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Date Printed: October 23, 2017: 02:17 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-01

Original Effective Date: 05/15/09

Reviewed: 10/12/16

Revised: 11/15/16

Subject: Pemetrexed Disodium (Alimta®) IV

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Pemetrexed (Alimta) was initially approved by the U.S. Food and Drug Administration (FDA) in February 2004 for use in combination with cisplatin for the treatment of malignant pleural mesothelioma in adults whose disease is unresectable or who are not otherwise candidates for curative surgery. The FDA has since approved pemetrexed as single agent therapy in locally advanced or metastatic non-small cell lung cancer following prior chemotherapy, for use in combination with cisplatin for first-line therapy in locally advanced or metastatic non-squamous non-small cell lung cancer, and for maintenance treatment of advanced or metastatic nonsquamous non-small cell lung cancer after first-line treatment with platinum-based chemotherapy. The agent received orphan drug status from the FDA for the malignant pleural mesothelioma. Pemetrexed acts as a multi-targeted antifolate compound that disrupts folate-dependent metabolic processes that are essential for cell replication.

National Comprehensive Cancer Network (NCCN) Guidelines for Bladder Cancer (Version 2.2016), Malignant Pleural Mesothelioma (Version 3.2016), Non-Small Cell Lung Cancer (Version 4.2016), Ovarian Cancer (Version 1.2016), Thymomas and Thymic Carcinomas (Version 3.2016), and Central Nervous System Cancers (Version 1.2016) include recommendations for use of pemetrexed.

POSITION STATEMENT:

Initiation of pemetrexed meets the definition of medical necessity for members diagnosed with ANY of the following conditions when ALL associated criteria are met:

1. Bladder Cancer (including primary carcinoma of the urethra, upper genitourinary tract tumors, and urothelial carcinoma of the prostate)

a. Member is diagnosed with locally advanced, recurrent, or metastatic disease

b. Member has failed or not tolerated treatment with another chemotherapy agent/regimen

c. Pemetrexed is used alone

d. Pemetrexed dose does not exceed 500 mg/m2 every 21 days

2. Malignant Pleural Mesothelioma

a. Member meets one of the following:

i. Pemetrexed is used alone

ii. Pemetrexed is used in combination with cisplatin or carboplatin

iii. Pemetrexed is used in combination with bevacizumab and cisplatin

b. Pemetrexed dose does not exceed 500 mg/m2 every 21 days

3. Non-Small Cell Lung Cancer

a. Member meets one of the following:

i. Pemetrexed is used alone

ii. Pemetrexed is used in combination with a cisplatin- or carboplatin-based regimen with or without bevacizumab

b. Pemetrexed dose does not exceed 500 mg/m2 every 21 days

4. Ovarian Cancer

a. Member is diagnosed with persistent or recurrent disease

b. Pemetrexed is used alone

c. Pemetrexed dose does not exceed 500 mg/m2 every 21 days

5. Thymoma or Thymic Carcinoma

a. Member has failed or not tolerated treatment with another chemotherapy agent/regimen

b. Pemetrexed is used alone

c. Pemetrexed dose does not exceed 500 mg/m2 every 21 days

6. Primary Central Nervous System Lymphoma

a. Member is diagnosed with progressive or recurrent disease

b. Pemetrexed is used alone

c. Pemetrexed dose does not exceed 500 mg/m2 every 21 days

Duration of approval: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

• 500 mg/m2 IV on Day 1 of each 21-day cycle

Dose Adjustments

Renal impairment

• CrCl < 45 mL/min: Not recommended

Drug Availability

• 100 mg and 500 mg vial for injection

Usual Dosage: Pemetrexed disodium is administered 500mg/m2 every 21 days.

PRECAUTIONS:

Precautions/Warnings

• Premedication regimen: Prior to treatment with ALIMTA, initiate supplementation with oral folic acid and intramuscular vitamin B12 to reduce the severity of hematologic and gastrointestinal toxicity

• Bone marrow suppression: Reduce doses for subsequent cycles based on hematologic and nonhematologic toxicities

• Do not administer when CrCl <45 mL/min

• Do not initiate a cycle unless ANC ≥1500 cells/mm3, platelets ≥100,000 cells/mm3, and CrCl ≥45 mL/min

• Fetal harm can occur when administered to a pregnant woman

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J9305

Injection, pemetrexed, 10mg

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of main bronchus, unspecified side

