*Valid only for those patients with commercial prescription insurance coverage for products who meet eligibility criteria. Offer not valid for prescriptions, administration, or related labs reimbursed, in whole or in part, by any federal, state, or government-funded insurance programs (for example, Medicare, Medicare Advantage, Medigap, Medicaid, VA, DoD, or TRICARE), for cash-paying patients, where product, administration, or related labs are not covered by patient’s commercial insurance, where patient’s commercial insurance plan reimburses them for the entire cost of their prescription drug, administration, and/or related labs, or where prohibited by law or by the patient’s health insurance provider. Patients who are residents of certain states (MA or RI) are not eligible for drug administration co-pay support. Patients who are residents of certain states (MI, MN, or RI) are not eligible for laboratory services co-pay support. If at any time a patient begins receiving prescription drug, administration, or related lab coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the BioMarin Co-Pay Assistance Program and patient must notify BioMarin RareConnections at 1-833-ROCTAVIAN (1-833-762-8284) to stop participation. Patients may not seek reimbursement for the value of the out-of-pocket expense amount covered by the Program from any third-party payer, whether public or private. The Program is valid ONLY for qualifying patients residing in the 50 US states or in Puerto Rico with commercial insurance who have a valid prescription for an FDA-approved indication for the qualifying BioMarin therapy. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. Co-payment assistance under the Program is not transferable. BioMarin Pharmaceutical Inc. reserves the right to rescind, revoke, or amend the Program without notice. Patient/caregiver certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer. The Program is subject to termination or modification at any time. Some restrictions apply.
†Mobile blood draw services and walk-in lab support for blood draws related to ROCTAVIAN gene therapy are for commercially insured patients only. These services are not available to residents of certain states (MI, MN, RI). Some restrictions apply.
Do not take ROCTAVIAN if you:
What is the most important information I should know about ROCTAVIAN?
ROCTAVIAN may cause serious side effects during the infusion and afterward:
What should I tell my doctor before I get ROCTAVIAN?
Talk to your doctor about the following:
What should I avoid after taking ROCTAVIAN?
What are the possible side effects of ROCTAVIAN?
What other information should I know before getting ROCTAVIAN?
Talk to your doctor about the potential risks and benefits of ROCTAVIAN. Whether a patient experiences a benefit or not, the risks discussed here and with your doctor still apply.
These are not all the possible side effects of ROCTAVIAN. Talk to your doctor for medical advice about side effects. You may report side effects to BioMarin Pharmaceutical Inc. at 1-866-906-6100 or FDA at 1-800-FDA-1088.
What is ROCTAVIAN?
ROCTAVIAN is a one-time gene therapy used for the treatment of adults with severe hemophilia A who do not have antibodies to the virus, AAV5 which is determined by a blood test. ROCTAVIAN uses a modified virus, called a vector, to deliver a working copy of the Factor VIII gene to liver cells to enable your body to produce clotting factor on its own, which helps the blood to clot and prevents or reduces the occurrence of bleeding. The modified virus does not contain viral DNA and does not cause disease in humans.