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Date Printed: July 21, 2017: 12:38 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-J1000-05

Original Effective Date: 05/15/09

Reviewed: 06/14/17

Revised: 07/15/17

Subject: Nab-Paclitaxel Injection (Abraxane®)

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:

Nano-particle albumin-bound (Nab)-Paclitaxel (Abraxane®) is formulated using nanotechnology to combine human albumin to paclitaxel. Paclitaxel is the active component of the formulation and is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. It induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis. Tumor penetration is facilitated by albumin-receptor mediated endothelial transcytosis. Because nab-paclitaxel does not contain solvents, there is a reduced risk of certain hypersensitivity-related side effects. As such, hypersensitivity premedications, such as steroids and antihistamines, are not necessary.

POSITION STATEMENT:

Initiation of nab-paclitaxel (Abraxane) IV meets the definition of medical necessity when administered for the indications listed in Table 1 and ALL of the indication-specific criteria are met:

Table 1

Indication

Specific Criteria

Bladder Cancer (also includes cancer of the urethra, upper genitourinary tract, and prostate)

When ALL of the following are met:

1. Member is diagnosed with urothelial carcinoma and has ONE of the following:

1. Locally advanced disease

2. Metastatic disease

3. Recurrent disease

2. Nab-paclitaxel is used as a single agent

3. Member’s disease progressed on or after initial chemotherapy

4. The dose does not exceed 260 mg/m2 every 21 days

Breast Cancer

When ALL of the following are met:

1. When ONE of the following is met:

1. Nab-paclitaxel is used as a single agent and member is diagnosed with recurrent or metastatic breast cancer

2. Nab-paclitaxel is used combination with trastuzumab (Herceptin) and member is diagnosed with recurrent or metastatic breast cancer

3. Nab-paclitaxel is used with one of the following as a substitute for paclitaxel or docetaxel:

i. bevacizumab

ii. capecitabine

iii. carboplatin/trastuzumab

iv. cyclophosphamide

v. cyclophosphamide/trastuzumab

vi. doxorubicin/cyclophosphamide

vii. gemcitabine

viii. trastuzumab

ix. trastuzumab/pertuzumab

2. Member has a documented hypersensitivity to conventional paclitaxel (Taxol), docetaxel (Taxotere), or to standard hypersensitivity premedications (e.g., diphenhydramine, H2 receptor antagonists, corticosteroids)

3. The dose does not exceed ONE of the following:

1. 450 mg/m2 every 28 days

2. 260 mg/m2 every 21 days

3. 125 mg/m2 every 7 days

Melanoma

When ALL of the following are met:

1. Nab-paclitaxel is used as a single agent

2. Member’s disease is metastatic or unresectable

3. Member’s ECOG performance status is 0-2

4. The dose does not exceed 450 mg/m2 every 28 days

Non-small cell lung cancer (NSCLC)

When ALL of the following are met:

1. When ONE of the following is met:

a. Nab-paclitaxel is used as a single agent

b. Nab-paclitaxel is used in combination with carboplatin

c. Member has a documented hypersensitivity to conventional paclitaxel (Taxol), docetaxel (Taxotere), or to standard hypersensitivity premedications (e.g., diphenhydramine, H2 receptor antagonists, corticosteroids) and nab-paclitaxel will be given as a single agent or in combination with carboplatin (with or without bevacizumab), cisplatin or gemcitabine.

2. Member’s disease is recurrent or metastatic

3. Member’s Eastern Cooperative Oncology Group (ECOG) performance status is 0-2.

4. The dose does not exceed 300 mg/m2 every 21 days.

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

When ALL of the following are met:

1. When ONE of the following is met

a. Nab-paclitaxel is used as a single agent

b. Nab-paclitaxel is used in combination with carboplatin

2. Member’s disease is recurrent or persistent

3. Member’s ECOG performance status is 0-2

4. Member has a documented hypersensitivity to conventional paclitaxel (Taxol), docetaxel (Taxotere), or to standard hypersensitivity premedications (e.g., diphenhydramine, H2 receptor antagonists, corticosteroids)

5. The dose does not exceed 260 mg/m2 every 21 days

Pancreatic cancer

When ALL of the following are met:

1. Member’s meets ONE of the following:

a. Member’s ECOG performance status is 0-1 or KPS greater than or equal to 70 and nab-paclitaxel is used for treatment of ONE of the following:

i. Metastatic disease

ii. Locally advanced disease that is unresectable

iii. Member has disease recurrence following resection

b. Nab-paclitaxel will be used as neoadjuvant treatment for ONE of the following:

i. Borderline resectable disease

ii. Resectable disease with high risk features (e.g., elevated carbohydrate antigen (CA) 19-9, large primary tumors, large regional lymph notes, excessive weight loss, extreme pain)

2. Nab-paclitaxel is used in combination with gemcitabine (Gemzar)

3. The dose does not exceed 375 mg/m2 every 28 days

Duration of approval: 6 months

Continuation of nab-paclitaxel (Abraxane) meets the definition of medical necessity for the indications in Table 1 when the following criteria are met:

1. The member has been previously approved by Florida Blue or another health plan in the past 2 years, OR the member has previously met all indication-specific criteria for coverage

2. Member’s disease has not progressed while receiving nab-paclitaxel

3. The dose does not exceed indication-specific dosing found in Table 1

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 IT’S USAGE.

