Helpful Resources for Your Practice

HEMLIBRA Access Solutions offers a range of access and reimbursement resources for your patients and practice after HEMLIBRA is prescribed, including help with benefits investigations (BIs), resources for prior authorizations (PAs), sample billing and coding information, resources for denials and appeals, information about distribution and referrals to potential financial assistance options.

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Coverage

Get help understanding insurance benefits and coverage, such as with benefits investigations and prior authorization resources.

Benefits investigations

HEMLIBRA Access Solutions can conduct a benefits investigation (BI) which can determine:

  • If treatment is covered
  • If treatment is denied
  • If a prior authorization or pre-determination is required*
  • If your patient's insurance plan has a mandated or preferred SP

*If your patient’s request for a prior authorization is not granted, your HEMLIBRA Access Solutions Specialist can work with you to determine your next steps.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and healthcare provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.

HEMLIBRA Case Managers

A Case Manager may assist during your patients' treatment with access and reimbursement.

Learn more about HEMLIBRA Case Managers

Starter Program

Patients facing a coverage delay may be eligible for the HEMLIBRA Starter Program while awaiting insurance verification. If you would like your patient considered for the HEMLIBRA Starter Program, you can indicate that when enrolling in HEMLIBRA Access Solutions with the Prescriber Service Form. You will also need to have your patient complete the Patient Consent Form.

Eligible patients can receive up to two 30-day supplies of HEMLIBRA. Once coverage has been determined, the patient no longer qualifies for the HEMLIBRA Starter Program.

Subject to eligibility requirements and terms and conditions. This program is void where prohibited by law and may not be used in or by residents of restricted states, if applicable.

View full TERMS AND CONDITIONS.

HEMLIBRA Benefits Reverification

When a medical treatment is authorized by the patient’s insurance plan for a limited period of time, it will generally require reverification of coverage for continued treatment. HEMLIBRA Access Solutions can help you obtain reverification for your patients.

If the patient’s health insurance plan denies the request for reverification, your practice may file an appeal on behalf of your patient.


Reimbursement

Sample coding information and resources for denials and appeals

HEMLIBRA Sample Coding

This coding information may assist you as you complete the payer forms for HEMLIBRA. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding.

Download sample coding and the important safety information for HEMLIBRA below.

Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

Appeals

If your patient’s health insurance plan has issued a denial, your HEMLIBRA Access Solutions Specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements. 

If a plan issues a denial: 

  1. The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
  2. Your HEMLIBRA Access Solutions Specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

A sample appeal letter and additional considerations are available on the Practice Forms and Documents page.

Appeals cannot be completed or submitted by Genentech on your behalf.


Online patient enrollment

My Patient Solutions is an online tool to help you enroll patients in HEMLIBRA Access Solutions and manage your service requests, all through one portal. It allows you the flexibility to work with HEMLIBRA Access Solutions when it’s convenient for you.

With My Patient Solutions, you can:

  • Enroll and re-enroll patients in financial assistance programs entirely online
  • Communicate with your HEMLIBRA Access Solutions Specialist
  • Easily identify next steps for service requests
  • View Benefits Investigation reports for all your enrolled patients
  • Follow up on prior authorizations or appeals
  • View co-pay assistance outcomes and referral information

How to register

Account registration can be completed by one person for the entire practice and for multiple practice locations. For help with registration or if you have questions, call us at 877-GENENTECH (877-436-3683) (6AM-5PM PST, Monday through Friday).


HEMLIBRA Distribution

HEMLIBRA Access Solutions works with specialty pharmacies (SPs) to help patients receive their prescribed Genentech medicines.

In addition to distributing medicines, an SP may provide the following services:

  • Reimbursement resources
  • Clinical services to help patients throughout their treatment
  • The ability to manage the specialty handling and shipping needs linked with many specialty therapies

You can work with your preferred SP or contact HEMLIBRA Access Solutions to learn which SP the patient’s health insurance plan mandates or prefers.

Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item. For any product-specific distribution questions, call HEMLIBRA Access Solutions at 888-249-4918 (6AM-5PM PST, Monday through Friday).

Contact Us

Questions? Contact HEMLIBRA Access Solutions

Call 888-249-4918 (Mon.–Fri., 6AM–5PM PST)

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. Due to the long half-life of HEMLIBRA, the potential for an interaction with aPCC may persist for up to 6 months after the last dose. 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.

