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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-J1000-00

Original Effective Date: 05/15/09

Reviewed: 04/09/14

Revised: 12/15/16

Subject: Oxaliplatin (Eloxatin®) Injection

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.

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

DESCRIPTION:

Oxaliplatin (Eloxatin®) is a third generation platinum analog that demonstrates a wide spectrum of anti-cancer activity including colorectal cancer, ovarian cancer, pancreatic cancer, non-Hodgkin’s lymphoma, and breast cancer. It has distinct biochemical, pharmacologic and cytotoxic properties that are different than other platinum compounds, including cisplatin and carboplatin. Importantly, when compared to other platinum compounds, it has a different toxicity profile and different mechanisms of resistance. As such, it lacks cross-resistance with these compounds and confers activity in the setting of platinum insensitive tumor types.

Oxaliplatin was originally approved in August 2002 by the US Food and Drug Administration (FDA) as second-line therapy for metastatic colorectal cancer. Two years later the approval was expanded to include treatment of advanced colorectal cancer (in combination with infusional 5-FU and leucovorin) and for adjuvant treatment of stage III colorectal cancer. In addition to its FDA-approved indications, oxaliplatin is used off-label for the treatment of a variety of other cancers. It is usually used in combination with other agents including capecitabine (Xeloda) and 5-FU/leucovorin.

POSITION STATEMENT:

Oxaliplatin (Eloxatin®) IV meets the definition of medical necessity when administered for ANY of the following indications and the dosage does not exceed 130 mg/meter squared:

1. Bladder Cancer

2. Chronic Lymphocytic Leukemia

3. Small Lymphocytic Lymphoma

4. Colon Cancer

5. Esophageal and Esophagogastric Junction Cancer

6. Gastric Cancer

7. Head and Neck Cancer

8. Hepatobiliary Cancer

9. Neuroendocrine Tumors of the Pancreas

10. Non-Hodgkin’s Lymphoma

11. Occult Primary Cancer

12. Ovarian Cancer

13. Pancreatic Adenocarcinoma

14. Rectal Cancer

15. Testicular Cancer

Approval duration: 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: oxaliplatin is FDA-approved for use in combination with infusional 5-flourouracil/leucovorin for the treatment of the following:

1. Adjuvant treatment of stage III colon cancer in persons who have undergone complete resection of the primary tumor

2. Treatment of advanced colorectal cancer

Oxaliplatin is used off-label in several other cancers. The recommended oxaliplatin dose is dependent on the type of cancer it is used to treat and the regimen used. In general, the dose ranges from 85 mg/m2 to 130 mg/m2.

Dose Adjustments

1. Renal Impairment

a. Creatinine clearance [CrCl] 30 ml/min or greater: exercise caution and closely monitor

b. CrCl less than 30 ml/min: reduce the starting dose to 65 mg/m2

2. Toxicity: reduce the dose of oxaliplatin to 75 mg/m2 (adjuvant setting) or 65 mg/m2 (advanced colorectal cancer) when

a. There are persistent grade 2 neurosensory events that do not resolve

b. After recover from grade 3 or 4 gastrointestinal toxicities (despite prophylactic treatment) or grade 4 neutropenia or grade 3 or 4 thrombocytopenia. Delay next dose until neutrophils are at least 1.5 x 109/L and platelets are at least 75 x 109/L .

Drug Availability

Oxaliplatin is supplied as a single-use vial in the following strengths: 50- or 100 mg. The vial is a sterile, perseverative-free, aqueous solution at a concentration of 5 mg/mL.

PRECAUTIONS:

Boxed Warning

• Anaphylactic reactions have been reported and may occur within minutes of oxaliplatin administration; epinephrine, corticosteroids, and antihistamines have been used to alleviate symptoms.

Contraindications

• Oxaliplatin is contraindicated in persons known to have an allergy to oxaliplatin or other platinum containing compounds.

Warnings/Precautions

• Allergic reactions: monitor for development of rash, urticaria, erythema, pruritus, bronchospasm, and hypotension

• Neuropathy: reduce the dose or discontinue oxaliplatin if necessary

Severe neutropenia: Delay until neutrophils are at least 1.5 x 109/L. Withhold for sepsis.

• Pulmonary toxicity: may require discontinuation of therapy until interstitial lung disease or pulmonary fibrosis are excluded

• Hepatotoxicity: monitor liver function tests

Cardiovascular toxicity: correct hypokalemia or hypomagnesemia prior to initiating.

Rhabdomyolysis: discontinue if rhabdomyolysis occurs.

• Pregnancy category D: fetal harm can occur when administered to pregnant women. Women should be apprised of the potential harm to the fetus.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J9263

Injection, oxaliplatin, 0.5 mg

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

B20

Human immunodeficiency virus [HIV] disease

C15.3 – C15.9

Malignant neoplasm of esophagus

C16.0 – C16.9

Malignant neoplasm of stomach

C17.0 – C17.9

Malignant neoplasm of small intestine

C18.0 – C18.9

Malignant neoplasm of colon

C19

Malignant neoplasm of rectosigmoid junction

C20

Malignant neoplasm of rectum

C21.8

Malignant neoplasm of overlapping sites of rectum, anus and anal canal

C22.1

Intrahepatic bile duct carcinoma

C23

Malignant neoplasm of gallbladder

C24.0 – C24.9

Malignant neoplasm of other and unspecified parts of biliary tract

C25.0 – C25.9

Malignant neoplasm of pancreas

C38.4

Malignant neoplasm of pleura

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

C48.9

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C56.1 – C57.4

Malignant neoplasm of ovary, fallopian tube, broad ligament, round ligament, parametrium and uterine adnexa, unspecified

