Genzyme Co-pay Assistance Program
The Genzyme Co-Pay Assistance Program helps eligible individuals in the United States who are prescribed treatment with Myozyme pay for their eligible out-of-pocket drug related 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 Myozyme drug costs up to the program maximum.
The 2012 Co-Pay Program runs from January 1, 2012 through December 31, 2012.
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 are:
- U.S. citizens or legal residents who have primary commercial insurance
- Prescribed treatment with Myozyme
You are NOT eligible if:
- Are a resident of Massachusetts
- Have coverage or prescriptions paid for in part or full under any state or federally funded healthcare program including:
- Medicare
- Medicare Advantage Plans
(Example: FreedomBlue offered through Blue Cross Blue Shield)
- Medicaid
- Medigap
- Veterans Affairs, Department of Defense or Tri Care
- High Risk Pool or Pre-existing Condition Insurance Plan (PCIP)
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 cost of Myozyme only, not the cost of the infusion, medical evaluations/appointments, testing, or other related services.
How to get started:
STEP 1
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
STEP 2
Your Genzyme Case Manager verifies eligibility
Your Genzyme Case Manager will review your application to verify eligibility.
If you are eligible, you will be automatically enrolled in the program.
STEP 3
You're enrolled!
Once approved, you will receive confirmation from your Genzyme Case Manager and an enrollment card will be mailed to you within 7-10 days.
Your doctor or specialty pharmacy will also receive a confirmation letter 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 2012.
Your participation in the program is for the current calendar year (Calendar year runs January-December). You will be able to renew enrollment by visiting www.Myozyme.com to complete the online renewal form, or contact your Genzyme Case Manager directly or call 1-800-745-4447, Option 3.
Indication
MYOZYME (alglucosidase alfa) is a lysosomal glycogen-specific enzyme indicated for use in patients with Pompe disease (GAA deficiency). MYOZYME has been shown to improve ventilator-free survival in patients with infantile-onset Pompe disease as compared to an untreated historical control, whereas use of MYOZYME in patients with other forms of Pompe disease has not been adequately studied to assure safety and efficacy.
Important Safety Information
WARNING
Life-threatening anaphylactic reactions, severe allergic reactions and immune mediated reactions have been observed in some patients during MYOZYME infusions. Therefore, appropriate medical support should be readily available when MYOZYME is administered.
Risk of Cardiorespiratory Failure:
Patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to infusion reactions, and require additional monitoring.
Anaphylaxis and Allergic Reactions: Anaphylaxis and severe allergic reactions have been reported in some patients during and up to three hours after MYOZYME infusion, some of which were IgE-mediated. Some of the reactions were life-threatening and included: anaphylactic shock, cardiac arrest, respiratory distress, hypotension, bradycardia, hypoxia, bronchospasm, throat tightness, dyspnea, angioedema, and urticaria. Interventions have included: cardiopulmonary resuscitation, mechanical ventilatory support, oxygen supplementation, intravenous (IV) fluids, hospitalization, treatment with inhaled beta-adrenergic agonists, epinephrine, and IV corticosteroids.
In clinical trials and postmarketing safety experience with MYOZYME, approximately 1% of patients developed anaphylactic shock and/or cardiac arrest during MYOZYME infusion that required life-support measures. In clinical trials and expanded access programs with MYOZYME, approximately 14% of patients treated with MYOZYME have developed allergic reactions that involved at least 2 of 3 body systems, cutaneous, respiratory or cardiovascular systems. These events included: Cardiovascular: hypotension, cyanosis, hypertension, tachycardia, ventricular extrasystoles, bradycardia, pallor, flushing, nodal rhythm, peripheral coldness; Respiratory: tachypnea, wheezing/bronchospasm, rales, throat tightness, hypoxia, dyspnea, cough, respiratory tract irritation, decreased oxygen saturation; Cutaneous: angioedema, urticaria, rash, erythema, periorbital edema, pruritus, hyperhidrosis, cold sweat, livedo reticularis.
If anaphylactic or other severe allergic reactions occur, immediate discontinuation of the administration of MYOZYME should be considered, and appropriate medical treatment should be initiated. Because of the potential for severe allergic reactions, appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available when MYOZYME is administered.
Risk of Acute Cardiorespiratory Failure: Acute cardiorespiratory failure requiring intubation and inotropic support has been observed up to 72 hours after infusion with MYOZYME in infantile-onset Pompe disease patients with underlying cardiac hypertrophy, possibly associated with fluid overload with intravenous administration of MYOZYME. Patients with acute underlying respiratory illness, compromised cardiac function and/or sepsis may be at risk of serious exacerbation of their cardiac or respiratory compromise during infusions. Appropriate medical support and monitoring measures should be readily available during MYOZYME infusion, and infants with cardiac dysfunction may require prolonged observation times that should be individualized based on the needs of the patient.
