Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Coverage Policy Manual
Policy #:	2017012
Category:	Pharmacy
Initiated:	April 2017
Last Review:	April 2025

Nab-Paclitaxel (e.g., Abraxane)

Description:

Paclitaxel protein-bound particles, also known as “nanoparticle albumin-bound” (nab)-paclitaxel, are microtubule inhibitors that result in the assembly and stabilization of microtubules by preventing depolymerization. This stability results in the inhibition of interphase and mitotic cellular functions, preventing cell division. (Clinical Pharmacology, 2017).

Regulatory Status

In January 2005, Nab-Paclitaxel (e.g., Abraxane) for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) was approved for the treatment of 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.

In October 2012, the FDA approved Nab-Paclitaxel (e.g., Abraxane) for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), as first-line treatment in combination with carboplatin, in individuals who are not candidates for curative surgery or radiation therapy.

In September 2013, the FDA approved Nab-Paclitaxel (e.g., Abraxane) for a new indication for the first-line treatment of individuals with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine (U.S. Food and Drug Administration 2005, 2012, 2013).

In March 2019, the FDA approved Nab-Paclitaxel (e.g., Abraxane) for treatment of individuals with unresectable locally advanced or metastatic triple-negative breast cancer that is PD-L1 positive, in combination with atezolizumab. This indication has been approved under accelerated approval designation based on progression-free-survival data. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Coding

See CPT/HCPCS Code section below.

Policy/
Coverage:

Effective August 1, 2021, for members of plans that utilize an oncology benefits management program, Prior Approval is required for this service and is managed through the oncology benefits management program.

The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmar or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.

Effective April 9, 2025

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Nab-paclitaxel (e.g., Abraxane) meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:

For FDA labeled indications, Nab-paclitaxel (e.g., Abraxane) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.

For off-label indications, authorizations will not exceed the maximum FDA labeled dose and frequency across all the FDA labeled indications unless higher dose is allowed for the specific indication in the dosage and administration section.

FDA Labeled Indications

The use of this drug is covered if an FDA-approved oncologic indication exists [not listed as an indication below with the member meeting all of the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”)].

BREAST CANCER

INITIAL APPROVAL STANDARD REVIEW for up to 12 months:

1. Individual has a diagnosis of metastatic breast cancer (Abraxane, 2020); AND

2. Individual has failure of combination chemotherapy for metastatic disease; OR

3. Individual has had a relapse within 6 months of adjuvant chemotherapy; AND

4. Prior therapy should have included an anthracycline unless clinically contraindicated.

NON-SMAL LUNG CANCER (NSCLC)

INITIAL APPROVAL STANDARD REVIEW for up to 12 months:

1. Individual has a diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC) (Abraxane, 2020); AND

2. Nab-paclitaxel will be used as first-line treatment; in combination with carboplatin; AND

3. Individual is not a candidate for curative surgery or radiation.

PANCREATIC CANCER

INITIAL APPROVAL STANDARD REVIEW for up to 12 months:

1. Individual has a diagnosis metastatic adenocarcinoma of the pancreas(Abraxane, 2020); AND

2. Nab-paclitaxel will be used as first-line treatment; AND

3. Nab-paclitaxel will be used in combination with gemcitabine.

CONTINUED APPROVAL for up to 12 months:

1. Individual continues to meet the initial approval criteria; AND

2. Individual experiences objective benefit from continued treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND

3. Individual does not have unacceptable toxicity resulting from the treatment (e.g., life-threatening hypersensitivity reactions) (Abraxane, 2020).

Off-Label Indications

The use of this drug for off-label indications not listed below is subject to policy 2000030.

The following indications are covered when the individual meets the related NCCN category 1 or 2A recommendations specific to the indications below (e.g., histology, cancer staging, surgical status, mono- or combination therapy, and previous lines of therapy):

INITIAL APPROVAL STANDARD REVIEW for up to 12 months:

1. Ampullary Adenocarcinoma (NCCN 2A); OR

2. Kaposi Sarcoma (NCCN 2A); OR

3. Melanoma:

a. Uveal (NCCN 2A); OR

b. Cutaneous (NCCN 2A); OR

4. Pancreatic Adenocarcinoma (NCCN 1 and 2A); OR

5. Vaginal Cancer (NCCN 2A); OR

6. Uterine Neoplasms -Endometrial Carcinoma (NCCN 2A); OR

7. Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer:

a. Epithelia Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer (NCCN 1 and 2A); OR

b. Carcinosarcoma (Malignant Mixed Mullerian Tumors) (NCCN 1 and 2A); OR

c. Clear Cell Carcinoma of the Ovary (NCCN 1 and 2A); OR

d. Mucinous Neoplasms of the Ovary (NCCN 1 and 2A); OR

e. Grade 1 Endometrioid Carcinoma (NCCN 1 and 2A); OR

f. Low-Grade Serous Carcinoma (NCCN 2A); OR

8. Biliary Tract Cancers:

a. Gallbladder Cancer (NCCN 2A); OR

b. Intrahepatic Cholangiocarcinoma (NCCN 2A); OR

c. Extrahepatic Cholangiocarcinoma (NCCN 2A); OR

9. Cervical Cancer (NCCN 2A); OR

10. Non-Small Cell Lung Cancer (NCCN 1 and 2A); OR

11. Breast Cancer:

a. Invasive Breast Cancer (NCCN 1 and 2A); OR

b. Inflammatory Breast Cancer (NCCN 1 and 2A); OR

12. Small Bowel Adenocarcinoma (NCCN 2A).

CONTINUED APPROVAL for up to 12 months:

1. Individual continues to meet the initial approval criteria; AND

2. Individual experiences objective benefit from continued treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND

3. Individual does not have unacceptable toxicity resulting from the treatment (e.g., life-threatening hypersensitivity reactions).

Please see the NCCN Drugs and Biologics Compendium for a complete list of NCCN 1 & 2A indications. To view the most recent and complete version of the guideline or Compendium, go online to NCCN.org. Please note, NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Policy Guidelines

Eastern Cooperative Oncology Group Performance Status (ECOG) (ECOG-ACRIN Cancer Research Group, 2022)

0 = Fully active, able to carry on all pre-disease performance without restriction
1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light housework, office work
2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5 = Dead

Dosage and administration

Dosing per FDA Guidelines unless otherwise specified below.

Metastatic Breast Cancer (MBC): Recommended dosage is 260 mg/square meters intravenously over 30 minutes every 3 weeks.

Non-Small Cell Lung Cancer (NSCLC): Recommended dosage is 100 mg/square meters intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after nab-paclitaxel.

