About HAEGARDA

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About hereditary angioedema

With hereditary angioedema (HAE), almost all costs increase with disease severity. ln fact, emergency department (ED) and hospitalization costs are more than 100 times greater in severe attacks vs mild attacks.1 In an exploratory endpoint of the pivotal trial, patients on HAEGARDA experienced fewer severe attacks.2

C1 esterase inhibitor (C1-INH) is currently a preferred long-term prophylaxis for the prevention of HAE attacks, including those in pregnant and breastfeeding patients, as well as in children aged ≤12 years.3,4* Patients with HAE are deficient in the C1-INH protein or have malfunctioning C1-INH protein and can have several attacks per week, which can range from mild to severe.5-7

HAEGARDA, C1 esterase inhibitor subcutaneous (human), replaces the missing or dysfunctional C1-INH. In the pivotal trial, HAEGARDA 60 IU/kg reduced the number of HAE attacks by a median of 95%.7 In a long-term study following patients over 1.4 years, HAEGARDA reduced the HAE attack rate to a median of 1 per year vs a mean of 4.3 attacks per month in the 3 months prior to study entry.8†

HAEGARDA is an affordable HAE therapy that is safe and approved for use in ages ≥6 years.7-10

Explore more clinical information here.
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*The World Allergy Organization/European Academy of Allergy and Clinical Immunology (WAO/EAACI) 2021 guidelines state that plasma-derived C1-INH is currently a preferred long-term prophylaxis for the prevention of HAE attacks.3 The US Hereditary Angioedema Association (HAEA) Medical Advisory Board 2020 Guidelines state that C1-INH is the preferred therapy for pregnant or breastfeeding patients with HAE and long-term prophylaxis in children.4

†Median attack rate in patients who were followed an average of 1.4 years.8

What is HAEGARDA?

HAEGARDA, C1 esterase inhibitor subcutaneous (human), is a plasma-derived concentrate of C1-INH indicated for routine prophylaxis to prevent HAE attacks in patients aged ≥6 years. HAEGARDA is for subcutaneous use after reconstitution only.

HAEGARDA is the only C1-INH subcutaneous therapy for the prevention of HAE attacks.

What are the key benefits?

95% icon

reduction

in HAE attacks vs placebo2‡
>99% icon

reduction

in the use of rescue medication2§
≥6 years icon

Age ≥6 years

Approved for use in ages ≥6 years
Please see full prescribing information for HAEGARDA.
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‡Median reduction in number of attacks in patients receiving 60 IU/kg of HAEGARDA vs placebo.2
§Median reduction in rescue medication use in patients receiving 60 IU/kg of HAEGARDA vs placebo.2

What has ICER said about HAEGARDA?

  • Demonstrated the lowest cost per HAE attack avoided among long-term prophylaxis options evaluated9,10ll:
18.9 times icon

more cost effective

than Cinryze® (C1 esterase inhibitor [human])
3.2 times icon

more cost effective

than Takhzyro® (lanadelumab-flyo)
  • Achieved an “A” rating from the Institute for Clinical and Economic Review (ICER)9,10ll
  • Reduced the number of rescue medications used per month, which can represent dramatic cost savings2‡§¶

‡Median reduction in number of attacks in patients receiving 60 IU/kg of HAEGARDA vs placebo.2

§Median reduction in rescue medication use in patients receiving 60 IU/kg of HAEGARDA vs placebo.2

IIICER study design: In 2018, ICER published results from a cost-effectiveness study of long-term prophylaxis over a lifetime horizon for patients with HAE. The incremental cost-effectiveness ratio was calculated by considering the differences in survival, quality-adjusted survival, and costs between prophylaxis and no prophylaxis.9

COMPACT study design: In a 32-week, placebo-controlled crossover study, patients aged ≥12 years with symptomatic type I or II HAE (N=90) were randomly assigned to twice-weekly HAEGARDA 40 IU/kg or 60 IU/kg. Patients initiated 16 weeks of active therapy or placebo and crossed over to placebo or active therapy for the subsequent 16 weeks. Baseline HAE attack frequency was a mean of 8.8 in the 3 months before screening for the 60 IU/kg group.2

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Important Safety Information

The healthcare economic information provided herein is pursuant to Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) and Section 3037 of the 21st Century Cures Act (Public Law 114-255). It is intended for payors, formulary committees, or other similar entities with knowledge and expertise in the area of healthcare economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement.

