Abraxane (paclitaxel, protein bound) — Clinical Coverage Criteria
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Clinical coverage criteria for use of Abraxane (protein/albumin-bound paclitaxel) across oncology indications; governs prior authorization and medical necessity determinations for members.
Add FDA use in combination with LifyoRli for platinum-resistant ovarian cancer.
Add NCCN 2A criteria for use as fourth-line therapy and beyond in HER2 positive breast cancer.
Clarified multiple NCCN disease-state criteria (melanoma, uveal melanoma, Kaposi sarcoma, endometrial, biliary tract) and removed maintenance therapy for pancreatic adenocarcinoma.
Coding updates: added ICD-10-CM codes to breast cancer range C50.011-C50.929 and previously added/removed various HCPCS codes across prior years.
Coverage Criteria for Abraxane (paclitaxel, protein bound)
Approved Indications and Required Conditions
Requests may be approved when ANY one of the following indication-specific groups is met
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 1, 2A)
(NCCN 2A)
(NCCN 1, 2A)
(NCCN 2A)
(NCCN 1, 2A; FDA addition per document history)
(Label, NCCN 1, 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
(NCCN 2A)
Guideline/FDA-aligned coverage
Policy aligns coverage with FDA approvals and NCCN guideline recommendations (various versions cited) for multiple tumor types and lines of therapy.
Full conditional logic and specific line‑of‑therapy criteria are detailed in the indication‑specific sections of this policy.
Use of Abraxane for indications not explicitly listed in this policy may not be approved. Requests will be reviewed against the policy’s specified clinical groups and regimen-level criteria; if the requested indication is not described in those criteria, authorization is not expected to be granted.
Per the document history, maintenance therapy for pancreatic adenocarcinoma was removed from the NCCN-based criteria and is no longer an approved indication under this policy. Providers requesting Abraxane for pancreatic disease should confirm the request matches current combination or line-of-therapy criteria (for example, use in combination with gemcitabine) rather than maintenance use.
Requests for Abraxane that do not meet the policy’s listed coverage criteria are not medically necessary and will not be approved. Authorization decisions require demonstration that the patient meets the applicable indication-specific conditions and regimen/line-of-therapy requirements in the policy.
Certain labeled contraindications are considered non-approvable under this policy. The document history notes inclusion of a baseline neutrophil count threshold among non-approvable criteria per the product labeling; requests for Abraxane that fail to meet such baseline neutrophil requirements will not be approved.
Covered Regimens and Indication-Specific Combinations
| Regimen | Indication / Histology | Line of Therapy / Key Conditions | Coverage Status |
|---|---|---|---|
| {"text":"Abraxane + carboplatin + pembrolizumab","status":""}|{"text":"Recurrent, advanced, or metastatic squamous non–small cell lung cancer","status":""}|{"text":"First-line therapy; individual has ECOG 0-2","status":""}|{"text":"Covered","status":"covered"} | |||
| {"text":"Abraxane + carboplatin + atezolizumab","status":""}|{"text":"Recurrent, advanced, or metastatic nonsquamous non–small cell lung cancer","status":""}|{"text":"First-line therapy; individual has ECOG 0-2","status":""}|{"text":"Covered","status":"covered"} | |||
| {"text":"Abraxane + carboplatin + durvalumab + tremelimumab-actl","status":""}|{"text":"Recurrent, advanced, or metastatic squamous non–small cell lung cancer","status":""}|{"text":"First-line therapy; PD-L1 expression 1–49%; no sensitizing EGFR/ALK aberrations; not receiving systemic immunosuppressant; ECOG 0-2","status":""}|{"text":"Covered","status":"covered"} |
| Regimen | Indication | Line of Therapy / Setting | Coverage Status |
|---|---|---|---|
| {"text":"Abraxane + gemcitabine","status":""}|{"text":"Metastatic adenocarcinoma of the pancreas","status":""}|{"text":"First-line therapy for metastatic disease; also listed for locally advanced adenocarcinoma as first-line, subsequent, or continuation therapy","status":""}|{"text":"Covered","status":"covered"} |
| Regimen | Indication / Biomarker | Line of Therapy / Key Conditions | Coverage Status |
|---|---|---|---|
| {"text":"Abraxane + pembrolizumab","status":""}|{"text":"Triple-negative breast cancer; PD-L1 positive","status":""}|{"text":"Combination use as first-line therapy (NCCN 1) or second/subsequent therapy if PD-1/PD-L1 inhibitor not previously used; prior conditions as specified in policy","status":""}|{"text":"Covered","status":"covered"} |
