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Clinical Policy Bulletin:
Temsirolimus (Torisel)
Number: 0873


Aetna considers temsirolimus (Torisel) medically necessary for members with advanced (metastatic or unresectable) renal cell carcinoma.

Aetna considers temsirolimus medically necessary for members with endometrial cancer that has progressed on prior cytotoxic chemotherapy.

Temsirolimus is considered experimental and investigational for all other indications.



Temsirolimus (Torisel) is an intravenous chemotherapeutic agent in the class mTOR inhibitor for the treatment of renal cell carcinoma. It was approved by the U.S. Food and Drug Administration (FDA) in May 2007 for the treatment of advanced renal cell carcinoma in adults.

Current guidelines from the National Comprehensive Cancer Network (NCCN, 2013) recommend use of temsirolimus in kidney cancer for the following indications: 1) first-line therapy as a single agent for relapsed or medically unresectable stage IV disease (clear cell or non-clear cell); 2) subsequent therapy as a single agent for relapsed or medically unresectable stage IV disease with predominant clear cell histology.

NCCN Guidelines (2014) recommend temsirolimus as single-agent therapy in patients with endometriod adenocarcinoma who have progressed with prior cytotoxic chemotherapy, and as single agent therapy in patients with serous or clear cell endometrial adenocarcinoma and patients with endometrial carcinosarcoma who have progressed on prior cytotoxic chemotherapy. 


Continued use beyond 3 months (12 weeks) is considered medically necessary for persons with stable disease (tumor size within 25% of baseline).  Continued use is considered not medically necessary when there is evidence of disease progression or unacceptable toxicity occurs.

CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96413 - 96417
HCPCS codes covered if selection criteria are met:
J9330 Injection, temsirolimus, 1 mg (Torisel)
ICD-9 codes covered if selection criteria are met:
182.0 Malignant neoplasm of corpus uteri, except isthmus
189.0 - 189.1 Malignant neoplasm of kidney and renal pelvis

The above policy is based on the following references:
  1. Hudes  G, et al. Temsirolimus, Interferon Alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007;356:2271-81.
  2. Wyeth Pharmaceuticals, Inc. Torisel® (temsirolimus) prescribing information.  Philadephia, PA: Wyeth Pharmaceuticals; May 2012.
  3. Torisel®, NCI website:, accessed 03/11/13
  4. Torisel® monograph, Facts and Comparisons online, accessed March 24, 2011.
  5. National Comprehensive Cancer Network (NCCN). Kidney cancer. NCCN Clinical Practice Guidelines in Oncology v.1.2013. Fort Washington, PA: NCCN; 2013.
  6. National Comprehensive Cancer Network (NCCN). Uterine neoplasms. NCCN Clinical Pratice Guidelines in Oncology v.1.2014. Fort Washington, PA: NCCN, 2014. 

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Copyright Aetna Inc. All rights reserved. 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.
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