Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Pemetrexed (AlimtaŽ)

Policy #:08.00.87f



The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract. The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Pemetrexed (AlimtaŽ) is considered medically necessary and, therefore, covered as a single agent for the following conditions:

BLADDER, URETHRAL AND UPPER GENITOURINARY (GU) TRACT CANCERS (e.g., Renal Pelvis Tumors, Ureteral Tumors)
As a single-agent treatment for post-platinum or post-checkpoint inhibitor for the following indications:
  • Metastatic disease of upper GU tract tumors
  • Metastatic disease of urothelial carcinoma of prostate
  • Bladder cancer as a subsequent systemic therapy when one of the following criteria is met:
    • clinical stage IIIB (cT1-T4a, N2,3) disease following partial response or progression after primary treatment with downstaging systemic therapy or concurrent chemoradiotherapy
    • clinical stage IVA (cT4b, any N, M0) disease if tumor is present following reassessment of tumor status after primary treatment with systemic therapy or concurrent chemoradiotherapy
    • stage IVB (any T, any N, M1b) disease
    • metastatic or local recurrence post cystectomy
  • Primary carcinoma of the urethra for recurrent or metastatic disease (except recurrence of clinical stage T3-T4 disease or palpable inguinal lymph nodes)

PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA
As a single-agent treatment for relapsed or refractory disease:
    • In individuals who received prior whole brain radiation therapy (RT)
    • In individuals who have received prior high-dose methotrexate-based regimen without prior radiation therapy
    • In individuals who received whole brain RT or involved field RT in combination with a prior high-dose methotrexate-based regimen, without prior RT after no response or short response duration (12 months or more) to prior regimen
    • In individuals who received prior high-dose chemotherapy with stem cell rescue

MALIGNANT PLEURAL MESOTHELIOMA (EPITHELIAL, MIXED, SARCOMATOID)
  • In combination with bevacizumab and cisplatin followed by single-agent maintenance bevacizumab:
    • Treatment of unresectable clinical stage I-IIIa disease and tumors of epithelial histology or sarcomatoid mixed histology
    • Treatment of clinical stage IIIb or IV disease, tumors of sarcomatoid or mixed histology, or medically inoperable tumors in individuals with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
  • As induction therapy in combination with cisplatin or carboplatin for medically operable clinical stage I-IIIa disease
  • As a single agent or in combination with cisplatin or carboplatin for:
    • Treatment of unresectable clinical stage I-IIIa disease and tumors of epithelial or sarcomatoid mixed histology
    • Treatment of resected clinical stage I-IIIa disease in individuals not treated with induction chemotherapy
    • Treatment of clinical stage IIIb or IV disease or medically inoperable tumors in individuals with (PS) 0-2
  • Subsequent systemic therapy as a single agent:
    • If not administered first-line
    • If administered first-line as rechallenge if good sustained response at the time initial chemotherapy was interrupted (if administered first line)
  • In combination with bevacizumab and carboplatin followed by single-agent maintenance bevacizumab:
    • Treatment of unresectable clinical stage I-IIIa disease and tumors of epithelial histology or sarcomatoid mixed histology
    • Treatment of clinical stage IIIb or IV disease or medically inoperable tumors in individuals with (PS) 0-2
NONSQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) (E.G., ADENOCARCINOMA WITH MIXED SUBTYPES), LARGE CELL CARCINOMA, LOCALLY ADVANCED OR METASTATIC
Pemetrexed (AlimtaŽ) is not indicated for the treatment of individuals with squamous cell NSCLC.

