Subject: temozolomide-Temodar 1665-A SGM P2024a

Drug

Temodar  (temozolomide)

temozolomide

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 Indications
               1.  Newly Diagnosed Glioblastoma
                    Temodar is indicated for the treatment of adult patients with newly diagnosed
                    glioblastoma concomitantly with radiotherapy and then as maintenance treatment.

               2.  Anaplastic Astrocytoma
                    Temodar is indicated for the:
                    a.  adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma;
                    b.  treatment of adults with refractory anaplastic astrocytoma.

          B.  Compendial Uses
               1.   Central nervous system (CNS) cancer
               2.   Ewing sarcoma
               3.   Neuroendocrine tumors of the pancreas, gastrointestinal tract, lung, and thymus
               4.   Well-differentiated grade 3 neuroendocrine tumors
               5.   Extrapulmonary Poorly differentiated (high grade) neuroendocrine carcinoma/large or
                     small cell carcinoma
               6.   Pheochromocytoma/paraganglioma
               7.   Cutaneous melanoma
               8.   Uveal melanoma
               9.   Mycosis fungoides (MF)/Sézary syndrome (SS)
               10. Small cell lung cancer
               11. Soft tissue sarcoma
               12. Uterine sarcoma
               13. Neuroblastoma

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


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Central nervous system (CNS) cancer
               Authorization of 12 months may be granted for treatment of CNS cancers.

          B.  Ewing sarcoma
               Authorization of 12 months may be granted for treatment of Ewing sarcoma.

          C.  Neuroendocrine tumors
               Authorization of 12 months may be granted for treatment of neuroendocrine tumors.

          D.  Extrapulmonary Poorly differentiated (high-grade) neuroendocrine carcinoma/large
               or small cell carcinoma
               Authorization of 12 months may be granted for treatment of extrapulmonary poorly
               differentiated (high-grade) neuroendocrine carcinoma or large or small cell carcinoma.

          E.  Pheochromocytoma/paraganglioma
               Authorization of 12 months may be granted for treatment of pheochromocytoma or
               paraganglioma.

          F.  Cutaneous Melanoma
               Authorization of 12 months may be granted for treatment of cutaneous melanoma for
               metastatic or unresectable disease.

          G.  Uveal Melanoma
               Authorization of 12 months may be granted for treatment of uveal melanoma for
               unresectable or metastatic disease.

          H.  Mycosis fungoides (MF)/Sézary syndrome (SS)
               Authorization of 12 months may be granted for treatment of MF or SS.

          I.  Small cell lung cancer (SCLC)
               Authorization of 12 months may be granted for treatment of SCLC.

         J.  Soft tissue sarcoma (STS)
              Authorization of 12 months may be granted for treatment of STS.

          K.  Uterine sarcoma
               Authorization of 12 months may be granted for treatment of uterine sarcoma.

          L.  Neuroblastoma
               Authorization of 12 months may be granted for treatment of neuroblastoma when used in
               combination with irinotecan, dinutuximab, and sargramostim.


   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. Temodar [package insert]. Rahway, NJ: Merck & Co., Inc.; September 2023.
2. Temozolomide [package insert]. Durham, NC: Accord Healthcare, Inc.; October 2021.
3. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org.  Accessed July 9, 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 18, 2024