Subject: Specialty Quantity Limit Arcalyst 1744-H P2023

Drug

ARCALYST  (rilonacept)

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
Arcalyst   (rilonacept)   injection 220   mg vial	8 vials per   28 days	Cryopyrin-associated periodic syndromes   (CAPS), Familial Cold Autoinflammatory   Syndrome (FCAS), Muckle-Wells Syndrome   (MWS), and recurrent pericarditis:   •     Adult patients 18 years and older: Loading          dose of 320 mg (2 vials) followed by 160          mg (1 vial) once weekly   •     Pediatric patients 12 years to 17 years:          Loading dose of 4.4 mg/kg (max 320 mg          [2 vials]) followed by 2.2 mg/kg (max 160          mg) once weekly   Deficiency of interleukin-1 receptor   antagonist (DIRA):   •     Adult patients 18 years and older: 320 mg          once weekly (2 vials)   •     Pediatric patients weighing at least 10 kg:         4.4 mg/kg (max 320 mg [2 vials]) once          weekly

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Arcalyst [package insert]. London, UK: Kiniksa Pharmaceuticals (UK), Ltd.; May 2021.

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.

June 11, 2023