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, bronchus or lung, unspecified side

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, right bronchus or lung

C34.30

Malignant neoplasm of lower lobe, bronchus or lung, unspecified side

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of bronchus and lung, unspecified side

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of bronchus or lung, unspecified, unspecified side

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C37

Malignant neoplasm of thymus

C38.4

Malignant neoplasm of pleura

C45.0

Mesothelioma of pleura

C45.1

Mesothelioma of peritoneum

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.9

Malignant neoplasm of ovary, unspecified side

C57.00

Malignant neoplasm of fallopian tube, unspecified side

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of broad ligament, unspecified side

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of round ligament, unspecified side

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C61

Malignant neoplasm of prostate

C65.1

Malignant neoplasm of right renal pelvis

C65.2

Malignant neoplasm of left renal pelvis

C65.9

Malignant neoplasm of renal pelvis, unspecified side

C66.1

Malignant neoplasm of right ureter

C66.2

Malignant neoplasm of left ureter

C66.9

Malignant neoplasm of ureter, unspecified side

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

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

C68.0

Malignant neoplasm of urethra

C83.31

Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck

C83.39

Diffuse large B-cell lymphoma, extranodal and solid organ sites

C83.80

Other non-follicular lymphoma, unspecified site

C83.81

Other non-follicular lymphoma, lymph nodes of head, face, and neck

C83.89

Other non-follicular lymphoma, extranodal and solid organ sites

D09.0

Carcinoma in situ of bladder

D15.0

Benign neoplasm of thymus

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage: The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: PEMETREXED, (L33978) located at fcso.com. No National Coverage Determination (NCD) was found at the time of the last guideline revised date.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Carboplatin (Paraplatin®) IV, 09-J0000-93
Docetaxel (Taxotere®) IV, 09-J0000-95

Gemcitabine (Gemzar®), 09-J0000-96

Irinotecan HCl (Camptosar®) IV, 09-J0000-99

Vitamin B-12 Injections, 09-J0000-10

OTHER:

None applicable.

REFERENCES:

  1. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2013 [cited 2013 Sept 9]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Bladder cancer treatment guidelines [Internet]. Version 2.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 9]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp/.
  3. Central nervous system treatment guidelines [Internet]. Version 1.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 9]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp/.
  4. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016 Sept 9]. Available from: http://www.clinicalpharmacology.com/.
  5. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2016 Sept 9]. Available from: http://clinicaltrials.gov/.
  6. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016 Sept 9]. Available from: http://www.thomsonhc.com/.
  7. Eli Lilly and Company. Alimta (pemetrexed disodium) injection. 2004 [cited 2016 Sept 9]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f5a860f3-37ec-429c-ae04-9c88d7c55c08/.
  8. Malignant Pleural Mesothelioma treatment guidelines [Internet]. Version 3.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 9]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp/.
  9. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 9]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  10. Non-small cell lung cancer treatment guidelines [Internet]. Version 4.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 9]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp/.
  11. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2016 Sept 9]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  12. Ovarian cancer treatment guidelines [Internet]. Version 1.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 9]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp/.
  13. Thymomas and thymic carcinomas treatment guidelines [Internet]. Version 3.2016. Fort Washington (PA): National Comprehensive Cancer Network; 2016 [cited 2016 Sept 9]. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 10/12/16.

GUIDELINE UPDATE INFORMATION:

05/15/09

New Medical Coverage Guideline.

10/15/09

Revision; consisting of clarifying dosage.

01/15/10

Revision; consisting of update to codes.

08/01/10

Revision; consisting of update to codes.

11/15/10

Review and revision; consisting of updating coding and references.

11/15/11

Review and revision to guideline; consisting of updating position statement and references.

10/15/12

Review and revision to guideline; consisting of removing cervical cancer indication, reformatting position statement, updating dosage and administration, exceptions, coding and references.

11/15/13

Review and revision to guideline; consisting of revision and reformatting description, position statement, dosage/administration, precautions, references, decision tree

11/15/14

Review and revision to guideline; consisting of description, position statement, coding, references

09/15/15

Revision to guideline; consisting of updating coding

11/01/15

Revision: ICD-9 Codes deleted.

11/15/15

Review and revision to guideline; consisting of updating position statement, references

11/15/16

Review and revision to guideline; consisting of updating position statement, coding, references.

Date Printed: October 23, 2017: 02:17 AM