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Paclitaxel Albumin-Bound: Abraxane®; Paclitaxel Albumin-Bound Ψ

Policy Number: VP-0001

 (Intravenous)

Last Review Date: 06/04/2024

Date of Origin:  10/17/2008

Dates Reviewed: 06/2009, 12/2009, 07/2010, 09/2010, 12/2010, 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 11/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 04/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 12/2020, 03/2021, 06/2021, 09/2021, 12/2021, 03/2022, 06/2022, 09/2022, 12/2022, 03/2023, 06/2023, 09/2023, 12/2023, 03/2024, 06/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage is provided for 6 months and may be renewed, unless otherwise specified.

  • Non-Small Cell Lung Cancer (NSCLC) in combination with tremelimumab, durvalumab, and carboplatin OR in combination with pembrolizumab and carboplatin: Coverage will be provided for up to a maximum of 12 weeks of therapy (4 doses) and may NOT be renewed.
  • Non-Small Cell Lung Cancer (NSCLC) in combination with atezolizumab and carboplatin: Coverage will be provided for up to a maximum of 18 weeks of therapy (6 doses) and may NOT be renewed.
  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Abraxane/Paclitaxel albumin-bound 100 mg powder for injection single-dose vial: 9 vials per 21-day supply
  1. Max Units (per dose and over time) [HCPCS Unit]:

Kaposi Sarcoma

  • 300 billable units per 28 days

Breast Cancer, Small Bowel Adenocarcinoma, Pancreatic Adenocarcinoma, & NSCLC

  • 900 billable units per 21 days

Cutaneous & Uveal Melanoma, Ovarian Cancer, Fallopian Tube & Primary Peritoneal Cancer, Cervical Cancer, Biliary Tract Cancers, Vaginal Cancer, Endometrial Cancer, & Ampullary Adenocarcinoma

  • 900 billable units per 28 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Breast Cancer † 1-3,9,21,27

  • Patient failed on combination chemotherapy for metastatic disease or relapsed within 6 months of adjuvant therapy ; AND
    • Used as a single agent; AND
    • Previous chemotherapy included an anthracycline unless clinically contraindicated; OR
  • Patient has recurrent unresectable (local or regional) or metastatic (stage IV [M1]) disease OR inflammatory breast cancer with no response to preoperative systemic therapy ; AND
    • Patient has HER2-negative hormone receptor-positive disease; AND
      • Patient is refractory to endocrine therapy or has visceral crisis; AND
      • Used as one of the following:
        • As a single agent
        • In combination with carboplatin in patients with high tumor burden, rapidly progressing disease, or visceral crisis; AND
      • Used in one of the following treatment settings:
        • First-line therapy if no germline BRCA 1/2 mutation
        • Second-line therapy if not a candidate for fam-trastuzumab deruxtecan-nxki
        • Third-line therapy and beyond; OR
  • Patient has triple negative breast cancer (TNBC) ***; AND
    • Used in combination with pembrolizumab for PD-L1 positive (PD-L1 CPS ≥10) disease; OR
    • Used as a single agent; AND
      • Used as first-line therapy if PD-L1 CPS <10 and no germline BRCA 1/2 mutation; OR
      • Used as subsequent therapy; OR
    • Used in combination with carboplatin in patients with high tumor burden, rapidly progressing disease, or visceral crisis; AND
      • Used as first-line therapy if PD-L1 CPS <10 and no germline BRCA 1/2 mutation; OR
      • Used as subsequent therapy; OR
  • Patient has HER2-positive disease; AND
    • Used as fourth-line therapy and beyond in combination with trastuzumab; OR
  • May be substituted for paclitaxel or docetaxel if the patient has experienced hypersensitivity reactions despite premedication or the patient has contraindications to standard hypersensitivity premedication

