Find Patient Assistance

Answer a few simple questions to find out which patient assistance option might be right for your patient.

  • Is your patient insured?

  • Does the patient's insurance cover his or her Genentech medicine?

  • Does your patient have commercial insurance?

    What does this mean?
  • Has your patient already been referred to the HEMLIBRA Co-pay Program and is either ineligible or no longer receiving assistance?

  • Has your patient already been referred to an independent co-pay assistance foundation and is either ineligible or no longer receiving assistance?

  • Is the patient taking HEMLIBRA for an approved use?

Your Patient Might Qualify for a Referral to the HEMLIBRA Co-pay Program

If eligible commercially insured patients need assistance with their out-of-pocket costs, HEMLIBRA Access Solutions can refer them to the HEMLIBRA Co-pay Program.*

 

Learn More

 

*In order to be eligible for the HEMLIBRA Co-pay Program, the patient must have commercial insurance, must not have Medicare, Medicaid or other government insurance, and must meet other eligibility criteria. They also must agree to the rules set forth in the terms and conditions for the program. Please visit HEMLIBRACopay.com for the full list of terms and conditions.

Your Patient Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

For eligible patients with commercial or public health insurance, HEMLIBRA Access Solutions offers referrals to independent co-pay assistance foundations.*

 

Learn More

 

*Genentech does not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from HEMLIBRA Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s endorsement or financial support. There may be other foundations to support the patient's disease state.

 

Your Patient Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Genentech medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.*

 

Learn More

 

*To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine must have exhausted all other forms of patient assistance (including the HEMLIBRA Co-pay Program and support from independent co-pay assistance foundations) and must meet financial criteria. Uninsured patients and insured patients without coverage for their medicine must meet different financial criteria.

Patient Assistance Options

Referrals to the HEMLIBRA Co-pay Program

HEMLIBRA Access Solutions can refer eligible patients to the HEMLIBRA Co-pay Program for help with the out-of-pocket costs associated with their Genentech medicine.*

Learn More

Referrals to Independent Co-pay Assistance Foundations

For eligible patients with commercial or public health insurance, HEMLIBRA Access Solutions offers referrals to independent co-pay assistance foundations.†

Learn More

Referrals to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Genentech medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.‡

Learn More

*In order to be eligible for the HEMLIBRA Co-pay Program, the patient must have commercial insurance, must not have Medicare, Medicaid or other government insurance, and must meet other eligibility criteria. They also must agree to the rules set forth in the terms and conditions for the program. Please visit HEMLIBRACopay.com for the full list of terms and conditions.

†Genentech does not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from HEMLIBRA Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s endorsement or financial support. There may be other foundations to support the patient's disease state.

‡To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine must have exhausted all other forms of patient assistance (including the HEMLIBRA Co-pay Program and support from independent co-pay assistance foundations) and must meet financial criteria. Uninsured patients and insured patients without coverage for their medicine must meet different financial criteria.

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

Thrombotic Microangiopathy (TMA) and Thromboembolism Associated With Hemlibra and aPCC

In clinical trials, TMA was reported in 0.8% of patients (3/391) and thrombotic events were reported in 0.5% of patients (2/391). In patients who received at least one dose of aPCC, TMA was reported in 8.1% of patients (3/37) and thrombotic events were reported in 5.4% of patients (2/37). Patients with TMA presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13.

Consider the benefits and risks if aPCC must be used in a patient receiving Hemlibra prophylaxis. Monitor for the development of TMA and/or thromboembolism when administering aPCC. Immediately discontinue aPCC and interrupt Hemlibra prophylaxis if clinical symptoms, imaging, or laboratory findings consistent with TMA and/or thromboembolism occur, and manage as clinically indicated. Consider the benefits and risks of resuming Hemlibra prophylaxis following complete resolution of TMA and/or thrombotic events on a case-by-case basis.

Laboratory Coagulation Test Interference

Hemlibra affects intrinsic pathway clotting-based laboratory tests, including activated clotting time (ACT); activated partial thromboplastin time (aPTT); and all assays based on aPTT, such as one-stage, factor VIII (FVIII) activity. Therefore, intrinsic pathway clotting-based coagulation laboratory test results in patients who have been treated with Hemlibra prophylaxis should not be used to monitor Hemlibra activity, determine dosing for factor replacement or anti-coagulation, or measure FVIII inhibitor titers.

Results affected by Hemlibra: aPTT; Bethesda assays (clotting-based) for FVIII inhibitor titers; one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); ACT.

Results unaffected by Hemlibra: Bethesda assays (bovine chromogenic) for FVIII inhibitor titers; thrombin time (TT); one-stage, prothrombin time (PT)-based single-factor assays; chromogenic-based single-factor assays other than FVIII (see Drug Interactions for FVIII chromogenic activity assay considerations); immuno-based assays (ie, ELISA, turbidimetric methods); genetic tests of coagulation factors (eg, Factor V Leiden, Prothrombin 20210).

Most Common Adverse Reactions

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

Adverse Reactions

Characterization of aPCC Treatment in Pooled Clinical Trials

There were 130 instances of aPCC treatment in 37 patients, of which 13 instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; 2 of the 13 were associated with thrombotic events and 3 of the 13 were associated with TMA. No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.

Injection Site Reactions

In total, 85 patients (22%) reported injection site reactions (ISRs). All ISRs observed in Hemlibra clinical trials were reported as mild to moderate intensity and 93% resolved without treatment. The commonly reported ISR symptoms were injection site erythema (11%), injection site pruritus (4%), and injection site pain (4%).

Other Less Common (<1%) Reactions

Rhabdomyolysis was reported in 2 adult patients with asymptomatic elevations in serum creatinine kinase without associated renal or musculoskeletal symptoms. In both instances, the event occurred following an increase in physical activity.

Drug Interactions

Clinical experience suggests that a drug interaction exists with Hemlibra and aPCC.

Pregnancy, Lactation, Females and Males of Reproductive Potential

Women of childbearing potential should use contraception while receiving Hemlibra. It is not known whether Hemlibra can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hemlibra should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Hemlibra and any potential adverse effects on the breastfed child from Hemlibra or from the underlying maternal condition.

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.