CurrentmhnPolicy CP.PHAR.176

Paclitaxel, Protein-Bound (Abraxane) Coverage Criteria

Defines medical necessity, initial and continued therapy criteria, dosing limits, and administrative requirements for coverage of paclitaxel protein-bound (Abraxane) for oncology indications for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyPaclitaxel, Protein-Bound (Abraxane) Coverage Criteria

Policy CodePolicy CP.PHAR.176

Change TypeNo material changes

Effective DateJul 1, 2015

Next Review Date

Key ActionPrior authorization required; provider must submit clinical documentation demonstrating the request meets listed initial or continuation criteria and include supporting diagnosis and dosing information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3FDA-approved indications listed

6 moInitial approval duration

12 moContinued therapy duration

260 mg/m2Max dose (breast/overall)

J9264Primary HCPCS

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Coverage and Medical Necessity Criteria

Initial Therapy - Breast Cancer

Initial Approval Criteria - Breast Cancer (must meet ALL):

Breast Cancer initial: 1) Diagnosis of breast cancer; 2) One of the following: (a) disease is recurrent, metastatic, or unresponsive to preoperative systemic therapy, OR (b) history of taxane (e.g., paclitaxel, docetaxel) hypersensitivity; 3) Prescribed by or in consultation with an oncologist; 4) Age ≥ 18 years; 5) For Abraxane (paclitaxel, protein-bound) requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced; 6) Request meets one of the following: (a) dose does not exceed 260 mg/m2 every 3 weeks, OR (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); Note: prescribed regimen must be FDA-approved or recommended by NCCN.dose <= 260 mg/m2 q3w when applicable

Approval duration: see per-indication initial durations in policy.

Initial Therapy - NSCLC

Initial Approval Criteria - Non-Small Cell Lung Cancer (must meet ALL):

NSCLC initial: 1) Diagnosis of non-small cell lung cancer (NSCLC); 2) One of the following: (a) disease is recurrent, advanced, or metastatic, OR (b) history of taxane (e.g., paclitaxel, docetaxel) hypersensitivity; 3) Prescribed by or in consultation with an oncologist; 4) Age ≥ 18 years; 5) Member must use paclitaxel unless contraindicated or clinically significant adverse effects are experienced (note: for Illinois HIM requests the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395); 6) For Abraxane (paclitaxel, protein-bound) requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced; 7) Request meets one of the following: (a) dose does not exceed 100 mg/m2 IV on Days 1, 8, and 15 of each 21-day cycle, OR (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); Note: prescribed regimen must be FDA-approved or recommended by NCCN.NSCLC schedule: 100 mg/m2 on D1,8,15 q21d

Approval duration: 6 months.

Initial Therapy - Pancreatic Adenocarcinoma

Initial Approval Criteria - Adenocarcinoma of the Pancreas (must meet ALL):

Pancreas initial: 1) Diagnosis of adenocarcinoma of the pancreas; 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) Abraxane (paclitaxel, protein-bound) will be used in combination with gemcitabine (note: gemcitabine may require prior authorization); 5) For Abraxane requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced; 6) Request meets one of the following: (a) dose does not exceed 125 mg/m2 on Days 1, 8, and 15 of each 28-day cycle, OR (b) dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); Note: prescribed regimen must be FDA-approved or recommended by NCCN.125 mg/m2 D1,8,15 q28d

Approval duration: 6 months.

Initial Therapy - NCCN Recommended Off-Label Uses

Initial Approval Criteria - Additional NCCN Recommended Uses (off-label) (must meet ALL):

NCCN off-label initial: 1) Prescribed for one of the NCCN-recommended categories 1 or 2A indications listed in the policy (examples include: cholangiocarcinoma or gallbladder cancer with specified combination requirements; cutaneous or uveal melanoma; ovarian cancer for persistent or recurrent disease or history of taxane hypersensitivity; ampullary adenocarcinoma with gemcitabine; cervical cancer as single agent; small bowel adenocarcinoma; vaginal cancer as single agent; Kaposi sarcoma); 2) Prescribed by or in consultation with an oncologist; 3) Age ≥ 18 years; 4) For Abraxane (paclitaxel, protein-bound) requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced; 5) Dose is within the FDA maximum limit for any FDA-approved indication or is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); Note: prescribed regimen must be FDA-approved or recommended by NCCN.

Approval duration: 6 months.

