​

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

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.

2. 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

2. 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

3. 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

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer ‡ ^2,8,22

• 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

4. 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

5. Dosage/Administration ^{1,11,15,16-19,21,22,25-35}

6. 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

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11. 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.

36. 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

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.

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