Non-Small Cell Lung Cancer (NSCLC) † 1,2,4,10,30-32

  • Used as first-line therapy for locally advanced or metastatic disease, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy ; OR
  • May be substituted for paclitaxel or docetaxel if the patient has experienced hypersensitivity reactions despite premedication or the patient has contraindications to standard hypersensitivity premedication; OR
  • Used for recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy; AND
  • Used as first-line therapy; AND
    • Used in one of the following:
      • Patients with a performance status (PS) 0-1 who have tumors that are negative for actionable molecular biomarkers* (may be KRAS G12C mutation positive) and PD-L1 <1%
      • Patients with tumors that are negative for actionable molecular biomarkers* (may be KRAS G12C mutation positive) and PD-L1 expression positive (≥1%)
      • Patients with a PS 0-1 who have tumors that are positive for one of the following molecular mutations: EGFR exon 20, BRAF V600E, NTRK1/2/3 gene fusion, MET exon-14 skipping, RET rearrangement, or ERBB2 (HER2); AND
    • Used in combination with carboplatin and pembrolizumab for squamous cell histology; OR
    • Used in combination with carboplatin and atezolizumab for non-squamous histology; OR
    • Used in combination with tremelimumab-actl, durvalumab, and carboplatin (excluding use in patients with PD-L1 ≥50%); OR
    • Used as a single agent (PS 2) or in combination with carboplatin in patients with contraindications ¥ to PD-1 or PD-L1 inhibitors; AND
      • Used in patients with tumors that are negative for actionable molecular biomarkers* (may be KRAS G12C mutation positive); OR
      • Used in patients with tumors that are positive for one of the following molecular mutations: EGFR exon 20, BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, RET rearrangement, or ERBB2 (HER2); OR
  • Used as subsequent therapy; AND
    • Used in one of the following:
      • Patients with a PS 0-1 who are positive for one of the following molecular mutations: BRAF V600E, NTRK1/2/3 gene fusion, MET exon-14 skipping, or RET rearrangement
        • Patients with a PS 0-1 who are positive for one of the following molecular mutations and have received prior targeted therapy§ for those aberrations: EGFR exon 19 deletion or exon 21 L858R tumors, EGFR S768I, L861Q, and/or G719X mutation, ALK rearrangement, or ROS1 rearrangement; AND
    • Used in combination with carboplatin and pembrolizumab for squamous cell histology; OR
    • Used in combination with carboplatin and atezolizumab for non-squamous histology; OR
    • Used in combination with tremelimumab-actl, durvalumab, and carboplatin; OR
    • Used in combination with carboplatin in patients with contraindications ¥ to PD-1 or PD-L1 inhibitors; AND
      • Used in patients with tumors that are positive for one of the following molecular mutations: BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, or RET rearrangement; OR
      • Used in patients with tumors that are positive for one of the following molecular mutations and have received prior targeted therapy§ for those aberrations: EGFR exon 19 deletion or exon 21 L858R tumors, EGFR S768I, L861Q, and/or G719X mutation, ALK rearrangement, or ROS1 rearrangement; OR
      • Used in patients with PD-L1 expression-positive (≥1%) tumors that are negative for actionable molecular biomarkers* with prior PD-1/PD-L1 inhibitor therapy but no prior platinum-containing chemotherapy; OR
    • Used as a single agent; AND
      • Used for first progression after initial systemic therapy (if not previously used); OR
      • Used in patients with a PS 2 who are positive for one of the following molecular mutations: BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, or RET rearrangement; OR
      • Used in patients with a PS 2 who are positive for one of the following molecular mutations and have received prior targeted therapy§ for those aberrations: EGFR exon 19 deletion or exon 21 L858R tumors, EGFR S768I, L861Q, and/or G719X mutation, ALK rearrangement, or ROS1 rearrangement; OR
      • Used in patients with a PS 2 and PD-L1 expression-positive (≥1%) tumors that are negative for actionable molecular biomarkers* with prior PD-1/PD-L1 inhibitor therapy but no prior platinum-containing chemotherapy

*Note: Actionable molecular genomic biomarkers include EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, and ERBB2 (HER2). Complete genotyping for EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, and ERBB2 (HER2), via biopsy and/or plasma testing. If a clinically actionable marker is found, it is reasonable to start therapy based on the identified marker. Treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes.

