Access Treatment and Support for Qfitlia

Getting started with HemAssist

HemAssist works with you and your patients to get them started on Qfitlia as efficiently as possible. Our support begins with the enrollment process. As soon as we receive an enrollment form, we can begin a benefits investigation to determine if your patient is eligible for financial assistance.

Our support includes supporting your office with claims and reimbursements, assisting with medication shipments, providing patients with supplemental injection training, and more. We can also triage the prescription to the patient’s specialty pharmacy. Soleo Health has been chosen as the specialty pharmacy partner of choice for commercially insured Qfitlia patients.

Our support

Affording Qfitlia

No matter your patient's situation, we are committed to helping them access and afford Qfitlia. The HemAssist team will verify your patient's insurance coverage and determine what financial assistance programs they may be eligible for.

Starting treatment

The HemAssist team can help your patient get started with Qfitlia right away. We can provide supplemental injection training, answer questions about antithrombin (AT), and review their bleed management plan.

Ongoing support

Our team provides support and guidance to your patient throughout the Qfitlia journey. This includes helping them understand the dose adjustment process, navigating insurance changes, and more.

Financial assistance

HemAssist works directly with your patients to help identify programs they may be eligible for.

Copay Assistance Program*

HemAssist may be able to help eligible patients gain access to Qfitlia for as little as $0.

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QuickStart Program†

Patients prescribed Qfitlia for the first time can receive up to 6 months of product while their insurance coverage is pending.

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Patient Assistance Program†

HemAssist's Patient Assistance Program may be available to help eligible Qfitlia patients who are uninsured, underinsured, or experiencing a temporary loss of insurance coverage.

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^{* Not valid if the patient is utilizing a state or federally funded health insurance program such as Medicare (including Medicare Part D), Medicaid, Medigap, VA, DoD, TRICARE®, state pharmaceutical assistance program, etc. to pay in part or in full for their QFITLIA prescription. Not valid where prohibited by law. Sanofi reserves the right to modify or terminate the Copay Program at any time without notice. Savings by patients may vary depending on their out of pocket costs. The program is intended to help patients afford their QFITLIA prescription. Patients may have insurance plans that attempt to dilute the impact of the assistance available under the program. In those situations, the program may change its terms.}

^{† Free Trial valid only for a patient s first prescriptions and it is limited to one use per patient per product for their lifetime. Free Trial not valid in Vermont. Claims for free products dispensed through the QuickStart or Patient Assistance programs shall not be submitted to any third-party payer, public or private (e.g. private insurance, Medicaid, Medicare, VA, DoD, TRICARE®, or similar federal or state programs) for reimbursement. All Programs not valid where prohibited by law. Sanofi reserves the right to modify or terminate the Programs at any time without notice. Program details provided upon registration.}

Meet your team

HemAssist works directly with your patients to help identify programs they may be eligible for.

HemAssist team member sitting at a desk with a headset

Clinical Educator (CE)

FOR PATIENTS

CEs provide the guidance and support patients may need throughout their Qfitlia journey. Their support includes navigating the dosing optimization process, answering questions about antithrombin (AT) testing, and offering supplemental injection training and ongoing support as needed.

FOR HCPs

CEs can answer questions about Qfitlia, walk you through the dosing adjustment process, provide information on the LabCorp antithrombin testing program, provide training on injecting Qfitlia, and more.

Portrayal of a smiling man sitting at a desk wearing a headset

Case Managers

FOR PATIENTS

Case Managers assist with navigating insurance coverage and identifying the financial support patients may be eligible for.

FOR HCPs

Case Managers provide you with personalized insurance investigations and answer questions about financial assistance options for eligible patients. They can help coordinate treatment shipments and assist with reimbursements

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Field Reimbursement Managers (FRM)

FOR HCPs

FRMs are healthcare insurance coverage experts who specialize in navigating insurance and provide reimbursement education and solutions.

Ready to enroll a patient in HemAssist?

It takes just a few steps. Enroll online or download and fax an enrollment form.

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INDICATION

Qfitlia™ (fitusiran) is an antithrombin (AT)-directed small interfering ribonucleic acid (siRNA) indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without Factor VIII or IX inhibitors.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOTIC EVENTS AND ACUTE AND RECURRENT GALLBLADDER DISEASE

THROMBOTIC EVENTS

Serious thrombotic events have occurred in Qfitlia-treated patients with risk factors for thromboembolism including persistent antithrombin (AT) activity less than 15%, use of Qfitlia 80 mg once monthly, presence of indwelling venous catheters, and in the post-operative setting when Bleed Management Guidelines were not followed.

Monitor AT activity using an FDA-cleared test and target AT activity 15-35% to reduce the risk of thrombosis. Monitor patients for signs and symptoms of thrombotic events. Interrupt Qfitlia in patients with a thrombotic event and manage as clinically indicated.

