Subject: Specialty Quantity Limit Takhzyro 3042-H P2023

Drug

TAKHZYRO®  (lanadelumab-flyo)

Policy:

I.  PROGRAM DESCRIPTION

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.


II.  COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Takhzyro (lanadelumab-flyo)   300 mg/2 mL (150 mg/mL)   single-dose vial	2 vials per 28 days	Adult and Pediatric Patients 12 Years of Age and   Older: 300 mg subcutaneously every 2 weeks   •   300 mg every 4 weeks may be considered if the        patient is well-controlled for more than 6        months   Pediatric Patients 6 to Less Than 12 Years of Age:   150 mg subcutaneously every 2 weeks   •   150 mg every 4 weeks may be considered if the        patient is well-controlled for more than 6         months   Pediatric Patients 2 to Less Than 6 Years of Age:   150 mg subcutaneously every 4 weeks
Takhzyro (lanadelumab-flyo)   300 mg/2 mL (150 mg/mL)   single-dose prefilled syringe	2 syringes   per 28 days
Takhzyro (lanadelumab-flyo)   150 mg/mL single-dose   prefilled syringe	2 syringes   per 28 days

Place of Service:

Outpatient

The above policy is based on the following references:

1. Takhzyro^® [package insert]. Lexington, MA: Dyax Corp., a Takeda company; February 2023.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 22, 2023