¥ Note: Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents, and some oncogenic drivers (e.g., EGFR exon 19 deletion or exon 21 L858R, ALK rearrangements) have been shown to be associated with less benefit from PD-1/PD-L1 inhibitors.

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer2,8,22

  • Patient has Grade 1 Endometrioid Carcinoma, Carcinosarcoma (Malignant Mixed Müllerian Tumors), Mucinous Carcinoma of the Ovary, Epithelial Ovarian/Fallopian Tube/Primary Peritoneal Cancer, Clear Cell Carcinoma of the Ovary; AND
    • Patient has recurrent or persistent disease; AND
    • Patient is not experiencing an immediate biochemical relapse (i.e., rising CA-125 without radiographic evidence of disease); AND
      • Used as one of the following:
        • As a single agent
        • In combination with carboplatin in patients with confirmed taxane hypersensitivity; AND
      • Patient has one of the following:
        • Platinum-resistant disease; AND
      • Used for progression on primary, maintenance, or recurrence therapy; OR
      • Used for stable or persistent disease if not currently on maintenance therapy; OR
      • Used for complete remission and relapse <6 months after completing chemotherapy; OR
      • Platinum-sensitive disease; AND
      • Used for complete remission and relapse ≥6 months after completing chemotherapy; OR
  • Patient has low-grade serous carcinoma; AND
    • Patient has recurrent disease; AND
      • Used as a single agent; OR
      • Used in combination with carboplatin in patients with confirmed taxane hypersensitivity; OR
  • May be substituted for paclitaxel if the patient has experienced hypersensitivity reactions despite premedication or the patient has contraindications to standard hypersensitivity premedication

Pancreatic Adenocarcinoma † Ф 1,2,5-7,24,34,35

  • Used in combination with gemcitabine; AND
    • Patient has locally advanced or metastatic disease; AND
      • Used as first-line therapy; OR
      • Used as induction therapy followed by chemoradiation (locally advanced disease only); OR
      • Used as subsequent therapy after disease progression with a fluoropyrimidine-based therapy; OR
    • Patient has local recurrence in the pancreatic operative bed OR recurrent metastatic disease after resection; AND
      • Used ≥6 months after completion of primary therapy; OR
      • Used <6 months from completion of primary therapy and previously treated with fluoropyrimidine-based therapy; OR
    • Used as neoadjuvant therapy; AND
      • Patient has resectable disease; OR
      • Patient has biopsy positive borderline resectable disease; OR
  • Used in combination with gemcitabine and cisplatin; AND
    • Patient has metastatic disease; AND
    • Patient has ECOG PS 0-1; AND
    • Used as first-line therapy

Cutaneous Melanoma 2,15,16

  • Patient has metastatic or unresectable disease; AND
  • Used as subsequent therapy as a single agent or in combination with carboplatin; AND
  • Used for disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy (e.g., dabrafenib/trametinib, vemurafenib/cobimetinib, encorafenib/binimetinib, etc.)

Uveal Melanoma ‡ 2,15,16

  • Used as a single agent for metastatic or unresectable disease

Endometrial Carcinoma (Uterine Neoplasms) 2,20

  • Used as single agent therapy; AND
  • Used as subsequent therapy for recurrent disease; AND
  • Patient has tried paclitaxel and treatment with paclitaxel was not tolerated due to a documented hypersensitivity reaction, despite use of recommended premedication or there is a documented medical contraindication to recommended premedication; AND
  • Patient has a negative skin test to paclitaxel (if available)

Biliary Tract Cancers (Gallbladder Cancer or Intra-/Extra-Hepatic Cholangiocarcinoma) 2,11,35

  • Used in combination with gemcitabine; AND
  • Patient has unresectable, resected gross residual (R2), or metastatic disease; AND
    • Used as primary treatment; OR
    • Use as subsequent treatment for progression on or after systemic therapy; OR
  • Patient has resectable locoregionally advanced gallbladder cancer; AND
      • Used as neoadjuvant therapy; AND
      • Patient has incidental finding of suspicious mass during surgery where hepatobiliary surgery expertise unavailable; OR
      • Patient has incidental finding on pathologic review (cystic duct node positive); OR
      • Patient has mass on imaging

