Oncology (Injectable) - Abraxane Utilization Review Medical Policy
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Medicare plan coverage and prior authorization criteria for Abraxane (paclitaxel albumin‑bound) for multiple cancer indications; applies to Aspirus Medicare Plans and providers seeking medical benefit coverage.
No material clinical or coverage changes in this revision.
Recommended Authorization Criteria
Breast Cancer - Initial or recurrent/metastatic
Approve for 1 year if ALL of the following are met
Dosing: Approve ONE of: A) up to 260 mg/m2 IV once every 3 weeks; OR B) up to 125 mg/m2 IV three times per 28-day cycle.
Non‑Small Cell Lung Cancer (NSCLC)
Approve for 1 year if ALL of the following are met
Dosing: Approve up to 100 mg/m2 IV no more frequently than three times in each 21-day cycle.
Pancreatic Adenocarcinoma
Approve for 1 year if ALL of the following are met
Dosing: Approve up to 125 mg/m2 IV no more frequently than three times in each 28-day cycle.
Ampullary Adenocarcinoma
Approve for 1 year if ALL of the following are met
Dosing: Approve up to 125 mg/m2 IV no more frequently than three times in each 28-day cycle.
Melanoma (unresectable or metastatic)
Approve for 1 year if ALL of the following are met
Dosing: Approve up to 150 mg/m2 IV no more frequently than three times in each 28-day cycle.
Cervical Cancer (subsequent therapy)
Approve for 1 year if BOTH are met
Dosing: Approve up to 125 mg/m2 IV no more frequently than three times in each 28-day cycle.
Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Approve for 1 year if ALL of the following are met
Dosing: Approve ONE of: A) up to 260 mg/m2 IV once every 3 weeks; OR B) up to 100 mg/m2 IV three times per 28-day cycle.
Uveal Melanoma
Approve for 1 year if BOTH are met
Dosing: Approve up to 150 mg/m2 IV no more frequently than three times in each 28-day cycle.
Endometrial Carcinoma
Approve for 1 year if BOTH are met
Dosing: Approve doses between 100 mg/m2 and 260 mg/m2 IV no more frequently than once every 21 days.
Biliary Tract Cancer
Approve for 1 year if ALL of the following are met
Dosing: Approve ONE of: A) 125 mg/m2 IV no more frequently than twice every 21 days; OR B) 125 mg/m2 IV no more frequently than three times every 28 days.
Kaposi Sarcoma
Approve for 1 year if BOTH are met
Examples of systemic chemotherapy include doxorubicin and paclitaxel. Dosing: Approve 100 mg IV no more frequently than three times in each 28-day cycle.
Small Bowel Adenocarcinoma
Approve for 1 year if BOTH are met
Dosing: Approve ONE of: A) up to 260 mg/m2 IV once every 3 weeks; OR B) up to 125 mg/m2 IV three times in each 28-day cycle.
Kaposi Sarcoma — Initial or Subsequent Therapy
Approve for 1 year if ALL of the following are met
Examples of systemic chemotherapy: doxorubicin, paclitaxel.
Small Bowel Adenocarcinoma — Advanced or Metastatic Disease
Approve for 1 year if ALL of the following are met
Dosing options per indication: up to 260 mg/m2 IV q3 weeks OR up to 125 mg/m2 IV three times per 28-day cycle.
Vaginal Cancer — Subsequent Therapy
Approve for 1 year if ALL of the following are met
Dosing: Approve up to 125 mg/m2 IV no more frequently than three times in each 28-day cycle.
Coding lists and companion-article code tables are provided for reference to support billing and review. However, the presence or absence of a specific HCPCS or ICD-10 code alone does not determine coverage. Prior authorization decisions require clinical documentation showing the patient meets the policy’s clinical criteria and dosing requirements; codes are adjunctive and should not be used as the sole basis for approval or denial.
Coverage is not recommended for uses that are not specified in the Recommended Authorization Criteria. Requests for indications, regimens, or clinical circumstances outside those listed in the criteria may be denied and will be reviewed only as new published data are incorporated into the policy.
