Pemetrexed
DESCRIPTION
Pemetrexed, a folate analog metabolic inhibitor, interferes with cell metabolic processes that are dependent on folate and are required for cell replication. It inhibits the formation of precursor purine and pyrimidine nucleotides and prevents the formation of the genetic material (DNA and RNA) required for the growth and survival of both cancer and normal cells.
An example of a preparation of pemetrexed is Alimta®.
REFER TO DECISION SUPPORT TREE
POLICY
Pemetrexed for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Bladder cancer, including upper genitourinary (i.e., GU) tract tumors
Lung cancer
Mesothelioma
Ovarian Cancer
Thymomas and Thymic Carcinomas
Pemetrexed for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Pemetrexed for the treatment of ANY ONE of the following is considered medically appropriate if the criteria are met:
Bladder cancer including upper GU tumors if ALL the following:
Disease is metastatic
Treatment is second-line therapy
Used as single agent
Lung cancer if ALL the following:
Disease is diagnosed as non-small cell lung cancer
Cell histology is non-squamous
Disease is ANY ONE of the following:
Locally advanced
Metastatic
Treatment is ANY ONE of the following:
Combination therapy with platinum agent for initial treatment
Maintenance therapy if no progression after four cycles platinum-based first-line therapy
Single-agent after prior chemotherapy
Mesothelioma if ALL the following:
Diagnosis of malignant pleural mesothelioma
Surgical treatment ruled out due to ANY ONE of the following:
Disease is unresectable
Individual is not a candidate for curative surgery
Combination therapy with cisplatin
Ovarian cancer if ALL the following:
Disease is ANY ONE of the following
Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
Disease is platinum resistant
Treatment is single-agent recurrence therapy for ANY ONE of the following:
Progressive, stable or persistent disease on primary chemotherapy
Relapse after complete remission post primary chemotherapy
Stage II to IV disease with partial response to primary treatment
Thymomas and thymic carcinomas if ALL of the following:
Treatment is second-line therapy
Used as single agent
Post radiation therapy
Disease is locally advanced unresectable
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies withTennessee 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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of pemetrexed in the treatment/prevention of any other conditions/diseases.
SOURCES
Lexi-Comp Online. (2011, May). AHFS DI. Pemetrexed. Retrieved July 22, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, February). Pemetrexed. Retrieved July 22, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Pemetrexed. Retrieved July 22, 2011 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2011, March). Center for Drug Evaluation and Research. Alimta® (pemetrexed). Retrieved July 22, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021462s033lbl.pdf.
ORIGINAL EFFECTIVE DATE: 10/8/2005
MOST RECENT REVIEW DATE: 1/14/2012
ID_BT
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
Pemetrexed (Alimta®)
Does the individual have a diagnosis of bladder cancer (including upper GU tumors) that is ALL the following?
Metastatic disease
Treatment is second-line therapy
Requesting pemetrexed as a single agent
If yes, this meets medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of non-small cell lung cancer that is non-squamous and locally advanced or metastatic?
If yes, go to question #3
If no, go to question #4
Is treatment ANY ONE of the following?
Combination therapy with platinum agent for initial treatment
Maintenance therapy if no progression after four cycles platinum-based first-line therapy
Single-agent after prior chemotherapy
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of malignant pleural mesothelioma?
If yes, go to question #5
If no, go to question #7
Is surgical treatment ruled out due to unresectability of disease or the individual is not a candidate for surgery?
If yes, go to question #6
If no, this does not meet medical necessity and/or medical appropriateness criteria
Will the individual receive platinum-based agent in combination therapy?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of ovarian cancer that is ANY ONE of the following?
Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
If yes, go to question #8
If no, go to question #10
Is the disease platinum resistant?
If yes, go to question #9
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the treatment single-agent recurrence therapy for ANY ONE of the following?
Progressive, stable or persistent disease on primary chemotherapy
Relapse after complete remission post primary chemotherapy
Stage II to IV disease with partial response to primary treatment
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual have a diagnosis of thymoma or thymic carcinoma with ALL the following?
Treatment is second-line therapy
Used as single agent
Post radiation therapy
Disease is locally advanced unresectable
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.