Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Pemetrexed (Alimta®)

Policy #:08.00.87e

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


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.

Pemetrexed (Alimta®) is considered medically necessary and, therefore, covered for any of the following conditions:

BLADDER CANCER
  • As a single agent for clinical stage T4b or T2-T4a, N1-3 disease, or for recurrence post cystectomy or metastatic disease as subsequent systemic therapy.

Primary Carcinoma of the Urethra, and Upper Genitourinary (GU) Tumors (e.g., Renal Pelvis Tumors, Ureteral Tumors), Urothelial Carcinoma of the Prostate
  • As subsequent systemic therapy as a single agent for metastatic disease

PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA
  • As a single-agent treatment for relapsed or refractory disease in individuals who have received prior high dose methotrexate-based regimen without prior radiation therapy:
    • After prolonged (12 months or more) response to prior regimen
    • In combination with radiation therapy after short (less than 12 months) or no response to prior regimen
  • Systemic treatment as a single agent for relapsed or refractory disease:
    • May be considered in individuals with prior whole brain radiation therapy
    • In individuals who received prior high-dose chemotherapy with stem cell rescue after a prolonged response (12 months or more)

MALIGNANT PLEURAL MESOTHELIOMA (EPITHELIAL, SARCOMATOID)
  • In combination with cisplatin for individuals with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery
  • As induction therapy in combination with cisplatin for medically operable clinical stage I-III disease
  • As a single agent or in combination with cisplatin or carboplatin for:
    • Treatment of unresectable clinical stage I-III disease and tumors of epithelial or mixed histology
    • Treatment of clinical stage IV disease or tumors of sarcomatoid or mixed histology, or medically inoperable tumors in individuals with performance status (PS) 0-2
    • Treatment of resected clinical stage I-III disease in individuals not treated with induction chemotherapy
  • In combination with bevacizumab and cisplatin as:
    • Treatment of unresectable clinical stage I-III disease and tumors of epithelial histology
    • Treatment of clinical stage IV disease, tumors of sarcomatoid or mixed histology, 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

NONSQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) (E.G., ADENOCARCINOMA WITH MIXED SUBTYPES), LARGE CELL CARCINOMA, LOCALLY ADVANCED OR METASTATIC

Pemetrexed (Alimta®) is not indicated for the treatment of individuals with squamous cell NSCLC.

PREOPERATIVE USE
  • Preoperative concurrent chemoradiation in combination with cisplatin or carboplatin for:
    • Resectable or possibly resectable superior sulcus tumors (T3 invasion or T4 extension, N0-1)
    • T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or mediastinum

AS INDUCTION CHEMOTHERAPY
  • In combination with cisplatin as induction chemotherapy:
    • For operable stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab-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
    • With or without radiation for T1-2 or T3 (other than invasive) N2, MO
    • For T1-3, N0-1 (including T3 with multiple nodules in the same lobe) as an alternative for individuals likely to receive adjuvant chemotherapy
  • In combination with cisplatin as neoadjuvant chemotherapy for T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or mediastinum

AS FIRST-LINE THERAPY
  • Initial treatment in combination with cisplatin for individuals with locally advanced or metastatic nonsquamous non-small cell lung cancer
  • Initial treatment as definitive concurrent chemoradiation in combination with carboplatin or cisplatin (with or without an additional 4 cycles of pemetrexed after concurrent chemoradiation if given with cisplatin) for:
    • Medically inoperable stage IB (peripheral T2a,N0), stage I (central T1ab-2a,N0), stage II (T1ab-2ab,N1 or T2b, N0), stage IIB (T3, N0), or stage IIIA (T3, N1) with negative mediastinal nodes and N1 disease
    • Unresectable superior sulcus tumors (T4 extension, N0-1)
    • Unresectable stage IIIA (T4, N0-1)
    • T1-2 or T3 (other than invasive), N2 nodes positive, M0
    • T3 invasion, N2 nodes positive, M0
    • Stage IIIB (T1-3, N3 positive, M0)
    • Contralateral or ipsilateral mediastinal node-positive stage IIIB (T4 extension, N2-3)
    • Stage IV, M1b disease and limited non-brain metastases confirmed, if definitive therapy for thoracic disease is feasible

AS A SECOND-LINE OR SUBSEQUENT THERAPY
  • Single agent for the treatment of individuals with locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy

ADJUVANT USE
  • In combination with cisplatin as adjuvant chemotherapy for:
    • May be considered following definitive radiation therapy in medically inoperable high-risk stage IIIA (T3, N1) with negative mediastinal nodes and N0 disease
    • High risk, margin-negative stage IB (T2a,N0) and IIA (T2b, N0)
    • Margin-positive stage IB (T2a, N0) and IIA (T2b, N0)
    • Margin-positive stage IIA (T2b, N0) following radiation
    • Stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1)
    • Margin-negative stage IIIA (T1-3, N2; T3, N1)
    • Resectable superior sulcus tumors (T3 invasion, T4 extension, N0-1)
    • T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment
    • 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
    • Clinical stage IIIA disease (T1-2, T3 other than invasive, N2 nodes positive, M0) with no apparent progression or local progression after induction
    • Separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N0-1
    • Margin-negative or margin-positive, R1 separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N2
  • In combination with cisplatin (with or without an additional 4 cycles of pemetrexed after concurrent chemoradiation if given cisplatin) or carboplatin as adjuvant concurrent chemoradiation
    • Margin-positive stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1)
    • Margin-positive stage IIIA (T1-3,N2; T3, N1)
    • 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
    • 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
    • Margin-positive separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N2

FOR RECURRENCE OR METASTASIS
  • Concurrent chemoradiation in combination with carboplatin or cisplatin (with or without an additional 4 cycles of pemetrexed after concurrent chemoradiation if given with cisplatin) if radiation not previously given for locoregional recurrence in the mediastinal lymph nodes or for superior vena cava obstruction
  • Treatment for recurrence or metastasis for tumors of nonsquamous cell histology (excluding locoregional recurrence with no evidence of disseminated disease, other than mediastinal lymph node recurrence with prior radiation) as a single agent for individuals with performance status (PS) 2 in combination with carboplatin and pembrolizumab (if pembrolizumab not previously given), in combination with cisplatin for PS 0-1, or in combination with carboplatin for PS 0-2 as:
    • First-line therapy for EGFR, ALK, ROS1,BRAF, and PD-L1 negative or unknown
    • First-line or subsequent therapy for BRAF V600E-mutation positive tumors
    • Subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib, gefitinib or osimertinib therapy
    • Subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, certinib, alectinib, or brigatinib therapy
    • Subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib therapy
    • Subsequent therapy for PD-L1 expression-positive (≥ 50%) tumors and EGFR, ALK, ROS1, and BRAF negative or unknown
  • Treatment for recurrence (excluding locoregional recurrence with no evidence of disseminated disease, other than mediastinal lymph node recurrence with prior radiation) or metastasis in cisplatin- or carboplatin-based regimens in combination with bevacizumab for individuals with performance status 0-1, tumors of nonsquamous cell histology, and no history of recent hemoptysis as:
    • First-line therapy for EGFR, ALK, ROS1,BRAF, and PD-L1 negative or unknown
    • First-line or subsequent therapy for BRAF V600E-mutation positive tumors
    • Subsequent therapy for sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib, gefitinib or osimertinib therapy
    • Subsequent therapy for ALK rearrangement-positive tumors and prior crizotinib, certinib, alectinib, or brigatinib therapy
    • Subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib therapy
    • Subsequent therapy for PD-L1 expression-positive (≥ 50%) tumors and EGFR, ALK, ROS1, and BRAF negative or unknown
  • Treatment for recurrence or metastasis in individuals with performance status 0-2 with tumors of nonsquamous cell histology who achieve tumor response or stable disease following chemotherapy as:
    • A single agent for continuation maintenance therapy if previously used with a first-line chemotherapy or in combination with bevacizumab (Avastin®) if bevacizumab (Avastin®) was previously used with a pemetrexed/ platinum chemotherapy regimen

AS MAINTENANCE THERAPY
  • For maintenance therapy in individuals with locally advanced or metastatic nonsquamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy

FOR PROGRESSIVE DISEASE
  • As a single agent (if not already given) as a subsequent therapy for metastatic disease following progression on a cytotoxic regimen in individuals with PS 0-2 and tumors of nonsquamous cell histology

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

THYMIC CARCINOMA, OR THYMOMA
  • As second-line therapy as a single agent

EXPERIMENTAL/INVESTIGATIONAL

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

Pemetrexed (Alimta®) is primarily excreted unchanged by the kidney. Decreased renal function will result in reduced clearance and greater exposure under area curve (AUC) to pemetrexed (Alimta®) 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 (Alimta®) 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 (Alimta®) IV infusion was first approved by the FDA on February 4, 2004 as a single agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy. Supplemental approvals for Pemetrexed (Alimta®) have since been issued by the FDA.

Description

Pemetrexed (Alimta®) 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 (Alimta®) 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 (Alimta®) 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 (Alimta®) 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 (Alimta®) 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 (Alimta®) 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 (Alimta®) versus docetaxel. The median overall survival for the pemetrexed (Alimta®) 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 (Alimta®).