Small Bowel Adenocarcinoma ‡ 2,17,18,26

  • Patient has advanced or metastatic disease; AND
  • Used as single agent or in combination with gemcitabine; AND
    • Used as initial therapy after previous FOLFOX/CAPEOX in the adjuvant setting within past 12 months or contraindication; OR
    • Used as subsequent therapy if not previously given

Kaposi Sarcoma 2,19,25

  • Used as subsequent therapy in patients intolerant to paclitaxel; AND
  • Patient has relapsed/refractory advanced cutaneous, oral, visceral, or nodal disease; AND
  • Disease has progressed on or not responded to first-line systemic therapy; AND
  • Disease has progressed on alternate first-line systemic therapy; AND
    • Used as a single agent for patients that do not have HIV; OR
    • Used in combination with antiretroviral therapy (ART) for patients with HIV

Ampullary Adenocarcinoma ‡ 2,24

  • Used in combination with gemcitabine; AND
  • Patient has pancreatobiliary or mixed type disease; AND
    • Used as neoadjuvant therapy for localized disease in high-risk patients (i.e., equivocal or indeterminate imaging findings, markedly elevated CA 19-9, markedly elevated carcinoembryonic antigen [CEA], large primary tumors, large regional lymph nodes, excessive weight loss, extreme pain); OR
    • Used as first-line therapy for unresectable localized or metastatic disease; OR
  • Used as subsequent therapy for disease progression

Cervical Cancer ‡ 2,28

  • Used as a single agent as subsequent therapy; AND
    • Patient has persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix (NECC); OR
    • Patient has recurrent or metastatic disease

Vaginal Cancer ‡ 2

  • Used as a single agent as subsequent therapy; AND
  • Patient has recurrent or metastatic disease

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

*** ER Scoring Interpretation (following ER testing by validated IHC assay)

Results

Interpretation

  • 0% – <1% of nuclei stain
  • ER-negative
  • 1%–10% of nuclei stain
  • ER-low–positive*
  • >10% of nuclei stain
  • ER-positive

*Note: Patients with cancers with ER-low–positive (1%–10%) results are a heterogeneous group with reported biologic behavior often similar to ER-negative cancers; thus, as such these cancers inherently behave aggressively and may be treated similar to triple-negative disease. Individualized consideration of risks versus benefits should be incorporated into decision-making.

§Genomic Aberration/Mutational Driver Targeted Therapies

(Note: not all inclusive, refer to guidelines for appropriate use)

EGFR exon 19 deletion or exon 21 L858R tumors

EGFR S768I, L861Q, and/or G719X mutation positive tumors

EGFR exon 20 insertion mutation positive tumors

NTRK1/2/3 gene fusion positive tumors

  • Afatinib
  • Erlotinib
  • Dacomitinib
  • Gefitinib
  • Osimertinib
  • Amivantamab
  • Afatinib
  • Erlotinib
  • Dacomitinib
  • Gefitinib
  • Osimertinib
  • Amivantamab
  • Amivantamab
  • Larotrectinib
  • Entrectinib

ALK rearrangement-positive tumors

ROS1 rearrangement-positive tumors

BRAF V600E-mutation positive tumors

ERBB2 (HER2) mutation positive tumors

  • Alectinib
  • Brigatinib
  • Ceritinib
  • Crizotinib
  • Lorlatinib
  • Ceritinib
  • Crizotinib 
  • Entrectinib
  • Lorlatinib
  • Repotrectinib
  • Dabrafenib ± trametinib
  • Encorafenib + binimetinib
  • Vemurafenib
  • Fam-trastuzumab deruxtecan-nxki
  • Ado-trastuzumab emtansine

