Terms and Conditions

This HEMLIBRA Co-pay Program is valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid, Medigap, Veteran's Affairs (VA), Department of Defense (DoD), TRICARE or any other federal or state government program (collectively, "Government Programs") to pay for their medications are not eligible. The program is not valid for medications that are eligible to be reimbursed in their entirety by private insurance plans or other programs.

Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all remaining out-of-pocket expenses. This program is not health insurance or a benefit plan. The program does not obligate the use of any specific product or provider. Patients receiving assistance from charitable assistance programs (such as Genentech Patient Foundation) are not eligible. The co-pay benefit cannot be combined with any other rebate, free trial or similar offer for the medication. No party may seek reimbursement for all or any part of the benefit received through this program.

The program may be accepted by participating pharmacies, physician offices or hospitals. Once a patient is enrolled, this program will not honor claims with date of service or medication dispensing that precede program enrollment by more than 180 days. Use of this program must be consistent with all relevant health insurance requirements. Participating patients, pharmacies, physician offices and hospitals are responsible for reporting the receipt of all program benefits as required by any insurer or by law. Program benefits may not be sold, purchased, traded or offered for sale.

The patient or their guardian must be 18 years or older to receive program assistance. This program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. Program eligibility is contingent upon the patient's ability to meet and maintain all requirements set forth by the program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time.

Indication and Important Safety Information

 

Indication

HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.

Important Safety Information

Boxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM
Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

Warnings and Precautions

  • Laboratory coagulation test interference: HEMLIBRA interferes with activated clotting time (ACT); activated partial thromboplastin time (aPTT); and coagulation laboratory tests based on aPTT, including one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); and Bethesda assays (clotting-based) for factor VIII (FVIII) inhibitor titers. Intrinsic pathway clotting-based laboratory tests should not be used

Most Common Adverse Reactions

The most common adverse reactions (incidence rate ≥ 10%) were injection site reactions and headache, and arthralgia.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the HEMLIBRA full Prescribing Information for additional Important Safety Information, including Boxed WARNING.