Health Net fitusiran (Qfitlia) Coverage Update

Coverage Criteria for Qfitlia (fitusiran)

Initial Therapy — Covered when ALL of the following are met for routine prophylaxis in congenital hemophilia A or B.

Covered when ALL of the following are met for routine prophylaxis in congenital hemophilia A or B:

Diagnosis and prescriber: Prescribed for routine prophylaxis of bleeding episodes for congenital hemophilia A (FVIII deficiency) or congenital hemophilia B (FIX deficiency); prescribed by or in consultation with a hematologist.

Age: Patient is age ≥ 12 years.

Baseline severity: For hemophilia A: severe disease defined as FVIII level < 1%; for hemophilia B: moderately severe to severe disease defined as FIX level < 2%.FVIII <1% or FIX <2%

Factor level limits clarification applies to members new to Qfitlia who have not previously used bypassing agents, FVIII, or FIX products for routine prophylaxis.

Prior therapy or bleeding history (new-to-Qfitlia patients): For members new to Qfitlia and not previously on prophylactic bypassing agents or factor products, member must meet one of: (a) failure of a bypassing agent, FVIII, or FIX product used for routine prophylaxis as assessed and documented by prescriber; OR (b) ≥ 6 acute bleeding episodes in the previous 6 months treated with a bypassing agent, FVIII, or FIX product; OR (c) experienced at least one serious spontaneous bleed.6 bleeds in 6 months

Examples and acceptable reasons for failure are in Appendix D.

Concomitant therapy restriction: Provider confirms member will discontinue prophylactic use of emicizumab (Hemlibra), bypassing agents, FVIII, or FIX products while on Qfitlia; on-demand use may continue.

Dose limits: Dose does not exceed 50 mg per month (starting dose 50 mg subcutaneously every two months; adjust dose and/or interval to maintain antithrombin activity between 15-35%; maximum 50 mg/month).≤ 50 mg/month

Adjust to maintain AT activity 15-35%.

Continuation Therapy — Continued coverage when ALL of the following are met.

Continued coverage when ALL of the following are met:

Ongoing eligibility or prior criteria: Member is currently receiving medication via the health plan benefit or has previously met initial approval criteria for Qfitlia.

Clinical response: Member is responding positively to therapy as documented by the provider (e.g., reduction in total bleeds, joint bleeds, and/or target joint bleeds over time).

Examples provided in Appendix D.

Concomitant therapy restriction maintained: Provider confirms member will discontinue prophylactic use of Hemlibra, bypassing agents, FVIII, or FIX products while on Qfitlia; on‑demand use may be continued.

Dose limits for continuation: If request is for a dose increase, the new dose does not exceed 50 mg per month.

Coverage criteria highlights — Alignment with FDA labeling and policy-specific clarifications

Coverage aligned with FDA labeling and policy-specific clarifications

Dosing and prior therapy limits: Maximum dosing revised per FDA label; factor level limits apply only to members who are new to Qfitlia and have not previously used bypassing agents, FVIII, or FIX products for routine prophylaxis.see prescribing information

Applies to initial approval.

Approval duration - Commercial: Initial and continued approvals for commercial members are granted for 6 months or to the member's renewal date, whichever is longer.6 months or to renewal date

Applies to both initial and continued therapy unless otherwise specified.

Approval duration - Medicaid & HIM: Continued approval duration for Medicaid and Health Insurance Marketplace (HIM) members revised to 12 months.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety per the applicable off‑label use policies or evidence of coverage. Applicable off‑label policies include CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace (HIM), and CP.PMN.53 for Medicaid.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers and reviewers should consult the applicable state Medicaid manual for any state‑specific coverage rules that apply to this policy.

Uses outside the FDA‑approved indication, or uses that do not meet the explicit criteria listed in this policy, are not authorized unless supported by the applicable off‑label use policies or other evidence of coverage documents referenced for each line of business.

Inclusion or exclusion of specific procedure or billing codes in this document does not guarantee coverage. Absence of a particular code from the policy may affect claims processing or prior authorization workflows; providers should reference current professional coding guidance and submit claims using the most up‑to‑date codes.

Coding and Billing Codes

Referenced HCPCS Codes (added)HCPCS

J7174

HCPCS Codes (removed)HCPCSNot Covered

C9399
J3490

Antithrombin (AT) activity target

AT activity targetMaintain antithrombin (AT) activity between 15% and 35%

Maximum monthly dose relatedDose adjustments should be made to maintain AT activity within target while observing maximum dose of 50 mg per month

Starting regimen noteStarting dose: 50 mg subcutaneous every two months; adjust based on AT activity to remain within 15–35%

Monitoring implicationAT activity measurement is required to guide dose adjustments to remain within the 15–35% target range

Provider Actions, Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must demonstrate the member meets all initial approval criteria for routine prophylaxis and obtain prior authorization before Qfitlia is furnished.

Approval durations: Commercial — initial and continued approvals granted for 6 months or to the member's renewal date, whichever is longer; Medicaid & HIM — continued approval duration 12 months. Approval durations align with latest FDA labeling revisions.
Failure to obtain prior authorization may result in claim denial or non‑payment.

Documentation Required

Documentation Requirement

Providers must submit supporting clinical documentation to demonstrate the member meets all approval criteria. Failure to submit required documentation may trigger denial of the prior authorization request.

Background

Fitusiran (Qfitlia) is a small interfering RNA (siRNA) therapeutic that reduces antithrombin activity to decrease bleeding frequency in persons with congenital hemophilia A or B. This policy applies to use of fitusiran for routine prophylaxis to prevent or reduce bleeding episodes in patients aged ≥ 12 years with or without inhibitors. The product carries boxed warnings for thrombotic events and for acute or recurrent gallbladder disease; clinical decisions should weigh these risks and follow the prescribing information. Prior authorization and required documentation are necessary to confirm that patients meet the policy’s initial and continued therapy criteria before approval.

Definitions

Routine prophylaxis

DefinitionOngoing scheduled therapy to prevent or reduce the frequency of bleeding episodes

Indication contextApplied to routine prophylaxis of bleeding episodes in congenital hemophilia A or B

Therapy expectationsMay require periodic dose adjustments to achieve clinical response and laboratory targets

Serious spontaneous bleed

Examples of serious sitesIntracranial, neck/throat, gastrointestinal, joints (hemarthrosis), muscle compartments (e.g., iliopsoas, calf, forearm), or mucous membranes

Clinical significanceIncludes clinically significant bleeding such as hemarthroses, life‑threatening episodes, joint swelling, or bleeding not responding to current therapy

Revision History

2025-03-28policy_revisionLatest

FDA-aligned updates: maximum dosing revised; factor level limits clarified to apply only to members new to Qfitlia who have not previously used bypassing agents, FVIII, or FIX for routine prophylaxis; Commercial approval duration added as 6 months or to member renewal date; continued approval duration for Medicaid & HIM revised to 12 months.

2024-12-03policy_creation

Policy created pre-emptively (document notes pre-emptive creation and P&T approval date recorded later).

2025-04-09references_updated

OpenPayer

Clinical Policy: Fitusiran (Qfitlia)