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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-J0000-96

Original Effective Date: 04/15/09

Reviewed: 04/10/13

Revised: 12/15/15

Subject: Gemcitabine (Gemzar®)

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:

Gemcitabine (Gemzar®) is a nucleoside analogue that is similar in structure and metabolic pathway to cytarabine. It demonstrates activity against a variety of solid tumors including breast, lung, ovarian, and pancreatic tumors. Gemcitabine was initially approved in 1996 for advanced or metastatic pancreatic cancer. The approval has been expanded to also include treatment of inoperable, locally advanced or metastatic non-small cell lung cancer, metastatic breast cancer, and advanced, relapsed ovarian cancer. Gemcitabine is often used concomitantly with other anti-neoplastics including cisplatin, carboplatin, and paclitaxel. In addition to Food and Drug Administration (FDA)-approved use, standard reference compendia, including the National Comprehensive Cancer Network (NCCN), support the use of gemcitabine as treatment for a variety of off-label indications.

POSITION STATEMENT:

Gemcitabine HCl (Gemzar®) IV meets the definition of medical necessity when administered for ANY of the following indications and the dosage does not exceed 1250 mg/meter squared every 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: gemcitabine is indicated for treatment of

Gemcitabine should be administered as an intravenous (IV) infusion over 30 minutes. Table 1 lists the FDA-approved indications and recommended doses.

Table 1

FDA-approved indications and dosing

Indication

Recommended Dose (IV over 30 minutes)

Breast cancer

1250 mg/m2 on Days 1 and 8 of a 21-day cycle

Non-small cell lung cancer

28-day cycle

1000 mg/m2 on days 1, 8, and 15

21-day cycle

1250 mg/m2 on days 1 and 8

Ovarian cancer

1000 mg/m2 on days 1 and 8 of a 21-day cycle

Pancreatic cancer

  • 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity requires reducing or holding dose), followed by a week of rest from treatment.
  • Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

IV, intravenous

Dose Adjustments:

Drug Availability

Gemcitabine is supplied as a 200 mg, 1 g, and 2 g sterile single-use vial.

PRECAUTIONS:

Contraindications

Gemcitabine is contraindicated in persons with a known hypersensitivity to gemcitabine.

Warnings/Precautions

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J9201

Injection, gemcitabine HCl, 200mg

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

B20

Human immunodeficiency virus disease

C00.0 – C00.9

Malignant neoplasm of lip

C01

Malignant neoplasm of base of tongue

C02.4 – C02.9

Malignant neoplasm of lingual tonsil, overlapping sites of tongue and tongue, unspecified

C03.0 – C06.9

Malignant neoplasm of gum, floor of mouth, palate and other unspecified parts of mouth

C09.0 – C14.8

Malignant neoplasm of tonsil, oropharynx, nasopharynx, pyriform sinus, hypopharynx and other and ill defined sites in the lip, oral cavity and pharynx

C22.1 – C24.9

Intrahepatic bile duct carcinoma, gallbladder and other and unspecified parts of biliary tract

C25.0 – C25.9

Malignant neoplasm of pancreas

C31.0 – C31.1

Malignant neoplasm of maxillary sinus and ethmoidal sinus

C32.0 – C34.92

Malignant neoplasm of larynx, trachea, bronchus and lung

C37

Malignant neoplasm of thymus

C38

Malignant neoplasm of heart

C38.2

Malignant neoplasm of posterior mediastinum

C38.4

Malignant neoplasm of pleura

C40.00 – C41.9

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

C44.90

Unspecified malignant neoplasm of skin, site unspecified

C45.0

Mesothelioma of pleura

C47.8

Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system

C48.0 – C49.9

Malignant neoplasm of retroperitoneum, peritoneum and other connective and soft tissue