In September 2008, pemetrexed (Alimta®) 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 (Alimta®) 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 (Alimta®) 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 (Alimta®) to placebo administered immediately following platinum-based chemotherapy. The primary endpoints were progression-free survival and overall survival. The study demonstrated that pemetrexed (Alimta®) 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 (Alimta®) 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 (Alimta®) 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


American Cancer Society (ACS). What Is Non-Small Cell Lung Cancer? [ACS Web site]. 05/16/2016. Available at:http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer. Accessed October 3, 2017.

American Hospital Formulary Service (AHFS). Pemetrexed (Alimta®). AHFS Drug Information 2017. [LexiComp Web site]. Available at:http://online.lexi.com/lco/action/home# [via subscription only]. Accessed October 3, 2017.

Asukai Y, Valladares A, Camps C, et al. Cost-effectiveness analysis of pemetrexed versus docetaxel in the second-line treatment of non-small cell lung cancer in Spain: results for the non-squamous histology population. BMC Cancer.2010;10:26.

Azzoli C, Temin S, Aliff T. 2011 Focused Update of 2009 American Society of Clinical Oncology Clinical Practice guideline update on chemotherapy for stage IV non-small-cell-lung cancer. J Clin Oncol. 2012;8(1):63-66.

Barlesi F, Scherpereel A. Maintenance bevacizumab-pemetrexed after first-line cisplatin-pemetrexed-bevacizumab for advanced nonsquamous non-small-cell lung cancer: update survival analysis of the AVAPERL (MO22089) randomized phase III trial. Ann Oncol. 2014;25:1044-52.

Lexi-Drugs Compendium. Pemetrexed. [Lexicomp Online Web site]. 09/18/2017. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed October 3, 2017.

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.

Malempati S, Nicholson H, Reid J, et al. Phase I Trial and Pharmacokinetic Study of Pemetrexed in Children With Refractory Solid Tumors: The Children's Oncology Group. J Clin Oncol. 2007;25(12):1505-1511.

Micromedex® Healthcare Series [Internet database]. Pemetrexed. Greenwood Village, CO: Thomson Micromedex. 09/18/2017. Available at: http://www.micromedexsolutions.com/micromedex2/librarian. Accessed October 3, 2017.

Miller DS, Blessing JA, Krasner CN, et al. Phase II evaluation of pemetrexed in the treatment of recurrent or persistent platinum-resistant ovarian or primary peritoneal carcinoma: A study of the Gynecologic Oncology Group. J Clin Oncol. 2009;27(16):2686-2691.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Bladder Cancer V5.2017. 05/25/2017. Available from: http://www.nccn.org/professionals/physician_gls/PDF/bladder.pdf [log in required]. Accessed September 28, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Central Nervous System Cancers V1.2017. 08/18/2017. Available from: http://www.nccn.org/professionals/physician_gls/pdf/cns.pdf [log in required]. Accessed September 28, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Malignant Pleural Mesothelioma. V2.2017. 07/07/2017. Available from: http://www.nccn.org/professionals/physician_gls/PDF/mpm.pdf. [log in required]. Accessed September 28, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Non-Small Cell Lung Cancer V8.2017. 07/14/2017. Available from: http://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf [log in required]. Accessed September 28, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Ovarian Cancer V3.2017. 08/30/2017. Available from: http://www.nccn.org/professionals/physician_gls/PDF/ovarian.pdf [log in required]. Accessed September 28, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology™. Thymomas and Thymic Carcinomas V1.2017. 03/02/2017. Available from: http://www.nccn.org/professionals/physician_gls/PDF/thymic.pdf [log in required]. Accessed September 28, 2017.

National Comprehensive Cancer Network (NCCN). NCCN Drug & Biologics Compendium. Pemetrexed. Available at: http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=44. Accessed September 28, 2017.

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.

Paz-Ares L. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamouns non-small-cell lung cancer. J Clin Oncol. 2013;31:2895-2902.

Peters S. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012;Suppl 5:v116-v119.

Pemetrexed (Alimta®).[prescribing information]. Indianapolis, IN. Lilly USA, LLC. 2004. Updated 02/2015. Available at http://uspl.lilly.com/alimta/alimta.html#pi. Accessed September 28, 2017.

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 Alimta® (pemetrexed, LY231514). [FDA Website] 02/02/2004. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21462ltr.pdf. Accessed September 28, 2017.

US Food and Drug Administration (FDA). Pemetrexed (Alimta®) 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 28, 2017.

United States National Institutes of Health, National Cancer Institute (NCI). Drug information. FDA approval Pemetrexed Disodium. [NCI Web site]. Revised 07/03/2013. Available at: http://www.cancer.gov/cancertopics/druginfo/fda-pemetrexed-disodium. Accessed October 3, 2017.





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 (Alimta®)
Description: ICD-10 CODES AND NARRATIVES




Policy History

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: 12/13/2017
Version Issued Date: 12/13/2017
Version Reissued Date: N/A

Connect with Us        


© 2017 Independence Blue Cross.
Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.