Adenocarcinoma of the Pancreas: Recommended dosage is 125 mg/square meters intravenously over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle; administer gemcitabine on Day 1 of each 21-day cycle immediately after nab-paclitaxel.

Nab-paclitaxel is available as 100 mg lyophilized powder in a single-dose vial for reconstitution.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Nab-paclitaxel (e.g., Abraxane) for any indication or circumstance not described above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving outcomes.

For members with contracts without primary coverage criteria, Nab-paclitaxel (e.g., Abraxane) for any indication or circumstance not described above is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective April 17, 2024 to April 8, 2025

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Nab-paclitaxel meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:

FDA Approved Indications

For FDA labeled indications, all products must be dosed in accordance with the FDA label unless otherwise specified.

STANDARD REVIEW for up to 12 months:

1. Individual has a diagnosis of metastatic breast cancer; AND

a. Individual has failure of combination chemotherapy for metastatic disease; OR

b. Individual has had a relapse within 6 months of adjuvant chemotherapy; AND

c. Prior therapy should have included an anthracycline unless clinically contraindicated; OR

2. Individual has a diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC); AND

a. Nab-paclitaxel will be used as first-line treatment; in combination with carboplatin; AND

b. Individual is not a candidate for curative surgery or radiation; OR

3. Individual has a diagnosis metastatic adenocarcinoma of the pancreas; AND

a. Nab-paclitaxel will be used as first-line treatment; AND

b. Nab-paclitaxel will be used in combination with gemcitabine.

Off-Label Indications

For off-label indications, authorizations will not exceed 260 mg per square meter of body surface area unless medical literature supports a higher dose.

STANDARD REVIEW for up to 12 months:

1. Individual has a diagnosis of MELANOMA with the following characteristics:

a. Uveal disease

i. As a single agent therapy for metastatic or unresectable disease (NCCN 2A); OR

b. Cutaneous disease

i. As a single agent or in combination with carboplatin for metastatic or unresectable disease as second-line or subsequent therapy for disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy (NCCN 2A); OR

2. Individual has a diagnosis of KAPOSI SARCOMA:

a. For individuals intolerant to paclitaxel as subsequent systemic therapy, given alone (no HIV) or with antiretroviral therapy (ART) for individuals with HIV (PWH), for relapsed/refractory advanced cutaneous, oral, visceral, or nodal disease that has progressed on or not responded to first-line systemic therapy, and progressed on alternate first-line systemic therapy. (NCCN 2A); OR

3. Individual has a diagnosis of BILIARY TRACT CANCERS with the following characteristics:

a. Gallbladder Cancer

i. Primary treatment for unresectable or resected gross residual (R2) disease, or metastatic disease in combination with gemcitabine (NCCN 2A); OR

ii. Subsequent treatment for progression on or after systemic treatment for unresectable or resected gross residual (R2) disease, or metastatic disease in combination with gemcitabine. (NCCN 2A); OR

b. Intrahepatic Cholangiocarcinoma with adenocarcinoma histology:

i. Primary treatment for unresectable or resected gross residual (R2) disease, or metastatic disease in combination with gemcitabine (NCCN 2A); OR

ii. Subsequent treatment for progression on or after systemic treatment for unresectable or resected gross residual (R2) disease, or metastatic disease in combination with gemcitabine (NCCN 2A); OR

c. Extrahepatic Cholangiocarcinoma with adenocarcinoma:

i. Primary treatment for unresectable or resected gross residual (R2) disease, or metastatic disease in combination with gemcitabine (NCCN 2A); OR

4. Individual has a diagnosis of PANCREATIC ADENOCARCINOMA including adenosquamous carcinoma and squamous carcinoma histology:

a. In combination with gemcitabine as neoadjuvant therapy with or without subsequent chemoradiation for resectable disease or biopsy positive borderline resectable disease (NCCN 2A); OR

b. In combination with gemcitabine as first-line, or as induction therapy followed by chemoradiation for locally advanced disease with good performance status (defined as ECOG PS 0-1, with good biliary drainage and adequate nutritional intake) (NCCN 2A); OR

c. In combination with gemcitabine as a first-line, or as induction therapy followed by chemoradiation for locally advanced disease with intermediate performance status (ECOG PS 2); OR

d. As a fist-line therapy for metastatic disease with good performance status (defined as ECOG PS 0-1, with good biliary drainage and adequate nutritional intake) in combination with:

i. Gemcitabine (NCCN 1); OR

ii. Gemcitabine and cisplatin (NCCN 2A); OR

e. First-line therapy for metastatic disease with intermediate performance status (ECOG PS 2) in combination with gemcitabine (NCCN 1); OR

f. In combination with gemcitabine as a subsequent therapy for locally advanced or metastatic disease and disease progression if good performance status (defined as ECOG PS 0-1, with good biliary drainage with adequate nutritional intake) and previously treated with fluoropyrimidine-based therapy (e.g., capecitabine, fluorouracil) (NCCN 2A); OR

g. In combination with gemcitabine as a subsequent therapy for locally advanced or metastatic disease and disease progression if intermediate performance status (ECOG PS 2) and previously treated with fluoropyrimidine-based therapy (e.g., capecitabine, fluorouracil) (NCCN 2A); OR

h. In combination with gemcitabine as a:

i. Therapy if longer than 6 months from completion of primary therapy (NCCN 2A); AND

1. As repeat systemic therapy previously administered; OR

2 As alternate systemic therapy not previously used; AND

3. Individual has a good performance status (ECOG PS 0-1); AND

4. With (if not previously done) or without chemoradiation for local recurrence in the pancreatic operative bed after resection; OR

5. For recurrent metastatic disease with or without recurrence after resection; OR

ii. Therapy if less than 6 months from completion of primary therapy and previously treated with fluoropyrimidine-based therapy(e.g., capecitabine, fluorouracil) (NCCN 2A); AND

1. Individual has a good performance status (ECOG PS 0-1); OR

2. Individual has an intermediate performance status (ECOG PS 2); AND

3. As an alternate systemic therapy not previously used; AND

4. With (if not previously done) or without chemoradiation for local recurrence in the pancreatic operative bed after resection; OR

5. For recurrent metastatic disease with or without local recurrence after resection; OR

5. Individual has a diagnosis of AMPULLARY ADENOCARCINOMA:

a. Neoadjuvant therapy, with or without subsequent chemoradiation in combination with gemcitabine if ECOG performance status 0-2 (NCCN 2A); OR

b. First-line therapy in combination with gemcitabine (NCCN 2A):

i. In individuals with good performance status (PS) ECOG 0-1, with good biliary drainage and adequate nutritional intake; OR

ii. In select individuals with poor performance status and ECOG PS 2; OR

c. Therapy for disease progression in individuals with good performance status (ECOG 0-1, with good biliary drainage and adequate nutritional intake) and pancreatobiliary and mixed type if previously treated with fluoropyrimidine-based therapy (e.g., capecitabine, fluorouracil) in combination with gemcitabine (NCCN 2A); OR

d. As therapy for disease progression in select individuals (poor performance status (PS) and ECOG PS 2) with pancreatobiliary and mixed type in combination with gemcitabine (NCCN 2A); OR

