Paclitaxel (Albumin-Bound) (Abraxane®; Paclitaxel Albumin-Bound)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Metastatic Breast Cancer
Indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
Non-Small Cell Lung Cancer
Indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
Adenocarcinoma of the Pancreas
Indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
COVERAGE CRITERIA
Pancreatic adenocarcinoma
Authorization of 6 months may be granted for treatment of pancreatic adenocarcinoma, in combination with gemcitabine with or without cisplatin.
Breast cancer
Authorization of 6 months may be granted for treatment of breast cancer in any of the following settings:
Non-small cell lung cancer (NSCLC)
Authorization of 6 months may be granted for treatment of NSCLC in any of the following settings:
Cutaneous melanoma
Authorization of 6 months may be granted for subsequent treatment of metastatic or unresectable cutaneous melanoma, as a single-agent or in combination with carboplatin.
Epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer
Authorization of 6 months may be granted for treatment of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer in any of the following settings:
Kaposi sarcoma
Authorization of 6 months may be granted for treatment of Kaposi sarcoma.
Endometrial carcinoma
Authorization of 6 months may be granted for subsequent treatment of endometrial carcinoma,
as a single agent.
Biliary tract cancers
Authorization of 6 months may be granted for treatment of either of the following in combination with gemcitabine:
Uveal melanoma
Authorization of 6 months may be granted for treatment of uveal melanoma, as single-agent therapy for metastatic or unresectable disease.
Small Bowel Adenocarcinoma
Authorization of 6 months may be granted for treatment of advanced or metastatic small bowel adenocarcinoma, as a single agent or in combination with gemcitabine.
Ampullary Adenocarcinoma
Authorization of 6 months may be granted for treatment of ampullary adenocarcinoma, in combination with gemcitabine.
Cervical cancer
Authorization of 6 months may be granted for subsequent treatment of persistent, recurrent, or metastatic cervical cancer, as a single agent.
Vaginal cancer
Authorization of 6 months may be granted for subsequent treatment of recurrent or metastatic vaginal cancer, as a single agent.
Bladder cancer
Authorization of 6 months may be granted for subsequent treatment of platinum-resistant locally advanced or metastatic bladder cancer.
CONTINUATION OF THERAPY
Authorization of 6 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the Coverage Criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
MEDICATION QUANTITY LIMITS
|
Drug Name |
Maximum Dosing Regimen |
|
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Ampullary Adenocarcinoma, Cervical Cancer, Hepatobiliary Cancers: Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer |
Route of Administration: Intravenous 125mg/m² on days 1, 8, and 15 (28-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Breast Cancer |
Route of Administration: Intravenous 260mg/m² on day 1 (21-day cycle) 125mg/m² on days 1, 8, and 15 (28-day cycle) 125mg/m² on days 1 and 8 (21-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Cutaneous Melanoma, Uveal Melanoma |
Route of Administration: Intravenous 150mg/m² on days 1, 8, and 15 (28-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Endometrial Carcinoma |
Route of Administration: Intravenous 260mg/m² on day 1 (21-day cycle) 125mg/m² on days 1, 8, and 15 (28-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Fallopian Tube Cancer |
Route of Administration: Intravenous 260mg/m² on day 1 (21-day cycle) 100mg/m² on days 1, 8, and 15 (28-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Kaposi Sarcoma |
Route of Administration: Intravenous 100mg/m² on days 1, 8, and 15 (28-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Non-Small Cell Lung Cancer (NSCLC) |
Route of Administration: Intravenous 100mg/m² on days 1, 8, and 15 (21-day cycle) 125mg/m² on days 1, 8, and 15 (28-day cycle) 260mg/m² on day 1 (21-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Ovarian Cancer |
Route of Administration: Intravenous 260mg/m² on day 1 (21-day cycle) 100mg/m² on days 1, 8, and 15 (28-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Pancreatic Adenocarcinoma |
Route of Administration: Intravenous 125mg/m² on days 1, 8, and 15 (28-day cycle) 125mg/m² on days 1 and 8 (21-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Primary Peritoneal Cancer |
Route of Administration: Intravenous 260mg/m² on day 1 (21-day cycle) 100mg/m² on days 1, 8, and 15 (28-day cycle) |
|
Abraxane (Paclitaxel Protein-Bound Particles) |
Small Bowel Adenocarcinoma |
Route of Administration: Intravenous 260mg/m² on day 1 (21-day cycle) 125mg/m² on days 1, 8, and 15 (28-day cycle) |
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
ORIGINAL EFFECTIVE DATE: 8/10/2013
MOST RECENT REVIEW DATE: 9/30/2025
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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