Subject: Specialty Quantity Limit Takhzyro 3042-H P2022a

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.

March 19, 2023