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Date Printed: October 23, 2017: 07:21 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-J0000-95

Original Effective Date: 04/15/09

Reviewed: 03/08/17

Revised: 04/15/17

Subject: Docetaxel (Taxotere®) 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:

Docetaxel (Taxotere) is a semisynthetic antineoplastic that is similar to paclitaxel (Taxol) in structure, mechanism of action, and spectrum of anti-tumor activity. Docetaxel was isolated in 1986 as a result of the National Cancer Institute (NCI) screening program for natural cytotoxic products. It is synthesized from a substance extracted from the needles of the European yew tree (Taxus baccata). Docetaxel exerts is anti-cancer effects by disrupting the function of microtubules, which are essential for cell survival. It also antagonizes the anti-apoptotic gene Bc12 and encourages expression of p27, a cell-cycle inhibitor. Ultimately, docetaxel prevents new cells from forming, causes existing cells to undergo apoptosis, and stops other cells from maturing and replicating.

Docetaxel was initially approved by the US Food and Drug Administration (FDA) in May 1996 for the treatment of refractory, locally advanced or metastatic breast cancer; in August 2004, docetaxel in combination with doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan) was approved as adjuvant therapy in persons with breast cancer that was lymph node positive. Additional indications for the use of docetaxel have been approved by the FDA, including the treatment of advanced or metastatic non-small cell lung cancer after failure of platinum containing chemotherapy (December 1999), the treatment of metastatic, hormone-refractory prostate cancer in combination with prednisone (May 2004), the treatment of advanced gastric cancer in combination with cisplatin (Platinol) and 5-fluorouracil (Adrucil) (March 2006), and the treatment of locally advanced, squamous cell head and neck cancer in combination with cisplatin and 5-fluorouracil (October 2006).

In addition to its position as a treatment of choice within its licensed indications, the use of docetaxel for the treatment of a variety of off-label indications is supported by National Comprehensive Cancer Network guidelines and other standard reference compendia.

POSITION STATEMENT:

Docetaxel (Taxotere®) IV meets the definition of medical necessity when administered for any of the following indications and dosage does not exceed 100 mg/meter squared:

1. Anaplastic thyroid carcinoma

2. Bladder cancer

3. Bone cancer

4. Breast cancer

5. Endometrial carcinoma

6. Esophageal and esophagogastric junction cancer

7. Gastric adenocarcinoma

8. Head and neck cancer

9. Metastatic malignant melanoma

10. Non-small cell lung cancer (NSCLC)

11. Occult primary tumors (cancer of unknown primary)

12. Ovarian cancer (including epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer)

13. Prostate cancer

14. Small cell lung cancer

15. Soft tissue sarcoma

16. Uterine neoplasms

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: docetaxel is FDA-approved for the following indications

• Breast Cancer

• Non-Small Cell Lung Cancer (NSCLC)

• Prostate Cancer

• Gastric Adenocarcinoma

• Head and Neck Cancer

Docetaxel is administered as an intravenous (IV) infusion over 1 hour. The appropriate dose is based on the indication. The typical dose is 60-100 mg/m2 every 3 weeks. For all indications, toxicities may warrant dosage adjustments. Docetaxel administration has been associated with complications, including anaphylaxis; as such, it should be administered in a facility equipped to manage complications.

Drug Availability: docetaxel is available in a variety of concentrations and formulations including a concentrate for solution for injection and a non-concentrate solution for injection.

PRECAUTIONS:

Boxed Warning:

• Treatment-related mortality increases with abnormal liver function, at higher doses, and in persons with NSCLC and prior platinum-based therapy receiving docetaxel at 100 mg/m2

• Docetaxel should not be administered if bilirubin > ULN, or if AST and/or ALT > 1.5 × ULN concomitant with alkaline phosphatase > 2.5 × ULN. LFT elevations increase risk of severe or life-threatening complications. Obtain LFTs before each treatment cycle

• Docetaxel should not be administered if neutrophil counts are < 1500 cells/mm3. Obtain frequent blood counts to monitor for neutropenia

• Severe hypersensitivity, including very rare fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate discontinuation of docetaxel and administration of appropriate therapy (5.4)

• Docetaxel is contraindicated in persons with a history of severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80 (4)

• Severe fluid retention may occur despite dexamethasone pre-medication.