| Regimen (examples) | Context / Supporting Note | Where to find specific regimen criteria | Coverage Status |
|---|---|---|---|
| {"text":"Abraxane with carboplatin (various combinations)","status":""}|{"text":"Cited across document history and NCCN/FDA references for multiple tumor types (e.g., NSCLC, ovarian, biliary tract)","status":""}|{"text":"Specific regimen-level criteria and conditional requirements are detailed elsewhere in the policy (see COVERAGE CRITERIA and Document History entries)","status":""}|{"text":"Covered when policy criteria are met","status":"covered"} | |||
| {"text":"Abraxane + Lifyorli (relacorilant) with carboplatin/platinum agents","status":""}|{"text":"FDA addition for use in combination for platinum‑resistant ovarian cancer per 06/08/2026 document history","status":""}|{"text":"See Document History entry 06/08/2026 and the ovarian cancer criteria section for regimen‑level conditions","status":""}|{"text":"Covered when policy criteria are met","status":"covered"} | |||
| {"text":"Abraxane with pembrolizumab, atezolizumab, durvalumab, tremelimumab-actl (immune checkpoint combinations)","status":""}|{"text":"Used in select first-line and subsequent NSCLC and breast cancer settings aligned with NCCN or FDA guidance","status":""}|{"text":"Refer to the NSCLC and breast cancer sections for PD-L1 thresholds, ECOG requirements, and prior therapy conditions","status":""}|{"text":"Covered when policy criteria are met","status":"covered"} |
mixed
See individual indication nodes for exact line‑of‑therapy requirements (e.g., HER2+ breast fourth‑line and beyond; ovarian platinum‑resistant per document history).
first-line | second-line | salvage
Specific definitions of first‑line/second‑line/etc. and any prerequisite therapies are provided in the indication‑specific criteria of the policy.
Biomarker and Molecular Testing Requirements
Coding and Diagnosis Guidance
| No codes listed |
| J9264 | Injection, paclitaxel protein-bound particles, 1 mg [Abraxane] |
| C17.0-C17.9 | Malignant neoplasm of small intestine |
| C22.1 | Intrahepatic bile duct carcinoma |
| C23 | Malignant neoplasm of gallbladder |
| C24.0-C24.9 | Malignant neoplasm of other and unspecified parts of biliary tract |
| C25.0-C25.9 | Malignant neoplasm of pancreas |
| C33 | Malignant neoplasm of trachea |
| C34.00-C34.92 | Malignant neoplasm of bronchus and lung |
| C43.0-C43.9 | Malignant melanoma of skin |
| C46.0-C46.9 | Kaposi's sarcoma |
| C48.0-C48.8 | Malignant neoplasm of retroperitoneum and peritoneum |
| J9264 | Injection, paclitaxel protein-bound particles, 1 mg [Abraxane] |
| C17.0-C17.9 | Malignant neoplasm of small intestine |
| C22.1 | Intrahepatic bile duct carcinoma |
| C23 | Malignant neoplasm of gallbladder |
| C24.0-C24.9 | Malignant neoplasm of other and unspecified parts of biliary tract |
| C25.0-C25.9 | Malignant neoplasm of pancreas |
| C33 | Malignant neoplasm of trachea |
| C34.00-C34.92 | Malignant neoplasm of bronchus and lung |
| C43.0-C43.9 | Malignant melanoma of skin |
| C46.0-C46.9 | Kaposi's sarcoma |
| C48.0-C48.8 | Malignant neoplasm of retroperitoneum and peritoneum |
Provider Actions, Documentation, and Authorization
Prior authorization required; clinical criteria review
Prior authorization is required; requests will be reviewed against the policy's clinical criteria and approved only for listed indications and conditions (for example: indication, line of therapy, ECOG performance status, prior therapies, and hypersensitivity status).
Prior authorization must include indication and coding
Include the clinical indication and a supporting ICD-10 diagnosis code with prior authorization requests. Use the policy's listed HCPCS code for Abraxane (J9264) when submitting requests and claims.
- HCPCS: J9264 (Injection, paclitaxel protein-bound particles, 1 mg) [[see coding]]
Document required prior therapies for selected indications
For certain indications (for example metastatic breast cancer) document prior receipt of specified therapies—such as prior combination chemotherapy and an anthracycline unless contraindicated—before approval will be granted.
- Metastatic breast cancer examples: prior combination chemotherapy and prior anthracycline unless contraindicated (per breast cancer criterion language).
Follow guideline-based line-of-therapy sequencing
The policy aligns with NCCN and FDA-referenced sequencing; adherence to guideline-specified line-of-therapy sequencing (first-line, subsequent lines, fourth-line and beyond where specified) is implied for approval decisions.