Immunogenicity
Treatment with HEMLIBRA may induce anti-drug antibodies. Anti-emicizumab-kxwh antibodies were reported in 5.1% of patients (34/668) treated with HEMLIBRA in clinical trials. Most patients with anti-emicizumab-kxwh antibodies did not experience a change in HEMLIBRA plasma concentrations or an increase in bleeding events; however, in uncommon cases (incidence <1%), the presence of neutralizing antibodies with decreasing plasma concentration may be associated with loss of efficacy.

Monitor for clinical signs of loss of efficacy (eg, increase in breakthrough bleeding events) and if observed, promptly assess the etiology and consider a change in treatment if neutralizing anti-emicizumab-kxwh antibodies are suspected.

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.

    • Our commitment to provide transparent and timely safety information about emicizumab-kxwh. Genentech, Inc. https://www.emicizumabinfo.com/content/emicizumabinfo/en_us/patient.html#. Accessed August 25, 2020.

      Our commitment to provide transparent and timely safety information about emicizumab-kxwh. Genentech, Inc. https://www.emicizumabinfo.com/content/emicizumabinfo/en_us/patient.html#. Accessed August 25, 2020.

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      Chugai Pharmaceutical Co., Ltd. Randomized, placebo-controlled, double-blind, single ascending dose study and open-label multiple ascending dose study. https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-121934. Main ID: JPRN-JapicCTI-121934. Accessed August 25, 2020.

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    • HEMLIBRA [package insert]. South San Francisco, CA: Genentech, Inc.

      HEMLIBRA [package insert]. South San Francisco, CA: Genentech, Inc.

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      National Hemophilia Foundation. MASAC update on the approval and availability of the new treatment: Emicizumab (HEMLIBRA), for persons with hemophilia A with inhibitors to factor VIII: Interim guidance on acute bleed management and use of laboratory assays. November 24, 2017; New York, NY.

    • Kitazawa T, Esaki K, Tachibana T, et al. Factor VIIIa-mimetic cofactor activity of a bispecific antibody to factors IX/IXa and X/Xa, emicizumab, depends on its ability to bridge the antigens. Thromb Haemost. 2017;117(7):1348-1357.

      Kitazawa T, Esaki K, Tachibana T, et al. Factor VIIIa-mimetic cofactor activity of a bispecific antibody to factors IX/IXa and X/Xa, emicizumab, depends on its ability to bridge the antigens. Thromb Haemost. 2017;117(7):1348-1357.

    • Young G, Liesner R, Chang T, et al. A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. Blood. 2019;134(24):2127-2138.

      Young G, Liesner R, Chang T, et al. A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. Blood. 2019;134(24):2127-2138.

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      Shima M, Hanabusa H, Taki M, et al. Long-term safety and efficacy of emicizumab in a phase 1/2 study in patients with hemophilia A with or without inhibitors. Blood Adv. 2017;1(22):1891-1899.

    • Shima M, Nagao A, Masashi T, et al. Long-term safety and efficacy of emicizumab for up to >5 years in a phase 1/2 study in patients with severe hemophilia A. Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.

      Shima M, Nagao A, Masashi T, et al. Long-term safety and efficacy of emicizumab for up to >5 years in a phase 1/2 study in patients with severe hemophilia A. Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.

    • Wang S, Zhao X, Wang X, et al. A randomized, multicenter, open-label, phase III clinical trial to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in persons with hemophilia A in the Asia-Pacific region (HAVEN 5). Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.

      Wang S, Zhao X, Wang X, et al. A randomized, multicenter, open-label, phase III clinical trial to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in persons with hemophilia A in the Asia-Pacific region (HAVEN 5). Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.

    • Shima M, Nogami K, Nagami S, et al. A multicentre, open-label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors. Haemophilia. 2019;25(6):979-987.

      Shima M, Nogami K, Nagami S, et al. A multicentre, open-label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors. Haemophilia. 2019;25(6):979-987.

    • Jiménez-Yuste V, Klamroth R, Castaman G, et al. Second interim analysis results from the STASEY trial: a single-arm, multicenter, open-label, phase III clinical trial to evaluate the safety and tolerability of emicizumab prophylaxis in people with hemophilia A (PwHA) with FVIII inhibitors. Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.

      Jiménez-Yuste V, Klamroth R, Castaman G, et al. Second interim analysis results from the STASEY trial: a single-arm, multicenter, open-label, phase III clinical trial to evaluate the safety and tolerability of emicizumab prophylaxis in people with hemophilia A (PwHA) with FVIII inhibitors. Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.

