Policy/
Coverage:
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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 17, 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 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.
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.
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 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.
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
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
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References:
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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.
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