Pemetrexed (Alimta®; Pemfexy™, Pemetrexed™, Pemrydi RTU )
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Non-squamous non-small cell lung cancer (NSCLC)
a. In combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EFGR or ALK genomic tumor aberrations.
b. In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC).
c. As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
d. As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.
Limitations of use: Pemetrexed is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer (NSCLC).
2. Mesothelioma
In combination with cisplatin, for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.
B. Compendial Uses
1. Bladder cancer
2. Pleural mesothelioma
3. Peritoneal mesothelioma
4. Pericardial mesothelioma
5. Tunica vaginalis testis mesothelioma
6. Nonsquamous non-small cell lung cancer (NSCLC)
7. Ovarian cancer, fallopian tube cancer, and primary peritoneal cancer: epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, carcinosarcoma (malignant mixed Mullerian tumors), clear cell carcinoma of the ovary, grade 1 endometrioid carcinoma, low-grade serious carcinoma/ovarian borderline epithelial tumor (low malignant potential), and mucinous carcinoma of the ovary
8. Primary central nervous system (CNS) lymphoma
9. Thymomas and thymic carcinomas
10. Cervical cancer
All other indications are considered experimental/investigational and not medically necessary.
II. EXCLUSIONS
Coverage will not be provided for members with squamous cell NSCLC.
III. CRITERIA FOR INITIAL APPROVAL
A. Bladder Cancer
Authorization of 6 months may be granted for treatment of locally advanced, metastatic, or relapsed transitional cell urothelium cancer, as second-line treatment.
B. Pleural or Peritoneal Mesothelioma
Authorization of 6 months may be granted for treatment of pleural or peritoneal mesothelioma, including pericardial mesothelioma and tunica vaginalis testis mesothelioma, when any of the following criteria are met:
1. The requested medication will be used as a single agent or in combination with cisplatin or carboplatin; or
2. The requested medication will be used in combination with bevacizumab or durvalumab (Imfinzi) and either cisplatin or carboplatin.
C. Non-Small Cell Lung Cancer (Non-Squamous Histology)
Authorization of 6 months may be granted for treatment of non-squamous non-small cell lung cancer.
(including leptomeningeal metastases).
D. Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Authorization of 6 months may be granted for treatment of persistent or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, carcinosarcoma (malignant mixed Mullerian tumors), clear cell carcinoma of the ovary, grade 1 endometrioid carcinoma, low-grade serious carcinoma/ovarian borderline epithelial tumor (low malignant potential), or mucinous carcinoma of the ovary, as single agent therapy.
E. Primary Central Nervous System (CNS) Lymphoma
Authorization of 6 months may be granted for treatment of primary CNS lymphoma, as a single agent.
F. Thymomas and Thymic Carcinomas
Authorization of 6 months may be granted for treatment of thymoma or thymic carcinoma, as a single agent.
G. Cervical Cancer
Authorization of 6 months may be granted for treatment of persistent, recurrent or metastatic cervical cancer.
IV. CONTINUATION OF THERAPY
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication in Section III when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
MEDICATION QUANTITY LIMITS
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
Alimta (Pemetrexed), Pemfexy (Pemetrexed), Pemetrexed (Pemetrexed) |
Bladder Cancer, Malignant Pleural Mesothelioma, Malignant Peritoneal Mesothelioma, Pericardial Mesothelioma, or Tunica Vaginalis Testis Mesothelioma, Non-small Cell Lung Cancer, Thymoma or Thymic Carcinoma |
Route of Administration: Intravenous 500mg/m² every 21 days |
Alimta (Pemetrexed), Pemfexy (Pemetrexed), Pemetrexed (Pemetrexed) |
Cervical Cancer, Fallopian Tube Cancer, Ovarian Cancer, Primary Central Nervous System Lymphoma, Primary Peritoneal Cancer |
Route of Administration: Intravenous 900mg/m² every 21 days |
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.
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).
REFERENCES
1. Alimta [package insert]. Indianapolis, IN: Lilly USA, LLC; August 2022.
2. Pemfexy [package insert]. Woodcliff Lake, NJ: Eagle Pharmaceuticals, Inc.; December 2022.
3. Pemetrexed disodium [package insert]. Princeton, NJ: Dr. Reddy’s Laboratories Inc.; September 2022.
4. Pemrydi RTU [package insert]. Ahmedabad, India: Zydus Lifesciences Limited; June 2023
5. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed July 13, 2023.
6. Lexicomp [database online]. Hudson, OH: Lexi-Comp, Inc.; https://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed July 13, 2023.
7. IBM Micromedex® DRUGDEX® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at https://www.micromedexsolutions.com Accessed July 17, 2023.
ORIGINAL EFFECTIVE DATE: 10/8/2005
MOST RECENT REVIEW DATE: 8/13/2024
ID_CHS
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.
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