6. Individual has a diagnosis of CERVICAL CANCER with histology of Adenocarcinoma, Adenosquamous, Small cell neuroendocrine carcinoma of the cervix (NECC), Squamous cell carcinoma:

a. Second-line or subsequent therapy as a single agent for (NCCN 2A):

i. Local/regional recurrence; OR

ii. Stage IVB or recurrence with distant metastases; OR

iii. Persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix (NECC); OR

7. Individual has a diagnosis of SMALL BOWEL ADENOCARCINOMA:

a. Therapy as a single agent or in combination with gemcitabine for advanced or metastatic disease (NCCN 2A):

i. As initial therapy if individual received previous FOLFOX/CAPEOX in the adjuvant setting within past 12 months or contraindication; OR

ii. As second-line and subsequent therapy (if not previously given): OR

8. Individual has a diagnosis of OVARIAN CANCER/FALLOPIAN TUBE CANCER/PRIMARY PERITONEAL CANCER with:

a. Endometrioid or Serous histology; AND

i. Single-agent therapy for persistent disease or recurrence (NCCN 2A):

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant disease); OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease); OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant disease); OR

4. For radiographic and/or clinical relapse in individuals with previous complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive disease); OR

ii. In combination with carboplatin if persistent disease or recurrence for individuals with confirmed taxane hypersensitivity:

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant) (NCCN 2A); OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant) (NCCN 2A); OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant) (NCCN 2A); OR

4. In individuals with complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive) (NCCN 1); OR

iii. Substitute for paclitaxel in individuals who experience a hypersensitivity reaction to paclitaxel (NCCN 2A); OR

b. Individual has a diagnosis of Carcinosarcoma

i. Single-agent therapy for persistent disease or recurrence (NCCN 2A):

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant disease); OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease); OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant disease); OR

4. For radiographic and/or clinical relapse in individuals with previous complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive disease); OR

ii. In combination with carboplatin if persistent disease or recurrence for individuals with confirmed taxane hypersensitivity:

1. For progression n primary, maintenance, or recurrence therapy (platinum-resistant) (NCCN 2A); OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant) (NCCN 2A); OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant) (NCCN 2A); OR

4. In individuals with complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive) (NCCN 1); OR

iii. Substitute for paclitaxel in individuals who experience a hypersensitivity reaction to paclitaxel (NCCN 2A); OR

c. Individual has a diagnosis of Clear Cell Carcinoma of the Ovary:

i. Single-agent therapy for persistent disease or recurrence (NCCN 2A):

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant disease); OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease); OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant disease); OR

4. For radiographic and/or clinical relapse in individuals with previous complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive disease); OR

ii. In combination with carboplatin if persistent disease or recurrence for individuals with confirmed taxane hypersensitivity:

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant) (NCCN 2A); OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant) (NCCN 2A); OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant) (NCCN 2A); OR

4. In individuals with complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive) (NCCN 1); OR

iii. Substitute for paclitaxel in individuals who experience a hypersensitivity reaction to paclitaxel (NCCN 2A); OR

d. Individual has a diagnosis of Mucinous Carcinoma of the Ovary:

i. Single-agent therapy for persistent disease or recurrence (NCCN 2A):

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant disease); OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease); OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant disease); OR

4. For radiographic and/or clinical relapse in individuals with previous complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive disease); OR

ii. In combination with carboplatin if persistent disease or recurrence for patients with confirmed taxane hypersensitivity:

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant) (NCCN 2A): OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant) (NCCN 2A): OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant); OR

4. In individuals with complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive) (NCCN 1); OR

iii. Substitute for paclitaxel in individuals who experience a hypersensitivity reaction to paclitaxel (NCCN 2A); OR

e. Individual has a diagnosis of Grade 1 Endometrioid Carcinoma:

i. Single-agent therapy for persistent disease or recurrence (NCCN 2A):

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant disease); OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease); OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant disease); OR

4. For radiographic and/or clinical relapse in individuals with previous complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive disease); OR

ii. In combination with carboplatin if persistent disease or recurrence for individuals with confirmed taxane hypersensitivity:

1. For progression on primary, maintenance, or recurrence therapy (platinum-resistant) (NCCN 2A): OR

2. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant) (NCCN 2A): OR

3. For complete remission and relapse less than 6 months after completing chemotherapy (platinum-resistant); OR

4. In individuals with complete remission and relapse 6 months or longer after completing prior chemotherapy (platinum-sensitive) (NCCN 1); OR

iii. Substitute for paclitaxel in individuals who experience a hypersensitivity reaction to paclitaxel (NCCN 2A); OR

f. Individual has a diagnosis of Low-grade serous Carcinoma with Borderline epithelial, Serous histology:

i. Single-agent for platinum-sensitive or platinum-resistant recurrence (NCCN 2A); OR

ii. In combination with carboplatin if platinum-sensitive or platinum-resistant recurrence for patients with confirmed taxane hypersensitivity (NCCN 2A); OR

iii. Substitute for paclitaxel in individuals who experience a hypersensitivity reaction to paclitaxel (NCCN 2A); OR

9. Individual has a diagnosis of ENDOMETRIAL CARCINOMA; AND

a. Histology of Carcinosarcoma, Clear Cell Carcinoma, Endometrioid adenocarcinoma, Serous Carcinoma, Undifferentiated/dedifferentiated carcinoma

i. Second-line or subsequent therapy as a single agent for recurrent disease (NCCN 2A):

1. With isolated metastases; OR

2. For disseminated metastases with or without sequential palliative external beam radiation therapy (EBRT); OR

3. With sequential EBRT and with or without brachytherapy for locoregional recurrence in individuals with no prior RT to site of recurrence, or previous vaginal brachytherapy only; OR

4. After surgical exploration, with sequential EBRT for locoregional recurrence in individuals with disease confined to the vagina or paravaginal soft tissue, or in pelvic or para-aortic lymph nodes; OR

5 After surgical exploration, with or without sequential EBRT for locoregional recurrence in individuals with upper abdominal or peritoneal disease; OR

6. With or without sequential palliative EBRT or brachytherapy for locoregional recurrence in individuals who have received prior EBRT to site of recurrence; OR

