BlueCross BlueShield of Tennessee Medical Policy Manual

C1 Esterase Inhibitor Subcutaneous (Human) (Haegarda®)

NDC CODE(S)

63833-0828-XX Haegarda 2000 UNIT SOLR  (CSL BEHRING)

 

63833-0829-XX Haegarda 3000 UNIT SOLR  (CSL BEHRING)

DESCRIPTION

On March 28, 2017, the FDA approved the first subcutaneous C1 Esterase Inhibitor for the prevention of Hereditary Angioedema (HAE) attacks.  Haegarda® is a human plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.  Haegarda® is prepared from large pools of human plasma from U.S. donors and is a purified, pasteurized, lyophilized concentrate of C1-INH to be reconstituted for subcutaneous administration. The potency of C1-INH is expressed in International Units (IU), which is related to the current WHO Standard for C1-INH products.

HAE patients have absence or low levels of endogenous or functional C1-INH. Although the events that cause attacks of angioedema in HAE patients are not well defined, it is theorized that increased vascular permeability and the clinical manifestation of HAE attacks may be primarily mediated through contact system activation. Suppression of contact system activation by C1-INH through the inactivation of plasma kallikrein and factor XIIa is thought to modulate vascular permeability by preventing the generation of bradykinin. Administration of Haegarda® replaces the missing or malfunctioning C1-INH protein in patients with HAE.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Prophylaxis of Hereditary Angioedema (HAE) attacks 60 IU/kg body weight injected subcutaneously twice weekly (every 3 or 4 days)

LENGTH OF AUTHORIZATION

Coverage will be provided for 12 months and may be renewed

Refer to DOSAGE LIMITS below

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

IMPORTANT REMINDER

We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.

ADDITIONAL INFORMATION 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

SOURCES

Bernstein, J. A. (2018). Severity of hereditary angioedema, prevalence, and diagnostic considerations. American Journal of Managed Care, 24 (14), S292-S298.

Lumry, W. R. (2018). Current and emerging therapies to prevent hereditary angioedema attacks. American Journal of Managed Care, 24 (14), S299-S307.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, July). C1 esterase inhibitor subcutaneous (human). Retrieved August 9, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2017, March). Center for Biologics Evaluation and Research. HAEGARDA® (C1 esterase inhibitor subcutaneous [human]). Retrieved August 9, 2018 from:

https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM564335.pdf.   

ORIGINAL EFFECTIVE DATE: 10/1/2018

MOST RECENT REVIEW DATE:  4/2/2019

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

This document has been classified as public information.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit  

DIAGNOSIS

BILLABLE UNIT

MAXIMUM UNITS

Prophylaxis of Hereditary Angioedema (HAE) attacks

1 billable unit = 10 IU

5,600 billable units per 28 days