Subject: Asparlas 2833-A SGM P2021

Drug

ASPARLAS  (calaspargase pegol - mknl)

Policy:

I.    INDICATIONS

       The indications below including FDA-approved indications and compendial uses are considered
       a covered benefit provided that all the approval criteria are met and the member has no
       exclusions to the prescribed therapy.

      A.  FDA-Approved Indication
           Asparlas is indicated as a component of a multi-agent chemotherapeutic regimen for the
           treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1
           month to 21 years.

      B.  Compendial Uses
           1.  Lymphoblastic lymphoma (managed in the same manner as ALL)
           2.  Acute lymphoblastic leukemia (ALL) as a substitute for pegaspargase in patients 21 years
                and younger for more sustained asparaginase activity2
           3.  Pediatric acute lymphoblastic leukemia (ALL) as a substitute for pegaspargase in patients
                age 1 month to 21 years for more sustained asparaginase activity2

      All other indications are considered experimental/investigational and are not medically
      necessary.

II.  CRITERIA FOR INITIAL APPROVAL

      Authorization of 12 months may be granted for the treatment of acute lymphoblastic leukemia
      or lymphoblastic lymphoma when all of the following criteria are met:
      A. The requested medication will be used in conjunction with multi-agent chemotherapy.
      B. The member is 21 years of age or younger.
 

III. CONTINUATION OF THERAPY  

      Authorization of 12 months total may be granted for continued treatment in members
      requesting reauthorization for an indication listed in Section II when there is no evidence of
      unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Asparlas [package insert]. Boston, MA: Servier Pharmaceuticals LLC; June 2020.
2. National Comprehensive Cancer Network. The NCCN Drugs & Biologics Compendium. http://www.nccn.org. Accessed June 1, 2021.
3. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: Acute Lymphoblastic Leukemia. Version 1.2021. http://www.nccn.org/professionals/physician_gls/pdf/all.pdf. Accessed June 3, 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.

November 17, 2021