For Patients & Caregivers

Practice Forms and Documents

Find the enrollment forms you'll need to help patients access HEMLIBRA after it's been prescribed, including for coverage, reimbursement and financial assistance services. There are also tips for composing a letter of medical necessity and appeal letter.

To learn more about the resources available to help your practice, including information on benefits investigations and prior authorizations, go to Helpful Resources for Your Practice.

Quick Links

HEMLIBRA Access Solutions Enrollment Forms
Genentech Patient Foundation Enrollment Forms
Tips for Composing Letters of Medical Necessity and Appeal

HEMLIBRA Access Solutions Enrollment Forms

HEMLIBRA Access Solutions can help your patients better understand their coverage, find financial assistance options, learn how to get HEMLIBRA, understand which specialty pharmacy their health insurance plan requires, reverify coverage if needed and enroll in additional support options in the event of a coverage delay.

Prescriber Service Form

This form is used to collect the patient’s health insurance and treatment information for enrollment in HEMLIBRA Access Solutions.

Download the Prescriber Service Form

Patient Consent Form 

This form is signed and dated by your patient, giving written permission for HEMLIBRA Access Solutions to discuss their health information with you and the patient's health insurance plan.

e-Submit Patient Consent Form
Formulario de Consentimiento del Paciente

Genentech Patient Foundation Enrollment Forms

The Genentech Patient Foundation provides free HEMLIBRA to people who don’t have insurance coverage or who have financial concerns and meet eligibility criteria.

The following forms are needed for applying for assistance from the Genentech Patient Foundation. Learn more about the Genentech Patient Foundation and other resources programs.

Prescriber Foundation Form

Includes patient, insurance and prescription information. Page two must be completed and submitted by the prescriber.

Download the Prescriber Foundation Form

Patient Consent Form

This form is signed and dated by your patient, giving written permission for HEMLIBRA Access Solutions to discuss their health information with you and the patient's health insurance plan.

Download the Patient Consent Form
Download Formulario de Consentimiento del Paciente

Tips for Composing Letters of Medical Necessity and Appeal

Letter of Medical Necessity

This guide provides tips to help you draft a letter of medical necessity. A sample letter is also included for your reference.

Tips for drafting a letter of medical necessity

Appeal Letter

This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference.

Tips for drafting an appeal letter

Appeals

Use the links below to find additional information to enclose in your letter of medical necessity or appeal letter:

FDA approval letter
HEMLIBRA Prescribing Information
Sample Coding: Hemophilia A
NEXT: Financial Assistance Options

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. 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.

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      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.

    • 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.

      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.

    • 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, 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.

    • Di Minno A, Spadarella G, Nardone A, et al. Attempting to remedy sub-optimal medication adherence in haemophilia: the rationale for repeated ultrasound visualisations of the patient’s joint status. Blood Rev. 2019;33:106-119.

      Di Minno A, Spadarella G, Nardone A, et al. Attempting to remedy sub-optimal medication adherence in haemophilia: the rationale for repeated ultrasound visualisations of the patient’s joint status. Blood Rev. 2019;33:106-119.

    • Rocino A, Franchini M, Coppola A. Treatment and prevention of bleeds in haemophilia patients with inhibitors to factor VIII/IX. J Clin Med. 2017;6(4):46.

      Rocino A, Franchini M, Coppola A. Treatment and prevention of bleeds in haemophilia patients with inhibitors to factor VIII/IX. J Clin Med. 2017;6(4):46.

    • Schrijvers LH, Schuurmans MJ, Fischer K. Promoting self-management and adherence during prophylaxis: evidence-based recommendations for haemophilia professionals. Haemophilia. 2016;22(4):499-506.

      Schrijvers LH, Schuurmans MJ, Fischer K. Promoting self-management and adherence during prophylaxis: evidence-based recommendations for haemophilia professionals. Haemophilia. 2016;22(4):499-506.

    • Manco-Johnson MM, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544.

      Manco-Johnson MM, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544.

    • National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (HEMLIBRA®) for hemophilia A with and without inhibitors. December 6, 2018; New York, NY.

      National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (HEMLIBRA®) for hemophilia A with and without inhibitors. December 6, 2018; New York, NY.

    • FDA approves Genentech’s HEMLIBRA (emicizumab-kxwh) for hemophilia A without factor VIII inhibitors. [press release]. South San Francisco, CA: Genentech; October 4, 2018.

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    • Hoffmann-La Roche. A study to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in hemophilia A participants with inhibitors (HAVEN 1). https://clinicaltrials.gov/ct2/show/NCT02622321. NLM identifier: NCT02622321. Accessed August 25, 2020.

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      Hoffmann-La Roche. A study of emicizumab administered subcutaneously (SC) in pediatric participants with hemophilia A and factor VIII (FVIII) inhibitors (HAVEN 2). https://clinicaltrials.gov/ct2/show/NCT02795767. NLM identifier: NCT02795767. Accessed August 25, 2020.

    • 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 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.

    • 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.

      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.

    • 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.

      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.