00002-7640-XX - Alimta 100 MG SOLR (LILLY)
|00002-7623-XX - Alimta 500 MG SOLR (LILLY)|
Pemetrexed is a folate analog metabolic inhibitor. It interferes with cell metabolic processes by disrupting the folate-dependent processes required for cell replication by inhibiting the biosynthesis of thymidine and purine nucleotides. This prevents the formation of the DNA and RNA required for the growth and survival of both cancer and normal cells.
Pemetrexed for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Central nervous system cancers
Thymomas and thymic carcinomas
Pemetrexed for the treatment of other conditions/diseases is considered investigational.
Pemetrexed is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older unless otherwise specified
Diagnosis of ANY ONE of the following
Bladder cancer urothelial carcinoma if ALL of the following
Treatment is used as subsequent therapy following prior systemic therapy, i.e., platinum or checkpoint inhibitor
Used as a single agent
Disease is ANY ONE of the following:
Locally advanced or metastatic
Metastatic Upper GU tract tumors
Metastatic Carcinoma of the Prostate
Primary Carcinoma of the Urethra that is recurrent or metastatic
Disease has not progressed to recurrent stage T3-4 disease or exhibit palpable inguinal lymph nodes
Central nervous system (CNS) cancer further diagnosed as primary CNS lymphoma if ALL of the following:
Used as a single agent for relapsed or refractory disease if ANY ONE of the following:
Individual failed prior methotrexate based regimen (without prior radiation)
Individual previously received whole brain radiation therapy
Individual received prior high-dose therapy with stem cell rescue after a prolonged response (≥12 months)
Lung cancer if disease is non-squamous non-small cell lung cancer (NSCLC) if treatment is ANY ONE of the following:
In combination with carboplatin or cisplatin for ANY ONE of the following:
Induction, neoadjuvant or adjuvant therapy
Initial therapy for unresectable disease
With concurrent chemoradiation if radiation not previously given for locoregional recurrence or symptomatic local disease with mediastinal lymph nodes or for superior vena cava obstruction
Recurrent, advanced or metastatic disease in individual who does not have locoregional recurrence without evidence of disseminated disease for ANY ONE of the following:
In combination with pembrolizumab and either carboplatin or cisplatin as first-line therapy for PD-L1 expression positive (≥50%) tumors that are genomic tumor aberration EGFR and ALK negative or unknown
In combination with pembrolizumab as continuation maintenance therapy for PD-L1 expression positive (≥50%) tumors that are genomic tumor aberration EGFR and ALK negative or unknown
As a single agent OR in combination with pembrolizumab and either carboplatin or cisplatin OR in combination with either carboplatin or cisplatin with or without bevacizumab for ANY ONE of the following:
First-line therapy for genomic tumor aberration (e.g., EGFR, ALK, ROS1, BRAF) negative or unknown and PD-L1 <50% or unknown OR BRAF V600E-mutation positive
Subsequent therapy for genomic tumor aberration (e.g., EGFR, ALK, ROS1) positive and prior targeted therapy OR BRAF V600E-mutation positive OR PD-L1 ≥ 50% and EGFR, ALK negative or unknown with no prior platinum doublets
Continuation maintenance therapy with PS ≤ 2 for ALL of the following:
Disease has not progressed (achieved tumor response or stable disease) after first-line chemotherapy
Pemetrexed must have been included in patient’s first-line chemotherapy regimen for recurrent, advanced, or metastatic disease
Used as ANY ONE of the following:
Single agent (or may be used for switch maintenance as well)
In combination with bevacizumab if bevacizumab was previously used with a first-line pemetrexed/platinum chemotherapy regimen
In combination with pembrolizumab if pembrolizumab was previously used first-line as part of pembrolizumab/pemetrexed/carboplatin or cisplatin regimen
Single agent for subsequent therapy after progression on initial therapy, if not previously given, for recurrent, advanced or metastatic disease and a performance status score ≤ 2
Mesothelioma if diagnosed as malignant pleural mesothelioma if used as ANY ONE of the following:
As a single agent
In combination with cisplatin or carboplatin
In combination with bevacizumab and either cisplatin or carboplatin followed by single-agent bevacizumab maintenance therapy
Ovarian cancer if ALL of the following:
Diagnosed as ANY ONE of the following:
Epithelial ovarian cancer
Fallopian tube cancer
Primary peritoneal cancer
Disease is persistent or recurrent
Individual is not experiencing an immediate biochemical relapse as evidenced by rising CA125 levels
Treatment is single-agent therapy
Thymomas / thymic carcinomas if ALL of the following:
Treatment is second-line
Used as single agent
Genomic Aberration Targeted Therapies (not all inclusive)
Sensitizing EGFR mutation-positive tumors
ALK rearrangement-positive tumors
ROS1 rearrangement-positive tumors
BRAF V600E-mutation positive tumors
PD-L1 expression-positive tumors (greater than or equal to 50%)
Pemetrexed is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug, e.g., bone marrow suppression, renal impairment, bullous and exfoliative skin toxicity, interstitial pneumonitis, radiation recall, etc.
For a diagnosis of Non-squamous non-small cell lung cancer as continuation maintenance therapy of locally advanced, recurrent, or metastatic disease if ANY ONE of the following:
Used as a single agent, if used as part of a first-line chemotherapy regimen
Used in combination with bevacizumab if bevacizumab was previously used with a first-line pemetrexed/platinum chemotherapy regimen
Used in combination with pembrolizumab, if pembrolizumab was previously used with a first-line pemetrexed/platinum chemotherapy regimen
Used as a single agent for switch maintenance
DOSAGE & ADMINISTRATION
500mg/m2 every 21 days
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Refer to DOSAGE LIMITS below
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.
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.
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).
Lexi-Comp Online. (2019). AHFS DI. Pemetrexed. Retrieved February 5, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, February). Pemetrexed. Retrieved February 5, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Pemetrexed. Retrieved February 5, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2019, January). Center for Drug Evaluation and Research. Alimta® (pemetrexed for injection), for intravenous use. Retrieved February 5, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021462s053lbl.pdf.
ORIGINAL EFFECTIVE DATE: 10/8/2005
MOST RECENT REVIEW DATE: 5/31/2019
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 10mg