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MP 8.01.07 Paclitaxel Chemotherapy

Medical Policy
Original Policy Date
Last Review Status/Date
Reviewed by consensus/1:2004
Return to Medical Policy Index


Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.


Paclitaxel (Taxol‚, Bristol-Myers Squibb, Princeton, NJ) was approved by the U.S. Food and Drug Administration (FDA) in December 1992 for use in patients with metastatic ovarian carcinoma that failed first-line or subsequent chemotherapy.

First-line ovarian carcinoma chemotherapy typically consists of a combination including cisplatin (e.g., cisplatin and cyclophosphamide), although specific agents are not specified in the FDA-approved label.

In April 1993, the FDA approved use of paclitaxel in patients with metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The FDA labeling indicated that prior therapy should have included an anthracycline (e.g., doxorubicin), unless clinically contraindicated.

The FDA-approved label states that paclitaxel (Taxol‚) is contraindicated in patients who have a history of hypersensitivity reaction to paclitaxel or other drugs formulated in Cremophor‚ EL (polyoxyethylated castor oil). Paclitaxel should not be used in patients with a baseline neutropenia of less than1,500 cells/mm3.


Paclitaxel (Taxol‚) is medically necessary when used for its labeled indications.

Paclitaxel (Taxol‚) as first-line treatment of breast cancer or for patients with metastatic disease who are still able to undergo treatment with doxorubicin is considered investigational.

Paclitaxel (Taxol‚) is also considered investigational in the treatment of the following:

  • brain cancer;
  • cervical cancer;
  • colon cancer;
  • head and neck cancer;
  • lymphoma;
  • melanoma;
  • non-small-cell lung cancer;
  • pancreatic cancer;
  • prostate cancer;
  • renal cell carcinoma;
  • small-cell lung cancer;
  • stomach cancer.

Policy Guidelines

Paclitaxel may be considered medically necessary as second-line therapy for patients with Stage IV metastatic breast cancer in whom doxorubicin therapy is contraindicated.

Benefit Application

BlueCard/National Account Issues

Plans will need to monitor the FDA-labeled indications for changes.

ICD-9-CM codes 196.0–198.89 are applicable for the metastatic ovarian and breast carcinomas. Codes 174.0–174.9 and 175.0–175.9 and 183.0 identify primary malignant neoplasm sites.


A search of literature was completed through the MEDLINE database for the period of January 1993 through January 1995. The search strategy focused on references containing the following Medical Subject Headings:


- Paclitaxel
- Therapeutic Use

Research was limited to English-language journals on humans.

See also:

TEC Evaluations 1993: Tab 9





CPT  96401, 96402, 96405, 96406, 96409, 96411, 96413, 96415, 96416, 96417, 96420, 96422, 96423, 96425, 96440, 96445, 96450, 96521, 96522, 96523, 96542, 96549  Chemotherapy administration range 
ICD-9 Procedure  99.25  Injection or infusion of cancer chemotherapeutic substance 
  196.0–198.89  Secondary malignant neoplasms code range 
ICD-9 Diagnosis  174.0–174.9  Malignant neoplasm of female breast code range 
  175.0–175.9  Malignant neoplasm of male breast code range 
  183.0  Malignant neoplasm of the ovary code range 
  V10.3  Personal history of malignant neoplasm of breast 
  V10.43  Personal history of malignant neoplasm of ovary 
HCPCS  J9265  Paclitaxel, 30 mg Taxol 
BCBSA  No Code 
Type of Service  Injection 
Place of Service  Inpatient


Chemotherapy, Taxol‚
Paclitaxel (Taxol‚) Chemotherapy
Taxol‚ (Paclitaxel) Chemotherapy  

Policy History

Date Action Reason
12/01/95 Add to Therapy Section New policy
8/18/00 Replace Policy Archived policy
7/12/02 Replace Policy Policy reviewed without literature review; new review date only
02/25/04 Replace Policy Policy reviewed without literature search; no further review scheduled.

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