BlueCross BlueShield of Tennessee Medical Policy Manual

Ecallantide

NDC CODE(S)

47783-0101-XX Kalbitor 10 MG/ML SOLN (SHIRE US INC.)

DESCRIPTION

Hereditary angioedema (HAE) is a rare genetic disorder caused by mutations to C1-esterase-inhibitor (C1-INH).  It is characterized by low levels of C1-INH activity and low levels of C4.  One function of C1-INH is as a major endogenous inhibitor of plasma kallikrein, part of the kallikrein-kinin system.  This system is a complex cascade involved in both the inflammatory and coagulation pathways.  Within this, one critical aspect is the conversion of High Molecular Weight (HMW) kininogen into bradykinin by plasma kallikrein.  In HAE, normal regulation of plasma kallikrein activity and the complement cascade is not present.  During attacks, unregulated activity of plasma kallikrein results in excessive in excessive bradykinin generation and is likely responsible for the characteristic HAE symptoms of localized swelling, inflammation and pain.

Ecallantide is a reversible inhibitor of plasma kallikrein.  It binds to plasma kallikrein, effectively blocking its binding site and therefore prevents the conversion of HMW kininogen into bradykinin.  This treats the symptoms of the disease during acute episodic attacks of HAE.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION

Hereditary Angioedema (HAE)

30 mg injected subcutaneously by a health care professional in three 10 mg injections. An additional dose of 30 mg may be administered if attack persists

Not to exceed a total of two 30 mg doses (60 mg) in 24 hours.

LENGTH OF AUTHORIZATION

Coverage will be provided for 12 weeks and is eligible for renewal.

The cumulative amount of medication(s) the patient has on-hand, indicated for the acute treatment of HAE, will be taken into account when authorizing. The authorization will provide a sufficient quantity in order for the patient to have a cumulative amount of HAE medication on-hand in order to treat up to 4 acute attacks per 4 weeks for the duration of the authorization

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

Lexicomp Online. (2018). AHFS DI. Ecallantide. Retrieved October 25, 2018 from Lexicomp Online with AHFS.

Maurer M, Magerl M, Ansotegui I, et al. The international WAO/EAACI guideline for the management of hereditary angioedema—The 2017 revision and update. Allergy. 2018;73:1575–1596. https://doi.org/10.1111/all.13384

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018 , February). Ecallantide. Retrieved October 25, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2014, October). Center for Drug Evaluation and Research. Kalbitor® (ecallantide) injection, for subcutaneous use. Retrieved October 25, 2018 fromhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/14/2016

MOST RECENT REVIEW DATE:  3/2/2019

ID_MRx

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

240 billable units per 28 days