Subject: Hycamtin capsules 1659-A SGM P2023

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 primary or recurrent metastatic
                    disseminated disease.
               2.  Member has contraindications to checkpoint
                    immunotherapy [e.g., Bavencio (avelumab), Keytruda
                    (pembrolizumab)].


   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^® © 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed February 27, 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.

August 18, 2023