CurrentAvMedPolicy N/A

Qfitlia (fitusiran) – Pharmacy Prior Authorization / Coverage Criteria

This document is a prior authorization and step-edit request form governing coverage criteria, clinical requirements, and quantity limits for Qfitlia (fitusiran) for AvMed members; it applies to prescribers and specialty pharmacy handling requests.

Policy Summary

PayerAvMed

PolicyQfitlia (fitusiran) – Pharmacy Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProvider must submit prescriber signature, member and prescriber details (including NPI), dosing, diagnosis, and supporting labs (notably antithrombin activity) to support each checked clinical criterion.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1quantity limit per 28 days

6 moinitial authorization duration

12 more-authorization duration

≥12minimum age

≥60%required baseline AT

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Coverage Criteria for Qfitlia (fitusiran)

inv-01: Initial Therapy Criteria

Covered when ALL of the following are met

Core eligibility: Member is ≥ 12 years of age; medication prescribed by a specialist familiar with treating patients with hemophilia (factor VIII or IX deficiency); baseline antithrombin (AT) activity documented ≥ 60% with a plan for periodic AT monitoring per the prescribing information; member does NOT have hepatic impairment (Child-Pugh Class A, B or C), a co-existing thrombophilic disorder, history of or risk factors predisposing to thrombosis, or symptomatic gallbladder disease (or planned interruption/discontinuation for acute/recurrent gallbladder disease).

Combination therapy restrictions: Fitusiran will NOT be used in combination with hemophilia bypassing agent prophylaxis (e.g., factor VIIa or anti-inhibitor coagulant complex), immune tolerance induction with clotting factor concentrates (factor VIII or IX) as prophylaxis, Hemlibra (emicizumab) for hemophilia A prophylaxis, or Hympavzi (marstacimab) or Alhemo (concizumab) for hemophilia A or B prophylaxis. Note: members may continue prior clotting factor concentrate (CFC) or bypassing agent (BPA) prophylaxis for the first 7 days of fitusiran treatment but must discontinue no later than 7 days after the initial dose.

Diagnosis-specific: Hemophilia A: Diagnosis of congenital factor VIII deficiency confirmed by blood coagulation testing AND severe disease documented by factor VIII activity < 1 IU/dL (in the absence of exogenous factor VIII) AND member has NOT received prior gene therapy for hemophilia A (e.g., Roctavian). Additionally, member has history of life-threatening hemorrhage requiring on-demand factor replacement OR history of repeated, serious spontaneous bleeding episodes requiring on-demand Factor VIII therapy.

Diagnosis-specific: Hemophilia B: Diagnosis of congenital factor IX deficiency confirmed by blood coagulation testing AND severe disease documented by factor IX activity ≤ 2 IU/dL (in the absence of exogenous factor IX) AND member has NOT received prior gene therapy for hemophilia B (e.g., Hemgenix, Beqvez). Additionally, member has history of life-threatening hemorrhage requiring on-demand factor replacement OR history of repeated, serious spontaneous bleeding episodes requiring on-demand Factor IX therapy.

inv-02: Reauthorization Criteria

Reauthorization covered when ALL of the following are met

Ongoing criteria: Member continues to meet the indication-specific criteria from the initial authorization (including combination therapy restrictions and absence of precluding medical conditions), has NOT experienced unacceptable toxicity from fitusiran (e.g., severe hepatotoxicity, thromboembolic events, severe gallbladder disease), and has demonstrated clinical benefit with submission of well-documented, quantitative assessments showing reduction in frequency and/or severity of bleeding episodes compared to pre-treatment baseline.

AT monitoring response actions: Provider has monitored AT-activity and submitted laboratory documentation showing ONE of the following: AT-activity < 15% with a provider plan to reduce fitusiran dose per package labeling (members on 10 mg every 2 months must discontinue); AT-activity 15%–35% with plan to continue the established dose per labeling (no dose increases approved); OR AT-activity > 35% after 6 months with inadequate bleed control compared to baseline, in which case the provider may escalate dosing frequency to monthly.

