BlueCross BlueShield of Tennessee Medical Policy Manual

Ecallantide

NDC CODE(S)

47783-0101-XX - Kalbitor 10 mg (Dyax Corp)

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Hereditary Angioedema (HAE) 30 mg injected subcutaneously in three 10 mg injections. An additional dose of 30 mg may be administered if attack persists for a total of two 30 mg doses in 24 hours.

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).

No controlled studies were found in the published literature that validate the use of ecallantide for the treatment of other conditions or diseases.

SOURCES

Lexicomp Online. (2016). AHFS DI. Ecallantide. Retrieved October 26, 2016 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016 , October). Ecallantide. Retrieved October 26, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2015, October). Center for Drug Evaluation and Research. Kalbitor® (ecallantide) injection, for subcutaneous use. Retrieved October 26, 2016 fromhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125277s071lbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/14/2016

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Ecallantide (Kalbitor ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #7

  1. Does the individual have a clinically verified diagnosis of Hereditary Angioedema with ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the individual’s disease classified as ANY ONE of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show evidence of confirmation of avoidance of the following triggers of HAE attacks?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is administration ALL of the following?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 360 billable units per 28 days for dosage of 30 mg injected subcutaneously in three 10 mg injections with an additional dose of 30 mg that may be administered if attack persists for a total of two 30 mg doses in 24 hours for an authorization of 12 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in questions 2 through 6?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has significant improvement in severity and duration of attacks been achieved and sustained through use of ecallantide?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent, such as hypersensitivity reactions?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.