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 malignant pleural mesothelioma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pemetrexed for the treatment of non-small cell lung cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Pemetrexed for the treatment of other conditions/diseases, including, but not limited to, the following: breast cancer, pancreatic cancer, cervical cancer, bladder cancer, head and neck cancer and colorectal cancer is considered investigational. (See Applicable Tennessee State Mandate Requirements below.)
MEDICAL APPROPRIATENESS
Pemetrexed is considered medically appropriate for the treatment of ANY ONE of the following:
Malignant pleural mesothelioma with ALL of the following:
The agent is used in combination with cisplatin
The disease is unresectable or the individual is not a candidate for curative surgery
Non-small cell lung cancer with ANY ONE of the following:
The agent is being used in combination with cisplatin therapy for the initial treatment of locally advanced or metastatic, nonsquamous, non-small cell lung cancer
The agent is being used as a single agent for the treatment of locally advanced or metastatic, nonsquamous, non-small cell lung cancer and the individual has received prior chemotherapy
The agent is being used as maintenance therapy in individuals with locally advanced or metastatic, nonsquamous, non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
The NCCN Drugs & Biologics Compendium recognizes the use of pemetrexed for additional uses beyond the FDA-approved labeling in the treatment of the following conditions (Refer to the NCCN Drugs & Biologics Compendium or NCCN Clinical Practice Guidelines for detailed recommendations):
Bladder cancer
Ovarian Cancer - Epithelial ovarian cancer
Thymic Malignancies
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 for the treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2009). AHFS DI. Pemetrexed disodium. Retrieved August 17, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluation. (2009) Pemetrexed. Retrieved August 17, 2009 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2009). NCCN Drugs & Biologics Compendium™. Alimta®. Retrieved August 17, 2009 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2009, July). Center for Drug Evaluation and Research. FDA Approval Letter. NDA 21-462/S-018, NDA 21-462/S-021, NDA 21-462/S-022. Retrieved August 17, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021462s018,021462s021,021462s022ltr.pdf.
U. S. Food and Drug Administration. (2009, July). Center for Drug Evaluation and Research. Label and Approval History. Alimta®. Retrieved August 17, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021462s018s021s022lbl.pdf.
ORIGINAL EFFECTIVE DATE: 10/8/2005
MOST RECENT REVIEW DATE: 3/11/2010
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®)
Is the requested medication being used to treat breast cancer, pancreatic cancer, cervical cancer, bladder cancer, head and neck cancer or colorectal cancer?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of malignant pleural mesothelioma and evidence of ALL the following?
The agent is used in combination with cisplatin
The disease is unresectable or the individual is not a candidate for curative surgery
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Does the individual have a diagnosis of non-small cell lung cancer and evidence of ANY ONE of the following?
The agent is being used in combination with cisplatin therapy for the initial treatment of locally advanced or metastatic, nonsquamous, non-small cell lung cancer
The agent is being used as a single agent for the treatment of locally advanced or metastatic, nonsquamous, non-small cell lung cancer and the individual has received prior chemotherapy
The agent is being used as maintenance therapy in individuals with locally advanced or metastatic, nonsquamous, non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
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.