Paclitaxel, albumin-bound (Abraxane®) 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. Paclitaxel (Abraxane) is an albumin-bound form of paclitaxel, a natural product with antitumor activity. In contrast to solvent-based paclitaxel, which requires premedication to decrease the risks of hypersensitivity reactions (eg, difficulty breathing, hives, swollen eyes and lips), paclitaxel (Abraxane) requires no premedication.

Paclitaxel, albumin-bound (Abraxane) may be considered medically necessary when used in the treatment of ANY ONE the following condition(s):

Bladder Cancer

• As a single agent for ureothelial cancers clinical stage T4b or T2-T4a, N1-3 disease; or
  • For recurrence post cystectomy; or
  • For metastatic disease as a second-line alternate regimen for bladder cancer.

Bladder Cancer – Primary Carcinoma of the Urethra

• Single agent for recurrent or metastatic disease as a second-line alternate regimen for primary carcinoma of the urethra, upper GU tract tumors, or urothelial carcinoma of the prostate.

Breast Cancer - Invasive

• As a single agent for recurrent or metastatic  human epidermal growth factor receptor  2 (HER2)-negative disease that has ANY ONE of the following indications:
  • With symptomatic visceral disease or visceral crisis; or
  • Disease that is hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory; or
• Therapy in combination with trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic trastuzumab-exposed disease that has ANY ONE of the following indications:
  • With symptomatic visceral disease or visceral crisis; or
  • Disease that is hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory; or
  • For treatment after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior chemotherapy must have included an anthracycline unless clinically contraindicated.

Cervical Cancer

• Second-line therapy as a single agent for ANY ONE of the following indications:
  • Local/regional recurrence; or
  • Distant metastases.

Melanoma

• As single agent therapy for individuals with metastatic or unresectable disease as second-line or subsequent therapy for disease progression; or
• As subsequent therapy after maximum clinical benefit from BRAF targeted therapy for individuals with an Eastern Cooperative Oncology Group [ECOG], performance status (PS) of 0-2.

Non-Small Cell Lung Cancer (NSCLC)

• First-line treatment of locally advanced or metastatic NSCLC in combination with carboplatin in individuals who are not candidates for curative surgery or radiation therapy; or
• As single agent therapy for recurrence or metastasis as a single agent for individuals with an ECOG PS 2, or in combination with carboplatin for ECOG, PS 0-2, for any of the following:
  • First-line therapy in cases of ALK, EGFR, ROS1, and PD-L1 negative or unknown; or
  • As subsequent therapy for sensitizing epidermal growth factor receptor (EGFR) mutation-positive tumors and prior erlotinib, afatinib, or gefitinib, or osimertinib therapy; or
  • As subsequent therapy for anaplastic lymphoma kinase (ALK)-positive tumors and prior crizotinib, ceritinib, or alectinib therapy; or
  • As subsequent therapy for ROS1-positive tumors and prior crizotinib therapy; or
  • As subsequent therapy for PD-L1-positive tumors (greater than or equal to 50%) and ALK, EGFR, and ROS1 negative tumors and prior pembrolizumab therapy; or
• Therapy in place of either paclitaxel or docetaxel in individuals with a history of hypersensitivity reactions to either of these agents despite premedication for same; or
• As an alternative therapy for individuals with contraindications to standard hypersensitivity premedications.

Ovarian Cancer – Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer

• Single agent therapy for epithelial ovarian cancer (persistent disease or recurrence); or
• Single agent therapy for fallopian tube cancer (persistent disease or recurrence); or
• Single agent therapy for primary peritoneal cancer (persistent disease or recurrence).

Pancreatic Adenocarcinoma

• Treatment for pancreatic adenocarcinoma in combination with gemcitabine for ANY ONE of the following indications:
  • As first-line chemotherapy, or as induction therapy followed by chemoradiation in selected individuals without systemic metastases, for individuals with locally advanced unresectable disease and good performance status; or
  • As preferred first-line treatment of individuals with metastatic disease with good performance status; or
  • Neoadjuvant treatment of biopsy positive borderline resectable disease or resectable disease with high risk features (e.g., large primary tumors, highly elevated CA 19-9, large regional lymph nodes, extreme pain, excessive loss of weight); or
  • As Second-line therapy for:
    • Locally advanced unresectable or metastatic disease for individuals with good performance status and disease progression who were previously treated with Fluoropyrimidine-based therapy; or
    • Local recurrence in the pancreatic bed; or
    • Metastatic disease with or without local recurrence.

The use of paclitaxel, albumin-bound (Abraxane) is considered experimental/investigational and therefore, non-covered for all other indications. Peer reviewed literature does not support the use of paclitaxel, albumin-bound (Abraxane) for any indications other than those listed on this medical policy.

NOTE: Dosage recommendations per the FDA label.