BlueCross BlueShield of Tennessee Medical Policy Manual

Temsirolimus

NDC CODE(S)

Torisel 25 MG/ML SOLN 00008-1179-xx (PFIZER U.S.)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Renal Cell Carcinoma 25 mg infused over a 30-60 minute period once every 7 days (weekly).

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

No controlled studies were found in the published literature that validate the use of temsirolimus for the treatment of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016, March). AHFS Dl. Temsirolimus. Retrieved June 29, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, June). Temsirolimus. Retrieved June 29, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Temsirolimus. Retrieved June 29, 2016 from the National Comprehensive Cancer Network.

U.S. Food and Drug Administration. (2015, February). Center for Drug Evaluation and Research. Torisel® kit (temsirolimus) injection for intravenous infusion only. Retrieved June 29, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022088s018lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  2/27/2018

ID_MRx

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.

Pharmaceutical Decision Support Tree

Temsirolimus (Torisel®)

  1. Is this the initial request for this agent for this individual?

If yes, go to question #2

If no, go to question #10

  1. Does the individual have a diagnosis of renal cell carcinoma (kidney cancer)?

If yes, go to question #3

If no, go to question #5

  1. Is the request for first-line therapy as a single agent for relapse or surgically unresectable stage IV disease for individuals with ANY ONE of the following?

If yes, go to question #7

If no, go to question #4

  1. Is the request for subsequent therapy following prior cytokine therapy without prior TKI therapy as ANY ONE of the following?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for single-agent therapy for a diagnosis of soft tissue sarcoma further identified as ANY ONE of the following?

If yes, go to question #7

If no, go to question #6

  1. Does the individual have a diagnosis of uterine neoplasms further identified as endometrial carcinoma requesting ANY ONE of the following?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 100 billable units or less (1 billable unit = 1 mg) every 28 days for dosage of 25 mg infused over a 30-60 minute period once every 7 days (weekly) in an authorization of six months or less?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria in numbers 2 through 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Did the tumor show response with stabilization of disease or decrease in size or spread?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there absence of unacceptable toxicity/extreme adverse reaction from the drug including, but not limited to, ANY ONE of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.