C50.011 – C50.929

Malignant neoplasm of breast

C53.0 – C53.9

Malignant neoplasm of cervix uteri

C54.0 C54.9

Malignant neoplasm of corpus uteri

C55

Malignant neoplasm of uterus, part unspecified

C56.0 – C56.9

Malignant neoplasm of ovary

C57.00 – C57.4

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

C61 – C62.92

Malignant neoplasm of prostate and testis

C64.1 - C64.9

Malignant neoplasm of unspecified kidney, except renal pelvis

C65.1 - C65.9

Malignant neoplasm of unspecified renal pelvis

C66.0 –C66.9

Malignant neoplasm of ureter

C67.0 – C67.9

Malignant neoplasm of bladder

C68.0

Malignant neoplasm of urethra

C68.9

Malignant neoplasm of urinary organ, unspecified

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C76.0

Malignant neoplasm of head, face and neck

C78.00 – C78.02

Secondary malignant neoplasm of lung

C78.7

Secondary malignant neoplasm of liver and intrahepatic bile duct

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

C79.81 – C79.89

Secondary malignant neoplasm of other specified sites

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

C81.00 – C81.09

Hodgkin lymphoma

C81.10 – C81.79

Classical Hodgkin lymphoma, various forms

C81.90 – C81.99

Hodgkin lymphoma, unspecified

C82.00 – C82.99

Follicular lymphoma, unspecified

C83.00 – C83.09

Small B-cell lymphoma

C83.10 – C83.19

Mantle cell lymphoma

C83.30 – C83.39

Diffuse large B-cell lymphoma

C83.50 – C83.59

Lymphoblastic (diffuse) lymphoma

C83.70 – C83.79

Burkitt lymphoma

C83.80 – C83.89

Other non-follicular lymphoma

C83.90 – C83.99

Non-follicular (diffuse) lymphoma, unspecified

C84.00 – C84.79

Mycosis fungoides, Sezary disease, peripheral T-cell lymphoma, not classified, anaplastic large cell lymphoma, ALK-positve and negative

C84.93

Mature T/NK-cell lymphomas, unspecified, intra-abdominal lymph nodes

C85.80 – C85.89

Other specified types of non-Hodgkin lymphoma

C86.0 – C86.6

Other specified types of T/NK-cell lymphoma

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 – C91.52

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

C91.90

Lymphoid leukemia, unspecified not having achieved remission

C91.92

Lymphoid leukemia, unspecified, in relapse

D09.0

Carcinoma in situ of bladder

D15.0

Benign neoplasm of thymus

D37.01 – D37.02

Neoplasm of uncertain behavior of lip and tongue

D37.04 – D37.05

Neoplasm of uncertain behavior of the minor salivary glands and pharynx

D37.1 – D37.2

Neoplasm of uncertain behavior of stomach and small intestine

D37.4 – D37.5

Neoplasm of uncertain behavior of colon or rectum

D38.0

Neoplasm of uncertain behavior of larynx

D41.4

Neoplasm of uncertain behavior of bladder

D48.1

Neoplasm of uncertain behavior of connective and other soft tissue

D49.0 – D49.2

Neoplasm of unspecified behavior of digestive system, respiratory system, bone, soft tissue, and skin

D49.6

Neoplasm of unspecified behavior of brain

D49.81 – D49.9

Neoplasm of unspecified behavior of retina and choroid, other specified sites and unspecified sites

G73.1

Lambert-Eaton syndrome

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: Gemcitabine (Gemzar), (L33726).

DEFINITIONS:

Apoptosis: A state in which a cell has ceased replication and is in the process of programmed cell death.

RELATED GUIDELINES:

Bevacizumab (Avastin®) Injection, 09-J0000-66
Carboplatin (Paraplatin®) IV, 09-J0000-93

Docetaxel (Taxotere®) IV, 09-J0000-95

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

Erythropoiesis Stimulating Agents, 09-J0000-31

Genetic Testing for Hereditary Breast or Ovarian Cancer, 05-82000-30

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

Granulocyte Colony Stimulating Factors, 09-J0000-62

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

Interferon alfa-n3 (Alferon N Injection®), 09-J0000-33

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

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

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

Rituximab (Rituxan®), 09-J0000-59

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

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 2/28/13.
  2. Gemzar (gemcitabine) [package insert]. Eli Lilly and Company. Indianapolis (IN): June 2011.
  3. Gemcitabine. In: McEvoy GK, editor. AHFS drug information 2012 [monograph on the Internet].Bethesda (MD): American Society of Health-System Pharmacists; 2012 [cited 2013 Feb 28]. Available from: http://online.statref.com. Subscription required to view
  4. Ingenix HCPCS Level II, Expert 2012.
  5. Ingenix ICD-9-CM for Physicians-Volumes 1 & 2, Expert 2012.
  6. Micromedex® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 2/28/13.
  7. National Comprehensive Cancer Network. Cancer Guidelines. Cancer Guidelines and Drugs and Biologics Compendium. Accessed 10/29/15.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 04/10/13.

GUIDELINE UPDATE INFORMATION:

04/15/09

New Medical Coverage Guideline.

10/15/09

Revision; consisting of clarifying dosage.

01/15/10

Revision; consisting of updating coding.

04/15/10

Review and revision; consisting of updating codes and references.

08/01/10

Revision; consisting of updating coding.

05/15/11

Review and revision to guideline; consisting of updating references.

10/01/11

Revision to guideline; consisting of updating coding.

05/15/12

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

12/15/12

Revision to guideline; consisting of updating coding.

05/15/13

Review and revision to guideline; consisting of revising position statement to include treatment of kidney cancer; reformatted and revised description, dosage/administration, and precautions section; updated references and coding. No Longer Review.

10/01/15

Revision consisting of update to Program Exceptions section.

12/15/15

Revision to guideline; consisting of revising position statement to include treatment of dermatofibrosarcoma protuberans; updated references and coding.

Date Printed: October 23, 2017: 07:26 AM