BlueCross BlueShield of Tennessee Medical Policy Manual

Lanadelumab-flyo

NDC CODE(S)

47783-0644-XX Takhzyro 300 MG/2ML SOLN (SHIRE US INC)

DESCRIPTION

Lanadelumab-flyo is a non-plasma derived, recombinant, fully human monoclonal antibody (IgG1/κ-light chain ) that binds plasma kallikrein and inhibits its proteolytic activity. Plasma kallikrein is a protease that cleaves high-molecular-weight-kininogen (HMWK) to generate cleaved HMWK (cHMWK) and bradykinin, a potent vasodilator that increases vascular permeability resulting in swelling and pain associated with HAE. In patients with HAE due to C1-inhibitor (C1-INH) deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks.  Lanadelumab-flyo decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.

Individuals with an inherited deficiency or dysfunction of C1-INH suffer from sudden, recurrent edematous swellings of the subcutaneous or submucosal tissues.  This condition is known as hereditary angioedema (HAE).

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Prophylaxis of Hereditary Angioedema (HAE) attacks

Administer 300 mg subcutaneously every 2 weeks

-A dosing interval of 300 mg every 4 weeks is also effective and may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months.

LENGTH OF AUTHORIZATION

Coverage will be provided 6 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

Mauer 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(8):1575-1596.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, August). Lanadelumab-flyo. Retrieved October  8, 2018 from MICROMEDEX Healthcare Series.  

U. S. Food and Drug Administration. (2018, August). Center for Drug Evaluation and Research. Takhzyro® (lanadelumab-flyo) injection, for subcutaneous use.  Retrieved October 2, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761090s000lbl.pdf     

ORIGINAL EFFECTIVE DATE:  1/31/2019

MOST RECENT REVIEW DATE:  1/31/2019

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

MAXIMUM UNITS

Prophylaxis of Hereditary Angioedema (HAE) attacks 300 mg per 14 days