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1 Moda Health Plan, Inc. Medical Necessity Criteria Subject: Alimta (pemetrexed) Page 1 of 6 Origination Date: 08/13 Revision Date(s): 12/13, 12/14, 04/2015 Developed By: Medical Criteria Committee Effective Date: 10/1/2013 Approved: Mary Engrav, MD Date: 05/27/2015 Description: Pemetrexed is an antifolate containing the pyrrolopyrimidine-based nucleus that exerts its antineoplastic activity by disrupting folate-dependent metabolic processes essential for cell replication. In vitro studies have shown that pemetrexed inhibits thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), all folate-dependent enzymes involved in the de novo biosynthesis of thymidine and purine nucleotides. Pemetrexed is transported into cells by both the reduced folate carrier and membrane folate binding protein transport systems. Once in the cell, pemetrexed 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 timeand concentration-dependent process that occurs in tumor cells and, to a lesser extent, in normal tissues. Polyglutamated metabolites have an increased intracellular half-life resulting in prolonged drug action in malignant cells. Preclinical studies have shown that pemetrexed inhibits the in vitro growth of mesothelioma cell lines (MSTO-211H, NCI-H2052). Studies with the MSTO-211H mesothelioma cell line showed synergistic effects when pemetrexed was combined concurrently with cisplatin. Criteria: CWQI HCS-0097 I. Alimta is medically necessary for patients with One or more of the following: a. Bladder Cancer with ALL of the following i. For a second line of treatment of metastatic disease b. Bladder Cancer Primary Carcinoma of the Urethra with ALL of the following: i. For second line treatment of metastatic disease; and c. Bladder Cancer upper genitourinary (GU) tumors with ALL of the following i. For second line treatment of metastatic disease d. Bladder Cancer Urothelial carcinoma of the prostate with ALL of the following i. For second line treatment of metastatic disease

2 e. Primary central nervous system lymphoma and ALL of the following: i. For progressive or recurrent disease; and. f. Malignant pleural mesothelioma with ONE or more of the following i. Must be used in combination with cisplatin or carboplatin ii. May be used as a single agent g. Nonsquamous non-small cell lung cancer with ONE or more of the following i. Must be used in combination with cisplatin or carboplatin ii. May be used as single agent (if not already given) as subsequent therapy for metastatic disease following progression on a cytotoxic regimen in patients with performance status 0-2 May be used for continuation maintenance therapy and ALL of the following: 1. Patient has recurrent or metastatic disease 2. Patient s disease has not progressed (achieved tumor response or stable disease) 3. Patient has a performance status of 0-2 and ONE or more of the following: a. Must be used in combination with bevacizumab if bevacizumab previously used with a first-line pemetrexed/platinum chemotherapy regimen b. Must be used as a single agent if given previously with chemotherapy h. Thymic malignancies with ALL of the following i. For second or third line treatment of locally advanced unresectable disease i. Ovarian Cancer with ALL of the following i. For persistent or recurrent disease II. Renewal of Alimta with ALL of the following a. Patient continues to meet criteria for specific disease; and b. Tumor response; and c. Absence of unacceptable toxicity Dosage/Administration: Indication All indications Dose 500mg/m 2 every 21 days

3 Information to be Submitted with Pre-Authorization Request: 1. Chart notes 2. Imaging studies and laboratory reports 3. Pathology reports Contraindication: a. History of severe hypersensitivity reaction to pemetrexed Applicable CPT Codes: JCode: J9305 Alimta (pemetrexed) 100 mg, 500 mg Injection: 1 billable unit = 10mg Max Units (per dose and over time): Male: 130 billable units every 21 days Female: 110 billable units every 21 days Covered Diagnosis: ICD-9 Codes Diagnosis Malignant neoplasm of specified parts of peritoneum Malignant neoplasm of peritoneum, unspecified Malignant neoplasm of trachea Malignant neoplasm of main bronchus Malignant neoplasm of upper lobe, bronchus or lung Malignant neoplasm of middle lobe, bronchus or lung Malignant neoplasm of lower lobe, bronchus or lung Malignant neoplasm of other parts of bronchus or lung Malignant neoplasm of bronchus and lung, unspecified Malignant neoplasm of parietal pleura Malignant neoplasm of visceral pleura Malignant neoplasm of other specified sites of pleura Malignant neoplasm of pleura, unspecified Malignant neoplasm of thymus Malignant neoplasm of ovary Malignant neoplasm of fallopian tube Malignant neoplasm of broad ligament of uterus Malignant neoplasm of parametrium Malignant neoplasm of round ligament of uterus Malignant neoplasm of other specified sites of uterine adnexa Malignant neoplasm of uterine adnexa, unspecified site 185 Malignant neoplasm of prostate Malignant neoplasm of trigone of urinary bladder Malignant neoplasm of dome of urinary bladder

4 188.2 Malignant neoplasm of lateral wall of urinary bladder Malignant neoplasm of anterior wall of urinary bladder Malignant neoplasm of posterior wall of urinary bladder Malignant neoplasm of bladder neck Malignant neoplasm of ureteric orifice Malignant neoplasm of urachus Malignant neoplasm of other specified sites of bladder Malignant neoplasm of bladder, part unspecified Malignant neoplasm of renal pelvis Malignant neoplasm of ureter Malignant neoplasm of the urethra Primary central nervous system lymphoma, unspecified site, extranodal and solid organ sites Primary central nervous system lymphoma, lymph nodes of head, face, and neck Benign neoplasm of thymus Carcinoma in situ of bladder V10.11 Personal history of malignant neoplasm of bronchus and lung V10.43 Personal history of malignant neoplasm of ovary Applicable ICD-10 Codes ICD-10 Code Diagnosis C48.1 Malignant neoplasm of specified parts of peritoneum C48.8 Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum C48.2 Malignant neoplasm of peritoneum, unspecified C33 Malignant neoplasm of trachea C34.00 Malignant neoplasm of unspecified main bronchus C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung C34.2 Malignant neoplasm of middle lobe, bronchus or lung C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung C38.4 Malignant neoplasm of pleura C37 Malignant neoplasm of thymus C45.9 Malignant neoplasm of unspecified ovary C57.00 Malignant neoplasm of unspecified fallopian tube C57.10 Malignant neoplasm of unspecified broad ligament C57.3 Malignant neoplasm of parametrium C57.20 Malignant neoplasm of unspecified round ligament C57.4 Malignant neoplasm of uterine adnexa, unspecified C61 Malignant neoplasm of prostate C67.0 Malignant neoplasm of trigone of bladder C67.1 Malignant neoplasm of dome of bladder C67.2 Malignant neoplasm of lateral wall of bladder

5 C67.3 Malignant neoplasm of anterior wall of bladder C67.4 Malignant neoplasm of posterior wall of bladder C67.5 Malignant neoplasm of bladder neck C67.6 Malignant neoplasm of ureteric orifice C67.7 Malignant neoplasm of urachus C67.8 Malignant neoplasm of overlapping sites of bladder C67.9 Malignant neoplasm of bladder, unspecified C65.9 Malignant neoplasm of unspecified renal pelvis C66.9 Malignant neoplasm of unspecified ureter C68.0 Malignant neoplasm of urethra C83.39 Diffuse large B-cell lymphoma, extranodal and solid organ sites C83.80 Other non-follicular lymphoma, unspecified site C83.89 Other non-follicular lymphoma, extranodal and solid organ sites C83.31 Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck C83.81 Other non-follicular lymphoma, lymph nodes of head, face, and neck D15.0 Benign neoplasm of thymus D09.0 Carcinoma in situ of bladder Z Personal history of other malignant neoplasm of bronchus and lung Z85.43 Personal history of malignant neoplasm of ovary Review Date Revisions Effective Date 12/2013 New criteria adopted from ICORE guidelines 10/01/ /2014 Annual Review: 12/31/2014 4/2015 New update to ICORE guidelines, deleted 1 a-d 05/27/2015 References: Alimta [package insert]. Indianapolis, IN; Eli Lilly; September Accessed February Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium ) for pemetrexed National Comprehensive Cancer Network, The NCCN Compendium is a derivative work of the NCCN Guidelines. NATIONAL COMPREHENSIVE CANCER NETWORK, NCCN, and NCCN GUIDELINES are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2015 Castagneto B, Botta M, Aitini E, et al, Phase II Study of Pemetrexed in Combination With Carboplatin in Patients With Malignant Pleural Mesothelioma (MPM), Ann Oncol, 2008, 19(2): [PubMed ] Ceresoli GL, Zucali PA, Favaretto AG, et al, Phase II Study of Pemetrexed Plus Carboplatin in Malignant Pleural Mesothelioma, J Clin Oncol, 2006, 24(9): [PubMed ] Jassem J, Ramlau R, Santoro A, et al, Phase III Trial of Pemetrexed Plus Best Supportive Care Compared With Best Supportive Care in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma, J Clin Oncol, 2008, 26(10): [PubMed ] Taylor P, Castagneto B, Dark G, et al, Single-Agent Pemetrexed for Chemonaïve and

6 Pretreated Patients With Malignant Pleural Mesothelioma: Results of an International Expanded Access Program, J Thorac Oncol, 2008, 3(7): [PubMed ] Cripps C, Burnell M, Jolivet J, et al. Phase II study of first-line LY (multi-targeted antifolate) in patients with locally advanced or metastatic colorectal cancer: an NCIC Clinical Trials Group study. Ann Oncol 1999;10: John W, Picus J, Blanke CD, et al. Activity of multitargeted antifolate (pemetrexed disodium, LY231514) in patients with advanced colorectal carcinoma: results from a phase II study. Cancer 2000;88: First Coast Service Options, Inc. Local Coverage Determinations (LCD) for PEMETREXED (L29255; L29464). Centers for Medicare & Medicaid Services. Updated on 07/01/2014 with effective date 11/23/2011. Accessed February Wisconsin Physicians Service Insurance Corporation. Local Coverage Determination (LCD) for Chemotherapy Drugs and their Adjuncts (L28576). Centers for Medicare & Medicaid Services. Updated on 01/20/2015 with effective date 02/01/2015. Accessed February Cahaba Government Benefit Administrators, LLC. Local Coverage Article for Drugs and Biologicals - Chemotherapeutic Agents (A48896). Centers for Medicare & Medicaid Services. Updated on 02/17/2015 with effective dates 01/01/2015. Accessed February 2015.

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