Initial Therapy — Initial coverage rules per indication

Initial coverage rules per indication

Initial therapy nodes: See indication-specific initial therapy criteria for breast cancer, NSCLC, adenocarcinoma of the pancreas, and additional NCCN-recommended off-label uses; each set requires oncologist involvement, adult age (≥18), appropriate use of paclitaxel/paclitaxel protein-bound where specified, and adherence to indication-specific dosing limits or submission of guideline-supported justification for alternate dosing.

Prescribed regimen must be FDA-approved or recommended by NCCN; initial approval durations vary by indication (commonly 6 months for select indications).

Coverage is NOT authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the provider submits sufficient documentation of efficacy and safety in accordance with the plan’s off‑label use requirements. Applicable off‑label evidence and documentation standards are those referenced in the policy (for example, CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

The policy was revised to remove indications or drug combinations that are no longer supported by NCCN. A specific example noted in the revision log is the removal of the Abraxane + Tecentriq combination for triple‑negative breast cancer after that indication was withdrawn in August 2021. The changes align covered uses to current NCCN recommendations and the product prescribing information.

The policy documentation and revision history explicitly record removal of some previously listed indications and therapeutic alternatives; where an indication was removed or a therapeutic alternative is no longer valid, the policy no longer authorizes coverage for that use. Explicit statements of not‑medically‑necessary (NMN) status for particular uses are contained in the policy sections and revision entries referenced in the revision log.

Continuation Therapy

Continued Therapy (all indications in Section I) (must meet ALL):

Continued therapy: 1) Member is currently receiving medication via Centene benefit, or documentation supports that member has been receiving Abraxane (paclitaxel, protein-bound) for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) For Abraxane requests, member must use paclitaxel protein-bound particles, if available, unless contraindicated or clinically significant adverse effects are experienced; 4) If request is for a dose increase, meets one of the following: (a) new dose does not exceed the indication-specific maximum (i. breast cancer: 260 mg/m2 IV every 3 weeks; ii. NSCLC: 100 mg/m2 IV on Days 1, 8, and 15 of each 21-day cycle; iii. adenocarcinoma of the pancreas: 125 mg/m2 on Days 1, 8, and 15 of each 28-day cycle), OR (b) new dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence); Note: prescribed regimen must be FDA-approved or recommended by NCCN.meets response and dose limits

Approval duration for continued therapy: 12 months.

Continuation — Continued therapy criteria

Continued therapy criteria and recent updates:

Continued therapy details: Continuation requires documentation of ongoing benefit and dosing within specified limits or guideline-supported justification for increases; policy updates have added continuation/usage options over time, including allowance for members with history of taxane hypersensitivity for selected indications (e.g., ovarian cancer, breast cancer, NSCLC) per NCCN and 2Q2025 revisions.

See revision history for state-specific step therapy bypasses (e.g., IL HB 5395).

Continuation therapy updates — Policy updates have added continuation/usage options over time (e.g., addition of use for members with history of taxane hypersensitivity).

Continuation therapy updates — historical and recent changes:

Continuation therapy updates: Policy updates have added continuation/usage options over time, including addition of option for Abraxane usage in members with history of taxane hypersensitivity for ovarian cancer, breast cancer and NSCLC (2Q2025), and added step therapy bypass for Illinois HIM per IL HB 5395 (07.09.25).

Revision log contains detailed timeline of changes to indications, codes, and step therapy requirements.

General coverage alignment to guidelines

Policy-level alignment to guidelines and historical revisions:

Policy-level alignment: Uses NCCN and product prescribing information as primary references for indication-specific coverage; revisions over time have adjusted indications, added or removed combinations, clarified language to apply to 'paclitaxel, protein-bound' (generic) and incorporated NCCN updates (e.g., removal of Abraxane+Tecentriq for triple-negative breast cancer, additions of gallbladder/cholangiocarcinoma and ampullary adenocarcinoma, separation of melanoma subtypes).

See revision history entries in chunks 25-29 for specific changes.

Initial therapy notes — Policy language clarifications made to indicate applicability to generic paclitaxel, protein-bound and to refine per-indication criteria.

Policy language clarifications and applicability notes:

Initial therapy guidance: Policy language was clarified (2Q2024) from 'Abraxane' to 'paclitaxel, protein-bound' where applicable to indicate applicability to generic paclitaxel protein-bound formulations; per-indication criteria were refined (e.g., pancreas criteria adjusted, melanoma subtypes separated).

These clarifications do not change the requirement that prescribed regimens be FDA-approved or recommended by NCCN; see indication-specific sections for exact requirements.

Step Therapy and Preferred Product Requirements

Prior Authorization

Prior Authorization for J9264

Prior authorization is required for HCPCS code J9264 (paclitaxel protein-bound particles, Abraxane). Providers must obtain approval before administration.