Nab-Paclitaxel dosage is based on the treated indication.

• Invasive breast cancer: 260mg/m2 IV every 21 days or 100 to 150 mg/m2 on days 1, 8 and 15 cycled every 28 days

• Non-small cell lung cancer (NSCLC) or ovarian cancer: 100mg/m2 IV on days 1, 8, and 15 every 28 days.

• Metastatic pancreatic cancer: 125 mg/m2 on days 1, 8, and 15 every 28 days

Drug Availability

Nab-paclitaxel: supplied as a 100 mg vial (powder for injection)

PRECAUTIONS:

Boxed Warning

• Do not administer to individuals with a baseline neutrophil count of less than 1500 cells/mm3

• Peripheral blood cell counts should be monitored frequently to assess for occurrence of bone marrow suppression.

• Do not substitute for or with other paclitaxel formulations.

Contraindications

• Neutrophil count less than 1500 cells/mm3

Severe hypersensitivity to nab-paclitaxel (members should not be re-challenged if they experience hypersensitivity).

Warnings and Precautions

• Hypersensitivity: severe and fatal reactions have occurred. Do not re-challenge with this drug.

• Myelosuppression: monitor complete blood count and withhold and/or reduce the dose as needed.

• Neuropathy: sensory neuropathy occurs frequently and may require reduction or treatment interruption.

• Hepatic impairment: administer with caution in persons with hepatic impairment as exposure and toxicity of paclitaxel can be increased in this population.

Fetal harm: women should avoid becoming pregnant; men should avoid fathering a child.

• Sepsis: this occurred in patients with or without neutropenia when used in combination with gemcitabine. Interupt therapy if sepsis occurs.

• Pneumonitis: this occurred when used in combination with gemcitabine. Permanently discontinue.

• Viral transmission: Albumin is derived from human blood and a theoretical risk of viral transmission exists.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J9264

Injection, paclitaxel protein-bound particles, 1 mg

ICD-10 Diagnoses Codes That Support Medical Necessity for Nab-Paclitaxel (protein-bound, Abraxane®) (J9264):

C25.0

Malignant neoplasm of head of pancreas

C25.1

Malignant neoplasm of body of pancreas

C25.2

Malignant neoplasm of tail of pancreas

C25.3

Malignant neoplasm of pancreatic duct

C25.7 – C25.8

Malignant neoplasm of other parts or overlapping sites of pancreas

C25.9

Malignant neoplasm of pancreas, unspecified

C33

Malignant neoplasm of trachea

C34.00 – C34.92

Malignant neoplasm of bronchus and lung

C43.0 – C43.9

Malignant melanoma of skin

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

C50.011 – C50.929

Malignant neoplasm of breast

C56.1 – C57.9

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

C61

Malignant neoplasm of prostate (urothelial carcinoma)

C65.1 – C65.9

Malignant neoplasm of renal pelvis

C66.1 – C66.9

Malignant neoplasm of ureter

C67.0 – C67.9

Malignant neoplasm of bladder

C68.0

Malignant neoplasm of urethra

C79.31

Secondary malignant neoplasm of brain

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

D09.0

Carcinoma in situ of bladder

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) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

DEFINITIONS:

None

RELATED GUIDELINES:

Bevacizumab (Avastin®) Injection, 09-J0000-66
Doxorubicin HCl Liposome (Doxil®) IV, 09-J0000-91

Gemcitabine (Gemzar®), 09-J0000-96

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

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

OTHER:

ECOG Performance Status

Grade

ECOG

0

Fully active, able to carry on all pre-disease performance without restriction

1

Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

2

Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours

3

Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours

4

Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair

5

Dead

Karnofsky Performance Status (KPS) (%)

Able to carry on normal activity and to work; no special care needed.

  100  

Normal no complaints; no evidence of disease.

90

Able to carry on normal activity; minor signs or symptoms of disease.

80

Normal activity with effort; some signs or symptoms of disease.

Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed.

70

Cares for self; unable to carry on normal activity or to do active work.

60

Requires occasional assistance, but is able to care for most of his personal needs.

50

Requires considerable assistance and frequent medical care.

Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly.

40

Disabled; requires special care and assistance.

30

Severely disabled; hospital admission is indicated although death not imminent.

20

Very sick; hospital admission necessary; active supportive treatment necessary.

10

Moribund; fatal processes progressing rapidly.

0

Dead

REFERENCES:

  1. Abraxane (paclitaxel protein-bound particles for injectable suspension) [package insert]. Celgene Corporation. Summit, NJ: February 2016.
  2. AHFS Drug Information. Bethesda (MD): American Society of Health-System Pharmacists, Inc; 2016 [cited 2017 May 22]. In: STAT!Ref Online Electronic Medical Library [Internet]. Available from: http://online.statref.com/.
  3. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2017 May 22]. Available from: http://www.clinicalpharmacology.com/.
  4. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine; 2000 Feb 29 - [cited 2014 Apr 29]. Available from: http://clinicaltrials.gov/.
  5. Coleman RL, Brady WE, McMeekin DS, et al. A phase II evaluation of nanoparticle, albumin-bound (nab) paclitaxel in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian, or primary peritoneal cancer: a gynecologic oncology group study. Gynecol Oncol 2011;122(1):111-15.
  6. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2017 May 22]. Available from: http://www.thomsonhc.com/.
  7. Ingenex, HCPCS Level II, Expert 2013.
  8. Ingenex, ICD-9-CM for Physicians – Volumes 1 & 2, Expert 2013.
  9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 5.2017. Bladder cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/bladder.pdf Accessed 5/30/17.
  10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2017. Invasive Breast Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/breast.pdf Accessed 5/30/17.
  11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2017. Melanoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/melanoma.pdf Accessed5/30/17.
  12. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 6.2017. Non-Small Cell Lung Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/nscl.pdf Accessed 5/30/17.
  13. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 2.2017. Pancreatic Adenocarcinoma. Available at http://www.nccn.org/professionals/physician_gls/PDF/pancreatic.pdf Accessed 5/31/17.
  14. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Version 1.2017. Ovarian Cancer. Available at http://www.nccn.org/professionals/physician_gls/PDF/ovarian.pdf Accessed 5/30/17.
  15. NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network; 2017 [cited 2017 May 30]. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/.
  16. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2016 [cited 2017 May 22]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  17. Socinski MA, Bondarenko I, Karaseva NA, et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol 2012;30(17):2055-62.
  18. Teneriello MG, Tseng PC, Crozier M, et al. Phase II evaluation of nanoparticle albumin-bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer. J Clin Oncol 2009;27(9):1426-31.
  19. Von Hoff DD, Ervin T, Arena FP, et al. Randomized phase III study of weekly nab-paclitaxel plus gemcitabine vs. gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT) [oral]. Oral presented at: Gastrointestinal Cancers Symposium (ASCO) 2013; January 24-26; San Francisco, CA, USA.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 06/14/17.

GUIDELINE UPDATE INFORMATION:

05/15/09

New Medical Coverage Guideline.

10/15/09

Revision; consisting of clarifying maximum dosage and updating coding.

01/15/10

Revision; consisting of updating coding.

04/15/10

Revision; consisting of updating coding.

07/15/10

Review and revision; consisting of updating references.

08/01/10

Revision; consisting of updating coding.

02/01/11

Revision; consisting of adding new indication and updating coding.

07/15/11

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

08/15/11

Revision to guideline; consisting of updating coding.

10/01/11

Revision to guideline; consisting of updating coding.

07/15/12

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

10/15/12

Revision to guideline; consisting of removing non-melanoma skin cancer indication and updating coding.

02/15/13

Revision to guideline; consisting of updating coding.

07/15/13

Review and revision to guideline; consisting of revising position statement to include NCCN compendia category 1 and 2A recommendations, orphan drug designations, and approval durations; revised dosage/administration and precautions; updating coding, program exceptions and references.

10/15/13

Revision to guideline; consisting of adding advanced or metastatic melanoma as medically necessary and updating coding.

07/15/14

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

01/01/15

Revision to guideline; consisting of annual HCPCS coding update

07/15/15

Review and revision to guideline; consisting of revising position statement to include NCCN compendia category 1 and 2A recommendations; revised dosage/administration and precautions; updating coding, and references.

09/15/15

Revision to guideline; consisting of updating coding and docetaxel hypersensitivity.

10/01/15

Revision consisting of update to Program Exceptions section.

11/01/15

Revision: ICD-9 Codes deleted.

01/15/16

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

07/15/16

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

10/01/16

Update to ICD-10 codes.

11/15/16

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

01/15/17

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

07/15/17

Revision to guideline; consisting of updating position statement, description, dosing, coding and references.

Date Printed: July 21, 2017: 12:38 AM