Subject: Hycamtin capsules 1659-A SGM P2022

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^® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed February 17, 2022.

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 24, 2022