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
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.
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
Chemotherapy administration; intravenous, push technique, single or initial substance/drug
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.
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