CurrentColorado Rocky Mountain Health PlansPolicy 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 bleeding in patients with hemophilia A or B aged 12 and older; affects providers requesting authorization and payers managing benefits.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyQfitlia (fitusiran) — Prior Authorization / Medical Necessity

Policy CodePolicy 2025 P 2372-2

Change TypeNew prior authorization programadded preferred-therapy requirementclarified inhibitor threshold

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, age (>=12), inhibitor status (including Bethesda units if applicable), and reason patient is not appropriate for Hympavzi when required.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Qfitlia (fitusiran) established.

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

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

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

12 monthsauthorization duration

>=12min age

>=5 BUhigh-titer threshold

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5/2025, 8/2025P&T approval

Coverage and Medical Necessity Criteria

inv-01: Initial Authorization — Hemophilia A with inhibitors

Covered when ALL of the following are met for hemophilia A with high-titer inhibitors:

ALL of the following

Diagnosis of hemophilia A
Inhibitor status: Patient has developed high-titer factor VIII inhibitors (>= 5 BU)>=5 BU
Age: Patient is 12 years of age or older>=12 years
Indication: Prescribed for the prevention of bleeding episodes (routine prophylaxis)
Authorization will be issued for 12 months

ALL of the following

Diagnosis of hemophilia A
Inhibitor status: Patient has developed high-titer factor VIII inhibitors (>= 5 BU)>=5 BU
Age: Patient is 12 years of age or older>=12 years
Indication: Prescribed for the prevention of bleeding episodes (routine prophylaxis)
Authorization will be issued for 12 months

inv-02: Initial Authorization — Hemophilia A without inhibitors (preferred-therapy logic)

Covered when ALL of the following are met for hemophilia A without high-titer inhibitors:

ALL of the following

Diagnosis of hemophilia A
Inhibitor status: Patient has not developed high-titer factor VIII inhibitors (< 5 BU)<5 BU
Age: Patient is 12 years of age or older>=12 years
Indication:

inv-03: Initial Authorization — Hemophilia B with inhibitors

Covered when ALL of the following are met for hemophilia B with high-titer inhibitors:

ALL of the following

Diagnosis of hemophilia B
Inhibitor status: Patient has developed high-titer factor IX inhibitors (>= 5 BU)>=5 BU
Age: Patient is 12 years of age or older>=12 years
Indication: Prescribed for the prevention of bleeding episodes (routine prophylaxis)

inv-04: Initial Authorization — Hemophilia B without inhibitors (preferred-therapy logic)

Covered when ALL of the following are met for hemophilia B without high-titer inhibitors:

ALL of the following

Diagnosis of hemophilia B
Inhibitor status: Patient has not developed high-titer factor IX inhibitors (< 5 BU)<5 BU
Age: Patient is 12 years of age or older>=12 years
Indication:

inv-05: Reauthorization

Reauthorization — Covered when the following met:

ALL of the following

Clinical response: Documentation of positive clinical response to Qfitlia therapy
Authorization issued for 12 months

ALL of the following

Clinical response: Documentation of positive clinical response to Qfitlia therapy
Authorization will be issued for 12 months

Coverage is subject to applicable state mandates, federal regulatory requirements, and the member’s specific benefit plan; these may modify or limit coverage determinations. Other UnitedHealthcare policies and utilization management programs may also apply when evaluating requests for Qfitlia (fitusiran). Authorization, when approved under the criteria in this policy, will be issued for 12 months.

Automated approval processes may be used where appropriate based on claims or medication history and diagnosis codes, but approval remains contingent on meeting the policy’s documented prior authorization and medical necessity criteria.