Members are ineligible for fitusiran (Qfitlia) if they have hepatic impairment (Child‑Pugh Class A, B, or C), a documented co‑existing thrombophilic disorder, a history of or risk factors predisposing to thrombosis, or symptomatic gallbladder disease (including situations requiring interruption or discontinuation of therapy). These conditions must be absent and documented before approval is granted. [[do not include chunk refs in paragraph]]

Fitusiran must not be used in combination with specified prophylactic hemophilia agents. Combination therapy exclusions include hemophilia bypassing agent prophylaxis (e.g., factor VIIa or anti‑inhibitor coagulant complex), immune tolerance induction with clotting factor concentrates, emicizumab (Hemlibra) for hemophilia A prophylaxis, and Hympavzi (marstacimab) or Alhemo (concizumab) for hemophilia A or B prophylaxis. Note: members may continue prior clotting factor concentrate (CFC) or bypassing agent (BPA) prophylaxis for up to 7 days after the initial dose of fitusiran but must discontinue CFC/BPA no later than 7 days after initiation.

Prior gene therapy for the corresponding hemophilia type (e.g., Roctavian for hemophilia A; Hemgenix or Beqvez for hemophilia B) is a disqualifying condition and must be documented as absent for approval.

Initial Therapy

inv-13: Initial Therapy

Initial authorization conditions

Initial eligibility: Member is ≥ 12 years of age; prescribed by a specialist familiar with treating hemophilia; baseline AT activity ≥ 60% with documentation and plan for periodic monitoring; no hepatic impairment (Child-Pugh A, B or C), no co-existing thrombophilic disorder, no history/risk factors for thrombosis, and no symptomatic gallbladder disease that would preclude therapy; fitusiran will not be initiated in combination with prohibited agents (see combination therapy restrictions); diagnosis of severe hemophilia A or B confirmed by testing with specified activity thresholds and qualifying bleeding history; member has NOT received prior gene therapy for the corresponding hemophilia type.

Continuation / Reauthorization Criteria

inv-14: Continuation Therapy

Reauthorization requirements and AT monitoring actions

Continuation monitoring: Periodic AT-activity monitoring with laboratory documentation is required; provider must confirm absence of unacceptable toxicity (severe hepatotoxicity, thromboembolic events, severe gallbladder disease) and demonstrate continued clinical benefit (decrease in bleeding frequency/severity) for reauthorization. Providers must submit supporting lab results, diagnostics, and chart notes for each checked criterion.

Clinical Thresholds and Coding-related Values

inv-04: Antithrombin (AT) activity — categories

Baseline AT activityBaseline antithrombin (AT) activity ≥ 60% required prior to initiation

Very low AT categoryAT-activity < 15% — triggers provider plan to reduce fitusiran dose per labeling

Low-moderate AT categoryAT-activity 15%–35% — provider may continue established fitusiran dose (no dose increase approved)

Higher AT category after 6 monthsAT-activity > 35% after 6 months with inadequate bleed control — provider may escalate administration frequency to monthly

inv-05: Severe hemophilia A activity level

Severe hemophilia A thresholdFactor VIII activity < 1 IU/dL (in the absence of exogenous factor VIII)

Confirmation requiredDiagnosis of congenital factor VIII deficiency must be confirmed by blood coagulation testing

Exclusion noteMember must not have received prior gene therapy for hemophilia A to meet initial criteria

inv-06: Severe hemophilia B activity level

Severe hemophilia B thresholdFactor IX activity ≤ 2 IU/dL (in the absence of exogenous factor IX)

Confirmation requiredDiagnosis of congenital factor IX deficiency must be confirmed by blood coagulation testing

Exclusion noteMember must not have received prior gene therapy for hemophilia B to meet initial criteria

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approvals are for 6 months; reauthorizations are for 12 months. Quantity limited to 1 vial or pen per 28 days (20 mg/0.2 mL vial or 50 mg/0.5 mL prefilled auto-injector pen).

