Aetna considers temsirolimus (Torisel) medically necessary for the following indications:
- advanced (metastatic or unresectable) renal cell carcinoma; or
- endometrioid adenocarcinoma; or
- endometrial carcinosarcoma or serous or clear cell endometrial carcinoma; or
- PEComa, recurrent angiomyolipoma, or lymphangioleiomyomatosis.
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 surgically unresectable stage IV disease (clear cell or non-clear cell); 2) subsequent therapy as a single agent for relapsed or surgically unresectable stage IV disease with predominant clear cell histology.
NCCN Guidelines (2014) recommend temsirolimus for endometrioid adenocarcinoma:
- Primary treatment as a single agent
- may be considered preoperatively for intra-abdominal disease
- with sequential radiation therapy (RT) and brachytherapy with or without surgery for extrauterine pelvic disease
- may be considered following palliative hysterectomy with bilateral salpingo-oophorectomy with or without RT and/or hormonal therapy for extra-abdominal or liver disease
- For surgically staged patients as a single agent
- with sequential pelvic radiation therapy (RT) and/or vaginal brachytherapy in patients with stage IB disease with histologic grade 3 tumors and adverse risk factors
- with sequential pelvic RT and vaginal brachytherapy in patients with stage II disease with histologic grade 3 tumors
- with sequential tumor-directed RT for stage IIIA disease
- with or without sequential tumor-directed RT for stage IIIB and IIIC disease
- with or without sequential RT for stage IIIA and IV disease
- Single agent
- for disseminated metastases that have progressed on hormonal therapy
- with or without sequential palliative radiation therapy (RT) for symptomatic, grade 2–3, or large-volume disseminated metastases
- may be considered for isolated metastases
- with sequential tumor-directed RT with or without brachytherapy for local recurrence in patients with disease confined to the vagina or in pelvic, para-aortic, or common iliac lymph nodes
- with or without sequential tumor-directed RT for microscopic upper abdominal or peritoneal recurrences
- for local/regional recurrence in patients who have received prior external beam RT to site of recurrence
NCCN guidelines (2014) recommend temsirloimus for endometrial carcinosarcoma or serous or clear cell endometrial carcinoma as adjuvant therapy as a single agent with or without: 1) vaginal brachytherapy for stage IA disease with no myometrial invasion; or 2) sequential tumor-directed radiation therapy for stage IA disease with myometrial invasion or stage IB-IV disease.
NCCN guidelines (2015) on soft tissue sarcoma recommend temsirolimua as single-agent therapy for the treatment of PEComa, recurrent angiomyolipoma, and lymphangioleiomyomatosis.
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.
The above policy is based on the following references:
|Information in the [brackets] below has been added for clarification purposes.  Codes requiring a 7th character are represented by "+":
|ICD-10 codes will become effective as of October 1, 2015:
|Other CPT codes related to the CPB:
||Chemotherapy administration; intravenous, push technique, single or initial substance/drug
|96413 - 96417
||Chemotherapy administration; intravenous infusion technique
|HCPCS codes covered if selection criteria are met:
||Injection, temsirolimus, 1 mg (Torisel)
|ICD-10 codes covered if selection criteria are met:
|C49.8 - C49.9
||Malignant neoplasm of connective and soft tissue
||Malignant neoplasm of endometrium
|C64.1 - C65.9
||Malignant neoplasm of kidney and renal pelvis
||Neoplasm of unspecified behavior of bone, soft tissue, and skin
- Hudes G, et al. Temsirolimus, Interferon Alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007;356:2271-2281.
- Wyeth Pharmaceuticals, Inc. Torisel Kit (temsirolimus) injection, for intravenous use only. Prescribing Information. Philadephia, PA: Wyeth Pharmaceuticals; revised May 2012.
- National Cancer Institute. Torisel, Cancer Topics. Bethesda, MD: NCI; updated October 28, 2011. Available at: www.cancer.gov/cancertopics/druginfo/temsirolimus. Accessed March 11, 2013.
- Torisel. Drug Facts and Comparisons. Facts & Comparisons [database online]. St. Louis, MO: Wolters Kluwer Health, Inc; October 2014. Accessed February 17, 2015.
- National Comprehensive Cancer Network (NCCN). Kidney cancer. NCCN Clinical Practice Guidelines in Oncology v.1.2013. Fort Washington, PA: NCCN; 2013.
- National Comprehensive Cancer Network (NCCN). Uterine neoplasms. NCCN Clinical Pratice Guidelines in Oncology v.2.2015. Fort Washington, PA: NCCN, 2015.
- National Comprehensive Cancer Network (NCCN). Soft tissue sarcoma. NCCN Clinical Practice Guidelines in Oncology v.1.2015. Fort Washington, PA: NCCN; 2015.