BlueCross BlueShield of Tennessee Medical Policy Manual

Icatibant

NDC CODE(S)

54092-0702-XX Firazyr 30 MG/3 ML SOLN (SHIRE)

DESCRIPTION

Icatibant, a synthetic decapeptide, is a competitive antagonist selective for the bradykinin B2 receptor, with an affinity similar to bradykinin. Hereditary angioedema is caused by an absence or dysfunction of C1 esterase inhibitor, a key regulator of the Factor XII/kallikrein proteolytic cascade that leads to bradykinin production.  Bradykinin is a vasodilator which is thought to be responsible for the characteristic HAE symptoms of localized swelling, inflammation, and pain. Icatibant inhibits bradykinin from binding the B2 receptor and thereby treats the clinical symptoms of an acute, episodic attack of HAE.

POLICY

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Hereditary Angioedema (HAE) 30 mg injected subcutaneously in the abdominal area. May be repeated every 6 hours up to a total of 3 doses (90 mg) in 24 hours. Patients may self-administer icatibant.

LENGTH OF AUTHORIZATION

Coverage will be provided for 12 weeks and may be renewed

See RENEWAL CRITERIA for information concerning the cumulative amount of medication(s) the individual may maintain per authorization. 

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.

Lexicomp Online. (2018). AHFS DI. Icatibant. Retrieved August 8, 2018 from Lexicomp Online with AHFS.

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, November). Icatibant. Retrieved November 21, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2015, November). Center for Drug Evaluation and Research. Firazyr® (icatibant) injection, for subcutaneous use. Retrieved November 21, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022150s007lbl.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

Hereditary Angioedema (HAE)

1 billable unit = 1 mg

360 billable units per 28 days