C62.00 – 62.92

Malignant neoplasm of testis

C67.0 – C67.9

Malignant neoplasm of bladder

C7B.00 – C7B.09

Secondary carcinoid tumors

C78.00 – 78.02

Secondary malignant neoplasm of lung

C78.6

Secondary malignant neoplasm of retroperitoneum and peritoneum

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

C82.20 – C82.99

Follicular lymphoma, unspecified, extranodal and solid organ sites, unspecified, lymph nodes of head, face, and neck, unspecified, intrathoracic lymph nodes, unspecified, intra-abdominal lymph nodes, unspecified, lymph nodes of axilla and upper limb, unspecified, lymph nodes of inguinal region and lower limb, unspecified, intrapelvic lymph nodes, unspecified, spleen and unspecified, lymph nodes of multiple sites

C83.00 – C83.09

Small cell B-cell lymphoma, unspecified

C83.10 – C83.19

Mantle cell lymphoma

C83.30 – C83.39

Diffuse large B-cell lymphoma

C83.50 – C83.59

Lymphoblastic (diffuse) lymphoma

C83.80 – C83.89

Other non-follicular lymphoma

C84.00 – C84.09

Mycosis fungoides, unspecified site, extranodal and solid organ sites, lymph nodes of head, face, and neck, intrathoracic lymph nodes, intra-abdominal lymph nodes, lymph nodes of axilla and upper limb, lymph nodes of inguinal region and lower limb, intrapelvic lymph nodes, spleen and lymph nodes of multiple sites

C84.40 – C84.49

Peripheral T-cell lymphoma, not classified

C84.60 – C84.79

Anaplastic large cell lymphoma, ALK-positive and ALK-negative

C84.Z0 – C84.Z9

Other mature T/NK-cell lymphomas

C84.90 – C84.99

Mature T/NK-cell lymphomas, unspecified

C85.80 – C85.89

Other specified types of non-Hodgkin lymphoma

C86.0 – C86.6

Other specified types of T/NK-cell lymphomas

C88.4

Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue [MALT – lymphoma]

C91.10

Chronic lymphocytic leukemia of B-cell type not having achieved remission

C91.12

Chronic lymphocytic leukemia of B-cell type in relapse

C91.50

Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission

C91.52

Adult T-cell lymphoma/leukemia (HTLV-1-associated) in relapse

C91.90

Lymphoid leukemia, unspecified not having achieved remission

C91.92

Lymphoid leukemia, unspecified, in relapse

D09.0

Carcinoma in situ of bladder

D37.1

Neoplasm of uncertain behavior of stomach

D37.2

Neoplasm of uncertain behavior of small intestine

D37.4

Neoplasm of uncertain behavior of colon

D37.5

Neoplasm of uncertain behavior of rectum

D37.8

Neoplasm of uncertain behavior of other specified digestive organs

D37.9

Neoplasm of uncertain behavior of digestive organ, unspecified

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 Products:

No National Coverage Determination (NCD) was found at the time of the last guideline revised date.

The following Local Coverage Determination (LCD) located at www.fcso.com was reviewed on the last guideline revised date: Oxaliplatin (Eloxatin), (L33729).

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Bortezomib (Velcade®) IV, 09-J0000-92
Carboplatin (Paraplatin®) IV, 09-J0000-93

Docetaxel (Taxotere®) IV, 09-J0000-95

Doxorubicin HCl Liposome (Doxil®) IV, 09-J0000-91

Fulvestrant (Faslodex®) IM, 09-J1000-04

Gemcitabine (Gemzar®) IV, 09-J0000-96

Gonadotropin Releasing Hormone Analogs and Antagonists, 09-J0000-48

Granulocyte Colony Stimulating Factors, 09-J0000-62

Human EGFR Inhibitors (cetuximab; panitumumab) IV, 09-J0000-94

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

Paclitaxel and Paclitaxel (protein-bound) IV, 09-J1000-05

Rituximab (Rituxan®), 09-J0000-59

Trastuzumab (Herceptin®) Injection, 09-J0000-86

Vinorelbine Tartrate (Navelbine®) IV, 09-J1000-03

OTHER:

None applicable.

REFERENCES:

  1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2012. URL www.clinicalpharmacilogy-ip.com Accessed 11/7/16.
  2. Eloxatin (oxaliplatin) [package insert]. Sanofi-Aventis LLC. Bridewater (NJ): October 2015.
  3. Ingenix HCPCS Level II, Expert 2012.
  4. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2012.
  5. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 11/7/16.
  6. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 11/7/16.
  7. Oxaliplatin. In: McEvoy GK, editor. AHFS drug information 2014 [monograph on the Internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2014 [cited 2014 Feb 18]. Available from: http://online.statref.com. Subscription required to view.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 04/09/14.

GUIDELINE UPDATE INFORMATION:

05/15/09

New Medical Coverage Guideline.

10/01/09

Revision; consisting of modifying the maximum dosage.

10/15/09

Revision; consisting of updating coding.

01/15/10

Revision; consisting of updating coding.

04/15/10

Revision; consisting of updating coding.

06/15/10

Review and revision; consisting of updating references.

08/01/10

Revision; consisting of updating coding.

06/15/11

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

06/15/12

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

02/15/13

Revision to guideline: consisting of updating coding.

05/15/13

Review and revision to guideline; consisting of revising and reformatting position statement; reformatting and revising description, dosage/administration, and precautions section; updated coding and references.

05/15/14

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

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

10/01/16

Revision to guideline; consisting of updating ICD10 codes.

12/15/16

Revision to guideline; consisting of updating position statement and coding.

Date Printed: October 20, 2017: 02:06 PM