SUPPORT FOR YOUR PATIENTS
CareConnectPSS, personalized support services for patients, represents Sanofi’s more than 25-year commitment to supporting the rare disease community. CareConnectPSS is designed to support each patient’s unique journey.
CareConnectPSS support includes:
Dedicated CareConnectPSS Case Managers and Patient Education Liaisons
Disease-specific information and resources
Information regarding genetic testing options and diagnostics
Care coordination for treatment
Help with handling insurance issues
SUPPORT FOR YOUR PATIENTS
Sanofi sponsors and offers educational events for Fabry patients, their families, and friends to learn more about Fabry disease and Fabrazyme. If your patients express interest in learning more, please refer them to our Rare Disease Events website.
Go to www.rarediseasesevents.com/fabry-disease
COPAY ASSISTANCE PROGRAM
COPAY ASSISTANCE PROGRAM.
The CareConnectPSS® Copay Assistance Program helps eligible patients in the United States who are prescribed Fabrazyme pay for their qualifying out-of-pocket drug costs and certain infusion-related (mixing and administration of the drug as well as infusion supplies such as saline, IV tubing, etc.) expenses, including copays, coinsurance, and deductibles.
Patients or their caregivers interested in applying for the CareConnectPSS Copay Assistance Program will need to complete the following application.
Download and learn more here.
Not valid for prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DoD, TRICARE, or similar federal or state programs including any state pharmaceutical assistance programs. Not valid where prohibited by law. Sanofi Genzyme reserves the right to modify or discontinue the programs at any time. Savings may vary depending on patients’ out-of-pocket costs. All program details provided upon registration.
BILLING AND REIMBURSEMENT
BILLING AND REIMBURSEMENT FOR FABRAZYME.
Treatment with Fabrazyme is a covered benefit under most major insurance plans, as well as Medicare and Medicaid programs. Sanofi is committed to working with providers, as well as public and private payers, to help ensure access to treatment for patients who would medically benefit from Fabrazyme.
About billing and reimbursement for Fabrazyme
COMMITTED TO INCREASING THE UNDERSTANDING OF FABRY DISEASE AND IMPROVING THE LIVES OF THOSE LIVING WITH THIS RARE CONDITION
The Fabry Registry, sponsored and administered by Sanofi, is the largest international patient registry database dedicated to Fabry disease. It is led by a group of physicians with extensive experience in managing patients with Fabry disease.
The Fabry Registry enables a better understanding of the variability and progression of Fabry disease in the population as a whole and in women specifically, and to monitor and evaluate long-term treatment effects of Fabrazyme.
The registry also monitors the effect of Fabrazyme on pregnant women and their offspring. Pregnant women and women of childbearing potential should be encouraged to enroll in the Fabry patient registry. Participation is voluntary and may involve long-term follow-up.
The registry’s database helps increase the understanding of Fabry disease by:
- Providing individualized patient reports and informative clinical summaries
- Encouraging physician collaboration and shared expertise
- Facilitating important publications
In addition, physicians may publish their own data or publish analyses on aggregate Registry data.
To register or find out more, please visit www.registryNXT.com
IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Anaphylaxis and Hypersensitivity Reactions
In clinical trials and postmarketing safety experience with Fabrazyme, approximately 1% of patients developed anaphylactic or severe hypersensitivity reactions during Fabrazyme infusion. Life-threatening anaphylactic and severe hypersensitivity reactions have been observed in patients during Fabrazyme infusions.
- Reactions have included localized angioedema (including swelling of the face, mouth, and throat), bronchospasm, hypotension, generalized urticaria, dysphagia, rash, dyspnea, flushing, chest discomfort, pruritus, and nasal congestion.
- Interventions have included cardiopulmonary resuscitation, oxygen supplementation, IV fluids, hospitalization, and treatment with inhaled beta-adrenergic agonists, antihistamines, epinephrine, and IV corticosteroids.
- If anaphylactic or severe hypersensitivity reactions occur, immediately discontinue administration of Fabrazyme and provide necessary emergency treatment. Because of the potential for severe hypersensitivity reactions, appropriate medical support measures should be readily available when Fabrazyme is administered.
In clinical trials with Fabrazyme, some patients developed IgE antibodies or skin test reactivity specific to Fabrazyme.
- Higher incidences of hypersensitivity reactions were observed in adult patients with persistent anti-Fabrazyme antibodies and in adult patients with high antibody titer compared to that in antibody negative adult patients.
- Physicians should consider testing for IgE antibodies in patients who experienced suspected hypersensitivity reactions and consider the risks and benefits of continued treatment in patients with anti-Fabrazyme IgE antibodies. Rechallenge of these patients should only occur under the direct supervision of qualified personnel, with appropriate medical support measures readily available.
In clinical trials with Fabrazyme, 59% of patients experienced infusion-associated reactions, some of which were severe. Infusion-associated reactions are defined as adverse reactions occurring on the same day as the infusion. The incidence of infusion-associated reactions was higher in patients who were positive for anti-Fabrazyme antibodies than in patients who were negative for anti-Fabrazyme antibodies.
- In patients experiencing infusion-associated reactions, pretreatment with an antipyretic and antihistamine is recommended. Infusion-associated reactions occurred in some patients after receiving pretreatment.
- If an infusion-associated reaction occurs, decreasing the infusion rate, temporarily stopping the infusion, and/or administrating additional antipyretics, antihistamines, and/or steroids may ameliorate the symptoms.
- If severe infusion-associated reactions occur, immediate discontinuation of the administration of Fabrazyme should be considered, and appropriate medical treatment should be initiated. Severe reactions are generally managed with administration of antihistamines, corticosteroids, intravenous fluids, and/or oxygen when clinically indicated. Because of the potential for severe infusion-associated reactions, appropriate medical support measures should be readily available when Fabrazyme is administered.
- Patients with advanced Fabry disease may have compromised cardiac function, which may predispose them to a higher risk of severe complications from infusion-associated reactions. Monitor closely patients with compromised cardiac function if Fabrazyme is administered to these patients
- Common adverse reactions reported (≥20% and >2.5% compared to placebo) were upper respiratory tract infection (53% vs 42%), chills (49% vs 13%), pyrexia (39% vs 22%), headache (39% vs 28%), cough (33% vs 25%), paresthesia (31% vs 18%), fatigue (24% vs 17%), peripheral edema (21% vs 7%), dizziness (21% vs 8%), and rash (20% vs 10%).
INDICATION AND USAGE
Fabrazyme® is indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.
Please see full Prescribing Information for Fabrazyme.
References: 1. Fabrazyme Prescribing Information. Cambridge, MA. Genzyme Corporation; 2021.