00008-1179-XX Torisel 25 MG/ML SOLN (PFIZER U.S.)
16729-0223-XX Temsirolimus 25 MG/ML SOLN (ACCORD HEALTHCARE)
Temsirolimus is an inhibitor of mTOR, mammalian target of rapamycin. Temsirolimus is a kinase inhibitor used as an antineoplastic agent. The mTOR kinase plays a role in activating a cascade that induces cell division, tumor growth and angiogenesis. Temsirolimus binds to an intracellular protein (FKBP-12) blocking the action of mTOR to activate the cascade. The result is in growth arrest in treated tumor cells and reduced levels of the vascular endothelial growth factor or VEGF.
Temsirolimus for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Renal cell carcinoma (kidney cancer)
Soft tissue sarcoma
Temsirolimus for the treatment of other conditions/diseases is considered investigational.
Temsirolimus is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Diagnosis of advanced renal cell carcinoma (kidney cancer) as a single
Diagnosis of soft tissue sarcoma further identified as ANY ONE of the following as single-agent therapy:
PEComa (Perivascular epithelioid cell tumor)
Diagnosis of uterine neoplasms further identified as endometrial carcinoma as a single agent
Temsirolimus is considered medically appropriate for renewal if ALL of the following:
Initial approval criteria are met
Tumor response indicated with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity/extreme adverse reaction from the drug including, but not limited to severe infusion reactions, severe hepatic impairment, hyperglycemia/glucose intolerance, opportunistic infection, interstitial lung disease, severe hyperlipidemia, bowel perforation, renal failure, wound healing complications, intracerebral hemorrhage, proteinuria/nephrotic syndrome, etc.
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Renal Cell Carcinoma||25 mg infused over a 30-60 minute period once every 7 days (weekly)|
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Lexi-Comp Online. (2019, February). AHFS Dl. Temsirolimus. Retrieved April 22, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, April). Temsirolimus. Retrieved April 22, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium™. Temsirolimus. Retrieved April 22, 2019 from the National Comprehensive Cancer Network.
U.S. Food and Drug Administration. (2018, March). Center for Drug Evaluation and Research. Torisel® kit (temsirolimus) injection for intravenous infusion only. Retrieved April 22, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022088s021s023lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 6/11/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit