Centene paclitaxel protein-bound Coverage Update

Coverage Criteria

Initial Therapy — Breast cancer

Covered when ALL of the following are met

Breast cancer initial: Member has a diagnosis of breast cancer; disease is recurrent, metastatic, or unresponsive to preoperative systemic therapy; prescribed by or in consultation with an oncologist; age >= 18 years; dose does not exceed 260 mg/m2 IV every 3 weeks; for Abraxane requests, member must use paclitaxel, protein-bound particles if available unless contraindicated or clinically significant adverse effects are experienced; 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 (prescriber must submit supporting evidence); prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy — NSCLC

Covered when ALL of the following are met

NSCLC initial: Member has a diagnosis of non‑small cell lung cancer that is locally advanced, recurrent, or metastatic; prescribed by or in consultation with an oncologist; age >= 18 years; member must use conventional paclitaxel unless contraindicated or clinically significant adverse effects are experienced; for Abraxane requests, member must use paclitaxel, protein-bound particles if available unless contraindicated or clinically significant adverse effects are experienced; dose does not exceed 100 mg/m2 IV on Days 1, 8, and 15 of each 21‑day cycle; prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy — Pancreatic adenocarcinoma

Covered when ALL of the following are met

Pancreatic adenocarcinoma initial: Member has a diagnosis of adenocarcinoma of the pancreas; prescribed by or in consultation with an oncologist; age >= 18 years; paclitaxel, protein‑bound (Abraxane) is used in combination with gemcitabine (gemcitabine may require separate authorization); for Abraxane requests, member must use paclitaxel, protein‑bound particles if available unless contraindicated or clinically significant adverse effects are experienced; dose does not exceed 125 mg/m2 IV on Days 1, 8, and 15 of each 28‑day cycle; prescribed regimen must be FDA‑approved or recommended by NCCN

Initial Therapy — NCCN‑recommended off‑label uses

Covered when ALL of the following are met

NCCN off-label uses: Prescribed for an NCCN Category 1 or 2A supported indication listed in the policy (examples include AIDS‑related Kaposi sarcoma; cervical cancer as single agent; ampullary adenocarcinoma with gemcitabine; endometrial carcinoma as single agent; cholangiocarcinoma or gallbladder cancer with gemcitabine including metastatic or neoadjuvant settings; cutaneous or uveal melanoma per NCCN; ovarian cancer; small bowel adenocarcinoma; vaginal cancer); age > 18 years; prescribed by or in consultation with an oncologist; for Abraxane requests, member must use paclitaxel, protein‑bound particles if available unless contraindicated or clinically significant adverse effects are experienced; dose is within FDA maximum limits for FDA‑approved indications or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); prescribed regimen must be FDA‑approved or recommended by NCCN

Continued Therapy

Covered when ALL of the following are met

Continued therapy: Member is currently receiving paclitaxel, protein‑bound via the Centene benefit or documentation supports the member has received therapy for at least 30 days; member is responding positively to therapy; requested dose is within the specified dosing limits for the indication (e.g., breast: 260 mg/m2 IV every 3 weeks; NSCLC: 100 mg/m2 IV on Days 1, 8, 15 of each 21‑day cycle; pancreas: 125 mg/m2 IV on Days 1, 8, 15 of each 28‑day cycle) or a new dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); for Abraxane requests, member must use paclitaxel, protein‑bound particles if available unless contraindicated or clinically significant adverse effects are experienced; prescribed regimen must be FDA‑approved or recommended by NCCN

Covered Indications (summary)

The policy covers paclitaxel, protein‑bound when indications and specific clinical criteria are met per NCCN or FDA prescribing information; criteria have been revised over multiple annual reviews.

Indications updated over time: Policy includes NCCN‑supported indications such as metastatic breast cancer, locally advanced/recurrent/metastatic NSCLC, metastatic pancreatic adenocarcinoma (with gemcitabine), gallbladder cancer, cholangiocarcinoma, ampullary adenocarcinoma (with gemcitabine), cervical cancer, vaginal cancer, ovarian cancer, cutaneous and uveal melanoma, Kaposi sarcoma, small bowel adenocarcinoma, and others per NCCN; specific indication requirements (single‑agent vs combination, neoadjuvant options, residual tumor R2) are defined in the main policy sections.

Refer to individual indication criteria for dosing and combination requirements; see revision history for changes across reviews.

Requests for uses that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the provider submits sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid). Providers should follow the formulary/non‑formulary guidance for the member’s line of business when the requested indication is not listed in this policy.

Per the 2022 annual review, the bladder cancer indication was removed because it is no longer supported by NCCN; the revision history documents removal of bladder cancer‑related diagnosis codes and clarifies that bladder cancer is not an authorized indication under this policy.

Non‑FDA indications that are not addressed in this policy remain outside coverage unless the submission includes evidence meeting the referenced off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53) or applicable evidence of coverage documents. In such cases, authorization decisions will be made only when documentation demonstrates sufficient efficacy and safety.

Certain prior therapy requirements and therapeutic‑alternative expectations previously listed in Appendix B (for example, routine prior‑anthracycline requirements or older sequencing rules) have been revised or removed across annual reviews; the policy history notes removal or modification of prior‑required alternatives (e.g., anthracyclines, gemcitabine) where they are no longer considered valid prerequisites.

Initial Authorization Criteria

Initial therapy — top-level initial authorization criteria by indication

Initial authorization — covered when indication‑specific criteria below are met

Initial therapy nodes: See individual indication sections for initial therapy criteria: breast cancer, NSCLC, pancreatic adenocarcinoma, and NCCN‑recommended off‑label uses. Each indication requires oncologist involvement, age >= 18 years, appropriate dosing limits or guideline‑supported dosing, and use of paclitaxel, protein‑bound particles for Abraxane requests if available unless contraindicated.

Initial therapy (high-level) — overview of revisions

Overview of recent revisions to initial therapy criteria

Revisions summary: Initial therapy criteria have been revised across annual reviews to clarify NSCLC as recurrent/advanced/metastatic, to change wording from 'Abraxane' to 'paclitaxel, protein‑bound', to add indications (gallbladder, ampullary adenocarcinoma, cervical, vaginal), to allow paclitaxel, protein‑bound for members with taxane hypersensitivity for select indications, and to remove or modify prior step requirements per NCCN guidance.

Continuation / Continued Therapy Criteria

Continued therapy

Criteria for continued coverage

Continued Abraxane: Member currently receiving paclitaxel, protein‑bound for a covered indication for at least 30 days; member demonstrating positive response to therapy; dose is within indication‑specific limits or a new dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); for Abraxane requests, member must use paclitaxel, protein‑bound particles if available unless contraindicated or clinically significant adverse effects are experienced; prescribed regimen must be FDA‑approved or recommended by NCCN

Continuation / alternative therapy allowances

Continuation and special-use options

Taxane hypersensitivity option: Policy allows use of paclitaxel, protein‑bound for members with a history of taxane (e.g., paclitaxel, docetaxel) hypersensitivity for selected indications (breast cancer, NSCLC, ovarian cancer) per NCCN guidance.

Step Therapy / Sequencing

Provider Action: Prior Authorization	What to Submit
No results

Provider Action: Claims documentation and coding	Required documentation
No results

Step Therapy

Step/Sequence therapy notes

Step/sequence therapy rules: Members must use conventional paclitaxel first for applicable indications unless contraindicated or clinically significant adverse effects occur; for paclitaxel, protein‑bound (Abraxane) requests, members must use paclitaxel protein‑bound particles if available unless contraindicated or clinically significant adverse effects are experienced. For certain indications (e.g., NSCLC recurrent/advanced/metastatic per NCCN, adenocarcinoma of the pancreas, etc.) these step requirements and dosing limits (as specified per indication) apply. Illinois HIM requests: step therapy requirements do not apply as of 01/01/2026 per IL HB 5395. Off‑label requests must be supported by practice guidelines or peer‑reviewed literature (prescriber must submit evidence).

Must use conventional paclitaxel first unless contraindicated or clinically significant adverse effects; documentation of intolerance or contraindication is required when bypassing this step.
When requesting paclitaxel, protein‑bound (Abraxane), indicate whether generic paclitaxel is available and provide rationale for selecting paclitaxel, protein‑bound.
Dosing limits per indication must be followed (e.g., NSCLC: dose does not exceed 100 mg/m2 IV on Days 1, 8, and 15 of each 21‑day cycle; pancreatic adenocarcinoma in combination with gemcitabine: dosing per regimen and approvals).
For Illinois HIM line of business, the step therapy requirement is waived effective 2026-01-01 (IL HB 5395).
Approval duration typically 6 months; off‑label use requires supporting evidence per policy.

Coding and Diagnosis Support

Covered HCPCS (drug)HCPCSCovered

J9264

Paclitaxel protein-bound (Abraxane) injection

Covered HCPCS CodesHCPCSCovered

J9264

Injection, paclitaxel protein-bound particles, 1 mg

Historic/other HCPCS codes mentioned in revision historyHCPCS

J9258	HCPCS code added then later removed per revision history
J9259	HCPCS code added (see revision history)

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

C17.0	Malignant neoplasm of duodenum
C17.1	Malignant neoplasm of jejunum
C17.2	Malignant neoplasm of ileum
C17.3	Meckel's diverticulum, malignant
C17.8	Malignant neoplasm of overlapping sites of small intestine
C17.9	Malignant neoplasm of small intestine, unspecified
C22.1	Intrahepatic bile duct carcinoma
C23	Malignant neoplasm of gallbladder
C24.0	Malignant neoplasm of extrahepatic bile duct
C24.1	Malignant neoplasm of ampulla of Vater

