CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior-authorization recommended medical-benefit coverage criteria, dosing, durations, and not-recommended situations for paclitaxel albumin-bound (Abraxane) across FDA-approved indications (breast cancer, NSCLC, pancreatic adenocarcinoma) and multiple other NCCN-supported malignancies. Applies to adult oncology patients when prescribed by or in consultation with an oncologist and includes dosing frequency limits.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeAnnual and Early Annual Revision (criteria edits)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; approve when criteria and dosing are met (typically 1 year) and ensure prescribing by or in consultation with an oncologist.

SourceLink

POLICY UPDATE CHANGES

Annual revision: Non-Small Cell Lung Cancer criterion updated to add exon 21 to the EGFR exon 19 deletion or exon 21 L858R mutation criterion.

Biliary tract cancer criteria expanded to include gallbladder cancer and neoadjuvant use; added resected gross residual disease to approval requirement.

Endometrial carcinoma criterion changed by removing 'high-risk' from requirement; Melanoma criterion changed by removing 'advanced' from wording.

3FDA-Approved Indications Listed

10+Other NCCN-Supported Indications

Coverage Summary

This policy defines prior-authorization–recommended medical‑benefit coverage criteria for paclitaxel albumin‑bound (Abraxane) in adult oncology patients (age ≥ 18 years) for FDA‑approved indications (breast cancer, non‑small cell lung cancer, and metastatic pancreatic adenocarcinoma) and multiple additional NCCN‑supported malignancies. Requests must be prescribed by or in consultation with an oncologist, and approvals are typically granted for 1 year when criteria and dosing are met.

Key thresholds and headline facts

Age thresholdPatient is ≥ 18 years of age

Typical approval duration1 year

FDA‑approved indications listed3

Other NCCN‑supported indications10+

Authorization Criteria (Medical Necessity)

Coding

Drug (generic / brand)mixed

Abraxane

paclitaxel albumin-bound suspension, intravenous infusion (Celgene, generic)

Provider Actions & Authorization Workflow

Prior Authorization

Prior authorization requirement

Prior authorization is recommended for medical-benefit coverage of paclitaxel albumin-bound. Approval is provided when the patient meets the policy’s criteria and dosing for the listed indications. Approvals are typically provided for a 1-year duration and may be extended if criteria and dosing continue to be met.

Documentation Required

Oncologist involvement

Medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist). This prescribing requirement is part of the authorization criteria across FDA-approved and NCCN-supported indications.

Background & Evidence

Paclitaxel albumin‑bound (nab‑paclitaxel, Abraxane) is a microtubule inhibitor with FDA‑labeled indications including breast cancer, non‑small cell lung cancer (in combination with carboplatin), and metastatic pancreatic adenocarcinoma (with gemcitabine).

NCCN guidelines and the NCCN Compendium provide supportive recommendations for many additional tumor types (for example, Kaposi sarcoma, biliary tract/gallbladder cancers, endometrial carcinoma, melanoma, ovarian/fallopian/primary peritoneal cancer, small bowel adenocarcinoma, uveal melanoma, vaginal cancer, and others). Recommended dosing varies by indication and includes regimens such as 100 mg/m2 IV three times per 21‑day cycle, 125 mg/m2 IV three times per 28‑day cycle, and 260 mg/m2 IV once every 3 weeks, with condition‑specific options noted in the policy.

Evidence sources

Product labelAbraxane prescribing information (August 2020)

GuidelinesNCCN Guidelines and NCCN Drugs & Biologics Compendium (multiple 2024 versions referenced)

Hypersensitivity to paclitaxel or docetaxel: a prior severe allergic reaction to paclitaxel or docetaxel that supports substitution with paclitaxel albumin‑bound.

Revision History

12/06/2023revised

Annual revision: Non-Small Cell Lung Cancer criterion updated to add exon 21 to the EGFR exon 19 deletion or exon 21 L858R mutation criterion.

12/06/2023revised

Biliary tract criteria revised (moved disease-specific statements and clarified approval conditions); added gallbladder cancer and neoadjuvant use; added 'resected gross residual' to the approval requirement for unresectable, resected gross residual, or metastatic disease.

10/02/2024revisedLatest

Billing Rule

Dosing frequency limits

Approve only the dosing regimens and maximum frequencies listed for each indication. Examples of approved dosing regimens referenced in the policy include: 125 mg/m2 IV administered no more frequently than three times in each 28-day cycle; 260 mg/m2 IV administered no more frequently than once every 3 weeks; 100 mg/m2 IV administered no more frequently than three times in each 21-day cycle; and 150 mg/m2 IV administered no more frequently than three times in each 28-day cycle.

125 mg/m2 IV — up to three times per 28-day cycle
260 mg/m2 IV — up to once every 3 weeks
100 mg/m2 IV — up to three times per 21-day cycle
150 mg/m2 IV — up to three times per 28-day cycle