Risk of Cardiac Arrhythmia and Sudden Cardiac Death During General Anesthesia for Central Venous Catheter Placement: Cardiac arrhythmia, including ventricular fibrillation, ventricular tachycardia and bradycardia, resulting in cardiac arrest or death, or requiring cardiac resuscitation or defibrillation have been observed in infantile-onset Pompe disease patients with cardiac hypertrophy, associated with the use of general anesthesia for the placement of a central venous catheter intended for MYOZYME infusion. Caution should be used when administering general anesthesia for the placement of a central venous catheter in infantile-onset Pompe disease patients with cardiac hypertrophy.
Infusion Reactions: Infusion reactions occurred in 20 of 39 (51%) of patients treated with MYOZYME in clinical studies. Severe infusion reactions reported in more than 1 patient in clinical studies and the expanded access program included: fever, decreased oxygen saturation, tachycardia, cyanosis and hypotension. Other infusion reactions reported in more than 1 patient in clinical studies and the expanded access program included: rash, flushing, urticaria, fever, cough, tachycardia, decreased oxygen saturation, vomiting, tachypnea, agitation, increased blood pressure/hypertension, cyanosis, irritability, pallor, pruritus, retching, rigors, tremor, hypotension, bronchospasm, erythema, face edema, feeling hot, headache, hyperhidrosis, increased lacrimation, livedo reticularis, nausea, periorbital edema, restlessness and wheezing. Some patients were pre-treated with antihistamines, antipyretics and/or steroids. Infusion reactions occurred in some patients after receiving antipyretics, antihistamines, or steroids. Infusion reactions may occur at any time during, or up to 2 hours after, the infusion of MYOZYME, and are more likely with higher infusion rates.
Immune Mediated Reactions: Severe cutaneous and systemic immune mediated reactions have been reported in postmarketing experience with MYOZYME in at least 2 patients, including ulcerative and necrotizing skin lesions, and possible type III immune complex-mediated reactions. Patients should be monitored for the development of systemic immune complex-mediated reactions involving skin and other organs while receiving MYOZYME.
Monitoring: Laboratory Tests: Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter. Testing for IgG titers may also be considered if patients develop allergic or other immune mediated reactions. Patients who experience anaphylactic or allergic reactions may also be tested for IgE antibodies to alglucosidase alfa and other mediators of anaphylaxis.
Adverse Reactions: The most serious adverse reactions reported with MYOZYME were anaphylactic reactions, acute cardiorespiratory failure, and cardiac arrest. Anaphylactic reactions have been reported during and within 3 hours after MYOZYME infusion. Acute cardiorespiratory failure has been observed in a few infantile-onset Pompe disease patients with underlying cardiac hypertrophy, possibly associated with fluid overload with intravenous administration of alglucosidase alfa.
The most common serious treatment-emergent adverse reactions occurring in >10% of patients observed in clinical studies with MYOZYME were pneumonia, respiratory failure, respiratory distress, catheter-related infection, respiratory syncytial virus infection, gastroenteritis and fever. The most common treatment-emergent adverse reactions occurring in ≥ 20% of patients were fever, diarrhea, rash, vomiting, cough, pneumonia, otitis media, upper respiratory tract infection, gastroenteritis and decreased oxygen saturation.
The most common adverse reactions requiring intervention were infusion reactions. Twenty of 39 patients (51%) treated with MYOZYME in clinical studies developed infusion reactions.
Immunogenicity: The majority of patients (34 of 38; 89%) in the two clinical trials tested positive for IgG antibodies to alglucosidase alfa. Most patients who develop antibodies do so within the first 3 months of exposure. There is evidence to suggest that patients developing sustained titers ≥12,800 of anti-alglucosidase alfa antibodies may have a poorer clinical response to treatment, or may lose motor function as antibody titers increase. Five patients with antibody titers ≥ 12,800 at Week 12 had an average increase in clearance of 50% from Week 1 to Week 12. The effect of antibody development on the long-term efficacy of MYOZYME is not fully understood. However, CRIM-negative infants have shown poorer clinical response in the presence of high sustained IgG antibody titers and inhibitory and positive inhibitory antibodies. Patients who develop IgE antibodies to alglucosidase alfa appear to be at a higher risk for the occurrence of anaphylaxis and severe allergic reactions. Therefore, these patients should be monitored more closely during administration of MYOZYME.
To report suspected adverse reactions, contact Genzyme at 800-745-4447, option 2 or FDA at 800-FDA-1088 or http://www.fda.gov/Safety/MedWatch
Please see full prescribing information for complete details, including boxed warning.