PD-L1 tumor

expression ≥ 1%

MET exon-14 skipping mutations

RET rearrangement-positive tumors

KRAS G12C mutation positive tumors

  • Pembrolizumab
  • Atezolizumab
  • Nivolumab + ipilimumab
  • Cemiplimab
  • Tremelimumab + durvalumab
  • Capmatinib
  • Crizotinib
  • Tepotinib
  • Selpercatinib
  • Cabozantinib
  • Pralsetinib
  • Sotorasib
  • Adagrasib
  1. Renewal Criteria 1,2

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe myelosuppression (e.g., severe neutropenia [absolute neutrophil count < 1,500 cell/mm3] or thrombocytopenia, sensory neuropathy, sepsis, pneumonitis, severe hypersensitivity reactions [including anaphylactic reactions], hepatic impairment, etc.; AND

Non-Small Cell Lung Cancer (in combination with tremelimumab, durvalumab, and carboplatin OR pembrolizumab and carboplatin OR atezolizumab and carboplatin):

  • Coverage may not be renewed
  1. Dosage/Administration 1,11,15,16-19,21,22,25-35

Indication

Dose

Breast Cancer

Single agent:

Administer 260 mg/m² intravenously every 21 days until disease progression or unacceptable toxicity

OR

Administer 100 mg/m² OR 125 mg/m² intravenously days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity

In combination with pembrolizumab:

Administer 100 mg/m² intravenously days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity

In combination with carboplatin:

Administer 125 mg/m² intravenously days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity

In combination with trastuzumab:

Administer 125mg/m2 intravenously days 1,8, 15 of a 28-day cycle until disease progression or unacceptable toxicity

**Note: If being used as a substitute for weekly paclitaxel or docetaxel, the weekly dose of albumin-bound paclitaxel should not exceed 125 mg/m²

NSCLC

Single agent:

Administer 260 mg/m² intravenously every 21 days until disease progression or unacceptable toxicity

In combination with carboplatin:

Administer 100 mg/m² intravenously days 1, 8, and 15 of a 21-day cycle until disease progression or unacceptable toxicity

In combination with tremelimumab, durvalumab, and carboplatin:

Administer 100 mg/m² intravenously days 1, 8, and 15 of a 21-day cycle for 4 cycles

In combination with pembrolizumab and carboplatin:

Administer 100 mg/m² intravenously days 1, 8, and 15 of a 21-day cycle for 4 cycles

In combination with atezolizumab and carboplatin:

Administer 100 mg/m² intravenously days 1, 8, and 15 of a 21-day cycle for 4 to 6 cycles

Cutaneous Melanoma, Uveal Melanoma, Ovarian Cancer, Fallopian Tube Cancer, &  Primary Peritoneal Cancer

Administer 100 mg/m² intravenously days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity

Kaposi Sarcoma

Administer 100 mg (fixed dose) intravenously days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity

Cervical Cancer, Biliary Tract Cancers, Ampullary Adenocarcinoma, Vaginal Cancer & Endometrial Carcinoma

Administer 125 mg/m² intravenously days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity

Pancreatic Adenocarcinoma

In combination with gemcitabine:

Administer 125 mg/m² intravenously days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity

In combination with gemcitabine and cisplatin:

Administer 125 mg/m² intravenously days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity

Small Bowel Adenocarcinoma

Single agent:

Administer 220 – 260 mg/m² intravenously every 21 days as a single agent until disease progression or unacceptable toxicity

In combination with gemcitabine:

Administer 125 mg/m² intravenously days 1, 8, and 15 of a 28-day cycle in combination with gemcitabine until disease progression or unacceptable toxicity

  1. Billing Code/Availability Information

HCPCS Code(s):

  • J9264 – Injection, paclitaxel protein-bound particles, 1 mg; 1 billable unit = 1 mg
  • J9259 – Injection, paclitaxel protein-bound particles (american regent), not therapeutically equivalent to J9264, 1 mg; 1 billable unit = 1 mg Ψ
  • J9258 – Injection, paclitaxel protein-bound particles (teva), not therapeutically equivalent to J9264, 1 mg; 1 billable unit = 1 mg Ψ

NDC:

