Print

Date Printed: December 18, 2017: 11:19 AM

Private Property of Blue Cross and Blue Shield of Florida.
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-J0000-99

Original Effective Date: 05/15/09

Reviewed: 01/15/14

Revised: 11/01/15

Subject: Irinotecan HCl (Camptosar®) 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.

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

DESCRIPTION:

Irinotecan (Camptosar®), a semisynthetic derivative of camptothecin, is an antineoplastic agent. Irinotecan exerts its cytotoxic activity through inhibition of type I DNA topoisomerase; ultimately, this inhibition causes damage to double-strand DNA. It is indicated as first-line therapy in combination with 5-flourouracil (5-FU) and leucovorin (LV) for persons with metastatic carcinoma of the colon or rectum and for persons with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. In addition to its Food and Drug Administration (FDA)-approved indications, of irinotecan is used off-label in a variety of other cancers, which is supported by the National Comprehensive Cancer Network (NCCN) and other standard reference compendia.

POSITION STATEMENT:

Irinotecan HCl (Camptosar®) IV meets the definition of medical necessity when administered for ANY of the following indications and the dosage does not exceed 125 mg/meter squared in 7 days:

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: Irinotecan is indicated as first-line therapy in combination with 5-flourouracil (5-FU) and leucovorin (LV) for persons with metastatic carcinoma of the colon or rectum and for persons with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

The following are suggested dosage regimens for the treatment of colorectal cancer:

Pre-medication with anti-emetic agents is recommended and should be administered on the day of treatment, starting at least 30 minutes before administration of irinotecan.

Drug Availability: irinotecan is supplied in five single-dose sizes

PRECAUTIONS:

Boxed Warning

Contraindications

Irinotecan is contraindicated in persons with a hypersensitivity to irinotecan or its excipients

Warnings and Precautions

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J9206

Injection, irinotecan , 20mg

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

C15.3 – C16.9

Malignant neoplasm of esophagus and stomach

C17.0

Malignant neoplasm of duodenum

C17.1

Malignant neoplasm of jejunum

C17.2

Malignant neoplasm of ileum

C17.8

Malignant neoplasm of overlapping sites of small intestine

C17.9

Malignant neoplasm of small intestine, unspecified

C18.0 – C20

Malignant neoplasm of colon, rectosigmoid junction and rectum

C21.8

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

C25.0 – C25.3

Malignant neoplasm of pancreas including head, body, tail and pancreatic duct

C25.7 – C25.9

Malignant neoplasm of other parts, overlapping sites and unspecified parts of pancreas

C33 – C34.92

Malignant neoplasm of trachea , bronchus and ling

C40.00 – C41.9

Malignant neoplasm of bone and articular cartilage of limbs and articular cartilage of other and unspecified sites

C48.1 – C48.8

Malignant neoplasm of retroperitoneum and peritoneum

C49.9

Malignant neoplasm of connective and soft tissue, unspecified

C56.0 – C57.4

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

C71.0 – C71.9

Malignant neoplasm of brain

C72.9

Malignant neoplasm of central nervous system, unspecified

C78.00 – C78.02

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

C79.31

Secondary malignant neoplasm of brain

C79.51 – C79.52

Secondary malignant neoplasm of bone and bone marrow

C79.70 – C79.72

Secondary malignant neoplasm of adrenal gland

C7A.1

Malignant poorly differentiated neuroendocrine tumors

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

Z85.00

Personal history of malignant neoplasm of unspecified digestive organ

Z85.01 – Z85.038

Personal history of malignant neoplasm of esophagus, stomach and other malignant neoplasm of large intestine

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.43

Personal history of malignant neoplasm of ovary

Z85.830

Personal history of malignant neoplasm of bone

Z85.841

Personal history of malignant neoplasm of brain

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: Irinotecan (Camptosar), (L33727)

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Gonadotropin Releasing Hormone Analogs & Antagonists, 09-J0000-48
Bevacizumab (Avastin®) Injection, 09-J0000-66

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

Carboplatin (Paraplatin®) IV, 09-J0000-93

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

Docetaxel (Taxotere®) IV, 09-J0000-95

Gemcitabine (Gemzar®) IV, 09-J0000-96

Oxaliplatin (Eloxatin®) IV, 09-J1000-00

Pemetrexed (Alimta®) Injection, 09-J1000-01

Topotecan HCl (Hycamtin®) IV, 09-J1000-02

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

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

Tetrabenazine (Xenazine®) Oral, 09-J1000-07

OTHER:

None applicable.

REFERENCES:

  1. Camptosar (irinotecan hydrochloride) [package insert]. Pharmacia and Upjohn Co. New York (NY): July 2012.
  2. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.;2012. URL www.clinicalpharmacilogy-ip.com Accessed 2/27/13.
  3. Ingenix HCPCS Level II, Expert 2012.
  4. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2012.
  5. Irinotecan. In: McEvoy GK, editor. AHFS drug information 2012 [monograph on the Internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2012 [cited 2013 Feb 27]. Available from: http://online.statref.com. Subscription required to view
  6. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 2/27/13.
  7. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 2/27/13.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 01/15/14.

GUIDELINE UPDATE INFORMATION:

05/15/09

New Medical Coverage Guideline.

10/15/09

Revision to guideline; consisting of clarifying dosage.

01/15/10

Revision to guideline; consisting of updating coding.

04/15/10

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

08/01/10

Revision to guideline; consisting of updating coding.

05/15/11

Review and revision to guideline; consisting of updating references.

08/15/11

Revision to guideline; consisting of adding new indication to position statement.

05/15/12

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

10/15/12

Revision to guideline; consisting of adding NCCN category 2A indication, penile cancer

05/15/13

Review and revision to guideline; consisting of revising position statement, reformatting and revising description, dosage/administration, and precautions sections; updating coding and references. No Longer Review

12/15/13

Revision to guideline; consisting of adding new indication and updating coding.

02/15/14

Revision to guideline; consisting of removing penile cancer indications and codes.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: December 18, 2017: 11:19 AM