- Example: HER2‑positive breast cancer — coverage added for fourth-line therapy and beyond in combination with trastuzumab per NCCN 2A (document history).
- Example: TNBC — first-line versus second-line use determined by PD‑L1 and germline BRCA1/2 status per NCCN nodes.
Required clinical and laboratory documentation (ANC, prior chemo, biomarkers)
Document baseline and follow-up peripheral blood cell counts because Abraxane's label includes a black box warning for neutropenia (baseline ANC < 1,500 cells/mm3 contraindicates use). Also document prior chemotherapy history and relevant tumor biomarker or hypersensitivity status to support indication-specific criteria.
- Baseline ANC and frequent peripheral blood cell counts to monitor for bone marrow suppression (black box warning).
- Prior chemotherapy details (e.g., prior anthracycline in breast cancer) and tumor biomarker results (PD‑L1, germline BRCA1/2, EGFR/ALK where applicable).
- Document confirmed taxane hypersensitivity when that is the basis for using Abraxane.
Include a listed ICD-10 diagnosis code with the request
When requesting coverage, specify an applicable ICD‑10 diagnosis code from the policy's listed ranges to support medical necessity (use one of the listed codes that matches the member's diagnosis).
- Examples of listed ranges: C17.0‑C17.9; C25.0‑C25.9; C34.00‑C34.92; C50.011‑C50.A2; and other codes in the policy's ICD‑10 list.
Potential denial when coverage criteria are unmet
If the request does not meet the policy's listed coverage criteria, Abraxane will not be approved; requests for indications not explicitly listed are not approved.
Coding mismatch risk if HCPCS not J9264
Use the policy-listed HCPCS code J9264 for Abraxane; claims submitted with other HCPCS codes that are not listed in the policy may trigger coding review or denial for coding mismatch.
- CMS coding history notes removal of other HCPCS (J9258, J9259) and policy lists J9264 as the covered code.
Definitions and Key Concepts
Background
Abraxane is nanoparticle albumin-bound paclitaxel (a taxane). It is FDA-approved and used for multiple malignancies including metastatic breast cancer (after prior chemotherapy), first-line non-small cell lung cancer in combination with carboplatin for locally advanced or metastatic disease, and metastatic pancreatic adenocarcinoma in combination with gemcitabine. The policy aligns coverage with these FDA indications and with NCCN guidance for additional tumor types and lines of therapy.
Revision History and Policy Changes
Added FDA indication for use in combination with Lifyorli (LifyoRli) for platinum‑resistant ovarian cancer and updated 'may not be approved' criteria; coding reviewed (no changes).
Added NCCN 2A criteria for fourth‑line and beyond use in HER2‑positive breast cancer and clarified multiple NCCN disease‑state criteria (melanoma, uveal melanoma, Kaposi sarcoma, endometrial, biliary tract) and removed pancreatic maintenance therapy; coding updated to add ICD‑10‑CM C50.A0–C50.A2 to the breast cancer range C50.011–C50.929.
Added NCCN 2A Kaposi sarcoma and NCCN 2A vaginal cancer recommendations; clarified cervical and pancreatic recommendations and removed broader ICD‑10 ranges and D00.0‑D09.9; CMS coding update on 11/25/2024 removed HCPCS J9258 and J9259.
Updated criteria for breast, pancreatic, and small bowel adenocarcinoma; added NCCN 2A biliary tract and cervical cancer recommendations; coding reviewed and HCPCS J9258 added.
Added NCCN 2A criteria for small bowel and ampullary adenocarcinomas and for recurrent advanced/metastatic squamous NSCLC in combination with tremelimumab‑actl, durvalumab, and carboplatin; coding updated to add HCPCS J9259 and ICD‑10‑CM C17.0‑C17.9 and C24.1.
Documented regimen‑level additions including NCCN 2A biliary tract cancer use with gemcitabine and other regimen clarifications for breast and pancreatic disease; coding noted addition of HCPCS J9258.
Added regimen‑level language for recurrent, advanced, or metastatic squamous NSCLC in combination with tremelimumab‑actl, durvalumab, and carboplatin; coding updated to add HCPCS J9259.
Updated criteria to allow use of Abraxane in combination with pembrolizumab for triple‑negative breast cancer per NCCN guidance.
Removed use with atezolizumab for triple‑negative breast cancer following FDA withdrawal; coding ranges for relevant diagnoses were extended.
Updated NSCLC criteria to include first‑line therapy use in recurrent and advanced disease and added specificity about mutation confirmation when used with atezolizumab and carboplatin.
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