Subject: Loqtorzi 6237-A SGM P2023

Drug

LOQTORZI  (toripalimab-tpzi)

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.

          FDA-Approved Indications

          A.  Loqtorzi is indicated, in combination with cisplatin and
               gemcitabine, for first-line treatment of adults with metastatic
               or with recurrent locally advanced nasopharyngeal carcinoma
               (NPC).
          B.  Loqtorzi is indicated, as a single agent, for the treatment of
               adults with recurrent unresectable or metastatic NPC with
               disease progression on or after a platinum-containing
               chemotherapy.

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


    II.  EXCLUSIONS

          Coverage will not be provided for members who have
          experienced disease progression while on PD-1 or PD-L1
          inhibitor therapy.


  III.  CRITERIA FOR INITIAL APPROVAL

          Nasopharyngeal carcinoma (NPC)
          Authorization of 6 months may be granted when either of the
          following criteria are met:
          A.  The requested medication will be used in combination with
               cisplatin and gemcitabine for the first-line treatment of
               metastatic or recurrent locally advanced NPC.
          B.  The requested medication will be used as a single agent for
               treatment of recurrent unresectable or metastatic NPC with
               disease progression on or after a platinum-containing
               chemotherapy.


   IV.  CONTINUATION OF THERAPY

          Authorization of 6 months (for up to 24 months total when being
          used as first line therapy) may be granted for continued
          treatment in members requesting reauthorization for an
          indication listed in Section III 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. Loqtorzi [package insert]. Redwood City, CA: Coherus BioSciences, Inc; October 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.

December 31, 2023