Initial Authorization: 6 months
Reauthorization: 12 months
Quantity Limits: 1 vial or pen per 28 days
Formulations: 20 mg/0.2 mL vial; 50 mg/0.5 mL prefilled auto-injector pen

Step Therapy

Verification of Prior Therapies

Prior therapies will be verified through pharmacy paid claims or submitted chart notes. Note: samples used to initiate therapy do NOT meet step-edit/preauthorization criteria.

Verification source: pharmacy claims or submitted chart notes
Samples do not meet step-edit criteria

Documentation Required

Required Documentation / Incomplete Documentation

Required documentation must be provided with the request. Incomplete, incorrect, or illegible information (including missing labs, diagnostics, or chart notes) can delay processing and may result in denial.

Prescriber signature (no preprinted stamps)
Member and prescriber details including NPI, contact phone and fax
Drug name, dosing schedule, length of therapy, and quantity requested
Diagnosis and ICD code if applicable
Supporting laboratory results (e.g., antithrombin activity ≥ 60% prior to start and periodic monitoring) and other chart notes
Documentation of clinical criteria supporting approval (see clinical checklist)

Step Therapy / Prior Treatment Verification

Requirement	Verification method
Prior therapies must be verified before approval	Pharmacy paid claims or submitted chart notes
Use of drug samples to initiate therapy	Samples do not meet step-edit or preauthorization criteria

Quantity Limits and Dispensing

inv-16: fitusiran (Qfitlia) — Quantity limits

Quantity limit1 vial or pen per 28 days

Vial strength20 mg/0.2 mL vial

Prefilled pen strength50 mg/0.5 mL prefilled auto-injector pen

Dispensing Site / Specialty Pharmacy

Note

Specialty pharmacy fulfillment (Proprium Rx)

This medication is dispensed through a specialty pharmacy (Proprium Rx); coordinate fulfillment and any required specialty pharmacy processes with Proprium Rx.

Medication being provided by Specialty Pharmacy - Proprium Rx.

Background and Therapy Overview

Fitusiran (Qfitlia) is an siRNA therapy directed at lowering antithrombin to reduce bleeding in people with hemophilia A or B. It is prescribed for patients with severe disease meeting laboratory‑confirmed activity thresholds and a qualifying bleeding history, and should be prescribed by a clinician experienced in hemophilia care.

Safety monitoring for fitusiran requires baseline and periodic measurement of antithrombin (AT) activity; baseline documentation of AT activity ≥ 60% is required prior to starting therapy and AT‑activity must be monitored throughout treatment per the prescribing information. Providers must also monitor for and report significant adverse events, including hepatotoxicity, thromboembolic events, and severe gallbladder disease during treatment.

Authorization and dispensing logistics: initial prior authorization is granted for 6 months with reauthorization available for 12 months; quantity is limited to 1 vial or pen per 28 days. The medication is dispensed via specialty pharmacy.

Definitions and Laboratory Thresholds

inv-12: Antithrombin (AT) activity — definition and monitoring

Definition and baseline requirementAntithrombin (AT) activity is a laboratory measure required at baseline (must be ≥ 60%) prior to starting fitusiran

Periodic monitoringAT-activity must be monitored periodically during therapy and laboratory documentation submitted for reauthorization

Action: AT < 15%If AT-activity < 15%, provider will reduce fitusiran dose according to package labeling (members on 10 mg every 2 months must discontinue)

Action: AT 15%–35%If AT-activity is 15%–35%, provider will continue established dose per labeling (no dose increase approved)

Action: AT > 35% after 6 monthsIf AT-activity > 35% after 6 months and bleed control is inadequate, provider may escalate dosing frequency to monthly