ModifiedAmbetter NevadaPolicy CP.PHAR.706

Fitusiran (Qfitlia) Coverage and Prior Authorization

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Coverage of Qfitlia for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric members aged 12 years and older with congenital hemophilia A or B across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerAmbetter Nevada

PolicyFitusiran (Qfitlia) Coverage and Prior Authorization

Policy CodePolicy CP.PHAR.706

Change TypeModified

Effective DateMar 28, 2025

Last ReviewFeb 1, 2026

Next Review DateN/A

Key ActionSubmit documentation supporting all applicable initial- or continued-therapy criteria, including diagnosis, laboratory values, prior treatment or bleeding history, dose, and absence of concurrent prophylaxis.

SourceLink

POLICY UPDATE CHANGES

Maximum fitusiran dosing was revised to align with FDA labeling.

Factor-level limits in the initial approval criteria apply only to members who are new to Qfitlia and have not previously used bypassing agents, factor VIII, or factor IX products for routine prophylaxis.

Commercial initial and continued approval duration was set at 6 months or the member's renewal date, whichever is longer.

Medicaid and HIM continued-therapy approval duration was revised to 12 months.

HCPCS code J7174 was added for fitusiran injection.

HCPCS codes C9399 and J3490 were removed.

The provider confirmation regarding discontinuation of bypassing agents and factor products for prophylaxis was revised to an exclusion for concurrent use of a hemophilia prophylaxis agent, with additional examples.

A step-therapy bypass was added for Illinois HIM under Illinois HB 5395.

Medicaid and HIM initial approval duration was revised from 6 months to 12 months.

≥12 yearsMinimum age

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ModifiedAmbetter NevadaPolicy CP.PHAR.706

Fitusiran (Qfitlia) Coverage and Prior Authorization

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Sign up for Ambetter Nevada Policy CP.PHAR.706 alerts

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Policy Summary

PayerAmbetter Nevada

PolicyFitusiran (Qfitlia) Coverage and Prior Authorization

Policy CodePolicy CP.PHAR.706

Change TypeModified

Effective DateMar 28, 2025

Last ReviewFeb 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Maximum fitusiran dosing was revised to align with FDA labeling.

Commercial initial and continued approval duration was set at 6 months or the member's renewal date, whichever is longer.

Medicaid and HIM continued-therapy approval duration was revised to 12 months.

HCPCS code J7174 was added for fitusiran injection.

HCPCS codes C9399 and J3490 were removed.

A step-therapy bypass was added for Illinois HIM under Illinois HB 5395.

Medicaid and HIM initial approval duration was revised from 6 months to 12 months.

≥12 yearsMinimum age

Coverage Criteria

Initial Therapy

Covered for congenital hemophilia A or B when ALL of the following are met.

Initial approval

Covered indication
- Hemophilia A: Qfitlia is prescribed for routine prophylaxis of bleeding episodes in congenital hemophilia A due to FVIII deficiency.
- Hemophilia B: Qfitlia is prescribed for routine prophylaxis of bleeding episodes in congenital hemophilia B due to FIX deficiency.
Prescriber: Prescribed by or in consultation with a hematologist.
Age: Member is at least 12 years old.≥12 years
Antithrombin activity: Member has antithrombin activity at or above the required level.≥60%
New-to-Qfitlia disease severity or bleeding history
- Hemophilia A severity: Member has severe hemophilia A.FVIII level ≤1%
- Hemophilia B severity: Member has moderately severe to severe hemophilia B.FIX level ≤2%
- Serious spontaneous bleed: Member has experienced at least one serious spontaneous bleed.≥1 serious spontaneous bleed
Prior therapy or bleeding frequency
- Failure of prior prophylaxis: Prescriber documents failure of a bypassing agent, FVIII product, or FIX product used for routine prophylaxis.
  Prior authorization may be required for these products.
- Acute bleeding frequency: Member experienced at least 6 acute bleeding episodes in the previous 6 months treated with a bypassing agent, FVIII, or FIX product.≥6 episodes in 6 months
No concurrent prophylaxis: Qfitlia is not prescribed concurrently with another hemophilia prophylaxis agent.
On-demand FVIII or FIX use may continue.
Dose: The dose does not exceed the policy maximum.≤50 mg/month

Continuation Therapy

Covered for continued therapy for congenital hemophilia A or B when ALL of the following are met.

Continued therapy

Eligibility for continuation: Member is currently receiving Qfitlia through a Centene benefit, previously met initial approval criteria, or is currently receiving the medication and is enrolled in a state and product with continuity-of-care regulations.
Refer to applicable state-specific continuity-of-care addendums.
Positive response: Member is responding positively to therapy, such as a reduction over time in all bleeds, joint bleeds, and/or target-joint bleeds.
No concurrent prophylaxis: Qfitlia is not prescribed concurrently with another hemophilia prophylaxis agent.
On-demand FVIII or FIX use may continue.

