HEMLIBRA Insurance & Financial Resources

We’re dedicated to helping every patient get the medicine they need

Insurance and access support for your practice

More than 95% of people nationally have insurance coverage for HEMLIBRA.*1

HEMLIBRA has established coverage under Medicaid in 45 states.


The HEMLIBRA distribution network reaches all hemophilia treatment centers (HTCs) and hospitals and a broad network of specialty pharmacies and distributors.


Access Process Tips Worksheet

Make sure you have the appropriate documentation before filling out prior authorization forms. 


Financial support for your patients

Eligible commercially insured patients pay as little as $5 for their medicine with the HEMLIBRA Co-pay Program. The program: 

  • Helps with up to $15,000 per year in out-of-pocket (drug co-pay, co-insurance, or deductible) costs of HEMLIBRA
  • Covers up to 6 months of past HEMLIBRA treatment cost
  • Does not have any household income or other financial criteria requirements

HEMLIBRA Access Solutions® provides helpful access and reimbursement support to assist your patients and practice after HEMLIBRA is prescribed.

HEMLIBRA Access Solutions can help your patients:

  • Better understand their coverage
  • Find financial assistance options
  • Learn how to get their HEMLIBRA 
  • Know which specialty pharmacy their health insurance plan requires

If eligible publicly or commercially insured patients have difficulty paying for their co-pay, co-insurance, or other out-of-pocket (OOP) costs, HEMLIBRA Access Solutions can refer them to an independent co-pay assistance foundation supporting their disease state. Patients must meet eligibility criteria.

Learn more about HEMLIBRA Access Solutions.


People who do not have health insurance, who have health insurance that does not cover their HEMLIBRA, or who can’t afford their OOP costs and meet eligibility criteria may get free medicine§ through the Genentech Patient Foundation


How can I enroll my patients in HEMLIBRA Access Solutions?

To enroll in HEMLIBRA Access Solutions, complete and submit the following 2 forms:

  • The Prescriber Service Form—a form with patient, insurance, and prescription information used when contacting a patient’s health insurance plan to determine his or her coverage
  • Patient Consent Form—a form signed and dated by your patient giving written permission for HEMLIBRA Access Solutions to discuss his or her health information with you and the patient’s health insurance plan

Have more access questions?
A dedicated expert for hemophilia A can answer any access-related questions at (877) 233-3981

*Coverage defined as a payer with a published policy for HEMLIBRA. Coverage may vary for individual and plan. Data as of July 2020.
Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications. Patients must be taking HEMLIBRA for FDA-approved indication. See full terms and conditions at HEMLIBRACopay.com.
Genentech and HEMLIBRA do 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 HEMLIBRA 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.

Indication & 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
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 creatine 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.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

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