10. Individual has a diagnosis of BREAST CANCER; AND

a. Individual has Invasive Breast Cancer

i. Single agent therapy or in combination with carboplatin (useful in certain circumstances, in select patients with high tumor burden, rapidly progressing disease, and visceral crisis) for recurrent unresectable (local or regional) or stage IV (M1) human epidermal growth factor receptor 2 (HER2)-negative disease that is hormone receptor-positive with visceral crisis or endocrine therapy refractory as (NCCN 2A):

1. First-line therapy if no germline BRCA 1/2 mutation; OR

2. Second-line therapy if not a candidate for fam trastuzumab deruxtecan-nxki; OR

3. Third-line therapy and beyond; OR

ii. Single agent therapy or in combination with carboplatin for recurrent unresectable (local or regional) or stage IV (M1) triple negative breast cancer (TNBC) as (NCCN 2A):

1. First-line therapy if PD-L1 CPS < 10 and no germline BRCA 1/2 mutation; OR

2. Second-line therapy; OR

3. Third-line therapy and beyond; OR

iii. Fourth-line therapy and beyond in combination with trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive recurrent unresectable (local or regional) or stage IV (M1) disease that is (NCCN 2A):

1. Hormone receptor-negative; OR

2. Hormone receptor-positive with or without endocrine therapy; OR

iv. Therapy in combination pembrolizumab for PD-L1 positive (PD-L1 CPS ≥10) triple negative recurrent unresectable (local or regional) or stage IV (M1) disease:

1. As preferred first-line therapy (NCCN 1); OR

2. As second and subsequent lines of therapy if PD-1/PD-L1 inhibitor has not been previously used (NCCN 2A); OR

v. Substitute for other taxanes (e.g., paclitaxel or docetaxel) in select individuals due to medical necessity (i.e., hypersensitivity reaction) (NCCN 2A); OR

b. Individual has INFLAMMATORY BREAST:

i. Single agent therapy or in combination with carboplatin for individuals with no response to preoperative systemic therapy, or recurrent unresectable (local or regional) or stage IV (M1) human epidermal growth factor receptor 2 (HER2)-negative disease that is hormone receptor-positive with visceral crisis or endocrine therapy refractory as (NCCN 2A):

1. First-line therapy if no germline BRCA 1/2 mutation; OR

2. Second-line therapy if not a candidate for fam trastuzumab deruxtecan-nxki; OR

3. Third-line therapy and beyond; OR

ii. Single agent therapy or in combination with carboplatin for individuals with no response to preoperative systemic therapy, or recurrent unresectable (local or regional) or stage IV (M1) triple negative breast cancer (TNBC) as (NCCN 2A):

1. First-line therapy if PD-L1 CPS <10 and no germline BRCA 1/2 mutation; OR

2. Second-line therapy; OR

3. Third-line therapy and beyond; OR

iii. Fourth-line therapy and beyond in combination with trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive disease in individuals with no response to preoperative systemic therapy, or recurrent unresectable (local or regional) or stage IV (M1) disease that is (NCCN 2A):

1. Hormone receptor-negative; OR

2. Hormone receptor-positive with or without endocrine therapy; OR

iv. Therapy in combination pembrolizumab for PD-L1 positive (PD-L1 CPS ≥10) triple negative recurrent unresectable (local or regional) or stage IV (M1) disease:

1. As preferred first-line therapy (NCCN 1); OR

2. As second and subsequent lines of therapy if PD-1/PD-L1 inhibitor has not been previously used (NCCN 2A); OR

v. Substitute for other taxanes (e.g., paclitaxel or docetaxel) in select individuals due to medical necessity (i.e., hypersensitivity reaction) (NCCN 2A); OR

11. Individual has a diagnosis of NON-SMALL CELL LUNG CANCER; AND

a. Histology of Adenocarcinoma (with mixed subtypes), Large cell carcinoma, Squamous cell carcinoma:

i. Treatment for recurrent, advanced, or metastatic disease as first-line therapy for PD-L1 expression positive (≥1%) tumors that are negative for actionable molecular biomarkers (may be KRAS G12C mutation positive) and no contraindications to PD-1 or PD-L1 inhibitors and performance status 0-2:

1. In combination with pembrolizumab and carboplatin for squamous cell histology (preferred) (NCCN 1); OR

2. In combination with carboplatin and atezolizumab for nonsquamous cell histology (NCCN 2A); OR

3. In combination with tremelimumab-actl, durvalumab, and carboplatin (squamous cell histology) when PD-L1 is less than 50% (NCCN 2A); OR

ii. Treatment for recurrent, advanced, or metastatic disease (not covered for locoregional recurrence or symptomatic local disease with no evidence of disseminated disease, unless mediastinal lymph node occurrence with prior radiation therapy):

1. In combination with carboplatin for those with performance status (PS) 0-2 (useful in certain circumstances if contraindications to PD-1 or PD-L1 inhibitors and PS 0-1 for both nonsquamous cell histology and squamous cell histology, or other recommended regimen for nonsquamous cell histology and PS 2, or preferred for squamous cell histology and PS 2) (NCCN 1); OR

2. As a single agent for PS 2 (useful in certain circumstances for both nonsquamous cell histology and squamous cell histology) (NCCN 2A); OR

iii. Treatment for recurrent, advanced, or metastatic disease for individuals with performance status (PS) 0-1 and no contraindications to PD-1 or PD-L1 inhibitors, in combination with:

1. Atezolizumab and carboplatin for nonsquamous cell histology (NCCN 2A); OR

2. Carboplatin and pembrolizumab for squamous cell histology (preferred) (NCCN 1); OR

3. Tremelimumab-actl, durvalumab, and carboplatin (NCCN 2A); OR

iv. Single agent (if not already given) as subsequent systemic therapy for recurrent, advanced, or metastatic disease (not covered for locoregional recurrence or symptomatic local disease with no evidence of disseminated disease, unless mediastinal lymph node occurrence with prior radiation therapy) in those with performance status 0-2 and first progression after initial systemic therapy (NCCN 2A); OR

v. Substituted for either paclitaxel or docetaxel in those who have experienced hypersensitivity reactions after receiving paclitaxel or docetaxel despite premedication, or for those in whom standard hypersensitivity premedications are contraindicated (NCCN 2A); OR

12. Individual has a diagnosis of VAGINAL CANCER:

a. Second-line or subsequent therapy as a single agent for (NCCN 2A):

i. Local/regional recurrence; OR

ii. Stage IVB or recurrent distant metastases.

