Subject: Hycamtin capsules 1659-A SGM P2024

Drug

HYCAMTIN CAPSULES  (topotecan)

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
               Hycamtin capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC)
               in patients with a prior complete or partial response and who are at least 45 days from the
               end of first-line chemotherapy.

          B.  Compendial Uses
               1.  Small Cell Lung Cancer (SCLC)
               2.  Merkel Cell Carcinoma (MCC)

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


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Small Cell Lung Cancer (SCLC)
               Authorization of 12 months may be granted for treatment of small cell lung cancer.

          B.  Merkel Cell Carcinoma (MCC)
               Authorization of 12 months may be granted for treatment of Merkel cell carcinoma when all
               of the following criteria are met:
               1.  Member has metastatic disseminated disease.
               2.  Member has contraindications to or member has disease that has progressed on anti-
                    PD-L1 or anti-PD-1 monotherapy [e.g., Bavencio (avelumab), Keytruda (pembrolizumab)
               3.  The medication will be used as a single agent.


   III.  CONTINUATION OF THERAPY

          Authorization of 12 months 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. Hycamtin Capsules [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp.; September 2018.
2. The NCCN Drugs & Biologics Compendium^® © 2024 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed March7, 2024.

 

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.

August 19, 2024