  • Abraxane 100 mg powder for injection; single-dose vial*: 68817-0134-xx

*Multiple manufacturers produce ANDA generics

Ψ Designated products approved by the FDA as a 505(b)(2) NDA of the innovator product. These products are not rated as therapeutically equivalent to their reference listed drug in the Food and Drug Administration’s (FDA) Orange Book and are therefore considered single source products based on the statutory definition of “single source drug” in section 1847A(c)(6) of the Act. For a complete list of all approved 505(b)(2) NDA products please reference the latest edition of the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book | FDA

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  5. References
  1. Abraxane [package insert]. Princeton, NJ; Bristol-Myers Squibb Company; October 2022. Accessed January 2024.
  2. Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) paclitaxel, albumin bound. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed May 2024.
  3. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase Ill trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794-7803.
  4. 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 Ill trial. J Clin Oncol. 2012;30(17):2055-2062.
  5. Tabernero J, Chiorean EG, Infante JR, et al. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015;20(2):143-150.
  6. Goldstein D, El-Maraghi RH, Hammel P, et al. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015;107(2):1-10.
  7. Scheithauer W, Ramanathan RK, Moore M, et al. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016;7(3):469-478.
  8. 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 Mar 20; 27(9):1426-31. Epub 2009 Feb 17.
  9. Gradishar WJ, Krasnojon D, Cheporov S, et al, “Significantly Longer Progression-Free Survival With nab-paclitaxel Compared With Docetaxel as First-Line Therapy for Metastatic Breast Cancer,” J Clin Oncol, 2009, 27(22):3611-9.
  10. Rizvi NA, Riely GJ, Azzoli CG, et al, “Phase I/II Trial of Weekly Intravenous 130-nm Albumin-Bound Paclitaxel as Initial Chemotherapy in Patients With Stage IV Non-Small-Cell Lung Cancer,” J Clin Oncol, 2008, 26(4):639-43.
  11. Sahai V, Catalano PJ, Zalupski MM, et al. Nab-Paclitaxel and Gemcitabine as First-line Treatment of Advanced or Metastatic Cholangiocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018;4(12):1707–1712. doi:10.1001/jamaoncol.2018.3277.
  12. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
  13. Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
  14. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
  15. Hersh EM, O'Day SJ, Ribas A, et al. A phase 2 clinical trial of nab-paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Cancer. 2010 Jan 1;116(1):155-63.
  16. Kottschade LA, Suman VJ, Amatruda T 3rd, et al. A phase II trial of nab-paclitaxel (ABI-007) and carboplatin in patients with unresectable stage IV melanoma: a North Central Cancer Treatment Group Study, N057E(1). Cancer. 2011 Apr 15;117(8):1704-10.
  17. Overman MJ, Adam L, Raghav K, et al. Phase II study of nab-paclitaxel in refractory small bowel adenocarcinoma and CpG island methylator phenotype (CIMP)-high colorectal cancer. Ann Oncol. 2018 Jan 1;29(1):139-144.
  18. Aldrich JD, Raghav KPS, Varadhachary GR, et al. Retrospective Analysis of Taxane-Based Therapy in Small Bowel Adenocarcinoma. Oncologist. 2019 Jun;24(6):e384-e386.
  19. Fortino S, Santoro M, Luliano E, et al. Treatment of Kaposi’s Sarcoma (KS) with nab-paclitaxel. Ann Oncol 2016;27:suppl_4: iv124.
