Subject: temozolomide-Temodar 1665-A SGM P2022

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.  Refractory Anaplastic Astrocytoma
                      Temodar is indicated for the treatment of adult patients
                      with refractory anaplastic astrocytoma who have
                      experienced disease progression on a drug regimen
                      containing nitrosourea and procarbazine.

            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.    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

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

 

      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]. Whitehouse Station, NJ: Merck & Co., Inc.; November 2019.
2. Temozolomide [package insert]. Durham, NC: Accord Healthcare, Inc.; October 2021.
3. The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed January 12, 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.

June 26, 2022