Eastern Cooperative Oncology Group Performance Status (ECOG)

0 = Fully active, able to carry on all pre-disease performance without restriction
1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light housework, office work
2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
5 = Dead

The use of this drug is covered if an FDA-approved oncologic indication exists (not listed as an indication above) with the member meeting all the additional requirements of the prescribing information (package insert listed in the “Indications and Usage”) AND/OR a NCCN category 1 or 2A recommendation is recognized in the NCCN Drugs and Biologics Compendium with the member meeting specified criteria (See policy #2000030).

Dosage and administration

Dosing per FDA Guidelines

Metastatic Breast Cancer (MBC): Recommended dosage is 260 mg/square meters intravenously over 30 minutes every 3 weeks.

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Effective June 1, 2022 to April 16, 2024

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Nab-paclitaxel meets primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes in the treatment of the following listed indications:

Breast Cancer

1. Invasive Breast Cancer:

a. As single agent or in combination with carboplatin for recurrent unresectable (local or regional) or stage IV (M1) HER2 negative disease that is (NCCN 2A):

i. Hormone receptor-negative; or

ii. Hormone receptor-positive with visceral crisis or endocrine therapy refractory.

b. Third-line therapy and beyond in combination with trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive disease in individuals with recurrent unresectable (local or regional) or stage IV (M1) disease that is (NCCN 2A):

i. Hormone receptor-negative

ii. Hormone receptor-positive with or without endocrine therapy

c. Therapy in combination with pembrolizumab for PD-L1 positive triple negative recurrent unresectable (local or regional) or stage IV (M1) disease:

i. As preferred first-line therapy; (NCCN 1) or

ii. As second and subsequent lines of therapy if PD-L1 inhibitor has not been previously used. (NCCN 2A)

d. May be substituted for other taxanes (paclitaxel or docetaxel) in select individuals due to medical necessity (i.e., hypersensitivity reaction). (NCCN 2A)

2. Inflammatory Breast Cancer:

a. Third-line therapy and beyond in combination with trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive disease in individuals with no response to preoperative systemic therapy, or recurrent unresectable (local or regional) or stage IV (M1) disease that is (NCCN 2A):

i. Hormone receptor-negative

ii. Hormone receptor-positive with or without endocrine therapy

b. Single agent therapy or in combination with carboplatin (useful in certain circumstances, in select individuals with high tumor burden, rapidly progressing disease, and visceral crisis) for individuals with no response to preoperative systemic therapy, or recurrent unresectable (local or regional) or stage IV (M1) human epidermal growth factor receptor 2 (HER2)-negative disease that is (NCCN 2A):

i. Hormone receptor negative.

ii. Hormone receptor-positive with visceral crisis or endocrine therapy refractory.

c. Therapy in combination with pembrolizumab for PD-L1 positive triple negative disease in individuals with no response to preoperative systemic therapy, or recurrent unresectable (local or regional) or stage IV (M1) disease:

i. As preferred first-line therapy (NCCN 1); or

ii. As second and subsequent lines of therapy if PD-L1 inhibitor has not been previously used (NCCN 2A).May be substituted for other taxanes (paclitaxel or docetaxel) in select patients due to medical necessity (i.e., hypersensitivity reaction). (NCCN 2A)

Hepatobiliary Cancers-Biliary Tract Cancers: Gallbladder Cancer

a. Primary treatment for unresectable or metastatic disease in combination with gemcitabine; (NCCN 2A) or

b. Subsequent treatment for progression on or after systemic treatment for unresectable or metastatic disease in combination with gemcitabine. (NCCN 2A)

Hepatobiliary Cancers-Biliary Tract Cancers: Intrahepatic Cholangiocarcinoma

a. Subsequent treatment for progression on or after systemic treatment for unresectable or metastatic disease in combination with gemcitabine. (NCCN 2A)

Hepatobiliary Cancers-Biliary Tract Cancers: Extrahepatic Cholangiocarcinoma

a. Primary treatment for unresectable or metastatic disease in combination with gemcitabine (NCCN 2A); or

b. Subsequent treatment for progression on or after systemic treatment for unresectable or metastatic disease in combination with gemcitabine. (NCCN 2A).

Kaposi Sarcoma

a. Subsequent systemic therapy, given alone (no HIV) or with antiretroviral therapy (ART) for people with HIV (PWH), for relapsed/refractory advanced cutaneous, oral, visceral, or nodal disease that has progressed on or not responded to first-line systemic therapy, and progressed on alternate first-line systemic therapy. (NCCN 2A)

Cutaneous Melanoma

a. As a single agent or in combination with carboplatin for metastatic or unresectable disease as second-line or subsequent therapy for disease progression or after maximum clinical benefit from BRAF targeted therapy. (NCCN 2A)

Uveal Melanoma

a. As single agent therapy for distant metastatic disease. (NCCN 2A)

Non-Small Cell Lung Cancer

a. Treatment for recurrent, advanced, or metastatic disease as first-line therapy for PD-L1 expression positive (≥1%) tumors that are negative for actionable molecular markers* and no contraindications** to PD-1 or PD-L1 inhibitors and ECOG performance status 0-2:

i. In combination with pembrolizumab and carboplatin for squamous cell histology (preferred); (NCCN 1) or

ii. In combination with carboplatin and atezolizumab for nonsquamous cell histology. (NCCN 2A)

*If there is insufficient tissue to allow testing for all of EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET and RET, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes

**Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents, or presence of an oncogene (eg, EGFR [exon 19 deletions, p.L858R point mutation in exon 21], ALK rearrangements, RET rearrangements), which would predict lack of benefit.

b. Treatment for recurrent, advanced, or metastatic disease

i. In combination with carboplatin for individuals with ECOG performance status (PS) 0-1 (NCCN 1). (Useful in certain circumstances if contraindications** to PD-1 or PD-L1 inhibitors and PS 0-1 for both nonsquamous cell histology and squamous cell histology, or other recommended regimen for nonsquamous cell histology and PS 2, or preferred for squamous cell histology and PS 2); (NCCN 2A) or

ii. As a single agent for PS 2 (useful in certain circumstances for both nonsquamous cell histology and squamous cell histology). (NCCN 2A)

c. The above regimens are used as:

i. Initial systemic therapy for PD-L1 <1% and negative for actionable molecular markers*

ii. First-line (useful in certain circumstances) or subsequent therapy for BRAF V600E-mutation positive tumors

iii. First-line (useful in certain circumstances) or subsequent therapy for NTRK1/2/3 gene fusion positive tumors

iv. First-line (useful in certain circumstances) or subsequent therapy for MET exon 14 skipping mutation positive tumors

v. First-line or subsequent therapy for RET rearrangement positive tumors

vi. Subsequent therapy for EGFR mutation positive (eg, exon 19 deletion or L858R) tumors and prior erlotinib +/- (ramucirumab or bevacizumab), afatinib, gefitinib, osimertinib, or dacomitinib therapy

vii. Subsequent therapy for ALK rearrangement positive tumors and prior crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib therapy

viii. Subsequent therapy for ROS1 rearrangement positive tumors and prior crizotinib, entrectinib, or ceritinib therapy

ix. Subsequent therapy for PD-L1 expression positive (≥1%) tumors and negative for actionable molecular markers* after prior PD-1/PD-L1 inhibitor but no prior platinum-containing chemotherapy

