HEMLIBRA Coverage
Benefits Investigations
HEMLIBRA Access Solutions can conduct a benefits investigation (BI) to help you determine if a Genentech medicine is covered, if prior authorizations (PAs) are required, which specialty pharmacy (SP) the health insurance plan prefers and if patient assistance might be needed.
Potential outcomes of a BI:
- Treatment is covered
- PA is required
- Treatment is denied
A BI may be initiated once the SMN and PAN are submitted to HEMLIBRA Access Solutions.
These can be downloaded from Forms and Documents or submitted online via My Patient Solutions.
The completion and submission of coverage- or reimbursement-related
documentation are the responsibility of the patient and health care
provider. Genentech makes no representation or guarantee concerning
coverage or reimbursement for any service or item.
Prior Authorization
HEMLIBRA Access Solutions can help you identify if a prior authorization (PA) is necessary and offer resources as you obtain it for your patient. PA support may be provided once the SMN and PAN are submitted to HEMLIBRA Access Solutions.
If your patient’s request for a PA is not granted, your Field Reimbursement Manager (FRM) or HEMLIBRA Access Solutions Case Manager can work with you to determine your next steps. You can find more tips like this in Forms and Documents.
The completion and submission of coverage- or reimbursement-related
documentation are the responsibility of the patient and health care
provider. Genentech makes no representation or guarantee concerning
coverage or reimbursement for any service or item.
HEMLIBRA Starter Program
With the HEMLIBRA Starter Program, eligible patients taking HEMLIBRA may receive free medicine while awaiting an insurance coverage determination.
If you think your patient qualifies for the HEMLIBRA Starter Program, submit the completed SMN and PAN to HEMLIBRA Access Solutions.
Once coverage has been determined, the patient no longer qualifies for the HEMLIBRA Starter Program.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
SMN=Statement of Medical Necessity.
Important Safety Information & Indication
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 ≥10%) are injection site reactions, 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.