Medical Drug Criteria (MDC)

Policy Num:       M5.001.025
Policy Name:     Mitotic Inhibitors (Docetaxel, Abraxane, and Paclitaxel)
Policy ID:          [M5.001.025] [Ac /L/  M / P ]

Last Review:       September 25, 2025
Next Review:      August 20, 2026
 

Related Policies:None

Mitotic Inhibitors (Docetaxel, Abraxane, and Paclitaxel)

Summary

Mitotic inhibitors (Paclitaxel, Docetaxel, Abraxane) are chemotherapy agents used in multiple solid tumors, including breast, ovarian, lung, prostate, gastric, pancreatic, and Kaposi’s sarcoma.

Docetaxel 

Drug used alone or with other drugs to treat certain types of breast cancer, stomach cancer, gastroesophageal junction cancer, non-small cell lung cancer, prostate cancer, and squamous cell carcinoma of the head and neck. It is also being studied in the treatment of other types of cancer. Docetaxel stops cancer cells from growing and dividing and may kill them. It is a type of taxane.

Paclitaxel

A drug used alone or with other drugs to treat AIDS-related Kaposi sarcoma, advanced ovarian cancer, and certain types of breast cancer and non-small cell lung cancer. It is also being studied in the treatment of other types of cancer. Paclitaxel stops cancer cells from growing and dividing and may kill them. It is a type of taxane.

Abraxene

Paclitaxel protein-bound particles are an albumin-bound form of paclitaxel, an antineoplastic agent. Paclitaxel protein-bound particles are indicated for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease, or relapse within six months of chemotherapy. Recommended therapy is 260 mg/m2 administered via intravenous (IV) infusion over 30 minutes every 3 weeks. Paclitaxel protein-bound particles are contraindicated in patients with baseline neutrophil counts of less than 1,500.

A type of drug that blocks cell growth by stopping mitosis (cell division). They are used to treat cancer. Also called antimitotic agent.

Policy Statements

Approved FDA Indications

Paclitaxel

• Breast cancer (adjuvant, metastatic, HER2-positive in combination regimens).
• Ovarian cancer (first-line and recurrent settings).
• Non-small cell lung cancer (NSCLC).
• AIDS-related Kaposi’s sarcoma.

Docetaxel

• Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure;
• Breast Cancer (BC): in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable, node-positive BC
• Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer
• Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction
• Non-Small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure;
• Non-Small Cell Lung Cancer (NSCLC): with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC
• Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN.

Abraxane (Albumin-Bound Paclitaxel)

• Metastatic 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
• Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
• Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.

Policy Guidelines

Breast cancer (metastatic/adjuvant/neoadjuvant): paclitaxel, docetaxel, nab-paclitaxel (incl. MBC after anthracycline; nab preferred if Cremophor neuropathy/hypersensitivity).
 
Pancreatic cancer (metastatic): nab-paclitaxel + gemcitabine (first-line).
 
NSCLC: docetaxel (2nd-line or maintenance per guideline), paclitaxel (with platinum), nab-paclitaxel + carboplatin (1st-line squamous/non-squamous in candidates).
 
Prostate cancer (mCRPC/mHSPC): docetaxel with ADT ± ARTA as indicated.
 
Gastric/GEJ: docetaxel (with platinum/5-FU).
 
SCCHN: docetaxel or paclitaxel in induction/palliative regimens.
 
Ovarian/tubal/peritoneal: paclitaxel + carboplatin (adjuvant/recurrence); docetaxel as alternative.
 
Kaposi’s sarcoma: paclitaxel in refractory disease.
 
Cervical, endometrial, bladder, melanoma, biliary tract: when NCCN Cat. 1/2A or CMS compendium supported.
 
 
> Off-label: allowed when consistent with NCD 110.3 and supported by compendia; requires documentation and literature.

DOSAGE/ADMINISTRATION

ANC ≥1,500/mm³ (≥1,000/mm³ acceptable in validated weekly regimens) and platelets ≥100,000/mm³.
 
Bilirubin/AST/ALT within product-specific limits.

REQUIRED MEDICAL INFORMATION

ANC ≥1,500/mm³ (≥1,000/mm³ acceptable in validated weekly regimens) and platelets ≥100,000/mm³.
 
Bilirubin/AST/ALT within product-specific limits.
 
Premedication per product (see Section 7).
 
 
4.3 Continuation (renewal)
 
Up to 6 months additional coverage if response (CR/PR) or stable disease is documented, with tolerable toxicity and continued standard-of-care use.
 
4.4 Authorization duration
 
Initial: up to 6 months (or 8 cycles).
 
Renewal: in 6-month blocks with clinical benefit.

EXCLUSION CRITERIA

Cosmetic/benign uses;
 
Pregnancy (fetal toxicity risk);
 
Severe uncontrolled hypersensitivity to taxanes/vehicles;
 
Febrile neutropenia without adequate prophylaxis or dose adjustment;
 
Use outside FDA/Guidelines/Compendia.

BENEFIT APPLICATION

Paclitaxel must be used first in overlapping indications, unless contraindicated.

Docetaxel can be considered as second agent of choice

Docetaxel is the preferred agent for non shared indications.

Abraxane is the agent of choice for non shared indication of pancreatic Ca metastatic adenocarcinoma

Medical documentation must specify diagnosis, staging, prior therapies, and reason for selecting non-preferred agents.

OTHER CRITERIA

None

Practice Guidelines and Position Statements

NCCN Guidelines® 2025: Breast; Pancreatic; NSCLC; Prostate; Gastric/GEJ; Head & Neck; Ovarian; Cervical; Kaposi; others.
 
ASCO/ESMO: consistent recommendations on taxane selection, dosing, and supportive care.

Medicare National Coverage

Covered under Part B when reasonable and necessary for cancer.
 
Off-label: per NCD 110.3 using accepted compendia (NCCN Drugs & Biologics Compendium, etc.).

References

1. FDA Prescribing Information: Paclitaxel, Docetaxel, Abraxane.
2. NCCN Guidelines: Breast, Ovarian, Lung, Pancreatic, Prostate, Gastric, Head and Neck Cancers. 
3. CMS Medicare Coverage Database.
4. FDA — ABRAXANE® (paclitaxel protein-bound) Prescribing Information (USPI, 2020): https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021660s047lbl.pdf.
5. FDA/DailyMed — Paclitaxel injection (label overview): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=consumer&setid=6d04b514-c85c-4db1-919e-21dd98172791.
6. FDA — Taxotere® (docetaxel) Prescribing Information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020449s071lbl.pdf.
7. CMS — Billing & Coding: Paclitaxel (A52450): https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52450.
8. NCCN Guidelines for Patients  https://www.nccn.org/patients/guidelines/content/PDF/breast-invasive-patient.pdf 
9. NCCN Guidelines for Patient Metastatic Breast Cancer: https://www.nccn.org/patients/guidelines/content/PDF/stage_iv_breast-patient.pdf.
10. NCCN Guidelines for Patients Pancreatic Cancer: https://www.nccn.org/patients/guidelines/content/PDF/pancreatic-patient.pdf.
11. NCCN Guidelines for Patients Metastatic Non-Small Cell Lung Cancer (2025): https://www.nccn.org/patients/guidelines/content/PDF/lung-metastatic-patient.pdf.

Codes

Policy History