CurrentUnitedHealthcarePolicy 2025 P 2372-2

Qfitlia (fitusiran) prior authorization / medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce bleeding in patients with hemophilia A or B aged 12 years and older.

Policy Summary

PayerUnitedHealthcare

PolicyQfitlia (fitusiran) prior authorization / medical necessity

Policy CodePolicy 2025 P 2372-2

Change TypeNew program with material clarifications and preferred-therapy addition

Effective Date10/1/2025

Next Review Date

Key ActionSubmit prior authorization showing diagnosis, inhibitor status (>= or <5 BU), age >=12, prophylaxis intent, and documented rationale if not appropriate candidate for Hympavzi.

SourceLink

POLICY UPDATE CHANGES

New prior authorization/medical necessity program for Qfitlia (fitusiran) was created.

Removed criteria of failure to meet clinical goals after a trial of prophylactic factor replacement products.

Added preferred therapy criteria for hemophilia A or B without inhibitors (preference for Hympavzi consideration).

Clarified definition of high-titer inhibitor as >= 5 Bethesda units (BU).

12 monthsauthorization duration

>=12minimum age

>=5 BUhigh-titer threshold

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Qfitlia (fitusiran)

Initial - Hemophilia A with inhibitors

Covered when ALL of the following are met

Hemophilia A with high-titer inhibitors - Initial: (1) Diagnosis of hemophilia A; (2) Patient has developed high-titer factor VIII inhibitors (>= 5 Bethesda units [BU]); (3) Patient is 12 years of age or older; (4) Prescribed for routine prophylaxis (prevention of bleeding episodes)

Authorization issued for 12 months

Reauthorization - Hemophilia A with inhibitors

Covered when the following is met

Hemophilia A with inhibitors - Reauthorization: Documentation of positive clinical response to Qfitlia therapy

Authorization issued for 12 months

Initial - Hemophilia A without inhibitors (preferred therapy condition)

Covered when ALL of the following are met

Hemophilia A without inhibitors - Initial: (1) Diagnosis of hemophilia A; (2) Patient has NOT developed high-titer factor VIII inhibitors (< 5 Bethesda units [BU]); (3) Patient is 12 years of age or older; (4) Qfitlia is prescribed for routine prophylaxis (prevention of bleeding episodes); (5) One of the following: (a) Provider documents patient is not an appropriate candidate for Hympavzi (reason documented), OR (b) Patient is currently on Qfitlia therapy AND has not received a manufacturer-supplied sample at no cost in prescriber office or assistance from HemAssist/Sanofi to establish current use (patients established via manufacturer samples must meet initial criteria)

Patients started on manufacturer samples are treated as new to therapy; Authorization issued for 12 months

Reauthorization - Hemophilia A without inhibitors

Covered when the following is met

Hemophilia A without inhibitors - Reauthorization: Documentation of positive clinical response to Qfitlia therapy

Authorization issued for 12 months

Initial - Hemophilia B with inhibitors

Covered when ALL of the following are met

Hemophilia B with inhibitors - Initial: (1) Diagnosis of hemophilia B; (2) Patient has developed high-titer factor IX inhibitors (>= 5 Bethesda units [BU]); (3) Patient is 12 years of age or older; (4) Prescribed for routine prophylaxis (prevention of bleeding episodes)

Authorization issued for 12 months

Reauthorization - Hemophilia B with inhibitors

Covered when the following is met

Hemophilia B with inhibitors - Reauthorization: Documentation of positive clinical response to Qfitlia therapy

Authorization issued for 12 months

Initial - Hemophilia B without inhibitors (preferred therapy condition)

Covered when ALL of the following are met

Hemophilia B without inhibitors - Initial: (1) Diagnosis of hemophilia B; (2) Patient has NOT developed high-titer factor IX inhibitors (< 5 Bethesda units [BU]); (3) Patient is 12 years of age or older; (4) Qfitlia is prescribed for routine prophylaxis (prevention of bleeding episodes); (5) One of the following: (a) Provider documents patient is not an appropriate candidate for Hympavzi (reason documented), OR (b) Patient is currently on Qfitlia therapy AND has not received a manufacturer-supplied sample at no cost in prescriber office or assistance from HemAssist/Sanofi to establish current use (patients established via manufacturer samples must meet initial criteria)

Patients started on manufacturer samples are treated as new to therapy; Authorization issued for 12 months

Reauthorization - Hemophilia B without inhibitors

Covered when the following is met

Hemophilia B without inhibitors - Reauthorization: Documentation of positive clinical response to Qfitlia therapy

Authorization issued for 12 months

Coverage may be affected by state mandates, applicable federal regulatory requirements, and the member's specific benefit plan. Other UnitedHealthcare policies and utilization management programs may also apply and could impact coverage determinations for Qfitlia.