Initial Therapy

inv-16: Initial therapy

Initial authorization criteria

ANY of the following

Hemophilia A with inhibitors: Meets criteria set for hemophilia A with high-titer inhibitors (see coverage criteria)
Hemophilia A without inhibitors: Meets criteria set for hemophilia A without high-titer inhibitors including preferred-therapy logic
Hemophilia B with inhibitors: Meets criteria set for hemophilia B with high-titer inhibitors
Hemophilia B without inhibitors:

Reauthorization / Continuation Criteria

inv-17: Reauthorization / Continuation

Reauthorization rules

ALL of the following

Positive clinical response: Documentation of positive clinical response to Qfitlia therapy required for reauthorization
Authorization issued for 12 months

ALL of the following

Positive clinical response: Documentation of positive clinical response to Qfitlia therapy required for reauthorization
Authorization will be issued for 12 months

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Qfitlia. Authorization will be issued for up to 12 months when criteria are met. UnitedHealthcare (on behalf of the payer) may approve initial or reauthorization based on prior claim/medication history, diagnosis codes (ICD-10) and/or claim logic where applicable.

Authorization duration: 12 months
Automated approvals may occur based on claims/medication history and diagnosis codes

Prior Authorization

Preferred Therapy (Hympavzi) Requirement

Hympavzi is the preferred therapy. For patients without high-titer inhibitors or when prescribing Qfitlia instead of Hympavzi, the provider must document that the patient is not an appropriate candidate for Hympavzi and state the reason. For established Qfitlia users, the patient may qualify for reauthorization if currently on Qfitlia and the patient did not become established solely via a manufacturer-supplied sample or patient assistance program.

Provider must document clinical rationale why Hympavzi is not appropriate
Established-user condition: patient is currently on Qfitlia therapy AND patient was not established solely via a manufacturer-supplied sample or HemAssist/Sanofi Patient Support assistance

Step Therapy / Therapeutic Sequencing

Requirement	Details / Acceptable documentation	Coverage status
Provider documents that, based on clinical assessment, the patient is not an appropriate candidate for Hympavzi
Record of provider rationale describing why Hympavzi is inappropriate for this patient (clinical reasons documented in chart or prior auth submission)
Covered with criteria
OR: Patient is an established Qfitlia user who did not rely on manufacturer samples or HemAssist/Sanofi support to establish use
Evidence of ongoing Qfitlia therapy and documentation that the patient has not received a manufacturer-supplied sample at no cost in the prescriber office or any form of assistance from HemAssist or Sanofi Patient Support to establish use
Covered with criteria

Key Clinical Thresholds and Coding

inv-07: High-titer inhibitor threshold — clinical threshold value

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

Applies toFactor VIII or IX inhibitors as specified in hemophilia A or B criteria

Use in authorization decisionsUsed to distinguish 'with inhibitors' (>=5 BU) vs 'without inhibitors' (<5 BU) for initial approval logic

inv-08: Minimum age — patient age requirement for coverage

Minimum patient age for coverage>= 12 years

Applies toAll indications: hemophilia A and B, with or without inhibitors

Definitions

inv-14: High-titer inhibitor — definition (>= 5 BU)

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

Role in policyPatients meeting this threshold are classified as having high-titer inhibitors for initial authorization criteria

Document sourcePolicy language and references including Qfitlia package insert and clinical trials

inv-15: Routine prophylaxis — definition

DefinitionUse of Qfitlia to prevent or reduce the frequency of bleeding episodes rather than on-demand treatment (routine prophylaxis)

Indication age groupIndicated for patients aged 12 years and older with hemophilia A or B, with or without inhibitors

Background

Qfitlia (fitusiran) is an antithrombin-directed small interfering RNA indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B, with or without factor inhibitors, who are aged 12 years or older. Clinical trial programs (ATLAS) and the product label support its efficacy and safety for this indication.

The mechanism of action of Qfitlia involves targeted reduction of antithrombin to rebalance hemostasis, thereby decreasing bleeding risk in people with hemophilia. References include the Qfitlia package insert and pivotal ATLAS trial publications supporting the prophylactic use of fitusiran.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyQfitlia (fitusiran) — Prior Authorization / Medical Necessity

Policy CodePolicy 2025 P 2372-2

Change TypeNew prior authorization programadded preferred-therapy requirementclarified inhibitor threshold

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, age (>=12), inhibitor status (including Bethesda units if applicable), and reason patient is not appropriate for Hympavzi when required.