Prior authorization required for J9264

Documentation Required

Submit documentation demonstrating medical necessity at the time of prior authorization. Include detailed clinical notes, diagnosis, prior treatments and responses, and any relevant pathology or imaging reports.

Clinical notes with diagnosis and treatment history
Relevant pathology and imaging reports
Oncologist consultation notes

Documentation Required

Clinical Documentation

Clinical documentation should include: diagnosis (ICD-10 code), indication for Abraxane or paclitaxel, prior taxane exposure or hypersensitivity, rationale for product selection (including contraindications to non–protein-bound paclitaxel when applicable), dosing regimen with calculation, and treatment intent (neoadjuvant, adjuvant, metastatic, palliative).

Specify ICD-10 diagnosis code(s)
Note prior taxane hypersensitivity or intolerance
Provide dosing schedule and total dose calculations
Explain why paclitaxel protein-bound particles are requested if non–protein-bound paclitaxel was not used

Billing Rule

Required Coding Documentation

Required coding documentation: submit the appropriate HCPCS drug code (e.g., J9264 for paclitaxel protein-bound particles) with NDC when available, administration CPT/HCPCS codes, and corresponding ICD-10 diagnosis codes supporting medical necessity. Include units calculated per billing guidance.

Report HCPCS J9264 for Abraxane requests
Include NDC and units per billing guidance
Attach administration codes and ICD-10 diagnosis codes

Step Therapy

Step/Preferred Product Requirements

Step / Preferred product requirements: For many indications the policy requires use of paclitaxel (non–protein-bound) first when available unless contraindicated or clinically significant adverse effects are experienced. For Abraxane (paclitaxel protein-bound particles) requests, member must use paclitaxel protein-bound particles if available unless contraindicated or clinically significant adverse effects are experienced. Dosing must meet regimen limits or be supported by practice guidelines or peer-reviewed literature with prescriber-submitted evidence.

Paclitaxel (non–protein-bound) is preferred first-line when available unless contraindicated
Abraxane (J9264) may be used if member has taxane hypersensitivity or contraindication to non–protein-bound paclitaxel
Requested dose must not exceed regimen-specific maximums or must be supported by guidelines/literature

Step Therapy

Step Therapy Applicability

Step therapy applicability: Step therapy requirements apply to applicable indications except where jurisdictional law provides a bypass. For Illinois HIM requests, the step therapy requirements do not apply as of 01/01/2026 per IL HB 5395; a step therapy bypass was added for IL HIM per policy history.

Step therapy applies unless contraindicated or adverse reaction documented
IL HIM requests are exempt from step therapy requirements effective 01/01/2026 per IL HB 5395

Authorization, Documentation, and Billing Requirements

Prior Authorization

Obtain prior authorization and meet indication‑specific criteria

For any request, the provider must obtain prior authorization and demonstrate the request meets the listed initial or continuation criteria for the specific indication; requests must be prescribed by or in consultation with an oncologist and include supporting evidence for off‑label regimens.

Prescriber requirement: prescribed by or in consultation with an oncologist (see per‑indication criteria).
For off‑label uses, prescriber must submit supporting practice‑guideline or peer‑reviewed literature evidence.

Prior Authorization

Prior authorization applies to J9264 — include supporting diagnosis

The policy identifies HCPCS J9264 (Injection, paclitaxel protein‑bound particles, 1 mg) as the primary procedure code; prior authorization and claim support should reference this HCPCS and an appropriate supporting ICD‑10 diagnosis from the policy list.

Include J9264 on the claim when billing paclitaxel protein‑bound.
Ensure the claim is supported by an ICD‑10‑CM diagnosis code listed in the policy's diagnosis table.

Documentation Required

Submit clinical documentation to support approval

Providers must submit clinical documentation (for example, office chart notes, laboratory results, or other clinical information) demonstrating the member meets all approval criteria; failure to provide this documentation may result in denial.

Documentation should show the diagnosis, treatment history, response to therapy, and any contraindications to alternatives.
For off‑label dosing or escalation, include supporting guidelines or peer‑reviewed literature as evidence.

Documentation Required

Provide clinical records with the authorization request

Submit office chart notes, lab results, and other clinical information supporting that the member has met all approval criteria (diagnosis, prior treatment history, response, and any contraindications to alternatives).

Documentation must demonstrate diagnosis and that per‑indication criteria are met (e.g., metastatic disease, prior therapies, or taxane hypersensitivity).
If requesting dose above listed maxima, include guideline or peer‑reviewed literature justification.