    • Callaghan M, Negrier C, Paz-Priel I, et al. Emicizumab treatment is efficacious and well tolerated long term in persons with haemophilia (PwHA) with or without FVIII inhibitors: pooled data from four HAVEN studies. Slide deck presented at: International Society on Thrombosis and Haemostasis 2019 Congress; July 6–10, 2019; Melbourne, Australia.

      Callaghan M, Negrier C, Paz-Priel I, et al. Emicizumab treatment is efficacious and well tolerated long term in persons with haemophilia (PwHA) with or without FVIII inhibitors: pooled data from four HAVEN studies. Slide deck presented at: International Society on Thrombosis and Haemostasis 2019 Congress; July 6–10, 2019; Melbourne, Australia.

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    • Young G, Liesner R, Sidonio R Jr, et al. Emicizumab prophylaxis provides flexible and effective bleed control in children with hemophilia A with inhibitors: results from the HAVEN 2 study. Presented at: ASH 60th Annual Meeting of the American Society of Hematology; December 1–4, 2018; San Diego, CA.

      Young G, Liesner R, Sidonio R Jr, et al. Emicizumab prophylaxis provides flexible and effective bleed control in children with hemophilia A with inhibitors: results from the HAVEN 2 study. Presented at: ASH 60th Annual Meeting of the American Society of Hematology; December 1–4, 2018; San Diego, CA.

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      Hoffmann-La Roche. A clinical trial to evaluate prophylactic emicizumab versus no prophylaxis in hemophilia A participants without inhibitors (HAVEN 3). https://clinicaltrials.gov/ct2/show/NCT02847637. NLM identifier: NCT02847637. Accessed August 25, 2020.

    • Hoffmann-La Roche. A study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab given every 4 weeks in participants with hemophilia A (HAVEN 4). https://clinicaltrials.gov/ct2/show/NCT03020160. NLM identifier: NCT03020160. Accessed August 25, 2020.

      Hoffmann-La Roche. A study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab given every 4 weeks in participants with hemophilia A (HAVEN 4). https://clinicaltrials.gov/ct2/show/NCT03020160. NLM identifier: NCT03020160. Accessed August 25, 2020.

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      Kruse-Jarres R, Callaghan MU, Croteau SE, et al. Surgical experience in two multicenter, open-label phase 3 studies of emicizumab in persons with hemophilia A with inhibitors (HAVEN 1 and HAVEN 2) [abstract]. Presented at: 59th Annual Meeting of the American Society of Hematology; December 9-12, 2017; Atlanta, GA.

    • Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018;379(9):811-822.

      Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018;379(9):811-822.

    • HEMLIBRA Summary of Product Characteristics. Roche Registration Limited; 2019.

      HEMLIBRA Summary of Product Characteristics. Roche Registration Limited; 2019.

    • Santagostino E, Oldenburg J, Chang T, et al. Surgical experience from four phase III studies (HAVEN 1–4) of emicizumab in persons with haemophilia A (PwHA) with or without FVIII inhibitors. Slide deck presented at: International Society on Thrombosis and Haemostasis 2019 Congress; July 6–10, 2019; Melbourne, Australia.

      Santagostino E, Oldenburg J, Chang T, et al. Surgical experience from four phase III studies (HAVEN 1–4) of emicizumab in persons with haemophilia A (PwHA) with or without FVIII inhibitors. Slide deck presented at: International Society on Thrombosis and Haemostasis 2019 Congress; July 6–10, 2019; Melbourne, Australia.

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      Sampei Z, Igawa T, Soeda T, et al. Identification and multidimensional optimization of an asymmetric bispecific IgG antibody mimicking the function of factor VIII cofactor activity. PLoS One. 2013;8(2):e57479.

    • Santagostino E, Parnes A, Dhalluin C, et al. Surgical procedures in persons with haemophilia A (PwHA) without inhibitors receiving emicizumab – experience from the HAVEN 3 study. Presented at: 12th Annual Congress of the European Association of Haemophilia and Allied Disorders (EAHAD); February 6–8, 2019; Prague, Czech Republic.

      Santagostino E, Parnes A, Dhalluin C, et al. Surgical procedures in persons with haemophilia A (PwHA) without inhibitors receiving emicizumab – experience from the HAVEN 3 study. Presented at: 12th Annual Congress of the European Association of Haemophilia and Allied Disorders (EAHAD); February 6–8, 2019; Prague, Czech Republic.