Other Diagnoses or Indications

Other diagnoses or indications are handled under the applicable no-coverage, non-formulary, or off-label policy.

Other diagnoses or indications

Recent label change: The drug has undergone a label change within the last 6 months that is not yet reflected in this policy; refer to the applicable no-coverage or non-formulary policy based on formulary status and line of business.Within 6 months
Unlisted use: The requested use is not specifically listed under the policy's non-authorized indications and the recent-label-change pathway does not apply; refer to the applicable off-label-use policy.

Non-FDA-approved indications that are not addressed in this policy are not authorized unless sufficient documentation of efficacy and safety supports coverage under the applicable off-label-use policy or evidence-of-coverage documents.

Qfitlia is not covered when prescribed concurrently with another hemophilia prophylaxis agent, including Alhemo, Hemlibra, Hympavzi, bypassing agents, or FVIII/FIX products used as prophylactic therapy. On-demand FVIII or FIX use may continue.

Coding and Clinical Thresholds

Referenced HCPCS CodeHCPCS

J7174

Injection, fitusiran, 0.04 mg

HCPCS code referencedHCPCS

J7174

Injection, fitusiran, 0.04 mg

HCPCS codes removedHCPCS

C9399
J3490

Antithrombin Activity

MeasureAntithrombin (AT) activity

Required levelAt least 60%

ApplicationRequired for initial approval of congenital hemophilia A or B

Severe Hemophilia A

ConditionSevere hemophilia A

Laboratory measureFVIII level

Required level

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. The provider must submit documentation supporting that the member meets all applicable initial- or continued-therapy criteria for Qfitlia.

Submit office chart notes, laboratory results, and other relevant clinical information with the authorization request.
Document every applicable approval criterion, including diagnosis, treatment history, dosing, and response when requesting continued therapy.

Step Therapy

Prior Routine Prophylaxis Requirement

Qfitlia must be prescribed for routine prophylaxis of bleeding episodes in a member with congenital hemophilia A due to FVIII deficiency or congenital hemophilia B due to FIX deficiency. Initial requests must also establish the applicable prior routine-prophylaxis pathway: failure of a bypassing agent, FVIII, or FIX product, or at least six acute bleeding episodes in the previous six months treated with one of those products.

Background

Fitusiran (Qfitlia) is a small interfering ribonucleic acid therapy that targets antithrombin. It is indicated for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients aged 12 years and older with congenital hemophilia A caused by FVIII deficiency or congenital hemophilia B caused by FIX deficiency, with or without factor VIII or IX inhibitors.

Definitions and Abbreviations

Spontaneous Bleed

TermSpontaneous bleed

CauseOccurs without apparent cause

Trauma-relatedNot the result of trauma

Serious Bleeding Episode

Intracranial and upper airway sitesIntracranial; neck or throat

Internal and musculoskeletal sitesGastrointestinal tract; joints, including hemarthrosis; muscles, especially deep compartments such as the iliopsoas, calf, or forearm

Mucosal sitesMucous membranes of the mouth, nose, and genitourinary tract

Initial Therapy

Initial therapy is covered for congenital hemophilia A or B when ALL of the following criteria are met.

Initial therapy requirements

Covered indication
- Hemophilia A: Qfitlia is prescribed for routine prophylaxis of bleeding episodes in congenital hemophilia A due to FVIII deficiency.
- Hemophilia B: Qfitlia is prescribed for routine prophylaxis of bleeding episodes in congenital hemophilia B due to FIX deficiency.
Prescriber: Prescribed by or in consultation with a hematologist.

Continued Therapy

Continued therapy is covered when ALL of the following criteria are met.

Continuation requirements

Eligibility for continuation: Member is currently receiving Qfitlia through a Centene benefit, previously met initial approval criteria, or is currently receiving the medication and is enrolled in a state and product with continuity-of-care regulations.
Refer to applicable state-specific continuity-of-care addendums.
Positive response: Member is responding positively to therapy, such as a reduction over time in all bleeds, joint bleeds, and/or target-joint bleeds.
No concurrent prophylaxis: Qfitlia is not prescribed concurrently with another hemophilia prophylaxis agent.
On-demand FVIII or FIX use may continue.

Step Therapy

Step	Qualifying pathway	Requirement and documentation
1	Prior prophylaxis failure	Prescriber-documented failure of a bypassing agent, FVIII product, or FIX product used for routine prophylaxis. Acceptable support may include clinically significant bleeding, hemarthroses, life-threatening bleeding, joint swelling, inadequate response for an upcoming surgery or procedure, or another prescriber-determined clinical assessment.
1	Acute bleeding frequency	At least 6 acute bleeding episodes during the previous 6 months, with each episode treated with a bypassing agent, FVIII product, or FIX product.

Quantity Limits

ProductQfitlia (fitusiran)

Maximum quantity50 mg

Quantity periodPer month