Billing Rule

Include J9264 and a supporting ICD‑10 diagnosis

Include the HCPCS code J9264 and an ICD‑10‑CM diagnosis code from the policy's supported list on prior authorization requests and claims to align billing with coverage criteria.

Use J9264 description: “Injection, paclitaxel protein‑bound particles, 1 mg.”
Attach an ICD‑10 code from the policy’s diagnosis table (e.g., C25.0‑C25.9 for pancreas, C34.xx for lung, C50.xx for breast).

Denial Risk

Ensure diagnosis matches the billed procedure code

Claims submitted with procedure codes that do not have a supporting diagnosis code listed in the policy’s ICD‑10 table may not be covered; verify diagnosis‑to‑procedure alignment before submission.

Confirm the ICD‑10 diagnosis on the claim is one of the codes listed in the policy’s ICD‑10 Code Table.
Codes removed or added per revision history (see changes) — ensure current ICD‑10 list is used.

Billing Codes and Diagnosis Mapping

Covered HCPCS/Procedure CodesHCPCSCovered

J9264

Injection, paclitaxel protein-bound particles, 1 mg

Historical HCPCS changesHCPCS

J9258	HCPCS code previously added then removed (see revision log)
J9259	HCPCS code previously added then removed (see revision log)

ICD-10-CM Diagnosis Codes that Support Coverage CriteriaICD-10Covered

C17.0-C17.9	Malignant neoplasms of small intestine (various)
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
C34.00-C34.92	Malignant neoplasm of bronchus and lung (various)
C43.0-C43.9	Melanoma and other malignant neoplasms of skin
C46.0-C46.9	Kaposi's sarcoma
C48.1-C48.8	Malignant neoplasm of peritoneum/retroperitoneum (various)
C50.011-C50.922	Malignant neoplasm of breast (detailed site codes)

1–10 of 15

1/2

Maximum dose limits

Breast cancer maximum dose260 mg/m2 (IV every 3 weeks)

NSCLC maximum dose (overall)260 mg/m2 (NSCLC regimen: 100 mg/m2 IV on Days 1, 8, and 15 of each 21-day cycle; maximum listed as 260 mg/m2)

Pancreatic adenocarcinoma maximum dose260 mg/m2 (regimen: 125 mg/m2 IV on Days 1, 8, and 15 of each 28-day cycle)

Administration and Site-of-Care Notes

Note

Administer product from single‑use infusion vial in appropriate setting

For Abraxane (paclitaxel, protein‑bound) the product is supplied as a lyophilized injectable suspension in single‑use 100 mg vials for reconstitution; administration should occur in an appropriate infusion setting.

Drug presentation: 100 mg single‑use vial, reconstitute per product instructions.
Administer in an appropriate infusion center or hospital outpatient setting as clinically indicated.

Billing Rule

Bill J9264 for single‑use vial; follow site‑of‑care billing rules

Bill paclitaxel, protein‑bound using HCPCS J9264 for the single‑use vial product; site‑of‑care rules (infusion center, hospital outpatient, etc.) follow standard benefit and coding practice and should be applied per payer guidance.

Use J9264 when billing paclitaxel protein‑bound (1 mg units).
Follow applicable site‑of‑care and benefit rules when selecting billing place of service.

Product Definitions and Abbreviations

Abraxane — Protein-bound paclitaxel (Abraxane)

Generic namePaclitaxel, protein-bound (Abraxane)

Formulation descriptionAlbumin-bound formulation of paclitaxel (protein-bound paclitaxel)

Mechanism of actionMicrotubule inhibitor (taxane class)

Product presentation

PresentationInjectable suspension: lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in a single-use vial for reconstitution

Dosage unit in vial100 mg per single-use vial

Intended useFor reconstitution prior to IV administration in an appropriate infusion setting

Abbreviations

HER2human epidermal growth factor receptor 2

NSCLCnon-small cell lung cancer

Abraxane (term)Common name referring to paclitaxel, protein-bound

Background and Clinical Context

Protein‑bound paclitaxel (Abraxane) is an albumin‑bound formulation of paclitaxel in the taxane class that acts as a microtubule inhibitor. It is supplied as an injectable lyophilized suspension (single‑use vial containing 100 mg) for reconstitution and parenteral administration in an appropriate infusion setting.

Policy Summary

Payermhn

PolicyPaclitaxel, Protein-Bound (Abraxane) Coverage Criteria

Policy CodePolicy CP.PHAR.176

Change TypeNo material changes

Effective DateJul 1, 2015

Next Review Date

SourceLink

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