SourceLink

On This Page

Qfitlia is prescribed for the prevention of bleeding episodes (routine prophylaxis)

Preferred therapy: One of: provider documents patient is not an appropriate candidate for Hympavzi (document reason) OR patient is currently on Qfitlia and did not receive a manufacturer-supplied sample or HemAssist/Sanofi Patient Support assistance to establish use

Patients established via free samples/assistance must meet initial criteria as new to therapy; authorization will be issued for 12 months

ALL of the following

Diagnosis of hemophilia A
Inhibitor status: Patient has not developed high-titer factor VIII inhibitors (< 5 BU)<5 BU
Age: Patient is 12 years of age or older>=12 years
Indication: Qfitlia is prescribed for the prevention of bleeding episodes (routine prophylaxis)
Authorization will be issued for 12 months

Authorization will be issued for 12 months

ALL of the following

Diagnosis of hemophilia B
Inhibitor status: Patient has developed high-titer factor IX inhibitors (>= 5 BU)>=5 BU
Age: Patient is 12 years of age or older>=12 years
Indication: Prescribed for the prevention of bleeding episodes (routine prophylaxis)
Authorization will be issued for 12 months

Qfitlia is prescribed for the prevention of bleeding episodes (routine prophylaxis)

Patients established via free samples/assistance must meet initial criteria as new to therapy; authorization will be issued for 12 months

ALL of the following

Diagnosis of hemophilia B
Inhibitor status: Patient has not developed high-titer factor IX inhibitors (< 5 BU)<5 BU
Age: Patient is 12 years of age or older>=12 years
Indication: Qfitlia is prescribed for the prevention of bleeding episodes (routine prophylaxis)
Authorization will be issued for 12 months

Meets criteria set for hemophilia B without high-titer inhibitors including preferred-therapy logic

ANY of the following

Hemophilia A with inhibitors: Meets criteria set for hemophilia A with high-titer inhibitors (see coverage criteria)
Hemophilia A without inhibitors: Meets criteria set for hemophilia A without high-titer inhibitors including preferred-therapy logic
Hemophilia B with inhibitors: Meets criteria set for hemophilia B with high-titer inhibitors
Hemophilia B without inhibitors: Meets criteria set for hemophilia B without high-titer inhibitors including preferred-therapy logic

Patients established on therapy solely via manufacturer samples or assistance must meet initial authorization criteria as if new to therapy

Documentation Required

Required Documentation

Document the clinical information required to support initial authorization or reauthorization. Include diagnosis, age, inhibitor status with Bethesda unit measurement, indication for routine prophylaxis, prior therapy history, and for denials include missing documentation details.

Diagnosis: hemophilia A or B (ICD-10 code documented)
Age: patient is 12 years or older
Inhibitor status: specify whether high-titer (>= 5 Bethesda units) or not, and report Bethesda unit value
Indication: prescribed for prevention of bleeding episodes (routine prophylaxis)
Prior therapy history: documentation if patient is currently on Qfitlia, and whether established via manufacturer sample or assistance
If applicable, clinical rationale documenting why Hympavzi is not appropriate

Denial Risk

Denial Triggers

Requests will be denied if required information is missing or criteria are not met. Examples include absence of documented diagnosis, age, inhibitor titer (Bethesda units), lack of clinical rationale for not using Hympavzi when required, or if patient was established on therapy solely by a manufacturer sample or assistance and initial criteria are not satisfied.

Missing documentation: diagnosis, age, inhibitor titer, indication, or prior therapy history
Failure to document why Hympavzi is not appropriate when required
Patients established solely via manufacturer samples/assistance who do not meet initial criteria

Authorization duration

Initial and reauthorization approvals issued for 12 months

Policy requirementPrescription must be for prevention of bleeding episodes to meet coverage criteria