Dosing and Regimen Guidance
| Regimen | Indication / Notes | Coverage status |
|---|---|---|
| Paclitaxel albumin‑bound in combination with carboplatin; may be used with pembrolizumab or atezolizumab as noted | ||
| Non‑Small Cell Lung Cancer (recurrent, advanced, or metastatic); per NSCLC criteria and biomarker guidance; dosing per NSCLC node | ||
| Per policy: covered with criteria — approval for 1 year when criteria met |
| Dose / Schedule | Indication | Coverage status |
|---|---|---|
| 100 mg administered as an intravenous infusion no more frequently than three times in each 28‑day cycle | ||
| Kaposi sarcoma (patient ≥18 years and has tried at least one systemic chemotherapy) | ||
| Approve for 1 year when criteria met |
| Dose Option | Indication | Coverage status |
|---|---|---|
| A) Up to 260 mg/m2 IV given no more frequently than once every 3 weeks | ||
| Small bowel adenocarcinoma (advanced or metastatic); patient ≥18 years | ||
| Approve for 1 year when criteria met |
| Dose Option | Indication | Coverage status |
|---|---|---|
| B) Up to 125 mg/m2 IV no more frequently than three times in each 28‑day cycle | ||
| Small bowel adenocarcinoma (alternative dosing listed); patient ≥18 years | ||
| Approve for 1 year when criteria met |
Actions Required from Providers
Prior authorization required for Abraxane
Prior authorization is recommended for medical benefit coverage of Abraxane; approvals are provided for the durations listed in the criteria (typically 1 year).
Document indication-specific criteria for approval
Prior authorization is required and requests must document that the patient meets the indication-specific criteria (including patient age ≥ 18 years and the clinical requirements listed for the requested indication); approvals are issued for 1 year when criteria are met.
Prior therapy required for selected indications
Some indications require prior use of at least one other systemic therapy or systemic chemotherapy before Abraxane will be approved; examples of affected indications include unresectable or metastatic melanoma and Kaposi sarcoma.
Step therapy required for Kaposi sarcoma
For Kaposi sarcoma, prior authorization requires documentation that the patient has tried at least one systemic chemotherapy (examples provided: doxorubicin, paclitaxel) before approval.
- Examples of systemic chemotherapy include doxorubicin and paclitaxel.
- Approval duration when criteria met: 1 year; dosing: 100 mg IV up to three times per 28-day cycle.
Authorization and documentation expectations
Obtain prior authorization and include documentation of the specific indication, any required prior therapies, biomarker status when specified, patient age, and planned combination therapy as applicable to the indication.
- Document indication and that patient is ≥ 18 years of age when applicable.
- List prior systemic therapies when required by the indication.
- Include biomarker results when required by the NSCLC criteria and other indication-specific requirements.
Required clinical documentation
Clinical documentation submitted with the prior authorization must support patient age ≥ 18 and the specific criteria for the requested indication (for example, prior systemic chemotherapy for Kaposi sarcoma or that the medication is being used as subsequent therapy where listed).
- Examples: evidence of prior systemic chemotherapy for Kaposi sarcoma; documentation of advanced/metastatic disease for small bowel adenocarcinoma; note of subsequent‑therapy intent for vaginal cancer.
Prior authorization and coding note — noncoverage risk
Lack of prior authorization may lead to non-coverage; lists of HCPCS or ICD‑10 codes in companion articles are reference only and the presence or absence of a code alone does not determine approval.
- Use companion coding lists for reference but not as sole justification for coverage.
Coverage limitation for unlisted uses
Coverage is not recommended for uses that are not listed in the Recommended Authorization Criteria; requests for indications outside those criteria may be denied.
Coding and Age Requirements
Biomarker and Test Results
Position in Treatment Course
inv-32: first-line | subsequent — criteria node describing initial vs subsequent therapy usage positions
Specific per‑indication line of therapy requirements are captured in each indication's criteria.
inv-33: subsequent — single top-level node for subsequent therapy
Documentation must support prior therapies when required.
inv-34: subsequent — single top-level node for subsequent therapy (additional reference)
Approve for 1 year; dosing: 100 mg IV up to three times per 28-day cycle.
inv-35: advanced/metastatic — single top-level node describing advanced/metastatic disease use
Approve for 1 year; dosing per indication.
Policy Notation and Term Definitions
Background and Drug Overview
Paclitaxel albumin‑bound (Abraxane) is a microtubule inhibitor with FDA‑labeled and guideline‑supported indications across multiple solid tumors. Indications referenced in this policy include treatment of breast cancer (including after prior anthracycline‑based therapy or in early relapse), non‑small cell lung cancer in combination with carboplatin, and metastatic pancreatic adenocarcinoma in combination with gemcitabine. Dosing schedules vary by indication and include both infrequent higher‑dose regimens (for example, up to 260 mg/m2 IV every 3 weeks) and more frequent lower‑dose schedules (for example, 100–125–150 mg/m2 IV administered up to three times per cycle).
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