CurrentViva Health PlanPolicy IC-0001

Abraxane (paclitaxel albumin-bound) intravenous therapy

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This policy governs prior authorization, dosing limits, authorization duration, and medical-necessity criteria for intravenous Abraxane/paclitaxel albumin-bound in adult members with specified cancers. It applies to providers requesting initial or renewed coverage for oncology treatment.

Policy Summary

PayerViva Health Plan

PolicyAbraxane (paclitaxel albumin-bound) intravenous therapy

Policy CodePolicy IC-0001

Change TypeNo material change

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with the requested dose, dosing frequency, treatment duration, indication, and regimen.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18 yearsMinimum member age for initial approval

6 monthsStandard authorization period

24 weeksMaximum authorization for select indications

2,800 unitsMaximum dose for most listed cancers

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CurrentViva Health PlanPolicy IC-0001

Abraxane (paclitaxel albumin-bound) intravenous therapy

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0001 alerts

Get alerted when Policy IC-0001 changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerViva Health Plan

PolicyAbraxane (paclitaxel albumin-bound) intravenous therapy

Policy CodePolicy IC-0001

Change TypeNo material change

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with the requested dose, dosing frequency, treatment duration, indication, and regimen.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18 yearsMinimum member age for initial approval

6 monthsStandard authorization period

24 weeksMaximum authorization for select indications

2,800 unitsMaximum dose for most listed cancers

Approved disease categories

J9264HCPCS billing code

Disease-Specific Coverage Criteria

Baseline Initial Approval

All initial approval requests must meet the following baseline criterion.

Baseline initial approval: Member is at least 18 years of age.18 years

Required for initial approval.

Breast Cancer

Breast cancer is covered when one of the following distinct pathways is met.

Breast cancer pathways: Member failed combination chemotherapy for metastatic disease or relapsed within 6 months of adjuvant therapy, and treatment is single-agent therapy with prior anthracycline therapy unless clinically contraindicated; OR member has recurrent unresectable, metastatic stage IV (M1), or inflammatory breast cancer without response to preoperative systemic therapy, has HER2-negative hormone receptor-positive disease refractory to endocrine therapy or with visceral crisis, and treatment is single agent or carboplatin combination in an applicable first-, second-, or third-line setting; OR member has triple-negative breast cancer treated with pembrolizumab for PD-L1 CPS ≥10 disease, single-agent therapy or carboplatin combination when applicable, or subsequent therapy; OR member has HER2-positive disease treated in fourth-line therapy or beyond with trastuzumab; OR Abraxane substitutes for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.PD-L1 CPS ≥10 for the pembrolizumab pathway

The applicable pathway also requires the specified subtype, biomarker, prior-therapy, treatment-line, and regimen conditions.

Non-Small Cell Lung Cancer

NSCLC is covered when one of the following treatment pathways is met.

NSCLC pathways: Used as first-line therapy for locally advanced or metastatic disease in a member not eligible for curative surgery or radiation, in combination with carboplatin; OR used for recurrent, advanced, or metastatic disease, excluding locoregional recurrence or symptomatic local disease without disseminated disease, or for mediastinal lymph-node recurrence with prior radiation, with the policy's biomarker, histology, PD-L1, prior-treatment, and combination-regimen requirements; OR used as subsequent therapy under the specified biomarker and prior-targeted-therapy criteria, including pembrolizumab/carboplatin for squamous histology, atezolizumab/carboplatin for nonsquamous histology, or tremelimumab/durvalumab/carboplatin; OR used as single-agent therapy for first progression after initial systemic therapy if Abraxane was not previously used; OR substituted for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.PD-L1 ≥1% for the specified post-immunotherapy pathway; the tremelimumab/durvalumab/carboplatin combination excludes PD-L1 ≥50%

Complete actionable-biomarker testing is required for the applicable pathways.

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Coverage is available for the listed ovarian, fallopian tube, and primary peritoneal cancer histologies and disease settings.

Ovarian, fallopian tube, and primary peritoneal cancer pathways: Member has Grade 1 endometrioid carcinoma, carcinosarcoma, mucinous ovarian neoplasm, epithelial ovarian/fallopian tube/primary peritoneal cancer, or clear cell carcinoma of the ovary; has recurrent or persistent disease; and receives single-agent therapy, carboplatin combination for confirmed taxane hypersensitivity, or relacorilant combination after up to three lines of therapy and prior bevacizumab, with the applicable platinum-resistant or platinum-sensitive disease requirements; OR member has recurrent low-grade serous carcinoma treated as single agent, with carboplatin for confirmed taxane hypersensitivity, or with relacorilant after up to three lines and prior bevacizumab, and has platinum-resistant disease; OR Abraxane substitutes for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.

Immediate treatment of biochemical relapse—rising CA-125 without radiographic evidence of disease—is excluded. Relapse timing is less than 6 months or at least 6 months after completing chemotherapy, as applicable.

Pancreatic Cancer

Pancreatic cancer is covered when the applicable histology, disease status, regimen, and treatment setting criteria are met.

Pancreatic cancer pathways: Member has adenocarcinoma, adenosquamous carcinoma, or squamous carcinoma treated with gemcitabine for locally advanced or metastatic disease as first-line therapy, induction followed by chemoradiation for locally advanced disease, or subsequent therapy after progression; OR member has local recurrence or recurrent metastatic disease after resection and receives subsequent therapy under the applicable timing and prior fluoropyrimidine criteria; OR member receives neoadjuvant therapy for resectable or biopsy-positive borderline resectable disease or alternate therapy after minimal response or progression on first-line neoadjuvant therapy; OR member has metastatic disease treated first-line with gemcitabine and cisplatin and ECOG performance status 0–1; OR member receives neoadjuvant PAXG—gemcitabine, cisplatin, capecitabine, and albumin-bound paclitaxel—for resectable or biopsy-positive borderline resectable disease or after minimal response or progression on first-line neoadjuvant therapy; OR Abraxane substitutes for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.ECOG PS 0–1 for first-line gemcitabine/cisplatin metastatic therapy

PAXG consists of cisplatin, albumin-bound paclitaxel, capecitabine, and gemcitabine.

Cutaneous and Uveal Melanoma

Melanoma treatment is covered under the applicable cutaneous or uveal melanoma pathway.

Melanoma pathways: For cutaneous melanoma, member has metastatic or unresectable disease, receives subsequent single-agent or carboplatin-combination therapy, is not a candidate for further standard, immune-based, BRAF/MEK inhibitor, or clinical-trial-directed therapy, and has symptomatic disease; OR for uveal melanoma, single-agent therapy is used for metastatic or unresectable disease; OR Abraxane substitutes for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.

The symptomatic-disease requirement applies to the cutaneous melanoma subsequent-therapy pathway.

Endometrial Carcinoma

Endometrial carcinoma is covered when all specified conditions are met.

Endometrial carcinoma: Used as single-agent therapy and as subsequent therapy for recurrent disease when not previously used; AND the use is not for locoregional recurrence without prior radiation therapy to the recurrence site or with only prior vaginal brachytherapy, and not after surgical exploration when disease is confined to the vagina or paravaginal soft tissue; OR Abraxane substitutes for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.

Biliary Tract Cancers

Biliary tract cancer is covered when one of the following pathways is met.

Biliary tract cancer pathways: Used with gemcitabine for unresectable, gross residual (R2), or metastatic disease as primary treatment or subsequent treatment after progression on or after systemic therapy; OR used with gemcitabine as neoadjuvant therapy for resectable locoregionally advanced gallbladder cancer when there is an incidental suspicious mass found during surgery without hepatobiliary expertise, an incidental qualifying pathologic finding, or a mass on imaging; OR Abraxane substitutes for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.

This category includes gallbladder cancer and intrahepatic or extrahepatic cholangiocarcinoma.

Small Bowel Adenocarcinoma

Small bowel adenocarcinoma is covered when all applicable criteria are met.

Small bowel adenocarcinoma: Member has advanced or metastatic disease; AND therapy is single agent or combined with gemcitabine; AND treatment is initial therapy after prior adjuvant FOLFOX or CAPEOX within the past 12 months or because of a contraindication, with proficient mismatch repair/microsatellite-stable disease, OR treatment is subsequent therapy when not previously given; OR Abraxane substitutes for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.pMMR/MSS; prior FOLFOX or CAPEOX within 12 months for the specified initial-therapy pathway

Initial- and subsequent-therapy pathways have distinct requirements.

Endometrial Carcinoma

Covered for endometrial carcinoma when the applicable criteria are met.

Endometrial carcinoma criteria

Subsequent therapy: Used as single-agent therapy; used as subsequent therapy for recurrent disease; member has not previously received it.
Substitution: May substitute for paclitaxel or docetaxel because of hypersensitivity despite premedication or contraindication to standard hypersensitivity premedication.

Biliary Tract Cancers

Covered for biliary tract cancers when the applicable criteria are met.

Biliary tract cancer criteria: Use with gemcitabine for unresectable, gross residual (R2), or metastatic disease as primary treatment or subsequent treatment after progression on or after systemic therapy; or use with gemcitabine as neoadjuvant therapy for resectable locoregionally advanced gallbladder cancer under a listed qualifying circumstance; alternatively, substitute for paclitaxel or docetaxel for qualifying hypersensitivity or premedication contraindication.

Qualifying gallbladder circumstances include an incidental suspicious mass found during surgery where hepatobiliary expertise was unavailable, an incidental pathologic finding of a positive cystic duct node or T1b or greater disease or T1a disease with positive margins, or a mass identified on imaging.

Small Bowel Adenocarcinoma

Covered for small bowel adenocarcinoma when the applicable criteria are met.

Small bowel adenocarcinoma criteria: Member has advanced or metastatic disease and therapy is used as a single agent or with gemcitabine; for initial therapy, treatment follows prior adjuvant FOLFOX or CAPEOX within the past 12 months or is used because of a contraindication, and disease is proficient mismatch repair/microsatellite-stable; or treatment is subsequent therapy if not previously given; alternatively, substitute for paclitaxel or docetaxel for qualifying hypersensitivity or premedication contraindication.

Initial therapy requires prior adjuvant FOLFOX/CAPEOX within 12 months or a contraindication plus pMMR/MSS disease.

Kaposi Sarcoma

Covered for Kaposi sarcoma when the applicable criteria are met.

Kaposi sarcoma criteria: Member is intolerant to paclitaxel and treatment is subsequent therapy for relapsed or refractory advanced disease, with progression on or lack of response to first-line systemic therapy and progression on alternate first-line systemic therapy; use as a single agent in members without HIV or with antiretroviral therapy in members with HIV; OR use as alternative systemic therapy with rituximab for KSHV-associated inflammatory cytokine syndrome; OR substitute for paclitaxel or docetaxel for qualifying hypersensitivity or premedication contraindication.

Advanced disease includes T1 disease, extensive T0 cutaneous disease, or nodal disease.

Ampullary Adenocarcinoma

Covered for ampullary adenocarcinoma when the applicable criteria are met.

Ampullary adenocarcinoma criteria: Use with gemcitabine for pancreatobiliary or mixed-type disease as neoadjuvant therapy for localized disease in high-risk members, as first-line therapy for metastatic disease, or as subsequent therapy for disease progression; alternatively, substitute for paclitaxel or docetaxel for qualifying hypersensitivity or premedication contraindication.

High-risk localized disease features may include equivocal or indeterminate imaging, markedly elevated CA 19-9 or CEA, large primary tumors, large regional lymph nodes, excessive weight loss, or extreme pain.

Cervical Cancer

Covered for cervical cancer when the applicable criteria are met.

Cervical cancer criteria: Use as a single agent as subsequent therapy for persistent, recurrent, or metastatic small cell neuroendocrine carcinoma of the cervix, or for recurrent or metastatic disease; alternatively, substitute for paclitaxel or docetaxel for qualifying hypersensitivity or premedication contraindication.

Vaginal Cancer

Covered for vaginal cancer when the applicable criteria are met.

Vaginal cancer criteria: Use as a single agent as subsequent therapy for recurrent or metastatic disease, or substitute for paclitaxel or docetaxel for qualifying hypersensitivity or premedication contraindication.

Coverage Criteria — NSCLC Combination Exclusion

The following NSCLC combination is excluded at the stated PD-L1 level.

NSCLC combination exclusion: Do not use the tremelimumab, durvalumab, and carboplatin combination when tumor PD-L1 expression is at least 50%.PD-L1 ≥50%

For ovarian, fallopian tube, and primary peritoneal cancer, Abraxane is not covered for immediate treatment of a biochemical relapse—defined here as rising CA-125 without radiographic evidence of disease. This exclusion applies even when the requested treatment otherwise falls within an applicable recurrent or persistent disease pathway.

For endometrial carcinoma, Abraxane is excluded for locoregional recurrence when there has been no prior radiation therapy to the recurrence site or only prior vaginal brachytherapy. It is also excluded after surgical exploration when the recurrence is confined to the vagina or paravaginal soft tissue.

Initial Authorization Criteria

Initial Authorization Baseline

Initial approval requires all of the following.

Initial authorization baseline: Member is at least 18 years of age; AND the requested disease, treatment setting, regimen, prior therapy, biomarker status, and clinical conditions meet one of the covered medical-necessity pathways.18 years

Disease-specific pathways are detailed separately.

Initial Therapy

Initial authorization requires satisfaction of the applicable disease-specific criteria.

Disease-specific initial therapy: The requested use meets the applicable criteria for endometrial carcinoma, biliary tract cancer, small bowel adenocarcinoma, Kaposi sarcoma, ampullary adenocarcinoma, cervical cancer, or vaginal cancer, including required disease status, prior therapy, treatment line, combination therapy, or substitution rationale.

Renewal and Continuation Criteria

Renewal Therapy

Renewal requires all of the following.

Renewal criteria: Member continues to meet the relevant indication-specific criteria, including applicable concomitant-therapy requirements and performance status; authorization duration has not been exceeded; disease response is demonstrated by stabilization of disease or decrease in tumor size or tumor spread; and unacceptable drug toxicity is absent.

Examples of unacceptable toxicity include severe myelosuppression, severe neutropenia with absolute neutrophil count below 1,500 cells/mm3, thrombocytopenia, sensory neuropathy, sepsis, pneumonitis, severe hypersensitivity including anaphylaxis, and hepatic impairment.

Renewal and Continuation

Renewal may generally be authorized every 6 months, subject to indication-specific nonrenewal restrictions.

Continuation authorization: Prior authorization may be renewed every 6 months (180 days) unless otherwise specified; renewal is not permitted for NSCLC in combination with tremelimumab/durvalumab/carboplatin, pembrolizumab/carboplatin, or atezolizumab/carboplatin; ampullary adenocarcinoma neoadjuvant therapy; biliary tract cancer gallbladder neoadjuvant therapy; pancreatic cancer neoadjuvant or induction therapy; or pancreatic PAXG therapy.

Step-Therapy and Substitution Requirements

Step	Applicable use	Coverage requirement
1	Specified breast cancer, NSCLC, ovarian/fallopian tube/primary peritoneal cancer, cutaneous or uveal melanoma, endometrial carcinoma, biliary tract cancer, or small bowel adenocarcinoma indications	Abraxane may substitute for paclitaxel or docetaxel when the member experienced a hypersensitivity reaction despite premedication or has a contraindication to standard hypersensitivity premedication.

Step	Indication	Coverage requirement
1	Initial therapy for advanced or metastatic small bowel adenocarcinoma	The member must have received FOLFOX or CAPEOX in the adjuvant setting within the past 12 months, or have a contraindication to those therapies; disease must be proficient mismatch repair/microsatellite stable (pMMR/MSS).

Step	Indication	Coverage requirement
1	Subsequent therapy for advanced Kaposi sarcoma	The member must have relapsed or refractory advanced disease, with progression on or lack of response to first-line systemic therapy and progression on alternate first-line systemic therapy. Advanced disease includes T1 disease, extensive T0 cutaneous disease, or nodal disease.

Step	Indication	Coverage requirement
1	Specified Kaposi sarcoma use	The member must be intolerant to paclitaxel.

Dose and Quantity Limits

Quantity Limit

IndicationKaposi sarcoma

Limit300 billable units

PeriodPer 28 days

Quantity Limit

IndicationNon-small cell lung cancer (NSCLC)

Limit900 billable units

PeriodPer 21 days

Billing and Diagnostic Coding

Covered HCPCS CodesHCPCSCovered

J9264

Injection, paclitaxel protein-bound particles, 1 mg

Covered NDC CodesNDCCovered

68817-0134-xx

Abraxane 100 mg powder for injection single-dose vial

Covered Diagnosis CodesICD-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 the gallbladder
C24.0	Malignant neoplasm of extrahepatic bile duct
C24.1	Malignant neoplasm of ampulla of Vater

1–10 of 178

1/18

Covered Diagnosis CodesICD-10Covered

C57.20	Malignant neoplasm of unspecified round ligament
C57.21	Malignant neoplasm of right round ligament
C57.22	Malignant neoplasm of left round ligament
C57.3	Malignant neoplasm of parametrium
C57.4	Malignant neoplasm of uterine adnexa, unspecified
C57.7	Malignant neoplasm of other specified female genital organs
C57.8	Malignant neoplasm of overlapping sites of female genital organs
C57.9	Malignant neoplasm of female genital organ, unspecified
C69.30	Malignant neoplasm of unspecified choroid
C69.31	Malignant neoplasm of right choroid

1–10 of 26

1/3

TNBC PD-L1 Threshold

Cancer subtypeTriple-negative breast cancer (TNBC)

BiomarkerPD-L1 combined positive score (CPS)

Applicable thresholdCPS ≥10

NSCLC PD-L1 Thresholds

Minimum PD-L1 expressionPD-L1 ≥1% for the specified PD-L1-positive pathway

Combination-treatment exclusionThe tremelimumab, durvalumab, and carboplatin combination excludes members with PD-L1 ≥50%

Authorization, Documentation, and Denial Risks

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for Abraxane. Initial authorization is generally valid for 6 months (180 days), subject to shorter indication-specific limits, and the member must be at least 18 years of age.

Initial authorization may be limited to 24 weeks (18 doses) for ampullary adenocarcinoma neoadjuvant therapy, biliary tract/gallbladder cancer neoadjuvant therapy, and pancreatic cancer neoadjuvant or induction therapy.
Pancreatic cancer treated with cisplatin, capecitabine, and gemcitabine as PAXG: maximum 24 weeks (12 doses).
NSCLC with tremelimumab/durvalumab/carboplatin or pembrolizumab/carboplatin: maximum 12 weeks (12 doses); NSCLC with atezolizumab/carboplatin: maximum 18 weeks (18 doses).

Denial Risk

Renewal Restrictions

Renewal is generally available every 6 months (180 days), unless an indication-specific limit applies. Authorization may not be renewed for the listed NSCLC chemoimmunotherapy regimens or for the specified neoadjuvant, induction, or PAXG treatment courses.

Therapy Background

Abraxane (paclitaxel albumin-bound) is an intravenously administered albumin-bound formulation of paclitaxel. It may be used as single-agent therapy or in combination regimens across specified solid-tumor indications. Coverage is evaluated according to the cancer type, disease extent, biomarker status, prior treatment, treatment line, regimen, and clinical intent. In specified circumstances, Abraxane may substitute for conventional paclitaxel or docetaxel when hypersensitivity occurs despite premedication or standard hypersensitivity premedication is contraindicated.

Policy Definitions and Clinical Terms

Actionable Biomarkers

Listed biomarkersEGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, and ERBB2 (HER2)

Testing methodsComplete molecular testing may use biopsy and/or plasma testing

Treatment implicationIf a clinically actionable marker is identified, treatment may be based on that result

PD-1/PD-L1 Inhibitor Considerations

Autoimmune diseaseActive or previously documented autoimmune disease may contraindicate PD-1/PD-L1 inhibitor treatment

ImmunosuppressionCurrent use of immunosuppressive agents may contraindicate PD-1/PD-L1 inhibitor treatment

Policy Summary

PayerViva Health Plan

PolicyAbraxane (paclitaxel albumin-bound) intravenous therapy

Policy CodePolicy IC-0001

Change TypeNo material change

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with the requested dose, dosing frequency, treatment duration, indication, and regimen.

SourceLink

On This Page

The listed indications receive time-limited authorization without renewal under this policy.

Renewal Criteria

Prior authorization validity may be renewed when all renewal requirements are met.

Continuation therapy: The member continues to meet indication-specific criteria; authorization duration has not been exceeded; disease is stabilized or tumor size or spread has decreased; and there is no unacceptable toxicity.

IndicationsCervical cancer, biliary tract cancers, vaginal cancer, and ampullary adenocarcinoma

Limit900 billable units

PeriodPer 28 days

Quantity Limit

IndicationsBreast cancer, small bowel adenocarcinoma, pancreatic cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and endometrial carcinoma

Limit2,800 billable units

PeriodPer 84 days

Quantity Limit

IndicationsCutaneous and uveal melanoma

Limit1,200 billable units

PeriodPer 28 days

Testing contextPD-L1 expression is evaluated alongside actionable-biomarker results and prior treatment history

Pancreatic Cancer Performance Status

Cancer settingMetastatic pancreatic cancer

RegimenGemcitabine and cisplatin

Required performance statusECOG PS 0-1

Relapse Timing

Platinum-resistant relapseComplete remission with relapse less than 6 months after completing chemotherapy

Platinum-sensitive relapseComplete remission with relapse at least 6 months after completing chemotherapy

Other platinum-resistant settingProgression on primary, maintenance, or recurrence therapy, or stable or persistent disease when not currently on maintenance therapy

Mismatch-Repair Status

Disease settingAdvanced or metastatic small bowel adenocarcinoma

Mismatch-repair statusProficient mismatch repair (pMMR)

Microsatellite statusMicrosatellite stable (MSS)

Severe Neutropenia

Laboratory measureAbsolute neutrophil count (ANC)

Severe neutropenia thresholdBelow 1,500 cells/mm³

Renewal relevanceSevere neutropenia is an example of unacceptable toxicity that may preclude renewal

Weekly Substitution Dose

Substitution useSubstitution for weekly paclitaxel or docetaxel

Maximum weekly dose125 mg/m²

Policy requirementThe weekly dose of albumin-bound paclitaxel should not exceed 125 mg/m²

Nonrenewable NSCLC combinations: tremelimumab/durvalumab/carboplatin; pembrolizumab/carboplatin; or atezolizumab/carboplatin.
Nonrenewable indications: ampullary adenocarcinoma neoadjuvant therapy; biliary tract/gallbladder cancer neoadjuvant therapy; pancreatic cancer neoadjuvant or induction therapy; and pancreatic cancer treated as PAXG with cisplatin, capecitabine, and gemcitabine.

Prior Authorization

Renewal Authorization Requirements

For renewal, submit documentation showing that the member continues to meet the applicable indication-specific criteria and concomitant-therapy requirements, remains within the authorized duration, is responding, and has no unacceptable toxicity.

Continued indication-specific criteria, including applicable concomitant therapy and performance-status requirements, must be met.
Authorization duration must not exceed the limits in Section I.
Document stable disease or a decrease in tumor size or tumor spread.
Document absence of unacceptable toxicity, including severe myelosuppression, sensory neuropathy, sepsis, pneumonitis, severe hypersensitivity, or hepatic impairment.

Note

Prior Authorization Rationale

The prior authorization requirement is supported by review of the drug’s indication, safety and efficacy, potential for misuse or abuse, and cost. Indication, safety/efficacy, and cost were identified as factors supporting PA; misuse or abuse was not considered a PA priority.

Indication: consider for PA — Yes.
Safety and efficacy: consider for PA — Yes.
Potential for misuse/abuse: PA priority — No.
Cost of drug: consider for PA — Yes.

Documentation Required

Breast Cancer Clinical Documentation

For breast cancer requests, submit pathology and treatment documentation establishing the disease subtype, receptor and biomarker status, prior therapy, treatment line, and requested regimen. The record must support the applicable metastatic, recurrent, inflammatory, or TNBC pathway.

Document recurrent unresectable or metastatic disease, inflammatory breast cancer, or failure/relapse after metastatic or adjuvant chemotherapy, as applicable.
Document HER2 status and hormone-receptor status; for HER2-negative disease, include endocrine-refractory disease or visceral crisis when required.
For TNBC, document PD-L1 CPS (including whether CPS is ≥10 or <10) and germline BRCA1/2 pathogenic-variant status when relevant.
Document prior anthracycline use or clinical contraindication, prior endocrine therapy, prior pembrolizumab or other PD-1/PD-L1 therapy when applicable, and whether the member is a candidate for trastuzumab deruxtecan.
Identify whether Abraxane is single-agent therapy or combined with carboplatin, pembrolizumab, or trastuzumab, and document the proposed treatment line.

Documentation Required

NSCLC Biomarker and Treatment History

NSCLC requests must include histology, disease extent and recurrence status, complete biomarker testing, PD-L1 expression, prior targeted/immunotherapy and platinum treatment, contraindications, and the proposed regimen.

Document locally advanced, recurrent, advanced, or metastatic disease and whether the member is unsuitable for curative surgery or radiation; exclude isolated locoregional or symptomatic local recurrence without disseminated disease unless the policy pathway applies.
Provide complete molecular testing by biopsy and/or plasma, including EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, and ERBB2 (HER2).
Report actionable findings such as EGFR exon 20, BRAF V600E, NTRK fusion, MET exon 14 skipping, NRG1 fusion, ERBB2/HER2, EGFR 19 deletion or L858R, ALK, RET, or ROS1 alterations; include prior targeted therapy where required.
Document PD-L1 expression, including whether PD-L1 is ≥50% or ≥1%, and prior PD-1/PD-L1 inhibitor and platinum-containing chemotherapy.
Provide histology and regimen: squamous versus nonsquamous disease and use with carboplatin/pembrolizumab, carboplatin/atezolizumab, tremelimumab/durvalumab/carboplatin, or single-agent/carboplatin therapy when PD-1/PD-L1 inhibitors are contraindicated.
If claiming contraindication to PD-1/PD-L1 therapy, document autoimmune disease, immunosuppressive-agent use, or relevant oncogenic driver.

Documentation Required

Disease-Specific Oncology Documentation

For every other disease-specific request, submit records confirming the diagnosis, pathology or disease subtype, extent of disease, treatment history and line, prior response or progression, performance status when required, and the exact regimen. Documentation must support the applicable policy pathway rather than merely the presence of cancer.

Ovarian/fallopian tube/primary peritoneal cancer: document histology, recurrent or persistent disease, platinum sensitivity/resistance, relapse timing, prior lines and bevacizumab when relacorilant is requested, and taxane hypersensitivity if substituting.
Pancreatic cancer: document adenocarcinoma, adenosquamous or squamous pathology; locally advanced, metastatic, recurrent, or resectable/borderline-resectable status; prior therapy; ECOG 0-1 when required; and the gemcitabine-, cisplatin-, or PAXG-based regimen.
Biliary tract/gallbladder cancer and ampullary adenocarcinoma: document site, pathology/type, resectability or metastatic status, imaging/pathology findings, pancreatobiliary or mixed ampullary type, and neoadjuvant, primary, or subsequent treatment intent.
Small bowel adenocarcinoma: document advanced/metastatic disease, prior FOLFOX/CAPEOX or contraindication, pMMR/MSS status, and whether treatment is initial or subsequent therapy.
Cutaneous or uveal melanoma: document metastatic/unresectable disease, symptoms, prior standard/immune/BRAF-MEK or clinical-trial options, and the requested single-agent or carboplatin regimen.
Endometrial, cervical, and vaginal cancers: document recurrent disease, histology, prior therapy, treatment line, radiation or surgical history where relevant, and the proposed regimen.
Kaposi sarcoma: document HIV/KSHV status, intolerance to paclitaxel, relapsed/refractory extent, prior systemic therapies and response, and ART or rituximab use when applicable.

Billing Rule

Dose and Duration Documentation

The request must specify the indication, dose, frequency, duration, and complete regimen, and must remain within the applicable quantity limits and policy authorization period.

Identify whether treatment is single-agent or combined with pembrolizumab, carboplatin, trastuzumab, gemcitabine, cisplatin, capecitabine, atezolizumab, tremelimumab/durvalumab, relacorilant, or ART/rituximab.
Common regimens include 260 mg/m² IV every 21 days; 100 or 125 mg/m² on days 1, 8, and 15 of a 28-day cycle; and 125 mg/m² on days 1 and 8 of a 21-day cycle with carboplatin.
Document regimen-specific courses, including pancreatic neoadjuvant therapy for 6 cycles, induction therapy for 4–6 cycles, PAXG for 4–6 cycles, NSCLC atezolizumab/carboplatin for 4–6 cycles, and other treatment until progression or unacceptable toxicity where permitted.
Quantity limits per the policy include: Kaposi sarcoma 300 units/28 days; NSCLC 900 units/21 days; cervical, biliary, vaginal, and ampullary cancer 900 units/28 days; breast, small bowel, pancreatic, ovarian, fallopian tube, primary peritoneal, and endometrial cancer 2,800 units/84 days; and cutaneous/uveal melanoma 1,200 units/28 days.

Billing Rule

Medicare Coverage Compliance

For Medicare members, apply the Medicare Part B outpatient drug coverage requirements in the Medicare Benefit Policy Manual, Pub. 100-2, Chapter 15, §50, together with applicable NCDs, LCDs, and LCAs.

This policy’s preceding information is intended for non-Medicare coverage determinations.
Verify applicable CMS NCD, LCD, or LCA requirements and Part B benefit eligibility, including whether the drug may be self-administered.
Use the Medicare Coverage Database and comply with applicable jurisdictional coverage and claims-payment guidance.

Denial Risk

Failure to Meet Indication-Specific Criteria

A request may be denied when the member does not meet the indication-specific criteria, including required age, diagnosis, disease extent, biomarker or pathology findings, treatment line, prior therapy, regimen, or substitution requirements.

Member is younger than 18 years of age.
The diagnosis, histology, stage, recurrence status, or disease extent is outside a covered pathway, or required pathology/biomarker results are absent.
Required prior treatment, treatment line, response/progression history, performance status, or candidate-status requirement is not documented.
The requested combination or single-agent regimen does not match the applicable indication criteria.
A claimed substitution for paclitaxel or docetaxel lacks documented hypersensitivity despite premedication or a contraindication to standard hypersensitivity premedication.
Required exclusions or conditions are not satisfied, such as ovarian platinum status, pancreatic resectability or ECOG status, or melanoma lack of remaining standard options.

Denial Risk

Excess Quantity or Nonrenewable Indication

Claims or requests may be limited or denied when the requested quantity exceeds the indication-specific HCPCS-unit limit or when renewal is requested for a nonrenewable indication.

Apply the policy limits: 300 units/28 days for Kaposi sarcoma; 900 units/21 days for NSCLC; 900 units/28 days for cervical, biliary, vaginal, and ampullary cancer; 2,800 units/84 days for breast, small bowel, pancreatic, ovarian, fallopian tube, primary peritoneal, and endometrial cancer; and 1,200 units/28 days for cutaneous or uveal melanoma.
Do not request renewal for the specified NSCLC tremelimumab/durvalumab/carboplatin, pembrolizumab/carboplatin, or atezolizumab/carboplatin regimens.
Do not request renewal for ampullary or biliary tract neoadjuvant therapy, pancreatic neoadjuvant or induction therapy, or pancreatic PAXG therapy.

Denial Risk

Explicitly Excluded Treatment Settings

Abraxane is not covered under the listed pathways for treatment of an immediate biochemical relapse or certain isolated locoregional recurrences without the required disease extent or prior-treatment context.

Ovarian, fallopian tube, or primary peritoneal cancer: do not use for immediate treatment of biochemical relapse, such as rising CA-125 without radiographic disease.
NSCLC: exclude locoregional recurrence or symptomatic local disease without evidence of disseminated disease, except where the policy specifically permits mediastinal lymph-node recurrence after prior radiation.
Endometrial carcinoma: do not use for locoregional recurrence without prior radiation to the recurrence site or only prior vaginal brachytherapy; do not use after surgical exploration when disease is confined to the vagina or paravaginal soft tissue.

Denial Risk

Indication Criteria Not Met

Deny or limit authorization when the requested diagnosis, disease extent, treatment line, regimen, or substitution does not satisfy the policy’s indication criteria.

The disease is not the specified histology, site, recurrent/advanced status, or treatment setting; or required imaging, pathology, or molecular documentation is missing.
The requested line of therapy, prior treatment, platinum status, performance status, or combination regimen is not supported.
The request substitutes for paclitaxel or docetaxel without documented hypersensitivity despite premedication or a contraindication to standard hypersensitivity premedication.
Examples include unsupported locoregional endometrial recurrence, nonqualifying biliary or ampullary disease, pancreatic treatment without the required disease status or regimen, or Kaposi sarcoma without intolerance and the required relapsed/refractory history.

Denial Risk

Renewal Criteria Not Met

Renewal may be denied when continuation criteria are not demonstrated, the authorized duration has been exceeded, there is no documented response or stable disease, or unacceptable toxicity is present.

Submit current disease assessment showing stabilization or decreased tumor size or spread.
Confirm that the member still meets all relevant indication-specific and concomitant-therapy criteria.
Confirm that the requested renewal remains within the applicable initial or renewal duration and is not for a nonrenewable indication.
Document ongoing clinical benefit and absence of unacceptable toxicity.

Denial Risk

Unacceptable Toxicity

Do not renew or continue treatment when toxicity is unacceptable or makes further therapy unsafe. The policy specifically identifies severe myelosuppression, neuropathy, sepsis, pneumonitis, severe hypersensitivity, and hepatic impairment as examples.

Severe neutropenia, including absolute neutrophil count below 1,500 cells/mm³, or severe thrombocytopenia.
Sensory neuropathy or sepsis.
Pneumonitis or severe hypersensitivity, including anaphylactic reactions.
Hepatic impairment or other clinically significant toxicity that prevents safe continuation.

Denial Risk

Dose Outside Policy Regimen

Requests for doses, schedules, durations, or substitutions outside the policy regimen may be denied. The weekly substitute dose of albumin-bound paclitaxel must not exceed 125 mg/m².

Do not exceed the policy’s listed dose and schedule, including 260 mg/m² every 21 days; 100–125 mg/m² on days 1, 8, and 15 of a 28-day cycle; or regimen-specific 21-day schedules.
For weekly substitution for paclitaxel or docetaxel, the albumin-bound paclitaxel dose may not exceed 125 mg/m².
Document the requested number of cycles; examples of finite limits include pancreatic neoadjuvant therapy for 6 cycles, induction therapy for 4–6 cycles, PAXG for 4–6 cycles, and NSCLC atezolizumab/carboplatin for 4–6 cycles.
Requests exceeding indication-specific duration, using an unlisted combination, or continuing beyond disease progression or unacceptable toxicity are outside the policy regimen.

EGFR exon 19 deletion or L858R mutation, ALK, RET, or ROS1 gene fusion may be associated with less benefit from PD-1/PD-L1 inhibitors

Molecularly Selected Targeted Therapy

Selection basisTherapy is selected according to the member's identified molecular alteration

Examples of molecular alterationsEGFR exon 19 deletion or L858R mutation, EGFR S768I, L861Q, or G719X mutation, ALK gene fusion, RET gene fusion, and ROS1 gene fusion

Treatment guidanceRefer to applicable guidelines for appropriate use

Biochemical Relapse

Biochemical markerRising CA-125

Imaging findingNo radiographic evidence of disease

Policy treatment settingImmediate treatment of biochemical relapse without radiographic disease is excluded

Platinum Response Categories

Platinum-resistant diseaseIncludes complete remission with relapse less than 6 months after completing chemotherapy

Platinum-sensitive diseaseIncludes complete remission with relapse at least 6 months after completing chemotherapy

Treatment useThe classification determines the permitted treatment setting and timing in ovarian, fallopian tube, and primary peritoneal cancer

Indication Notation

†FDA-approved indication(s)

‡Compendia-recommended indication(s)

ФOrphan drug indication

Multiple Manufacturers

AvailabilityPaclitaxel albumin-bound products are available from multiple manufacturers

Generic pathwayMultiple manufacturers produce ANDA generics

Billing codeProducts are billed under HCPCS J9264

NDA-Authorized Generic

Product statusAvailable as an NDA-authorized generic

Product typePaclitaxel albumin-bound powder for injection

Billing contextThe policy lists NDA-authorized generic availability in the billing and product availability information

505(b)(2) Product

FDA statusApproved by the FDA as a 505(b)(2) NDA of the innovator product

Therapeutic equivalenceNot rated therapeutically equivalent to the reference listed drug in the FDA Orange Book

Product classificationConsidered a single-source product under the statutory definition cited in the policy