Co-pay Assistance Program
The Genzyme Co-Pay Assistance Program helps eligible individuals in the United States who are prescribed treatment with Fabrazyme pay for their eligible out-of-pocket drug and infusion-related (mixing and administration of the drug as well as infusion supplies such as saline, IV tubing, etc.) expenses, including co-pays, co-insurance and deductibles, regardless of financial status.
Once enrolled in Genzyme's Co-Pay Assistance Program, Genzyme will cover 100% of your eligible out-of-pocket drug and infusion-related costs up to the program maximum.
Once approved for assistance, your healthcare provider will be provided with information about your enrollment in this program along with directions on how to submit a claim to the Genzyme Co-Pay Assistance Program.
Who is eligible for the Genzyme Co-pay Assistance Program?
Regardless of financial status, the program is open to individuals who:
- Have primary commercial insurance
- Are prescribed treatment with Fabrazyme
You are NOT eligible if:
- Have coverage or prescriptions paid for in part or full under any state or federally funded healthcare program including:
- Medicare Advantage Plans (Example: FreedomBlue offered through Blue Cross Blue Shield)
- Medicare Part D
- Veterans Affairs, Department of Defense or TRICARE
- In accordance with State law, the Program does not reimburse infusion-related charges for patients residing in Massachusetts, Michigan, Minnesota and Rhode Island.
Genzyme reserves the right to make eligibility determinations, to set program benefit maximums, to monitor participation, and to modify or discontinue the program at any time. This program assists patients with their out-of-pocket drug and infusion-related costs of their enzyme replacement therapy treatment only, not the cost of MD office visits/evaluations, nursing services/observation periods, blood work, x-rays or other testing, pre-medications/other medications, Epi pens, transportation or other related services.
How to get started:
You complete the program application
Simply complete the online application available here.
Helpful information to have on hand when you apply:
- Your treating Physician’s contact information
- Your health insurance card
You can also call your Genzyme Case Manager directly to learn more about the program and application process at 1-800-745-4447, Option 3
Your eligibility is verified
Your application will be reviewed for eligibility.
If you are eligible, you will be automatically enrolled in the program. Enrollment in the program is subject to confirmation of eligibility.
Once approved, you will receive confirmation letter and an enrollment card within 7-10 days. Contact your Genzyme Case Manager if you do not receive this confirmation.
Your doctor or specialty pharmacy will also receive a phone call with instructions on how to submit claims for reimbursement through the program.
Your enrollment in the program is effective from the date of approval through the end of the calendar year (calendar year is January 1 through December 31).
If you are currently enrolled in our Co-Pay Assistance Program you will be automatically enrolled in the program for the next calendar year (January 1 through December 31) unless you decide to opt out of the program or your insurance coverage changes.
Indication and Usage
Fabrazyme® (agalsidase beta) is used to treat patients with Fabry disease. Fabrazyme lowers the amount of a substance called globotriaosylceramide (GL-3), which builds up in cells lining the blood vessels of the kidney and certain other cells. The lowering of GL-3 suggests that Fabrazyme may improve how Fabry disease affects your body; however a relationship of lower GL-3 to specific signs and symptoms of Fabry disease has not been proven.
Important Safety Information
Life-threatening severe allergic (anaphylactic) reactions have been seen in patients during Fabrazyme infusions. Approximately 1% of patients who have received Fabrazyme either during a clinical study or after Fabrazyme was approved have experienced anaphylactic or severe allergic reactions during their infusion. These reactions have included: localized swelling of the face, mouth and throat, narrowing of breathing airways, low blood pressure, hives, difficulty swallowing, rash, trouble breathing, flushing, chest discomfort, itching and nasal congestion. People who have experienced these reactions have required treatment including heart/lung resuscitation, oxygen, fluids given through the vein, hospitalization, and have needed treatment with inhaled drugs called beta-adrenergic agonists to help open the breathing airways, antihistamines, epinephrine (also known as adrenalin), and a medication given through the vein called a corticosteroid (or steroid) which helps to decrease the body’s allergic reaction by decreasing inflammation. If you experience a severe allergic or anaphylactic reaction, your healthcare professional will immediately stop the infusion of Fabrazyme and provide you the necessary emergency medical treatment. Because of the possibility that severe allergic reactions may occur, appropriate medical support should be available during your Fabrazyme infusion.
- For patients who have had reactions to their infusions, it is recommended that they be given anti-fever and antihistamine medications right before their next infusions.
- Infusion reactions have happened in some patients even after taking these medications and steroids by mouth before their infusions.
- If an infusion reaction occurs, slowing the infusion rate, stopping the infusion for a short time and/or giving more anti-fever and antihistamine medications and or steroids may improve the symptoms.
- If severe infusion reactions happen, your healthcare professional should consider stopping the Fabrazyme infusion right away and should provide medical care for your condition.
- Severe reactions are generally managed by giving antihistamine medications, corticosteroids, fluids through the vein, and/or oxygen when needed.
- Because severe infusions reactions may happen, medical treatment should be readily available during your Fabrazyme infusion.
Providing Fabrazyme to patients who have experienced severe or serious allergic reactions to Fabrazyme should only be done after carefully considering the risks and benefits of continuing the treatment, and only under the direct supervision of a qualified healthcare professional and with appropriate medical support readily available.
The most common side effects reported with Fabrazyme are infusion reactions, some of which were severe. When Fabrazyme was tested in clinical studies, infusion reactions occurred in approximately 50-55% of patients. Serious and/or frequently occurring side effects (occurring in 5% or more of the patients) thought to be related to Fabrazyme have included one or more of the following: chills, fever, feeling hot or cold, trouble breathing, nausea, flushing of the skin, headache, vomiting, burning and/or tingling sensation, fatigue, itching, pain in the hands and feet, high blood pressure, chest pain, throat tightness, abdominal pain, dizziness, rapid heart rate, nasal congestion, diarrhea, swelling in the legs, muscle pain, back pain, paleness of the skin, slow heart rate, hives, low blood pressure, face swelling, rash and sleepiness.
People with advanced Fabry disease may have heart problems, which may put them at a higher risk for severe complications from infusion reactions, and these patients should be watched closely during their infusion if the decision is made to give them Fabrazyme.
Other serious side effects that were seen in the clinical studies included stroke, pain, lack of muscle coordination, slow or irregular heartbeat, stopping of the heartbeat, decreased blood pumped by the heart, dizziness, hearing loss, and kidney problems resulting in too much protein leaving the body in the urine (nephrotic syndrome). These side effects also occur as part of Fabry disease.
Severe and serious infusion reactions have been reported since Fabrazyme has been approved, some of which were life threatening including anaphylactic shock (a severe allergic reaction). In addition to the above side effects, the following have been reported since Fabrazyme has been approved: joint pain, lack of strength or energy, redness of the skin, increased sweating, reactions at the place where the catheter to give the infusion is placed, increased tearing from the eyes, allergic inflammation of blood vessels, enlarged lymph nodes, decreased sensitivity to touch or pressure, decreased sensitivity of the mouth, sensations of an abnormal heartbeat, runny nose, low oxygen (in general), and low oxygen levels reaching different parts of the body.
Since Fabrazyme has been approved, there have been side effects that resulted in death that may or may not be related to the use of Fabrazyme. These included: the heart and/or lungs stop working (known as cardiorespiratory arrest, respiratory failure, and/or cardiac failure), life-threatening infection in the blood stream (known as sepsis), stroke, heart attack, kidney failure, and pneumonia. Some of these side effects were reported in Fabry disease patients with significant underlying disease.
The safety and effectiveness of Fabrazyme in patients younger than 8 years of age have not been studied.
Most patients taking Fabrazyme who develop IgG antibodies, which are commonly produced by your immune system in response to things it does not recognize as naturally being part of your body, do so within the first three months of taking the medication. In children, the development of these IgG antibodies was associated with Fabrazyme staying in the body for a longer time (prolonged half-life), which was rarely seen in adult patients.
In the clinical studies, a few patients developed IgE antibodies or a reaction to an allergy skin test specific to Fabrazyme. IgE antibodies are usually produced by the body’s immune system during an allergic reaction. Your doctor should consider testing for IgE antibodies if you experience suspected allergic reactions and consider the risks and benefits of continued treatment with Fabrazyme if you have IgE antibodies against Fabrazyme.
Fabrazyme is available by prescription only. Side effects should be reported promptly to Genzyme Medical Information at 800-745-4447, option 2. To learn more, please see the full prescribing information (PDF) or contact Genzyme at 1-800-745-4447.