Oncology (Injectable - Microtubule Inhibitor) - Paclitaxel Albumin-Bound Products Utilization Management Medical Policy
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Defines prior authorization, coverage criteria, and dosing for paclitaxel albumin-bound (Abraxane) for UCare Medical Assistance and Exchange plans; applies to oncologists and providers prescribing this agent for adult cancer indications.
Non-Small Cell Lung Cancer (NSCLC) criteria were revised to require the tumor be described as 'recurrent, advanced, or metastatic' and to specify actionable biomarkers that must be negative for certain uses, and additional EGFR and other mutation details were added for subsequent therapy options.
New conditions of approval were added for ampullary adenocarcinoma, cervical cancer, and vaginal cancer.
Breast cancer criteria were changed to remove the PD-L1 positive requirement for triple-negative disease and to remove requirement for combination with pembrolizumab in that context.
Uveal melanoma dosing was revised to allow up to 150 mg/m2 three times per 28-day cycle (changed from prior dosing ranges and frequency).
Recommended Authorization Criteria
Breast Cancer (FDA-approved)
Approve for 1 year if the patient meets ALL of the following (A, B, and C):
Breast Cancer Approval
- Subcriteria B.i: a) HER2-negative OR b) triple-negative OR c) HER2-positive with trastuzumab
- Subcriteria B.ii: history of hypersensitivity to paclitaxel or docetaxel
Non-Small Cell Lung Cancer (FDA-approved)
Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):
Pancreatic Adenocarcinoma (FDA-approved)
Approve for 1 year if the patient meets ALL of the following (A, B, and C):
Other Uses with Supportive Evidence (NCCN Compendium supported)
Approve for 1 year if the patient meets indication-specific criteria (generally: adult patients, disease state as listed, use often in combination with gemcitabine for select GI/biliary tumors, prior therapy requirements as noted, and oncology prescribing/consult requirement).
Coverage of paclitaxel albumin-bound (Abraxane) is not recommended for clinical circumstances that are not specifically listed in the Recommended Authorization Criteria. The policy’s authorization criteria define the approved indications, required clinical conditions, and prescribing requirements; uses outside those stated criteria are not supported unless and until the documented criteria are revised based on new published evidence.
Requests for coverage for indications or regimens that are not described in the Recommended Authorization Criteria are not recommended for approval (NMN). Providers seeking coverage for unlisted uses should note that the policy does not support approval for those indications and that criteria will be updated only when new published data justify expansion.
Supported Combination Regimens
| Indication | Regimen / Combination | Coverage status | Supporting guidance / notes |
|---|---|---|---|
| Non‑Small Cell Lung Cancer (recurrent, advanced, or metastatic) | Paclitaxel albumin‑bound in combination with carboplatin ± immunotherapy (e.g., with pembrolizumab for PD‑L1 positive tumors; with atezolizumab for non‑squamous histology) | Covered | NCCN recommends paclitaxel albumin‑bound with carboplatin and pembrolizumab or atezolizumab in appropriate histologies and PD‑L1 settings; used as first‑line for recurrent/advanced/metastatic disease when biomarker criteria met |
| Pancreatic adenocarcinoma | Paclitaxel albumin‑bound used in combination with gemcitabine | Covered | FDA‑approved and NCCN‑recommended; dosing: up to 125 mg/m2 IV no more frequently than three times per 28‑day cycle |
| Other NCCN‑supported indications (select GI, gynecologic, melanoma, Kaposi sarcoma, uveal melanoma, etc.) | Paclitaxel albumin‑bound in combinations or single‑agent regimens as indicated by disease‑specific NCCN Compendium (examples include combinations with gemcitabine for biliary/ampullary/gallbladder tumors; carboplatin combinations for select settings) | covered (with indication‑specific criteria) | NCCN Compendium supports multiple additional uses; approvals require meeting the indication‑specific criteria (age ≥18, prior therapy requirements where specified, and oncology prescribing/consultation) |
Billing Codes and Dosing
| J7505 | Paclitaxel protein-bound particles, per 1 mg (commonly used HCPCS for nab-paclitaxel) |
Prescribing and Authorization Requirements
Prior authorization required
Prior Authorization is recommended for medical benefit coverage of paclitaxel albumin-bound. Approvals are provided for the durations noted (typically 1 year) and extended approvals are allowed if the patient continues to meet the Criteria and Dosing. Requests for doses outside established dosing will be considered case-by-case by a clinician.