*If there is insufficient tissue to allow testing for all of EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET and RET, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes

**Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents, or presence of an oncogene (eg, EGFR [exon 19 deletions, p.L858R point mutation in exon 21], ALK rearrangements, RET rearrangements), which would predict lack of benefit

d. Treatment for recurrent, advanced, or metastatic disease for individuals with ECOG performance status (PS) 0-1 and no contraindications** to PD-1 or PD-L1 inhibitors, in combination with:

i. Atezolizumab and carboplatin for nonsquamous cell histology; (NCCN 2A) or

ii. Carboplatin and pembrolizumab for squamous cell histology (preferred). (NCCN 1)

e. The above regimens are used as:

i. Initial systemic therapy for PD-L1 <1% and negative for actionable molecular markers*

ii. First-line (useful in certain circumstances) or subsequent therapy for BRAF V600E-mutation positive tumors

iii. First-line (useful in certain circumstances) or subsequent therapy for NTRK1/2/3 gene fusion positive tumors

iv. First-line (useful in certain circumstances) or subsequent therapy for MET exon 14 skipping mutation positive tumors

v. Subsequent therapy for ROS1 rearrangement positive tumors and prior crizotinib, entrectinib, or ceritinib therapy

*If there is insufficient tissue to allow testing for all of EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET and RET, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes

**Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents, or presence of an oncogene (eg, EGFR [exon 19 deletions, p.L858R point mutation in exon 21], ALK rearrangements, RET rearrangements), which would predict lack of benefit

f. May be substituted for either paclitaxel or docetaxel in individuals who have experienced hypersensitivity reactions after receiving paclitaxel or docetaxel despite premedication, or for individuals in whom standard hypersensitivity premedications are contraindicated. (NCCN 2A)

g. Single agent (if not already given) as subsequent systemic therapy for recurrent, advanced or metastatic disease in individuals with performance status 0-2.

Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer-Includes Epithelial, Malignant Mixed Mullerian Tumors, Clear Cell Carcinoma, Mucinous Carcinoma, Grade 1 Endometrioid Carcinoma, Low-Grade Serous Carcinoma/Ovarian Borderline Epithelial Tumors

a. Single-agent therapy for persistent disease or recurrence (NCCN 2A):

i. For progression on primary, maintenance, or recurrence therapy (platinum-resistant disease); or

ii. For stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease); or

iii. For complete remission and relapse < 6 months after completing chemotherapy (platinum-resistant disease); or

iv. For radiographic and/or clinical relapse in individuals with previous complete remission and relapse ≥ 6 months after completing prior chemotherapy (platinum-sensitive disease).

b. Useful in certain circumstances in combination with carboplatin if platinum-sensitive persistent disease or recurrence for indiviiduals with confirmed taxane hypersensitivity:

i. In individuals with complete remission (NCCN 2A) and relapse ≥ 6 months after completing prior chemotherapy. (First relapse NCCN 1, subsequent relapse NCCN 2A)

c. May be a substitute for paclitaxel in individuals who experience a hypersensitivity reaction to paclitaxel. (NCCN 2A)

Pancreatic Adenocarcinoma

a. Preferred neoadjuvant therapy in combination with gemcitabine with or without subsequent chemoradiation for (NCCN 2A):

i. Resectable disease, particularly in high-risk individuals (i.e., very highly elevated CA 19-9, large primary tumors, large regional lymph nodes, excessive weight loss, extreme pain); or

ii. Biopsy positive borderline resectable disease.

b. First-line therapy, or as induction therapy followed by chemoradiation (useful in certain circumstances in selected individuals without systemic metastases) for individuals with locally advanced disease and good performance status (ECOG PS 0-2) in combination with gemcitabine (preferred regimen). (NCCN 2A)

c. Preferred first-line therapy for metastatic disease in individuals with good performance status (ECOG PS 0-2) in combination with gemcitabine (NCCN 1)

d. Subsequent therapy in combination with gemcitabine for locally advanced or metastatic disease for individuals with good performance status (ECOG PS 0-2), and disease progression who were previously treated with fluoropyrimidine-based therapy. (NCCN 2A)

e. If not previously done, therapy with or without chemoradiation in combination with gemcitabine for local recurrence in the pancreatic operative bed after resection in individuals with good performance status (ECOG PS 0-2): if less than 6 months from completion of primary therapy and previously treated with fluoropyrimidine-based therapy, or if ≥ 6 months from completion of primary therapy. (NCCN 2A)

f. Therapy in combination with gemcitabine for recurrent metastatic disease with or without local recurrence after resection in individuals with good performance status (ECOG PS 0-2): if less than 6 months from completion of primary therapy and previously treated with fluoropyrimidine-based therapy, or if ≥ 6 months from completion of primary therapy. (NCCN 2A)

Small Bowel Adenocarcinoma-Small Bowel Adenocarcinoma

a. Therapy as a single agent or in combination with gemcitabine for advanced or metastatic disease in individuals with prior oxaliplatin exposure in the adjuvant setting or contraindication (NCCN 2A):

i. As initial therapy; or

ii. As subsequent therapy in individuals who previously received initial therapy with nivolumab with or without ipilimumab, or pembrolizumab.

b. Subsequent therapy as a single agent or in combination with gemcitabine for advanced or metastatic disease in individuals who are appropriate or not appropriate for intensive therapy. (NCCN 2A)

Small Bowel Adenocarcinoma- Advanced Ampullary Cancer

a. Subsequent therapy for disease progression in individuals with good performance (ECOG 0-1, with good biliary drainage and adequate nutritional intake) and pancreatobiliary and mixed type if previously treated with fluoropyrimidine-based therapy

i. In combination with gemcitabine

b. Subsequent therapy for disease progression in select individuals (poor performance status (PS) and ECOG PS 2) with pancreatobiliary and mixed type in combination with gemcitabine.

c. First line therapy in combination with gemcitabine

i. In individuals with good performance status (PS) ECOG 0-1, with goof biliary drainage and adequate nutritional intake.