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Maximum single-agent dose — key facts

Maximum single-agent dose (breast cancer)260 mg/m2 every 3 weeks (maximum single-agent dose)

Maximum dose (general reference)Policy lists maximum dose as 260 mg/m2 for indications where applicable

Dose contextBreast cancer regimen specified as 260 mg/m2 IV every 3 weeks per dosing and administration section

Provider Actions, Prior Authorization & Billing

Prior Authorization

Prior authorization required

Prior authorization is required for paclitaxel, protein-bound; providers must submit documentation demonstrating the diagnosis, oncologist involvement/consultation, patient age, prior therapies or taxane hypersensitivity when relevant, and dosing consistent with policy criteria.

Prior authorization applies to J9264 (see coding guidance).
Documentation must align with the indication-specific criteria (dose limits, combination requirements, and NCCN/FDA-supported regimens).

Prior Authorization

Prior authorization for J9264 requires supporting ICD-10

Submit prior authorization with procedure code J9264 and an ICD-10 diagnosis code that supports the applicable coverage criteria; documentation must demonstrate the indication is consistent with policy and member benefits.

J9264 — Injection, paclitaxel protein-bound particles, 1 mg (listed in Coding Implications).
Include an ICD-10-CM diagnosis code from the policy's ICD-10 table that supports the requested indication.

Site of Care / Administration

Note

Infusion center: IV administration and single‑use vial reconstitution

Paclitaxel, protein-bound is supplied as a single‑use vial for reconstitution and is administered intravenously in an infusion setting; reconstitution of the single‑use vial occurs in the infusion center.

Product availability: single‑use 100 mg vial for reconstitution (injectable suspension).
Dosage regimens are IV-based per indication (e.g., 260 mg/m2 IV q3 weeks for breast cancer).

Note

No explicit site‑of‑care restrictions in policy extract

The extract includes no explicit site‑of‑care restrictions; typical administration is in infusion settings and site‑of‑care decisions should follow benefit terms and provider judgment.

Policy notes intravenous administration and single‑use vial presentation but does not impose specific site‑of‑care limitations in this extract.
Follow member benefit documents and applicable state/federal requirements for site‑of‑care determinations.

Definitions and Product Information

Abraxane (paclitaxel, protein-bound) — definition

Generic/brand identityAbraxane (paclitaxel, protein-bound)

Drug classMicrotubule inhibitor; taxane antineoplastic agent (albumin‑bound paclitaxel)

Formulation intentPaclitaxel formulated as albumin‑bound (protein‑bound) particles for intravenous administration

Product availability — formulations & presentation

Dosage formInjectable suspension: lyophilized powder for reconstitution

Drug content per vialContains 100 mg of paclitaxel formulated as albumin‑bound particles per single‑use vial

Background

Abraxane (paclitaxel, protein‑bound) is an albumin‑bound formulation of paclitaxel — a microtubule inhibitor — supplied as a single‑use vial for reconstitution. The agent is indicated and covered by this policy when used per FDA labeling and NCCN‑recommended regimens, including: metastatic breast cancer (dosing up to 260 mg/m2 every 3 weeks), first‑line non‑small cell lung cancer in combination with carboplatin (NSCLC dosing per regimen guidance), and metastatic pancreatic adenocarcinoma in combination with gemcitabine (dosing schedules documented in the indication‑specific criteria). The policy also incorporates multiple NCCN‑supported off‑label uses and has been updated over several annual reviews to add or remove specific indications (for example, addition of gallbladder cancer and clarification of wording from 'Abraxane' to 'paclitaxel, protein‑bound').

Revision History

2021-02-19annual_review

2Q 2021 annual review: clarified NSCLC to be recurrent/advanced/metastatic per NCCN; strengthened requirement to 'must use' conventional paclitaxel unless contraindicated; clarified cholangiocarcinoma wording and updated ICD-10 diagnosis codes.

2022-04-18annual_review

2Q 2022 annual review: removed Abraxane+Tecentriq combination criterion for triple-negative breast cancer (withdrawn Aug 2021); added gallbladder cancer and several single-agent indications; removed bladder cancer indication; updated code table and required use of generic Abraxane.

2023-01-28

OpenPayer

Paclitaxel, Protein-Bound (Abraxane) Coverage Criteria

Coverage Criteria

Initial Authorization Criteria

Continuation / Continued Therapy Criteria

Step Therapy / Sequencing

Coding and Diagnosis Support

Provider Actions, Prior Authorization & Billing

Site of Care / Administration

Definitions and Product Information

Background

Revision History