- Use HCPCS J7505 when submitting prior authorization requests as applicable.
Prior therapy required for some supportive-evidence uses
For certain supportive-evidence indications (e.g., Kaposi sarcoma; ovarian/fallopian/primary peritoneal cancer and other gynecologic indications), the criteria require prior systemic chemotherapy or at least one other systemic therapy to have been tried as specified in the indication-specific criteria.
- Ovarian/fallopian/primary peritoneal cancer: at least one other systemic chemotherapy regimen tried OR documented hypersensitivity to paclitaxel/docetaxel.
- Kaposi sarcoma: patient must have tried at least one systemic chemotherapy (see indication-specific criteria).
Specialist prescribing/consultation required
Approval requires paclitaxel albumin-bound to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., an oncologist).
- Many indication-specific criteria explicitly state the medication must be prescribed by or in consultation with an oncologist.
Coverage not recommended for unlisted indications
Coverage is not recommended for uses or circumstances that are not listed in the Recommended Authorization Criteria; requests for unlisted indications are not recommended for approval.
- Criteria will be updated as new published data are available; submitters should reference the listed indications and criteria.
Treatment Setting (First-line, Second-line, Salvage)
first-line | second-line | salvage
Molecular and Biomarker Preconditions
Key Terms and Guidance Sources
Background and Indication Summary
Paclitaxel albumin-bound (nab‑paclitaxel; Abraxane) is the nanoparticle albumin‑bound formulation of paclitaxel and acts as a microtubule inhibitor used in the treatment of multiple solid tumors. It is FDA‑approved for select settings in breast cancer, non‑small cell lung cancer (NSCLC) in combination regimens, and pancreatic adenocarcinoma with gemcitabine, and it is also supported for additional tumor types by the NCCN Drugs & Biologics Compendium and disease‑specific NCCN guidelines. Dosing and schedule vary by indication (examples in this policy include up to 260 mg/m2 q3 weeks, up to 125 mg/m2 three times per 28‑day cycle, and up to 100 mg/m2 three times per 21‑day cycle), and many approvals require prescribing by or in consultation with an oncologist.
Policy Updates and Material Changes
Breast cancer criteria revised: removed PD-L1 positivity and requirement for combination with pembrolizumab for triple-negative disease; hypersensitivity-related HER2 combination requirements removed; NSCLC criteria updated to require tumor be negative for specific actionable biomarkers (EGFR exon19/exon21, ALK, RET, ROS1) and to add RET rearrangement as an option for subsequent therapy; several first-line/targeted-therapy requirements were removed; uveal melanoma dosing revised to allow up to 150 mg/m2 three times per 28-day cycle; policy name updated.
Policy reviewed and approved by UCare P&T committee; policy name changed from 'Oncology (Injectable) - Paclitaxel Albumin-Bound Products UM Medical Policy' to 'Oncology (Injectable - Microtubule Inhibitor) - Paclitaxel Albumin-Bound Products UM Medical Policy'.
NSCLC: removed KRAS and added possible KRAS G12C positivity to Note and removed KRAS G12C as an option for first-line use; biliary tract cancer: added gallbladder neoadjuvant use and resected gross residual disease language; endometrial carcinoma: removed 'high-risk' language; melanoma: removed 'advanced' descriptor; small bowel adenocarcinoma: removed a prior Keytruda/Opdivo/Jemperli progression requirement; vaginal cancer: added new condition of approval.
NSCLC: added exon 21 (L858R) to EGFR criterion for biomarker specification.
NSCLC: added 'advanced' to recurrent/metastatic description; clarified negative/unknown targetable mutation requirement by listing examples and allowed use as initial or subsequent therapy; added EGFR exon19 or L858R and optional EGFR S768I, L861Q, G719X for subsequent therapy; added ERBB2 (HER2) as optional for approval; added new conditions of approval for ampullary adenocarcinoma and cervical cancer; added hypersensitivity option for ovarian/fallopian/primary peritoneal cancer; small bowel adenocarcinoma: added Jemperli to dMMR/MSI-H criteria; uveal melanoma dosing revised to up to 150 mg/m2 three times per 28-day cycle.
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