Subject: Specialty Quantity Limit Cerezyme 1695-H P2023

Drug

CEREZYME  (imiglucerase)

Policy:

      I.  PROGRAM DESCRIPTION

          The standard limit is designed to allow a quantity sufficient for
          the most common uses of the medication. If the member’s plan
          allows a quantity limit exception review for the requested
          medication, coverage of an additional quantity may be provided
          up to the exception limit with prior authorization.

 

II.  COVERED QUANTITIES

Medication	Standard Limit	Exception Limit*	FDA-recommended dosing
Cerezyme   (imiglucerase)   injection 400   units single-   dose vial	15 vials   per 14 days	30 vials   per 14 days	Dosing range: 2.5 units/kg infusion   three times a week to 60 units/kg   per 14 days (once every 2 weeks)

  *Coverage up to the exception limits may be provided with prior authorization via the Specialty Post
  Limit Quantity Exception Criteria for approval.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cerezyme [package insert]. Cambridge, MA: Genzyme Corporation; December 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 18, 2023