  20. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Uterine Neoplasms 2.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed May 2024.
  21. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer Version 2.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed May 2024.
  22. Benigno BB, Burrell MO, Daugherty P, et al. A phase II nonrandomized study of nab-paclitaxel plus carboplatin in patients with recurrent platinum-sensitive ovarian or primary peritoneal cancer. DOI: 10.1200/jco.2010.28.15_suppl.5011 Journal of Clinical Oncology 28, no. 15_suppl (May 20, 2010) 5011-5011.
  23. 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 tube, or primary peritoneal cancer: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 Jul;122(1):111-5. doi: 10.1016/j.ygyno.2011.03.036. Epub 2011 Apr 15.
  24. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
  25. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Kaposi Sarcoma Version 1.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed May 2024.
  26. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Bowel Adenocarcinoma Version 3.2024. National Comprehensive Cancer Network, 2024. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed May 2024.
  27. Straughn K, Hood R, Carrera L, et al. Hypersensitivity Reactions to Taxanes and Subsequent Treatment with Nab-Paclitaxel: Case Reports of 2 Women with Early-Stage Breast Cancer. J Hematol Oncol Pharm. 2021;11 (6):329-334 www.JHOPonline.com
  28. Alberts D, Blessing J, Landrum L, et al. Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study. Gynecol Oncol. 2012 Dec;127(3):451-5. doi: 10.1016/j.ygyno.2012.09.008. Epub 2012 Sep 14.
  29. Mirtsching B, Cosgriff T, Harker G, et al. A phase II study of weekly nanoparticle albumin-bound paclitaxel with or without trastuzumab in metastatic breast cancer. Clin Breast Cancer. 2011 Apr;11(2):121-8. doi: 10.1016/j.clbc.2011.03.007. Epub 2011 Apr 11.
  30. West H, et al. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol 2019;20:924-937.
  31. Novello S, Kowalski DM, Luft A, et al. Pembrolizumab Plus Chemotherapy in Squamous Non-Small-Cell Lung Cancer: 5-Year Update of the Phase III KEYNOTE-407 Study. J Clin Oncol. 2023 Apr 10;41(11):1999-2006. doi: 10.1200/JCO.22.01990. Epub 2023 Feb 3.
  32. Johnson ML, et al. Durvalumab with or without tremelimumab in combination with chemotherapy as first-line therapy for metastatic non-small-cell lung cancer: the phase III POSEIDON study. J Clin Oncol 2023;41:1213-1227.
  33. Green M, Manikhas G, Orlov S, et al. Abraxane®, a novel Cremophor® -free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer. Ann Oncol 2006;17:1263- 1268.
  34. Jameson GS, Borazanci E, Babiker HM, et al. Response rate following albuminbound paclitaxel plus gemcitabine plus cisplatin treatment among patients with advanced pancreatic cancer: A phase 1b/2 pilot clinical trial [published online ahead of print, 2019 Oct 3] [published correction appears in JAMA Oncol 2019;5:1643]. JAMA Oncol 2019;6:125-132.
  35. Shroff RT, Javle MM, Xiao L, et al. Gemcitabine, cisplatin, and nab-paclitaxel for the treatment of advanced biliary tract cancers: A phase 2 clinical trial. JAMA Oncol 2019;5:824-830.
  1. National Government Services, Inc. Local Coverage Article: Billing and Coding: Paclitaxel (e.g., Taxol®/Abraxane) (A52450). Centers for Medicare & Medicaid Services, Inc. Updated 01/04/2024 with effective date of 01/11/2024. Accessed May 2024.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C17.0