Preoperative Therapy
  • Preoperative concurrent chemoradiation in combination with cisplatin or carboplatin for:
    • Treatment of individuals with resectable or possibly resectable superior sulcus tumors (T3 invasion or T4 extension, N0-1)
    • Treatment of individuals with clinical stage T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or mediastinum
    • Treatment of individuals with clinical stage IIIA (T4, N0-1) disease
Continuation Maintenance Therapy
  • In combination with pembrolizumab for recurrent, advanced, or metastatic disease
    • Treatment of individuals with PD-L1 expression-positive (≥1%) tumors that are EGFR, ALK negative or unknown
    • For individuals with no contraindications to the addition of pembrolizumab or atezolizumab
    • Treatment of individuals with performance status 0-2 who achieve a response or stable disease following first-line therapy with pembrolizumab/pemetrexed and either cisplatin or carboplatin
Treatment for Recurrent, Advanced, or Metastatic Disease
  • In individuals with performance status 0-2 who achieve tumor response or stable disease following initial systemic therapy*:
    • As a single agent for continuation maintenance therapy
    • In combination with bevacizumab for continuation maintenance therapy if bevacizumab previously used with a first-line pemetrexed (AlimtaŽ)/platinum chemotherapy regimen
    • In combination with pembrolizumab for continuation maintenance therapy if previously used first-line as part of a pembrolizumab/ pemetrexed (AlimtaŽ) and either cisplatin or carboplatin regimen
    • As a single agent for switch maintenance
  • For the treatment of individuals with (PS) 2 as a single agent OR
  • For the treatment of individuals with PS 0-1 in combination with either cisplatin or carboplatin and pembrolizumab for (as preferred regimens if no contraindications to the addition of pembrolizumab or atezolizumab) OR
  • For the treatment of individuals with PS 0-1 in combination with cisplatin (if contraindications to the addition of pembrolizumab or atezolizumab), OR
  • For the treatment of individuals with PS 0-2 in combination with carboplatin (if contraindications to the addition of pembrolizumab or atezolizumab for PS 0-1):
    • As initial systemic therapy for EGFR, ALK, ROS1, BRAF negative or unknown, and PD-L1 <1% or unknown
    • As first-line or subsequent therapy for BRAF V600E-mutation positive tumors
    • As subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib, gefitinib, osimertinib, or dacomitinib therapy
    • As subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, ceritinib, alectinib, or brigatinib therapy
    • As subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib or ceritinib therapy
    • As subsequent therapy for PD-L1 expression-positive (≥1%) tumors and EGFR, ALK negative or unknown and no prior platinum-doublet chemotherapy
  • For the treatment of individuals with performance status 0-1 tumors and no history of recent hemoptysis in combination with bevacizumab and either cisplatin or carboplatin:
    • As initial systemic therapy for EGFR, ALK, ROS1, BRAF negative or unknown, and PD-L1 <1% or unknown
    • As first-line or subsequent therapy for BRAF V600E-mutation positive tumors
    • As subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib, gefitinib, osimertinib, or dacomitinib therapy
    • As subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, ceritinib, alectinib, or brigatinib therapy
    • As subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib or ceritinib therapy
    • As subsequent therapy for PD-L1 expression-positive (≥1%) tumors and EGFR, ALK negative or unknown and no prior platinum-doublet chemotherapy
*2A for all others | 2B for locoregional recurrence or symptomatic local disease (excluding mediastinal lymph node recurrence with prior radiation therapy) with no evidence of disseminated disease

Concurrent Chemoradiation Therapy
  • In combination with carboplatin or cisplatin (with or without an additional 4 cycles of pemetrexed (AlimtaŽ) after concurrent chemoradiation if given with cisplatin) if radiation not previously given for the treatment of locoregional recurrence or symptomatic local disease:
    • In individuals with the mediastinal lymph nodes
    • In individuals with superior vena cava obstruction with or without an SVC stent
Sequential Chemoradiation Therapy in Combination with Cisplatin or Carboplatin
  • In individuals with comorbidities or who are unable to tolerate cisplatin:
    • As initial definitive therapy for medically inoperable stage IB (peripheral T2a, N0), stage I (central T1abc-2a, N0), stage II (T1abc-2ab, N1 or T2b, N0), stage IIB (T3, N0), or stage IIIA (T3, N1) with negative mediastinal nodes and N1 disease
    • As adjuvant therapy for margin-positive, R1 stage IIB (T1abc-2a, N1; T3, N0; T2b, N1)
    • As adjuvant therapy for margin-negative stage IIIA (T1-2, N2) and stage IIIB (T3, N2)
    • As adjuvant therapy for margin-positive, R1 stage IIIA (T1-2, N2) and stage IIIB (T3, N2)
    • As adjuvant therapy for margin-positive, R1 T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment
    • As adjuvant therapy for margin-positive, R1 stage IIIA (T4, N0-1) disease if not given as initial treatment
    • As adjuvant therapy for clinical stage IIIA disease (T1-3, including T3 with multiple nodules in the same lobe) that was clinically N2 but has negative N2, N3 nodes on mediastinal biopsy and R1 positive margins post-surgery
    • As adjuvant therapy for margin-positive, R1 separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral non-primary lobe (T4), N2
    • As definitive therapy, if feasible, for thoracic disease in individuals with stage IV, M1b disease and limited non-brain metastases confirmed

Subsequent Systemic Therapy
  • As a single agent (if not already given) for first progression after initial systemic therapy in individuals with performance status 0-2 for recurrent, advanced, or metastatic disease
Adjuvant Concurrent Chemoradiation Therapy in Combination with Carboplatin or Cisplatin (with or without an Additional 4 cycles of Pemetrexed (AlimtaŽ) after Concurrent Chemoradiation If Given with Cisplatin)
  • For the treatment of individuals with margin-positive stage IIB (T1abc-2a, N1; T3, N0; T2b, N1)
  • For the treatment of individuals with margin-positive stage IIIA (T1-2, N2; T3, N1) and stage IIIB (T3, N2)
  • For the treatment of individuals with margin-positive T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment
  • For the treatment of individuals with margin-positive stage IIIA (T4, N0-1) disease if not given as initial treatment
  • For the treatment of individuals with clinical stage IIIA disease (T1-3, including T3 with multiple nodules in the same lobe) that was clinically N2 but has negative N2, N3 nodes on mediastinal biopsy and positive margins post-surgery
  • For the treatment of individuals with margin-positive separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral non-primary lobe (T4), N2

Adjuvant Chemotherapy in Combination with Cisplatin or Carboplatin (for individuals with comorbidities or who are unable to tolerate cisplatin)
  • For the treatment of individuals with medically inoperable high-risk stage IB (peripheral T2a, N0), stage I (central T1abc-2a, N0), stage II (T1abc- 2ab, N1; T2b, N0), stage IIB (T3, N0) with negative mediastinal nodes and N0 disease may be considered following definitive radiation therapy
  • For the treatment of individuals with high-risk, margin-negative stage IB (T2a, N0) and IIA (T2b, N0)
  • For the treatment of individuals with margin-positive stage IB (T2a, N0) and IIA (T2b, N0)
  • For the treatment of individuals with margin-positive stage IIA (T2b, N0) following radiation
  • For the treatment of individuals with stage IIB (T1abc-2a, N1; T3, N0; T2b, N1)
  • For the treatment of individuals with margin-negative stage IIIA (T1-2, N2; T3, N1) and stage IIIB (T3, N2)
  • For the treatment of individuals with resectable superior sulcus tumors (T3 invasion or T4 extension, N0-1)
  • For the treatment of individuals with T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment
  • For the treatment of individuals with stage IIIA (T4, N0-1) disease if not given as initial treatment
  • For the treatment of individuals with clinical stage IIIA disease (T1-3, including T3 with multiple nodules in the same lobe) that was clinically N2 but has negative N2, N3 nodes on mediastinal biopsy and negative margins post-surgery
  • For the treatment of individuals with clinical stage IIIA disease (T1-2, T3 other than invasive, N2 nodes positive, M0) with no apparent progression or local progression after induction chemotherapy
  • For the treatment of individuals with separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral non-primary lobe (T4), N0-1
  • For the treatment of individuals with margin-negative separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral non-primary lobe (T4), N2

First-Line Therapy
  • For the treatment of individuals with recurrent, advanced, or metastatic disease as for PD-L1 expression positive (≥1%) tumors that are EGFR, ALK negative or unknown and no contraindications to the addition of pembrolizumab or atezolizumab and performance status 0-2 in combination with pembrolizumab and either carboplatin or cisplatin (preferred if PD-L1 1-49%)

Initial Treatment

  • As definitive concurrent chemoradiation in combination with carboplatin or cisplatin (with or without an additional 4 cycles of pemetrexed (AlimtaŽ) after concurrent chemoradiation if given with cisplatin)
    • For the treatment of individuals with medically inoperable stage IB (peripheral T2a, N0), stage I (central T1abc-2a, N0), stage II (T1abc-2ab, N1 or T2b, N0), stage IIB (T3, N0), or stage IIIA (T3, N1) with negative mediastinal nodes and N1 disease
    • For the treatment of individuals with unresectable superior sulcus tumors (T4 extension, N0-1)
    • For the treatment of individuals with unresectable stage IIIA (T4, N0-1)
    • For the treatment of individuals with T1-2 or T3 (other than invasive), N2 nodes positive, M0
    • For the treatment of individuals with T3 invasion, N2 nodes positive, M0
    • For the treatment of individuals with stage IIIB (T1-2, N3) and stage IIIC (T3, N3)
    • For the treatment of individuals with contralateral or ipsilateral mediastinal node-positive stage IIIB (T4, N2) and stage IIIC (T4, N3)
    • For the treatment of individuals with stage IVA, M1b (T1-3, N1-2 or T4, N0-2) disease and limited non-brain metastases confirmed, if definitive therapy for thoracic disease is feasible
Combination with Cisplatin or Carboplatin
  • For the treatment of individuals with comorbidities or who are unable to tolerate cisplatin
    • As induction chemotherapy for operable stage IB (peripheral T2a, N0), stage I (central T1abc-2a, N0), stage II (T1abc-2ab, N1 or T2b, N0), stage IIB (T3, N0), or stage IIIA (T3, N1) with negative mediastinal nodes as an alternative for individuals likely to receive adjuvant chemotherapy
    • As neoadjuvant chemotherapy for T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or mediastinum
    • As neoadjuvant chemotherapy for stage IIIA (T4, N0-1) disease
    • As induction chemotherapy with or without radiation for T1-2 or T3 (other than invasive) N2, M0
    • As induction chemotherapy for T1-3, N0-1 (including T3 with multiple nodules in the same lobe) as an alternative for individuals likely to receive adjuvant chemotherapy

OVARIAN CANCER (E.G., EPITHELIAL OVARIAN CANCER, FALLOPIAN TUBE CANCER, AND PRIMARY PERITONEAL CANCER)
  • As a single-agent therapy for clinical relapse of a persistent disease or recurrence

THYMIC CARCINOMA, OR THYMOMA
  • Second-line therapy as a single agent:
    • For unresectable disease following first-line chemotherapy
    • For potentially resectable locally advanced disease, solitary metastasis, or ipsilateral pleural metastasis
    • For extrathoracic metastatic disease

EXPERIMENTAL/INVESTIGATIONAL

All other uses of pemetrexed (AlimtaŽ) are considered experimental/ investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Guidelines

Individuals undergoing treatment with pemetrexed (AlimtaŽ) should be pretreated with folic acid, vitamin B12, and dexamethasone to reduce the severity of hematologic and gastrointestinal toxicity of pemetrexed (AlimtaŽ). The vitamin therapy should continue on a daily basis as a prophylactic measure to reduce treatment-related hematologic toxicity.

Pemetrexed (AlimtaŽ) is primarily excreted unchanged by the kidney. Decreased renal function will result in reduced clearance and greater exposure under area curve (AUC) to pemetrexed (AlimtaŽ) compared to individuals with normal renal function. Hepatic and renal function should be monitored with periodic testing.

THE EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS

The Eastern Cooperative Oncology Group (ECOG), established in 1955, was one of the first groups to coordinate multicenter cancer clinical trials. The National Cancer Institute (NCI) is the primary funding source, and ECOG has evolved from a small consortium of institutions in the eastern US to one of the largest clinical cancer research organizations in the country. As part of their work in the treatment of cancer, ECOG has developed the ECOG Performance Status (EPS), originally published in 1982 in the American Journal of Clinical Oncology. The use of the scales and the criteria in the EPS allows clinicians and researchers to determine an individual’s disease progression in terms of how the activities of daily living (ADL) are affected.

ECOG Performance Status
Grade
ECOG
0
Fully active, able to carry on all predisease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work
2
Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50 percent of waking hours
3
Capable of only limited self care, confined to bed or chair more than 50 percent of waking hours
4
Completely disabled. Cannot carry on any self care: Totally confined to bed or chair
5
Dead
*Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, pemetrexed (AlimtaŽ) intravenous (IV) infusion is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION STATUS (FDA)

Pemetrexed (AlimtaŽ) IV infusion was first approved by the FDA on February 4, 2004 as a single agent for the treatment of individuals with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy. Supplemental approvals for Pemetrexed (AlimtaŽ) have since been issued by the FDA.

Description

Pemetrexed (AlimtaŽ) for intravenous infusion is classified as an antineoplastic agent for use in chemotherapy as a single agent or in combination with other chemotherapy drugs. It is a third-generation autofolate analog metabolic inhibitor and a known folic acid antagonist. The mechanism of action is the inhibition of three enzymes: thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT). These enzymes are necessary for folic acid metabolic processes that are essential for cell replication and growth.

Within the cellular matrix, pemetrexed (AlimtaŽ) is converted to polyglutamate forms by the enzyme folylpolyglutamate synthetase. The polyglutamate forms are retained in cells and are inhibitors of TS and GARFT. Polyglutamation is a time- and concentration-dependent process that occurs in tumor cells; it is thought to occur to a lesser extent in normal tissues. Polyglutamated metabolites are thought to have an increased intracellular half-life resulting in prolonged drug action in malignant cells.

In February 2004 pemetrexed (AlimtaŽ) was approved by the US Food and Drug Administration (FDA) for individuals with cisplatin who have malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery. This approval is based on the results of a multi-center, randomized, single-blind study comparing 448 chemo-naive individuals with malignant pleural mesothelioma receiving pemetrexed (AlimtaŽ) in combination with cisplatin to a control group treated with cisplatin alone. Treatment was received on Day 1 of each 21-day cycle. The protocol was changed to include folic acid and B12 supplementation after 114 individuals developed white cell and GI toxicity. Pemetrexed (AlimtaŽ) group had a statistically significant greater median overall survival of 12.1 months compared to the control group of 9.3 months.

In August 2004 pemetrexed (AlimtaŽ) was FDA approved as a single agent for the treatment of individuals with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) after prior chemotherapy. A multi-center, randomized, open-label study compared the overall survival of individuals with Stage III or IV NSCLC after prior chemotherapy following treatment with pemetrexed (AlimtaŽ) versus docetaxel. The median overall survival for the pemetrexed (AlimtaŽ) group was 8.3 months compared to 7.9 months in the control group, with a hazard ratio of 0.99. This study did not show an overall survival superiority of pemetrexed (AlimtaŽ).

In September 2008, pemetrexed (AlimtaŽ) was FDA approved in combination with cisplatin for the initial treatment of individuals with locally advanced or metastatic nonsquamous NSCLC. The overall survival following treatment of pemetrexed (AlimtaŽ) with cisplatin was compared to gemcitabine with cisplatin in a multi-center, randomized, open-label study of 1725 chemo-naive individuals with Stage IIIb/IV NSCLC. Treatment was administered up to 6 cycles with both treatment arms receiving folic acid, vitamin B12, and dexamethasone. The median overall survival for both groups was 10.3 months with an adjusted hazard ratio of 0.94.

In July 2009, pemetrexed (AlimtaŽ) was FDA-approved for the maintenance treatment of individuals with locally advanced or metastatic nonsquamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. A multi-center, randomized, double-blind, placebo-controlled study was conducted in 663 individuals with Stage IIIb/IV NSCLC who did not progress after four cycles of platinum-based chemotherapy to compare pemetrexed (AlimtaŽ) to placebo administered immediately following platinum-based chemotherapy. The primary endpoints were progression-free survival and overall survival. The study demonstrated that pemetrexed (AlimtaŽ) was statistically superior to placebo for overall survival (median 13.4 months versus 10.6 months) and progression-free survival (median 4.0 months versus 2.0 months).

Clinical research is ongoing for the use of pemetrexed (AlimtaŽ) in the treatment of other cancers. Some of these other cancerous processes are those of the breast, colorectal, esophagus, pancreas, cervical, and kidney. Health outcome effectiveness for individuals with these other types of cancers has yet to be determined. Professional literature states the need for ongoing studies to determine the effectiveness of pemetrexed (AlimtaŽ) in other cancers.

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References


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Lorusso D, Ferrandina G, Pignata S, et al. Evaluation of pemetrexed (Alimta, LY231514) as second-line chemotherapy in persistent or recurrent carcinoma of the cervix: the CERVIX 1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) Group. Ann Oncol. 2009;21(1):61-66.

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Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol.1982;5(6):649-655.

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Pemetrexed (AlimtaŽ).[prescribing information]. Indianapolis, IN. Lilly USA, LLC. 2004. Updated 02/2015. Available at http://uspl.lilly.com/alimta/alimta.html#pi. Accessed September 19, 2019.

Raizer J, Rademaker A. Pemetrexed in the treatment of relapsed/refractory primary central nervous syste. Cancer. 2011;118: 3743-8.

Ricciardi S, Tomao S, Filippo M. Pemetrexed as first-line therapy for non-squamous non-small cell lung cancer. Ther Clin Risk Manag.2009;5:781–787.

Scagliotti G, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage NSCLC. J Clin Oncol. 2008;26:3543-3551.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs@FDA. New drug application for the use of AlimtaŽ (pemetrexed, LY231514). [FDA Website] 02/02/2004. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21462ltr.pdf. Accessed September 19, 2019.

US Food and Drug Administration (FDA). Pemetrexed (AlimtaŽ) SUPPLEMENT APPROVAL. Supplemental New Drug Application. [FDA Web site]. 09/12/2013. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021462Orig1s045ltr.pdf. Accessed September 19, 2019, 2019.

United States National Institutes of Health, National Cancer Institute (NCI). Drug information. FDA approval Pemetrexed Disodium. [NCI Web site]. Revised 03/09/2018. Available at: https://www.cancer.gov/about-cancer/treatment/drugs/pemetrexeddisodium Accessed September 19, 2019.


Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

See Attachment A


HCPCS Level II Code Number(s)

J9305 Injection, pemetrexed, 10 mg


Revenue Code Number(s)

N/A



Coding and Billing Requirements


Cross References

Attachment A: Pemetrexed (AlimtaŽ)
Description: ICD-10 CODES AND NARRATIVES




Policy History

08.00.87f
12/16/2019This version of the policy will become effective 12/16/2019.

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling and NCCN compendia.

Extensive NCCN updates for policy criteria for primary carcinoma or urethra, Upper GU tumors, urothelial carcinoma of prostate, CNS lymphoma, malignant pleural mesothelioma, and NSCLC were updated to reflect NCCN recommendations.

08.00.87e
12/13/2017This version of the policy will become effective 12/13/2017.

This policy has been updated to be consistent with the US Food and Drug Administration (FDA) labeling and NCCN compendia.

Policy criteria for primary carcinoma or urethra, Upper GU tumors, urothelial carcinoma of prostate, CNS lymphoma, malignant pleural mesothelioma, and NSCLC were updated to reflect NCCN recommendations.

The following code was added: C57.9.

Effective 10/05/2017 this policy has been updated to the new policy template format.

Version Effective Date: 12/16/2019
Version Issued Date: 12/16/2019
Version Reissued Date: N/A



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