BlueCross BlueShield of Tennessee Medical Policy Manual

Temozolomide for Injection

NDC CODE(S)

00085-3004-XX Temodar 5mg capsule – (Merck Sharpe & Dohme Corp )

 

00085-1519-XX Temodar 20mg capsule – (Merck Sharpe & Dohme Corp )

 

00085-1366-XX Temodar 100mg capsule – (Merck Sharpe & Dohme Corp )

 

00085-1425-XX Temodar 140mg capsule – (Merck Sharpe & Dohme Corp )

 

00085-1430-XX Temodar 180mg capsule – (Merck Sharpe & Dohme Corp )

 

00085-1417-XX Temodar 250mg capsule – (Merck Sharpe & Dohme Corp )

 

00085-1381 Temodar 100mg powder for injection - (Merck Sharpe & Dohme Corp)

DESCRIPTION

Temozolomide is a cytotoxic agent of the imidazotetrazine class.  It is a second generation alkylating agent and a methylating agent.  While chemically related to another methylating agent, dacarbazine (DTIC), unlike DTIC, it does not require hepatic metabolism for activation.  Administered orally or by injection, temozolomide is spontaneously hydrolyzed to its active state with rapid, near-100% bioavailability.  Temozolomide enters the spinal fluid and its cytotoxicity is thought to be primarily due to alkylation of DNA but, as with other methylating agents (i.e., procarbazine, streptozotocin and DTIC), it forms no DNA crosslinks.  Temozolomide has activity against a variety of solid tumors and demonstrates minimal, non-cumulative myelosuppression that is rapidly reversible.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

All indications

Up to 200mg/m² on days 1 thru 5 of a 28 day cycle

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).

A review of the published literature located no controlled studies that validate the use of temozolomide in the treatment/prevention of any other conditions/diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Temozolomide. Retrieved November 29, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2016, November). Temozolomide. Retrieved November 29, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Temozolomide. Retrieved November 29, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, February). Center for Drug Evaluation and Research. Product Information. Temodar® (temozolomide). Retrieved November 29, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022277s011lbl.pdf.

ORIGINAL EFFECTIVE DATE:  3/10/2005

MOST RECENT REVIEW DATE:  12/1/2016

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

Temozolomide for Injection (Temodar®)

  1. Is this the initial request for this agent?

If yes, go to question # 2

If no, go to question # 25

  1. Does the individual have a diagnosis of Bone Cancer if ALL of the following?

If yes, go to question # 24

If no, go to question # 3

  1. Does the individual have a diagnosis of Central Nervous System (CNS) Cancer further classified as Glioblastoma multiforme (GBM) if ANY ONE of the following?

If yes, go to question # 24

If no, go to question # 4

  1. Does the individual have a diagnosis of Central Nervous System (CNS) Cancer further classified as Low-grade Infiltrative Supratentorial Astrocytoma/Oligodendroglioma with ALL of the following?

If yes, go to question # 24

If no, go to question # 5

  1. Does the individual have a diagnosis of Central Nervous System (CNS) Cancer further classified as Refractory anaplastic astrocytoma with documented disease progression on a drug regimen containing nitrosourea and procarbazine?

If yes, go to question # 24

If no, go to question # 6

  1. Does the individual have a diagnosis of Central Nervous System (CNS) Cancer further classified as Adult Intracranial and Spinal Ependymoma if ALL of the following?

If yes, go to question # 24

If no, go to question # 7

  1. Does the individual have a diagnosis of Central Nervous System (CNS) Cancer further classified as Adult medulloblastoma and Supratentorial Primitive Neuroectodermal tumors (PNET) if ALL of the following?

If yes, go to question # 24

If no, go to question # 8

  1. Does the individual have a diagnosis of Central Nervous System (CNS) Cancer further classified as Anaplastic Gliomas if ALL of the following?

If yes, go to question # 24

If no, go to question # 9

  1. Does the individual have a diagnosis of Central Nervous System (CNS) Cancer further classified as CNS Metastases if ALL of the following?

If yes, go to question # 24

If no, go to question # 10

  1. Does the individual have a diagnosis of Primary CNS Lymphoma if ANY ONE of the following?

If yes, go to question # 24

If no, go to question # 11

  1. Does the individual have a diagnosis of Lung Neuroendocrine Tumors if ALL of the following?

If yes, go to question # 24

If no, go to question # 12

  1. Does the individual have a diagnosis of Melanoma if ALL of the following?

If yes, go to question # 24

If no, go to question # 13

  1. Does the individual have a documented diagnosis of Pancreatic Neuroendocrine Tumors if ALL of the following?

If yes, go to question # 24

If no, go to question # 14

  1. Does the individual have a diagnosis of Neuroendocrine Tumors documented as Pheochromocytoma /Paraganglioma if ALL of the following?

If yes, go to question # 24

If no, go to question # 15

  1. Does the individual have a diagnosis of NHL further diagnosed as Mycosis fungoides/Sézary syndrome ONLY as second line therapy?

If yes, go to question # 24

If no, go to question # 16

  1. Does the individual have a diagnosis of Non-Melanoma Skin Cancer diagnosed as Dermatofibrosarcoma Protuberans (DFSP) that is metastatic disease?

If yes, go to question # 24

If no, go to question # 17

  1. Does the individual have a diagnosis of Small Cell Lung Cancer with ALL of the following?

If yes, go to question # 24

If no, go to question # 18

  1. Does the individual have a diagnosis of Soft Tissue Sarcoma further diagnosed as angiosarcoma if used as a single agent for palliative therapy?

If yes, go to question # 24

If no, go to question # 19

  1. Does the individual have a diagnosis of Soft Tissue Sarcoma further diagnosed as retroperitoneal /Intra-abdominal sarcoma if ALL of the following?

If yes, go to question # 24

If no, go to question # 20

  1. Does the individual have a diagnosis of Soft Tissue Sarcoma further diagnosed as Rhabdomyosarcoma if ANY ONE of the following?

If yes, go to question # 24

If no, go to question # 21

  1. Does the individual have a diagnosis of Soft Tissue Sarcoma further diagnosed as Solitary Fibrous Tumor/Hemangiopericytoma if used in combination with bevacizumab?

If yes, go to question # 24

If no, go to question # 22

  1. Does the individual have a diagnosis of Soft Tissue Sarcoma further diagnosed as Sarcoma of the Extremity/Superficial Trunk if ALL of the following?

If yes, go to question # 24

If no, go to question # 23

  1. Does the individual have a diagnosis of Uterine Sarcoma if ALL of the following?

If yes, go to question # 24

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

  1. Is the request for 2500 billable units every 28 days (J9238) every 28 days or 500 billable units every 28 days (J8700) for dosage of up to 200 mg/m2 on days 1 through 5 of a 28 day cycle for an authorization period of six months which may be renewed?

If yes, this satisfies medical necessity and 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 questions 2 through 24?

If yes, go to question # 26

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

  1. Is response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread with absence of unacceptable toxicity from the drug such as myelosuppression (neutropenia, thrombocytopenia, leukopenia, lymphopenia)?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

This document has been classified as public information.