ACUTE AND RECURRENT GALLBLADDER DISEASE

Acute and recurrent gallbladder disease, including cholelithiasis and cholecystitis have occurred in Qfitlia-treated patients, some of whom required cholecystectomy or had complications (e.g., pancreatitis) related to gallbladder disease. Monitor patients for signs and symptoms of acute and recurrent gallbladder disease.

Consider interruption or discontinuation of Qfitlia if gallbladder disease occurs. Consider alternative treatment for hemophilia in patients with a history of symptomatic gallbladder disease.

WARNINGS AND PRECAUTIONS

Thrombotic Events:

Serious thrombotic events have been reported in Qfitlia-treated patients. Thrombotic events were reported in 2.6% of patients receiving the 80 mg once monthly dose, including a fatal event of cerebral venous sinus thrombosis. The 80 mg once monthly dose is not approved or recommended for use. Thrombotic events were reported in 1.4% of patients receiving Qfitlia prophylaxis using the AT-based dose regimen (AT-DR) that targeted AT activity 15-35%
The risk of thrombosis is greater in patients with certain risk factors (see Boxed WARNING). Treatment of breakthrough bleeding episodes with clotting factor concentrate (CFC) or bypassing agent (BPA) at a dose greater or more frequent than recommended may also increase thrombotic risk

Acute and Recurrent Gallbladder Disease:

Treatment with Qfitlia is associated with an increased occurrence of acute and recurrent gallbladder disease, including cholelithiasis and cholecystitis (see Boxed WARNING). In the 270 patients in the clinical studies who received Qfitlia at a fixed dose of 80 mg once monthly, 17% experienced gallbladder events and 4% underwent cholecystectomy. In 286 patients who received the AT-DR, 3.8% experienced gallbladder events and 0.3% underwent cholecystectomy

Hepatotoxicity:

In the two randomized studies testing Qfitlia 80 mg once monthly, alanine transaminase (ALT) and aspartate transaminase (AST) elevations above 3 times the upper limit of normal (ULN) occurred in 32% of patients with hemophilia with inhibitors and 18% of patients with hemophilia without inhibitors. There was one case of moderate hepatic injury attributable to Qfitlia use. On the AT-DR, 3.4% of patients treated with Qfitlia had at least one ALT value >3x ULN
Avoid use of Qfitlia in patients with hepatic impairment (Child-Pugh Class A, B, and C)
Obtain baseline liver tests, including AST, ALT, and total bilirubin, prior to initiating Qfitlia, monthly for at least the first 6 months of Qfitlia use, monthly for at least 6 months after a dose increase, and periodically thereafter as clinically indicated
If new or worsening liver test abnormalities occur, initiate medical management as appropriate and monitor until they return to baseline. If ALT or AST elevations >5x ULN occur, interrupt Qfitlia treatment. If Qfitlia is restarted and ALT or AST elevations >5x ULN reoccur or the patient experiences jaundice due to hepatotoxicity with other causes of liver test elevation ruled out, permanently discontinue Qfitlia

DRUG INTERACTIONS

Hypercoagulability with Concomitant Use of CFC or BPA: Qfitlia prophylaxis leads to increased thrombin generation with additive increase in peak thrombin when used concomitantly with CFC or BPA.

ADVERSE REACTIONS

Common adverse reactions (incidence ≥10%) are viral infection, nasopharyngitis, and bacterial infection.

Please see full Prescribing Information, including Boxed WARNING.

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Patient support for Qfitlia™

Getting started with HemAssist

Our support

Affording Qfitlia

Starting treatment

Ongoing support

Financial assistance

Copay Assistance Program*

QuickStart Program†

Patient Assistance Program†

Meet your team

Clinical Educator (CE)

FOR PATIENTS

FOR HCPs

Case Managers

FOR PATIENTS

FOR HCPs

Field Reimbursement Managers (FRM)

FOR HCPs

Ready to enroll a patient in HemAssist?

INDICATION

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOTIC EVENTS AND ACUTE AND RECURRENT GALLBLADDER DISEASE

THROMBOTIC EVENTS

Monitor AT activity using an FDA-cleared test and target AT activity 15-35% to reduce the risk of thrombosis. Monitor patients for signs and symptoms of thrombotic events. Interrupt Qfitlia in patients with a thrombotic event and manage as clinically indicated.

ACUTE AND RECURRENT GALLBLADDER DISEASE

Consider interruption or discontinuation of Qfitlia if gallbladder disease occurs. Consider alternative treatment for hemophilia in patients with a history of symptomatic gallbladder disease.

WARNINGS AND PRECAUTIONS

Thrombotic Events:

Acute and Recurrent Gallbladder Disease:

Hepatotoxicity:

DRUG INTERACTIONS

ADVERSE REACTIONS

INDICATION

IMPORTANT SAFETY INFORMATION