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Medical Policy: 05.01.16
Original Effective Date: August 2007
Reviewed: October 2011
Revised: September 2010
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Temsirolimus, marketed as Torisel™, is a targeted anticancer drug that specifically inhibits the mammalian target of rapamycin (mTOR) kinase, a critical protein involved in coordinating signals that initiate the growth and proliferation of cells. Protein kinases are metabolic and regulatory enzymes that phosphorylate substrate proteins, which then drive key downstream processes. In response to nutrients and growth factors, the mTOR kinase phosphorylates serine or threonine residues on its target proteins and acts as a critical cell-growth node that signals increased protein translation rates and stimulates cell proliferation. Temsirolimus blocks mTOR phosphorylation of its target proteins and thus inhibits its signals for increased cell growth, cell cycle progression, protein synthesis, and angiogenesis.
Discovery of the mTOR pathway was the result of the development of rapamycin, also known as sirolimus and marketed as Rapamune®, which was FDA-approved in 1999 as an immunosuppressant for the prevention of organ rejection in patients undergoing kidney transplant. Research into rapamycin’s mechanism of action led to identification of mTOR and its role in cell growth; rapamycin blocks the proliferation of cells responsible for organ rejection through inhibition of mTOR. Subsequent research explored the development of a more stable and soluble mTOR inhibitor to be used as an anticancer drug. Temsirolimus is the first mTOR inhibitor developed for the treatment of cancer. Temsirolimus is administered as an intravenous infusion.
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Prior Approval:
Not applicable
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Policy:
Temsirolimus may be considered medically necessary in the treatment of kidney cancer or any of the following indications:
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First-line therapy as a single agent for relapsed or medically unresectable stage IV disease of predominant clear cell or non-clear cell histology
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Subsequent therapy as a single agent for relapsed or medically unresectable stage IV disease in patients with predominant clear cell histology who have progressed on prior first-line therapy.
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Second-line therapy as a single agent for relapsed, refractory, or progressive mantle cell lymphoma
All other applications of temsirolimus are considered investigational.
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Procedure Codes and Billing Guidelines:
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To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
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J9330 Injection, temsirolimus, 1 mg
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Selected References:
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Hudes G, Carducci M, Tomczak P et al., for the Global ARCC Trial. Temsirolimus, Interferon alfa, or Both for Advanced Renal Cell Carcinoma. N Engl J Med. 2007;356:2271-2281.
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Petroulakis E, Mamane Y, LeBacqer O et al. mTOR Signaling: Implications for Cancer and Anticancer Therapy. Br J Cancer. 2006;94:195-99.
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Nathan CO, Amirghahari N, Rong X et al. Mammalian Target of Rapamycin Inhibitors as Possible Adjuvant Therapy for Microscopic Residual Disease in Head and Neck Squamous Cell Cancer. Cancer Res. 2007 Mar 1; 67(5):2160-8.
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Goy A. New Directions in the Treatment of Mantle Cell Lymphoma: An Overview. Clin Lymphoma Myeloma. 2006 Oct; 7 Suppl 1:S24-32.
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Del Bufalo D, Ciuffreda L, Trisciuoglio D et al. Antiangiogenic Potential of the Mammailian Target of Rapamycin Inhibitor Temsirolimus. Cancer Res 2006; 66(11):5549-54.
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Figlin RA, Brown E, Armstrong AJ et al. NCCN Task Force Report: mTOR inhibition in solid tumors. J Natl Compr Cancer Netw. 2008 Sep 6; Suppl 5:S1-S20.
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Figlin RA, Brown E, Armstrong AJ et al. NCCN Task Force Report: mTOR inhibition in solid tumors. J Natl Compr Cancer Netw. 2008 Sep 6; Suppl 5:S1-S20.
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Wang L, Shi WY, Wu Zy et al. Cytostatic and anti-angiogenic effects of temsirolimus in refractory mantle cell lymphoma. J Hematol Oncol. 2010 Sep 9; 3(1):30. [Epub ahead of print].
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Hess G, Smith SM, Berkenblit A et al. Remsirolimus in mantle cell lymphoma and other non-Hodgkin lymphoma subtypes. Semin Oncol. 2009 Dec; 36 Suppl 3:S37-45.
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Samad N, Younes A. Temsirolimus in the treatment of relapsed or refractory mantle cell lymphoma. OncoTargets and Therapy 2010:3 167-78.
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Argyriou P, Economopoulou P, Papageorgiou S. The role of mTOR Inhibitors for the Treatment of B-cell Lymphomas. Adv Hematol. 2012;2012:435342. Epub 2011 Jun 16.
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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 Aug 20; 29(24):3278-85. Epub 2011 Jul 25.
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Behhakht K, Sill MW, Darcy KM et al. Phase II trial of the mTOR inhibitor, temsirolimus and evaluation of circulating tumor cells and tumor biomarkers in persistent and recurrent epithelial ovarian and primary peritoneal malignancies: A Gynecologic Oncology Group study. Gynecol Oncol. 2011 Oct; 123(1):19-26. Epub 2011 Jul 12.
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Negrier S, Gravis G, Perol D et al. Temsirolimus and bevacizumab, or sunitinib, or interferon alfa and bevacizumab for patients with advanced renal cell carcinoma (TORAVA): a randomised phase 2 trial. Lancet Oncol. 2011 Jul;12(7):673-80. Epub 2011 Jun 12.
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Policy History:
Date Reason Action
September 2010 Annual review Policy revised
October 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark 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 Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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