Malignant neoplasm of duodenum

C17.1

Malignant neoplasm of jejunum

C17.2

Malignant neoplasm of ileum

C17.3

Meckel's diverticulum, malignant

C17.8

Malignant neoplasm of overlapping sites of small intestine

C17.9

Malignant neoplasm of small intestine, unspecified

C22.1

Intrahepatic bile duct carcinoma

C23

Malignant neoplasm of the gallbladder

C24.0

Malignant neoplasm of extrahepatic bile duct

C24.1

Malignant neoplasm of ampulla of Vater

C24.8

Malignant neoplasm of overlapping sites of biliary tract

C24.9

Malignant neoplasm of biliary tract, unspecified

C25.0

Malignant neoplasm of head of pancreas

C25.1

Malignant neoplasm of body of the pancreas

C25.2

Malignant neoplasm of tail of pancreas

C25.3

Malignant neoplasm of pancreatic duct

C25.7

Malignant neoplasm of other parts of pancreas

C25.8

Malignant neoplasm of overlapping sites of pancreas

C25.9

Malignant neoplasm of pancreas, unspecified

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus or lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C43.0

Malignant melanoma of lip

C43.111

Malignant melanoma of right upper eyelid, including canthus

C43.112

Malignant melanoma of right lower eyelid, including canthus

C43.121

Malignant melanoma of left upper eyelid, including canthus

C43.122

Malignant melanoma of left lower eyelid, including canthus

C43.20

Malignant melanoma of unspecified ear and external auricular canal

C43.21

Malignant neoplasm of right ear and external auricular canal

C43.22

Malignant neoplasm of left ear and external auricular canal

C43.30

Malignant melanoma of unspecified parts of face

C43.31

Malignant melanoma of nose

C43.39

Malignant melanoma of other parts of face

C43.4

Malignant melanoma of scalp and neck

C43.51

Malignant melanoma of anal skin

C43.52

Malignant melanoma of skin of breast

C43.59

Malignant melanoma of other part of trunk

C43.60

Malignant melanoma of unspecified upper limb, including shoulder

C43.61

Malignant melanoma of right upper limb, including shoulder

C43.62

Malignant melanoma of left upper limb, including shoulder

C43.70

Malignant melanoma of unspecified lower limb, including hip

C43.71

Malignant melanoma of right lower limb, including hip

C43.72

Malignant melanoma of left lower limb, including hip

C43.8

Malignant melanoma of overlapping sites of skin

C43.9

Malignant melanoma of skin, unspecified

C46.0

Kaposi's sarcoma of skin

C46.1

Kaposi's sarcoma of soft tissue

C46.2

Kaposi's sarcoma of palate

C46.3

Kaposi's sarcoma of lymph nodes

C46.4

Kaposi's sarcoma of gastrointestinal sites

C46.50

Kaposi's sarcoma of unspecified lung

C46.51

Kaposi's sarcoma of right lung

C46.52

Kaposi's sarcoma of left lung

C46.7

Kaposi's sarcoma of other sites

C46.9

Kaposi's sarcoma, unspecified

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

Malignant neoplasm of nipple and areola, right female breast

C50.012

Malignant neoplasm of nipple and areola, left female breast

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right male breast

C50.022

Malignant neoplasm of nipple and areola, left male breast

C50.029

Malignant neoplasm of nipple and areola, unspecified male breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified male breast

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified  female breast

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

C52

Malignant neoplasm of vagina

C53.0

Malignant neoplasm of endocervix

C53.1

Malignant neoplasm of exocervix

C53.8

Malignant neoplasm of overlapping sites of cervix uteri

C53.9

Malignant neoplasm of cervix uteri, unspecified

C54.0

Malignant neoplasm of isthmus uteri

C54.1

Malignant neoplasm of endometrium

C54.2

Malignant neoplasm of myometrium

C54.3

Malignant neoplasm of fundus uteri

C54.8

Malignant neoplasm of overlapping sites of corpus uteri

C54.9

Malignant neoplasm of corpus uteri, unspecified

C55

Malignant neoplasm of uterus, part unspecified

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.3

Malignant neoplasm of bilateral ovaries

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

C69.30

Malignant neoplasm of unspecified choroid

C69.31

Malignant neoplasm of right choroid

C69.32

Malignant neoplasm of left choroid

C69.40

Malignant neoplasm of unspecified ciliary body

C69.41

Malignant neoplasm of right ciliary body

C69.42

Malignant neoplasm of left ciliary body

C69.60

Malignant neoplasm of unspecified orbit

C69.61

Malignant neoplasm of right orbit

C69.62

Malignant neoplasm of left orbit

Z85.068

Personal history of other malignant neoplasm of small intestine

Z85.07

Personal history of malignant neoplasm of pancreas

Z85.09

Personal history of malignant neoplasm of other digestive organs

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.3

Personal history of malignant neoplasm of breast

Z85.42

Personal history of malignant neoplasm of other parts of uterus

Z85.43

Personal history of malignant neoplasm of ovary

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

 

Medicare Part B Covered Diagnosis Codes

Jurisdiction

NCD/LCA/LCD Document (s)

Contractor

6, K

A52450

National Government Services, Inc. (NGS)

 

 

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC