Health Net paclitaxel (Abraxane) Coverage Update

Coverage and Medical Necessity Criteria

Initial Therapy — Breast Cancer

Initial Approval Criteria for breast cancer (must meet all):

Breast cancer initial criteria: 1. Diagnosis of breast cancer; 2. Disease is recurrent, metastatic, or unresponsive to preoperative systemic therapy OR 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. Dose does not exceed 260 mg/m2 IV every 3 weeks OR dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 7. Prescribed regimen must be FDA‑approved or recommended by NCCN.see node text

Approval duration: 6 months

Initial Therapy — NSCLC

Initial Approval Criteria for NSCLC (must meet all):

NSCLC initial criteria: 1. Diagnosis of non‑small cell lung cancer (NSCLC); 2. Disease is recurrent, advanced, or metastatic; 3. Prescribed by or in consultation with an oncologist; 4. Age >= 18 years; 5. Member must use conventional paclitaxel unless contraindicated or clinically significant adverse effects are experienced; 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. Dose does not exceed 100 mg/m2 IV on Days 1, 8, and 15 of each 21‑day cycle OR dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 7. Prescribed regimen must be FDA‑approved or recommended by NCCN.see node text

Approval duration: 6 months

Initial Therapy — Pancreatic Adenocarcinoma

Initial Approval Criteria for Metastatic Adenocarcinoma of the Pancreas (must meet all):

Pancreas initial criteria: 1. Diagnosis of adenocarcinoma of the pancreas; 2. Prescribed by or in consultation with an oncologist; 3. Age >= 18 years; 4. Paclitaxel, protein‑bound (Abraxane) will be used in combination with gemcitabine; 5. For Abraxane requests, member must use paclitaxel protein‑bound particles if available unless contraindicated or clinically significant adverse effects are experienced; 6. Dose does not exceed 125 mg/m2 IV on Days 1, 8, and 15 of each 28‑day cycle OR dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 7. Prescribed regimen must be FDA‑approved or recommended by NCCN.see node text

Approval duration: 6 months

Additional NCCN-Recommended Uses (Off-Label)

NCCN Recommended Off‑Label Uses (must meet all):

NCCN off‑label criteria: 1. Prescribed for an NCCN category 1 or 2A supported indication (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 Abraxane + gemcitabine where specified) including metastatic or as neoadjuvant for gallbladder; cutaneous or uveal melanoma as specified by NCCN; ovarian cancer; small bowel adenocarcinoma; vaginal cancer; and other NCCN‑listed tumors); 2. Age > 18 years; 3. Prescribed by or in consultation with an oncologist; 4. For Abraxane requests, member must use paclitaxel protein‑bound particles if available unless contraindicated or clinically significant adverse effects are experienced; 5. Dose is within FDA maximum limits 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); 6. Prescribed regimen must be FDA‑approved or recommended by NCCN.see node text

Approval duration: 6 months

Continued Therapy

Continued Therapy (must meet all):

Continued therapy general criteria: 1. Member is currently receiving medication via the benefit or documentation supports member has received Abraxane for at least 30 days for a covered indication; 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, the new dose must meet the specified dosing limits for the indication (e.g., breast 260 mg/m2 IV every 3 weeks; NSCLC 100 mg/m2 IV Days 1,8,15 of a 21‑day cycle; pancreas 125 mg/m2 IV Days 1,8,15 of a 28‑day cycle) or be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 5. Prescribed regimen must be FDA‑approved or recommended by NCCN.see node text

Approval duration: 12 months

Covered Indications (NCCN-referenced)

Coverage is provided when uses are consistent with NCCN‑recommended indications and the policy's listed ICD‑10 diagnosis codes:

NCCN‑supported indications: Policy covers uses of paclitaxel, protein‑bound when prescribed per NCCN‑supported indications for multiple cancers (including breast, pancreatic adenocarcinoma, recurrent/advanced/metastatic NSCLC, gallbladder/cholangiocarcinoma, ovarian, cervical, ampullary adenocarcinoma, melanoma subtypes, vaginal cancer, small bowel adenocarcinoma, Kaposi sarcoma, and others) as reflected in the ICD‑10 code table and revision history; exact per‑indication criteria and required prior therapies are in other sections of the policy.

See full policy (ICD‑10 table) for the complete list of diagnosis codes supporting coverage.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), and CP.PMN.53 (Medicaid).

The policy no longer supports a bladder cancer indication for paclitaxel, protein‑bound (Abraxane); the bladder cancer diagnosis codes (C67.0‑C67.9) and related history codes were removed during the 2022 review and are not covered.

Requests for uses that are on the formulary/PDL should follow the plan’s no‑coverage criteria policy for the applicable line of business (e.g., CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP PMN.255 for Medicaid). For uses not on the formulary/PDL, follow the non‑formulary policies (e.g., CP.CPA.190 commercial, HIM.PA.103 marketplace, CP PMN.16 Medicaid). If the requested diagnosis, age, or dosing regimen is not specifically listed in the policy, refer the request to the off‑label use policies (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid) for review.

Policy history documents removal of certain previously listed combinations and indications when no longer supported by NCCN or evidence. Examples include withdrawal of the Abraxane plus Tecentriq combination for triple‑negative breast cancer (removed August 2021) and removal of an anthracycline requirement; such items were removed from coverage when NCCN guidance or evidence did not support them.

Billing Codes, Diagnosis Codes, and Dosing Identifiers

Covered HCPCS CodesHCPCSCovered

J9264

Injection, paclitaxel protein-bound particles, 1 mg

ICD-10-CM Diagnosis Codes that Support Coverage Criteria (partial list present in this file)ICD-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-C24.9	Malignant neoplasm of other and unspecified parts of biliary tract
C25.0-C25.9	Malignant neoplasm of pancreas

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Dosing thresholds — regimen-specific dosing summaries (breast, NSCLC, pancreas)

Breast cancer dosing260 mg/m2 IV every 3 weeks (maximum dose 260 mg/m2)

NSCLC dosing100 mg/m2 IV on Days 1, 8, and 15 of each 21-day cycle (maximum dose listed as 260 mg/m2)

Pancreatic adenocarcinoma dosing125 mg/m2 IV on Days 1, 8, and 15 of each 28-day cycle (maximum dose listed as 260 mg/m2)

Vial strength — product vial strength information

Vial strength (per vial)100 mg paclitaxel per single-use vial (lyophilized powder for reconstitution)

Formulation note

Provider Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization required. Provider must obtain prior authorization before Abraxane (paclitaxel, protein-bound) is covered. The provider must demonstrate the member meets the policy approval criteria and follow any applicable formulary or off‑label referral process.

Affected HCPCS: J9264
Prior auth required for requests not meeting automatically approved criteria

Billing Rule

Diagnosis Must Be Linked to Claims

Claims for J9264 must be submitted with a supporting ICD-10-CM diagnosis code from the policy's listed codes (see Coding Implications / ICD-10 list). Submission without an appropriate diagnosis code that links to the policy criteria may result in denial.

Background and Drug Description

Paclitaxel, protein‑bound (Abraxane) is an albumin‑bound formulation of paclitaxel used as a microtubule inhibitor in multiple solid tumors. It is indicated in FDA‑approved and NCCN‑recommended regimens including: metastatic breast cancer (e.g., 260 mg/m2 IV every 3 weeks), non‑small cell lung cancer in combination regimens (e.g., 100 mg/m2 IV on Days 1, 8, and 15 of a 21‑day cycle), and pancreatic adenocarcinoma in combination with gemcitabine (e.g., 125 mg/m2 IV on Days 1, 8, and 15 of a 28‑day cycle). The product is supplied as a lyophilized injectable suspension (single‑use vial; 100 mg vial strength). Prescribing should be by or in consultation with an oncologist, and coverage requires adherence to the policy’s indication‑specific dosing and documentation requirements.

Product Definitions and Formulation

Abraxane — Protein-bound paclitaxel (Abraxane) definition

Generic termProtein-bound paclitaxel (Abraxane)

Mechanism of actionMicrotubule inhibitor

Indication contextUsed in multiple solid tumors including metastatic breast cancer, NSCLC (with carboplatin), and pancreatic adenocarcinoma (with gemcitabine)

Product availability / formulation — Injectable suspension lyophilized powder 100 mg vial description

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

PresentationSingle-use vial for parenteral administration after reconstitution

Line of Therapy Designations

first-line

First‑line NSCLC (top‑level): First‑line treatment in combination with carboplatin for locally advanced or metastatic NSCLC in patients who are not candidates for curative surgery or radiation therapy; prescribed per NCCN; patient meets indication‑specific criteria in policy.

first-line

First‑line Pancreas (top‑level): First‑line treatment for adenocarcinoma of the pancreas in combination with gemcitabine; prescribed per NCCN and policy dosing limits.

second-line

Second‑line Breast Cancer (top‑level): Used for metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy; prior therapy should have included an anthracycline unless contraindicated; prescribed per NCCN.

Biomarker and Testing Requirements

Not specified in this excerpt — placeholder for biomarker/test requirements

Biomarker requirement statusNot specified in this excerpt

GuidanceWhen biomarker or test requirements apply, policy references NCCN and the Drugs & Biologics Compendium for genotype- or biomarker-directed uses

Action for providersIf biomarker-driven indication is suspected, include test results in documentation as required by NCCN-supported prescribing criteria

Covered Regimens and Recommended Dosing Schedules

Indication	Regimen / Dose	Coverage Status
Metastatic breast cancer
260 mg/m2 IV every 3 weeks
Covered when policy criteria are met (see initial therapy breast cancer criteria)

Indication	Regimen / Dose	Coverage Status
Non-small cell lung cancer (NSCLC) — in combination with carboplatin
100 mg/m2 IV on Days 1, 8, and 15 of each 21-day cycle
Covered when prescribed per NCCN-supported regimen and policy criteria

Indication	Regimen / Dose	Coverage Status
Metastatic adenocarcinoma of the pancreas — in combination with gemcitabine
125 mg/m2 IV on Days 1, 8, and 15 of each 28-day cycle
Covered when used in combination with gemcitabine and policy criteria are met

Indication	Regimen / Dose / Use	Coverage Status
Pancreatic, gallbladder, or ampullary adenocarcinoma
Paclitaxel, protein-bound in combination with gemcitabine when supported by NCCN (includes neoadjuvant option for gallbladder; ampullary clarified in combination)
Covered when NCCN-supported and policy criteria are met

Document Revision History

2025-02-18annual_reviewLatest

Added option to use paclitaxel protein-bound for members with history of taxane hypersensitivity for ovarian cancer, breast cancer, and NSCLC; added gallbladder neoadjuvant option with gemcitabine, clarified ampullary adenocarcinoma combination with gemcitabine, added vaginal cancer and other single-agent NCCN-recommended off-label uses; updated ICD-10 codes.

2024-01-26annual_review

Clarified trade name 'Abraxane' to 'paclitaxel, protein-bound' across policy; removed pancreatic criteria requiring metastatic/unresectable/borderline resectable disease; separated cutaneous from uveal melanoma indications; added single-agent cervical cancer use; allowed treatment of gallbladder/cholangiocarcinoma with resected gross residual (R2) disease and added residual tumor classification to Appendix D.

OpenPayer

Paclitaxel, Protein-Bound (Abraxane) — Coverage Criteria

Coverage and Medical Necessity Criteria

Billing Codes, Diagnosis Codes, and Dosing Identifiers

Provider Requirements, Prior Authorization, and Billing Guidance

Background and Drug Description

Product Definitions and Formulation

Line of Therapy Designations

Biomarker and Testing Requirements

Covered Regimens and Recommended Dosing Schedules

Document Revision History