Warnings:

Acute myeloid leukemia: in persons administered docetaxel, doxorubicin and cyclophosphamide monitor for delayed myelodysplasia or myeloid leukemia.

Cutaneous reactions: reactions including erythema of the extremities with edema followed by desquamation may occur. Severe skin toxicity may require dose adjustment

Neurologic reactions: reactions including paresthesia, dysesthesia, and pain may occur. Severe neurosensory symptoms require dose adjustment or discontinuation if persistent.

Asthenia: severe asthenia may occur and may require treatment discontinuation.

Pregnancy: Fetal harm can occur when docetaxel is administered to pregnant women. Women of childbearing potential should be advised not to become pregnant when receiving docetaxel.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J9171

Injection, docetaxel, 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity

C00.0 – C02.9

Malignant neoplasm of lip, base of tongue and other and unspecified part of tongue

C03.0 – C03.9

Malignant neoplasm of gum

C04.0 – C04.9

Malignant neoplasm of floor of mouth

C05.0 – C06.9

Malignant neoplasm of palate and other and unspecified parts of ought

C07

Malignant neoplasm of parotid gland

C09.0 – C10.9

Malignant neoplasm of tonsil and oropharynx

C11.0 – C11.9

Malignant neoplasm of nasopharynx

C12 – C13.9

Malignant neoplasm of pyriform sinus and hypopharynx

C14.0 – C14.8

Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx

C15.3 – C15.9

Malignant neoplasm of esophagus

C16.0 – C16.9

Malignant neoplasm of stomach

C26.9

Malignant neoplasm of ill-defined sites within the digestive system

C31.0 – C31.1

Malignant neoplasm of maxillary sinus and ethmoidal sinus

C32.0 – C32.9

Malignant neoplasm of larynx

C33 – C34.92

Malignant neoplasm of trachea and bronchus and lung

C40.00 – C44.09

Malignant neoplasm of bone and articular cartilage of limbs

C41.0 – C41.9

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

C44.00

Unspecified malignant neoplasm of skin of lip

C44.01

Basal cell carcinoma of skin of lip

C44.02

Squamous cell carcinoma of skin of lip

C44.09

Other specified malignant neoplasm of skin of lip

C45.0

Mesothelioma of pleura

C45.1

Mesothelioma of peritoneum

C48.0 – C48.8

Malignant neoplasm of retroperitoneum and peritoneum

C49.0 – C49.9

Malignant neoplasm of other connective and soft tissue

C49.A0 – C49.A9

Gastrointestinal stromal tumor

C50.011 – C50.929

Malignant neoplasm of breast, female and male

C54.0 – C57.4

Malignant neoplasm of corpus uteri, uterus, part unspecified, ovary, fallopian tube, broad ligament, round ligament, parametrium and uterine adnexa, unspecified

