Last Review Date: 05/04/2023

Date of Origin: 08/01/2013

Dates Reviewed: 11/2013, 06/2014, 6/2015, 04/2016, 04/2017, 04/2018, 05/2019, 05/2020, 05/2021, 05/2022, 05/2023

1. Length of Authorization

Coverage is provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Torisel 25 mg/mL single-use vial: 1 vial every 7 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• 25 billable units every 7 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Therapy will not be administered concurrently with live vaccines and close contact with individuals who have received live vaccines will be avoided; AND
• Confirmation that patient does not have bilirubin >1.5 times the upper limit of normal (ULN); AND
• Used as a single agent (unless otherwise specified); AND

Renal Cell Carcinoma † Ф ^1-3

• • Patient has advanced disease

Soft Tissue Sarcoma (PEComa/Recurrent Angiomyolipoma/Lymphangioleiomyomatosis) ‡ ²

Soft Tissue Sarcoma (Non-pleomorphic Rhabdomyosarcoma) ‡ ²

• Used in combination with cyclophosphamide and vinorelbine

Uterine Neoplasms (Endometrial Carcinoma/Uterine PEComa) ‡ ²

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity/infusion reactions, hepatic impairment, hyperglycemia/glucose intolerance, infections, interstitial lung disease, hyperlipidemia, bowel perforation, renal failure, wound healing complications, intracerebral hemorrhage, proteinuria/nephrotic syndrome, etc.

5. Dosage/Administration ^1,5-8

6. Billing Code/Availability Information

HCPCS Code:

• J9330 – Injection, temsirolimus, 1 mg; 1 billable unit = 1 mg

NDC:

• Torisel* 25 mg/mL injection, single-use vial: 00008-1179-xx

*Note: available generically through various manufacturers

7. References

1. Torisel [package insert].  Philadelphia, PA; Wyeth Pharmaceuticals Inc; March 2018. Accessed April 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) temsirolimus. National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed April 2023.
3. Hudes G, Carducci M, Tomczak P, et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81.
4. Dutcher JP, de Souza P, McDermott D, et al. Effect of temsirolimus versus interferon-alpha on outcome of patients with advanced renal cell carcinoma of different tumor histologies.  Med Oncol. 2009;26(2):202-9.
5. Oza AM, Elit L, Tsao MS, et al. Phase II study of temsirolimus in women with recurrent or metastatic endometrial cancer: a trial of the NCIC Clinical Trials Group. J Clin Oncol. 2011;29(24):3278-3285.[PubMed 21788564])
6. Italiano A, Delcambre C, Hostein I, et al. Treatment with the mTOR inhibitor temsirolimus in patients with malignant PEComa. Ann Oncol (2010) 21 (5): 1135-1137. [PubMed 20215136])
7. Benson C, Vitfell-Rasmussen J, Maruzzo M, et al. A Retrospective Study of Patients With Malignant PEComa Receiving Treatment With Sirolimus or Temsirolimus: The Royal Marsden Hospital Experience. Anticancer Res. 2014 Jul;34(7):3663-8. PMID: 24982384
8. Fleming GF, Filiaci VL, Marzullo B, et al. Temsirolimus With or Without Megestrol Acetate and Tamoxifen for Endometrial Cancer: A Gynecologic Oncology Group Study. Gynecol Oncol. 2014 Mar;132(3):585-92. doi: 10.1016/j.ygyno.2014.01.015. Epub 2014 Jan 20

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A