBA); or already started on Qfitlia.
Hemophilia B without inhibitors: trial of Hympavzi required (or already started on Qfitlia).
Hemophilia B with inhibitors: trial of Alhemo required (or already started on Qfitlia).

Age requirementApplies to patients ≥ 12 years as part of initial therapy criteria

inv-24: Baseline Factor VIII level of ≤2%

Definition for hemophilia ABaseline (without Factor VIII replacement therapy) Factor VIII level of ≤ 2% defines moderately severe to severe hemophilia A

Measurement timingLevel must be measured off replacement therapy and documented per criteria

Purpose in policyThis threshold was revised from <1% to ≤2% to expand eligibility for initial therapy

inv-25: Hemophilia B phrasing standardized

Standardized phrasingPolicy uses the phrase 'moderately severe to severe hemophilia B' for eligibility statements

Factor IX thresholdBaseline (without Factor IX replacement therapy) Factor IX level ≤ 2% is used to define severity for hemophilia B

Related revisionProphylactic Factor IX product discontinuation timing was clarified to 'discontinued no later than 7 days following the initial Qfitlia dose'

HCPCS code J7174 added to the coding table (code effective date 10/01/2025).