C61

Malignant neoplasm of prostate

C63.7

Malignant neoplasm of other specified male genital organs

C63.8

Malignant neoplasm of overlapping sites of male genital organs

C65.0 – C67.9

Malignant neoplasm of unspecified renal pelvis, ureter and bladder

C68.0

Malignant neoplasm of urethra

C73

Malignant neoplasm of thyroid gland

C76.0

Malignant neoplasm of head, face and neck

C77.0

Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck

C78.00 – C78.02

Secondary malignant neoplasm of lung

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

C79.89

Secondary malignant neoplasm of other specified sites

C79.9

Secondary malignant neoplasm of unspecified site

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

D09.0

Carcinoma in situ of bladder

D37.01

Neoplasm of uncertain behavior of lip

D37.02

Neoplasm of uncertain behavior of tongue

D37.030 – D37.039

Neoplasm of uncertain behavior of the major salivary glands

D37.04

Neoplasm of uncertain behavior of the minor salivary glands

D37.05

Neoplasm of uncertain behavior of pharynx

D37.09

Neoplasm of uncertain behavior of other specified sites of the oral cavity

D37.1

Neoplasm of uncertain behavior of stomach

D37.2

Neoplasm of uncertain behavior of small intestine

D37.3

Neoplasm of uncertain behavior of appendix

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

D38.0

Neoplasm of uncertain behavior of larynx

D38.5

Neoplasm of uncertain behavior of other respiratory organs

D38.6

Neoplasm of uncertain behavior of respiratory organ, unspecified

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 and bone, soft tissue, and skin

D49.511

Neoplasm of unspecified behavior of right kidney

D49.512

Neoplasm of unspecified behavior of left kidney

D49.519

Neoplasm of unspecified behavior of unspecified kidney

D49.59

Neoplasm of unspecified behavior of other genitourinary organ

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 site

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 Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: DOCETAXEL (Taxotere®) (L33989) 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:

Azacitidine (Vidaza®) Injection, 09-J0000-84
Cabazitaxel (Jevtana®) 09-J1000-77

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

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

Enzalutamide (Xtandi®), 09-J1000-85

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

Gemcitabine (Gemzar®), 09-J0000-96

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

Octreotide Acetate (Sandostatin LAR® Depot) Injection, 09-J0000-90

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

Pemetrexed (Alimta®) IV, 09-J1000-01

Rituximab (Rituxan®), 09-J0000-59

Sipuleucel-T (Provenge), 09-J1000-29

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. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2015 [cited 2015 Jan 28]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2017 [cited 2017 Jan 28]. Available from: http://www.clinicalpharmacology.com/.
  3. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2017 Jan 28]. Available from: http://clinicaltrials.gov/.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017 Jan 28]. Available from: http://www.thomsonhc.com/.
  5. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 2017 Jan 28]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  6. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2017 [cited 2017 Jan 28]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  7. Sanofi-Aventis U.S. LLC. Taxotere (docetaxel) injection 2013 [cited 2017 Jan 28]. In: DailyMed [Internet]. Bethesda (MD): National Library of Medicine. Available from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=45e6dce4-92e2-4ad1-bf11-bbcefb753636/.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 03/08/17.

GUIDELINE UPDATE INFORMATION:

04/15/09

New Medical Coverage Guideline.

10/15/09

Revision to guideline; consisting of clarifying dosage and updating coding.

01/01/10

Annual HCPCS coding update: added HCPCS code J9171 and deleted code J9170.

01/15/10

Revision to guideline; consisting of updating coding.

04/15/10

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

08/01/10

Revision to guideline; consisting of updating coding.

11/15/10

Revision to guideline; consisting of updating coding.

04/15/11

Review and revision to guideline; consisting of updating references.

05/15/11

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

10/01/11

Revision to guideline; consisting of updating coding.

04/15/12

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

10/15/12

Revision to guideline; consisting of adding penile cancer and removing cervical and pancreatic cancer indications and updating coding.

12/15/12

Revision to guideline; consisting of updating coding.

04/15/13

Review and revision to guideline; consisting of revising position statement to include malignant melanoma and approval duration; revising and reformatting description, dosage/administration, and precautions sections; and updating references, related guidelines, and coding.

04/15/14

Review and revision to guideline; consisting of position statement, program exceptions, references, decision tree.

04/15/15

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

10/01/15

Revision to guidelines consisting of coding updates and update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

04/15/16

Review and revision; updated description, position statement, coding, references.

07/15/16

Revision to guideline; consisting of updating ICD10 codes.

10/01/16

Revision to guideline; consisting of updating ICD10 codes.

04/15/17

Review and revision to guidelines; updated references.

Date Printed: October 23, 2017: 07:21 AM