Initial Therapy Authorization Criteria

Initial therapy

Initial authorization criteria by diagnosis and inhibitor status

Initial therapy rules: See coverage criteria sets: diagnosis (hemophilia A or B), inhibitor status (>=5 BU vs <5 BU), age >= 12 years, prescribed for routine prophylaxis; for patients without high-titer inhibitors, provider must either document the patient is not an appropriate candidate for Hympavzi (reason documented) or meet existing-user conditions (currently on Qfitlia and not established via manufacturer sample/assistance).

Authorization issued for 12 months

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization rules

Continuation/Reauthorization: Documentation of positive clinical response to Qfitlia therapy is required for reauthorization.

Authorization issued for 12 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Qfitlia. Initial approvals are granted only when all listed clinical criteria are met (diagnosis of hemophilia A or B, inhibitor status, age ≥ 12 years, and use for routine prophylaxis). Authorization will be issued for 12 months when criteria are met.

Applies to Qfitlia for hemophilia A and B
Initial authorization period: 12 months

Step Therapy

Preferred Therapy Requirement (Hympavzi)

For patients with hemophilia A or B without high‑titer inhibitors, a preferred therapy requirement applies: the prescriber must either document that the patient is not an appropriate candidate for Hympavzi (include clinical rationale) or meet the established-user exception described below. Requests that do not include the required documentation may be denied.

Hemophilia A/B patients without inhibitors: document why Hympavzi is not appropriate, or meet exception for current Qfitlia users

Step Therapy / Access Restrictions

Step	Requirement
1	For patients with hemophilia A or B without high‑titer inhibitors (i.e., factor VIII or IX inhibitors < 5 BU), the prescriber must document that the patient is not an appropriate candidate for Hympavzi (clinical rationale must be provided).
[{"text":"1","status":""},{"text":"Alternatively, for existing Qfitlia users, the patient must be currently on Qfitlia therapy AND must not have been established on therapy by receipt of a manufacturer‑supplied sample in the prescriber\'s office or via assistance from HemAssist or Sanofi Patient Support (e.g., sample card); patients established by samples are treated as new to therapy and must meet initial criteria.","status":""}]

Step

Requirement

For patients with hemophilia A or B without high‑titer inhibitors (i.e., factor VIII or IX inhibitors < 5 BU), the prescriber must document that the patient is not an appropriate candidate for Hympavzi (clinical rationale must be provided).

[{"text":"1","status":""},{"text":"Alternatively, for existing Qfitlia users, the patient must be currently on Qfitlia therapy AND must not have been established on therapy by receipt of a manufacturer‑supplied sample in the prescriber\'s office or via assistance from HemAssist or Sanofi Patient Support (e.g., sample card); patients established by samples are treated as new to therapy and must meet initial criteria.","status":""}]

Coding and Key Clinical Parameters

High‑titer inhibitor threshold

High‑titer inhibitor threshold>= 5 Bethesda units (BU)

Applicable factorsFactor VIII or factor IX inhibitors

Use in criteriaDefines 'high‑titer' for initial authorization of patients with inhibitors

Minimum age for coverage

Minimum age for coverage>= 12 years

Referenced usagesRequired for initial authorization across hemophilia A and B criteria

Clinical indication age range

Background

Qfitlia (fitusiran) is an antithrombin-directed small interfering RNA indicated for routine prophylaxis to prevent or reduce bleeding in patients with hemophilia A or B aged >= 12 years, with or without factor VIII or IX inhibitors. Prior authorization is required for Qfitlia; initial approvals are granted only when the clinical criteria in this policy are met, and authorizations are issued for 12 months.

Definitions

High‑titer inhibitor

DefinitionPresence of factor VIII or IX inhibitors greater than or equal to 5 Bethesda units (BU)

Context of useUsed to distinguish 'with inhibitors' populations in initial authorization criteria

Documentation implicationLaboratory measurement (Bethesda assay) demonstrating >= 5 BU required to classify as high‑titer

Revision History

2025-05P&T approval

Program established: Prior Authorization/Medical Necessity program for Qfitlia (fitusiran) approved by P&T (program number 2025 P 2372-2).

2025-08P&T approval / material change

Program updated: removed requirement to fail prophylactic factor replacement therapy and added preferred-therapy criteria for hemophilia A or B without inhibitors; clarified high-titer inhibitor definition.