Important Safety Information

HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older. HAEGARDA is for subcutaneous use after reconstitution only.

HAEGARDA is contraindicated in patients with a history of life-threatening hypersensitivity reactions, including anaphylaxis, to C1-INH preparations or their excipients.

Severe hypersensitivity reactions to HAEGARDA could occur. In such cases, discontinue administration and institute appropriate treatment. Epinephrine should be immediately available to treat hypersensitivity reactions.

At the recommended subcutaneous dose of HAEGARDA, no causal relationship to thromboembolic events (TEs) has been established. However, TEs have been reported with intravenous administration of C1-INH products, usually at high doses.

In clinical trials, adverse reactions observed in more than 4% of subjects treated with HAEGARDA were injection-site reactions, hypersensitivity, nasopharyngitis, and dizziness.

HAEGARDA is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.

Please see full prescribing information for HAEGARDA.

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To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References: 1. Wilson DA, Bork K, Shea EP, Rentz AM, Blaustein MB, Pullman WE. Economic costs associated with acute attacks and long-term management of hereditary angioedema. Ann Allergy Asthma Immunol. 2010;104(4):314-320. doi:10.1016/j.anai.2010.01.024 2. Longhurst H, Cicardi M, Craig T, et al; COMPACT Investigators. Prevention of hereditary angioedema attacks with a subcutaneous C1 inhibitor. N Engl J Med. 2017;376(12):1131-1140. doi:10.1056/NEJMoa1613627 3. Maurer M, Magerl M, Betschel S, et al. The international WAO/EAACI guideline for the management of hereditary angioedema-The 2021 revision and update. Allergy. 2022;77(7):1961-1990. doi:10.1111/all.15214 4. Busse PJ, Christiansen SC, Riedl MA, et al. US HAEA Medical Advisory Board 2020 guidelines for the management of hereditary angioedema. J Allergy Clin Immunol Pract. 2021;9(1):132-150.e3. doi:10.1016/j.jaip.2020.08.046 5. Lumry WR. Overview of epidemiology, pathophysiology, and disease progression in hereditary angioedema. Am J Manag Care. 2013;19(7)(suppl):s103-s110. 6. Bernstein JA. HAE update: epidemiology and burden of disease. Allergy Asthma Proc. 2013;34(1):3-6. doi:10.2500/aap.2013.34.3623 7. Zuraw BL, Cicardi M, Longhurst HJ, et al. Phase II study results of a replacement therapy for hereditary angioedema with subcutaneous C1-inhibitor concentrate. Allergy. 2015;70(10):1319-1328. doi:10.1111/all.12658 8. Craig T, Zuraw B, Longhurst H, et al; COMPACT Investigators. Long-term outcomes with subcutaneous C1-inhibitor replacement therapy for prevention of hereditary angioedema attacks. J Allergy Clin Immunol Pract. 2019;7(6):1793-1802.e2. doi:10.1016/j.jaip.2019.01.054 9. Institute for Clinical and Economic Review. Prophylaxis for hereditary angioedema with lanadelumab and C1 inhibitors: effectiveness and value. Final evidence report. Published November 15, 2018. Accessed March 15, 2021. https://icer.org/wp-content/uploads/2020/10/ICER_HAE_Final_Evidence_Report_111518-1.pdf 10. Data on file. Available from CSL Behring as DOF HGD-003.

HAEGARDA is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.

HAEGARDA® is a registered trademark of CSL Behring GmbH.

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©2022 CSL Behring. The product information presented on this page is intended for US residents only.

HGD-0175-OCT22

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