ii. To be considered in select individuals with poor performance status and ECOG PS 2

c. To be used for pancreatobiliary and mixed type

i. Unresectable localized disease

ii. Stage IV resected ampullary cancer

iii. Metastatic disease at initial presentation

d. Neoadjuvant therapy, with or without subsequent chemoradiation, in combination with i. Gemcitabine

Uterine Neoplasms-Endometrial Carcinoma

a. Primary treatment as a single agent (NCCN 2A):

i. With sequential external beam radiation therapy (EBRT) and brachytherapy for disease that is not suitable for primary surgery in individuals with suspected or gross cervical involvement; or

ii. May be considered preoperatively for individuals presenting with abdominal/pelvic confined disease that is suitable for primary surgery; or

iii. With sequential EBRT and with or without brachytherapy for locoregional extrauterine disease that is not suitable for primary surgery; or

iv. With EBRT and/or stereotactic body radiation therapy for distant metastases that are suitable for primary surgery.

b. Adjuvant treatment for surgically staged individuals as a single agent with or without EBRT and with or without vaginal brachytherapy for stage III-IV disease. (NCCN 2A)

c. Single-agent therapy (NCCN 2A):

i. For disseminated metastases; or

ii. With sequential external beam radiation therapy (EBRT) and with or without brachytherapy for locoregional recurrence in individuals with no prior RT to site of recurrence, or previous brachytherapy only; or

iii. After surgical exploration, with sequential EBRT for locoregional recurrence in individuals with disease confined to the vagina or paravaginal soft tissue, or in pelvic, para-aortic or common iliac lymph nodes; or

iv. After surgical exploration, with or without sequential EBRT for locoregional recurrence in individuals with upper abdominal or peritoneal disease; or

v. With or without sequential palliative EBRT or brachytherapy for locoregional recurrence in individuals who have received prior EBRT to site of recurrence.

c. Single-agent therapy (NCCN 2A):

i. For disease that is suitable for primary surgery as additional treatment with or without sequential external beam radiation therapy (EBRT) and with or without vaginal brachytherapy for stage IB-IV disease: or

ii. For disease that is not suitable for primary surgery as primary treatment with or without sequential EBRT and with or without brachytherapy.

Dosage and administration

Dosing per FDA Guidelines

Please refer to a separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

The use of Nab-paclitaxel for any indication or circumstance other than those outlined above does not meet member benefit certificate primary coverage criteria that there be scientific evidence of efftectiveness in improving outcomes.

For members with contracts without primary coverage criteria, the use of Nab-paclitaxel for any other indication or circumstance other tha circumstances than those outlined above is considered investigational.

Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Due to the detail of the policy statement, the document containing the coverage statements for dates prior to June 1, 2022 are not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com

Rationale:

The safety and efficacy of nab-paclitaxel (ABI-007) was evaluated in a multicenter phase II clinical trial in which 63 women with histologically confirmed and measurable metastatic breast cancer (MBC) were treated with nab-paclitaxel by IV infusion. 48 patients had received prior chemotherapy, and 39 patients had not received prior treatment. Overall response rates (complete or partial responses) were 48% for all patients. For patients who received nab-paclitaxel as first-line and greater than first-line therapy for their metastatic disease, the respective response rates were 64% and 21%. Median time to disease progression was 26.6 weeks, and median survival was 63.6 weeks. No severe hypersensitivity reactions were reported. Toxicities observed were typical of paclitaxel and included neutropenia (24%), sensory neuropathy (11%), and febrile neutropenia (5%). Patients received a median of six treatment cycles. The authors concluded that treatment with nab-paclitaxel resulted in significant antitumor activity in patients with MBC, including those receiving the drug as first-line therapy (Ibrahim et al, 2005).

The safety and efficacy of nab-paclitaxel (ABI-007) was evaluated also evaluated in a comparative phase III trial in which 454 patients with metastatic breast cancer (MBC) were treated with either nab-paclitaxel or standard paclitaxel. ABI-007 demonstrated significantly higher response rates compared with standard paclitaxel (33% v 19%, respectively) and significantly longer time to tumor progression (23.0 v 16.9 weeks, respectively). The incidence of grade 4 neutropenia was significantly lower for nab-paclitaxel compared with standard paclitaxel (9% v 22%, respectively) despite a 49% higher paclitaxel dose. Grade 3 sensory neuropathy was more common in the nab-paclitaxel arm than in the standard paclitaxel arm (10% v 2%, respectively). No hypersensitivity reactions occurred with ABI-007 despite the absence of premedication and shorter administration time. The authors concluded that nab-paclitaxel demonstrated greater efficacy and a favorable safety profile compared with standard paclitaxel in patients with MBC (Gradishar et al, 2005).

The safety and efficacy of nab-paclitaxel plus carboplatin in advanced NSCLC was evaluated in a phase III clinical trial in which 1052 untreated patients with phase III to IV NSCLC were randomly assigned to received either nab-paclitaxel plus carboplatin or solvent-based paclitaxel plus carboplatin. Nab-paclitaxel was as effective as sb-paclitaxel. PFS was 6.3 months for the nab-paclitaxel group, as compared to the sb-paclitaxel group at 5.8 months. Overall survival was 12.1 in the nab-paclitaxel group versus 11.2 months in the sb-paclitaxel group. Safety was demonstrated in that significantly less neuropathy, neutropenia , arthralgia and myalgia occurred in the nab-paclitaxel groups. However, less thrombocytopenia and anemia occurred in the sb-paclitaxel groups. (Socinski, 2012)

The efficacy of nab-paclitaxel in recurrent ovarian, peritoneal and Fallopian tube was evaluated by two studies. The first was a phase II clinical trial in which 47 patients with histologically or cytologically confirmed epithelial cancer of the ovary, Fallopian tube, or peritoneum received nab-paclitaxel 260mg/m2 every 21 days for 6 cycles or until disease progression. The ORR was 64% (15 complete responses and 13 partial responses). Estimated median progression-free survival (PFS) was 8.5 months. (Teneriello, 2009). The second study evaluating nab-paclitaxel included 47 patients with platinum- and -taxane resistant cancer defined by persistence or progression after primary chemotherapy or recurrence within 6 months of completing treatment. The median progression-free survival (PFS) was 4.5 months. Overall survival was 17.4 months. (Coleman, 2011)

Nab-paclitaxel was evaluated for the treatment of recurrent or persistent advanced cervical cancer in a Phase II trial in which 37 patients were enrolled, and 35 were eligible. Of the 35 patients, 10 had a partial response and 25 had stable disease. Median PFS was 5 months and median overall survival was 9.4 months. Adverse events included neutropenia in 2 patients, which resolved with dose reduction and grade III neurotoxicity in 1 patient which resolved upon discontinuation. (Alberts, 2012)

Treatment options for urothelial cancer are limited, with typical responses less than 20% and without survival benefit. Nab-paclitaxel was studied for metastatic urothelial carcinoma in an open-label single group multicenter study. Patients were at least 18 years old with histologically-confirmed locally advanced or metastatic urothelial cancer. Treatment continued until disease progression or occurrence of unacceptable toxic effects. The primary end-point was objective tumor response, defined by a CR or PR according to Response Evaluation Criteria in Solid Tumors criteria. The study enrolled 48 patients; 1 had a complete response and 12 had a partial response for an ORR of 27.7%. (Ko, 2013)

Nab-paclitaxel was evaluated in histologically or cytologically confirmed metastatic melanoma in a cohort study that included 37 chemotherapy-naïve patients and 37 previously treated patients. The median progression-free survival (PFS) was 3.5 months for previously treated and 4.5 months for chemotherapy-naïve patients, and the median survival was 12.1 months and 9.6 months, respectively. The probability of being alive and free of disease progression at 6 months was 27% for the previously treated cohort and 34% for the chemotherapy-naive cohort; the probability of surviving 1 year was 49% and 41%, respectively, for the previously treated and chemotherapy-naive cohorts. Authors noted that this response rate, PFS, and survival compare favorably to current standard therapy. (Hersh, 2010) Another study of nab-paclitaxel in metastatic melanoma enrolled 76 patients in a phase II trial in which patients with unresectable stage IV melanoma received nab-paclitaxel and carboplatin. Of the patients enrolled, 41 where chemotherapy-naïve and 35 had received prior treatment. There were 10 responses in the chemotherapy naïve cohort (25.6%) and 3 responses in the prior treatment cohort (8.8%). Median progression-free survival was 4.5 months in the CN cohort and 4.1 months in the PT cohort. Median overall survival (OS) was 11.1 months in the CN group and 10.9 months in the PT group. (Kottschade, 2011)

Nab-paclitaxel was evaluated for use in the treatment of invasive bladder cancer in a phase-1 study which enrolled 18 patients with recurrent, high grade (Ta, T1 and Tis) transitional cell carcinoma of the bladder for which at least 1 prior standard intravesical regimen failed. Of the 18 patients 5 (28%) had no evidence of disease at posttreatment evaluation (McKiernan et al, 2011).

2019 Update

A literature search conducted through March 2019 did not reveal any new information that would prompt a change in the coverage statement.

2020 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2020. No new literature was identified that would prompt a change in the coverage statement.

2021 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using MEDLINE database through April 2023. No new literature was identified that would prompt a change in the coverage statement.

2024 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2024.

2025 Update

Annual policy review completed with a literature search using the MEDLINE database through April 2025.

CPT/HCPCS:

References:

Alberts DS, Blessing JA, Landrum LM, et al.(2012) Phase II trial of nab-paclitaxel in the treatment of recurrent or persistent advanced cervix cancer: A gynecologic oncology group study. Gynecologic oncology. 2012;127(3):451-455. doi:10.1016/j.ygyno.2012.09.008.

Celgene Corporation.(2015) Abraxane® [package insert]. Summit, NJ: Celgene Corporation.; 2015

Clinical Pharmacology [Internet].(2017) Nanoparticle Albumin-Bound Paclitaxel. Tampa (FL): Elsevier. c2017- [cited 2017 March 14]. Available from: http://www.clinicalpharmacology.com

Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, and O'Shaughnessy J.(2005) Phase III Trial of Nanoparticle Albumin-Bound Paclitaxel Compared With Polyethylated Castor Oil–Based Paclitaxel in Women With Breast Cancer. Journal of Clinical Oncology 2005 23:31, 7794-7803

Hersh, E. M., O'Day, S. J., Ribas, A., Samlowski, W. E., Gordon, M. S., Shechter, D. E., Clawson, A. A. and Gonzalez, R.(2010) A phase 2 clinical trial of nab-paclitaxel in previously treated and chemotherapy-naive patients with metastatic melanoma. Cancer, 2010.116: 155–163. doi:10.1002/cncr.24720

Ibrahim NK, Samuels B, Page R, Doval D, Patel KM, Rao SC, Nair MK, Bhar P, Desai N, and Hortobagyi GN.(2005) Multicenter Phase II Trial of ABI-007, an Albumin-Bound Paclitaxel, in Women With Metastatic Breast Cancer. Journal of Clinical Oncology 2005 23:25, 6019-6026

Ko YJ, Canil CM, Mukherjee SD, et al.(2013) Nanoparticle albumin-bound paclitaxel for second-line treatment of metastatic urothelial carcinoma: A single group, multicentre, phase 2 study. Lancet Oncol. 2013;14(8):769-776.

Kottschade LA, Suman VJ, Amatruda T 3rd, et al.(2011) 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;117(8):1704-1710.

McKiernan JM, Barlow LJ, Laudano MA, et al.(2011) A phase I trial of intravesical nanoparticle albumin-bound paclitaxel in the treatment of bacillus Calmette-Guérin refractory nonmuscle invasive bladder cancer. J Urol. 2011;186(2):448-451.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed on September 01, 2021. Breast Cancer. V8.2021. Revised September 13, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™ NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed on September 01, 2021. Hepatobiliary Cancers. V5.2021. Revised September 21, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. . NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/cervical.pdf. Accessed on September 01, 2021. Cervical Cancer. V1.2021. Revised October 2, 2020.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/uveal.pdf. Accessed on September 20, 2021. Melanoma: Uveal. V2.2021. Revised June 25, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/kaposi.pdf. Accessed on September 01, 2021. Karposi Sarcoma. V2.2021. Revised June 7, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed on September 20, 2021. Non-Small Cell Lung Cancer. V6.2021. Revised September 30, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed on September 20, 2021. Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer v.3.2021. Revised September 9, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed on September 20, 2021. Pancreatic Adenocarcinoma. V2.2021. Revised February 25, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/small_bowel.pdf. Accessed on September 20, 2021. Small Bowel Adenocarcinoma v.2.2021. Revised September 10, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/uterine.pdf. Accessed on September 20, 2021. Uterine Neoplasms. V4.2021. Revised September 3, 2021.

National Comprehensive Cancer Network, Inc.(2021) NCCN Clinical Practice Guidelines in Oncology™.NCCN Clinical Practice Guidelines in Oncology™. NCCN website: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf . Accessed on September 20, 2021. Melanoma: Cutaneous. V2.2021. Revised February 19, 2021.

NCCN(2017) NCCN Compendia. https://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=5. Accessed March 14, 2017.

Socinski MA, Bondarenko I, Karaseva NA, et al.(2012) 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 III trial. J Clin Oncol. 2012;30(17):2055-2062.

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association.