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 malignancies. It applies to providers requesting oncology treatment coverage under Viva Health Plan.

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 documentation showing an allowed cancer indication and the applicable disease, treatment-line, regimen, and combination-therapy requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18 yearsMinimum member age

6 monthsInitial and standard renewal authorization

18 dosesMaximum authorization for specified regimens

2,800 unitsHighest listed dosing limit

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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

Receive email alerts as soon as relevant payer policies are published or updated.

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 documentation showing an allowed cancer indication and the applicable disease, treatment-line, regimen, and combination-therapy requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18 yearsMinimum member age

6 monthsInitial and standard renewal authorization

18 dosesMaximum authorization for specified regimens

2,800 unitsHighest listed dosing limit

J9264Covered HCPCS code

Covered Indications and Renewal Criteria

Breast cancer

Covered when the member is at least 18 years old and meets one of the following breast cancer pathways.

Breast cancer pathways

Metastatic or relapsed disease: Member failed combination chemotherapy for metastatic disease or relapsed within 6 months of adjuvant therapy; Abraxane is used as a single agent; and previous chemotherapy included an anthracycline unless clinically contraindicated.
HER2-negative hormone receptor-positive disease: Member has recurrent unresectable local or regional disease, stage IV M1 disease, or inflammatory breast cancer without response to preoperative systemic therapy; disease is HER2-negative and hormone receptor-positive; member is refractory to endocrine therapy or has visceral crisis; and treatment is single-agent, carboplatin combination for high tumor burden, rapidly progressing disease, or visceral crisis, or an applicable first-, second-, or later-line regimen.
First-line use requires no germline BRCA1/2 pathogenic variant and/or HER2 IHC 0+, 1+, or 2+/ISH-negative disease; second-line use requires not being a candidate for fam-trastuzumab deruxtecan.
Triple-negative breast cancer: Treatment is pembrolizumab combination for PD-L1-positive disease, single-agent therapy, or carboplatin combination for high tumor burden, rapidly progressing disease, or visceral crisis, with the specified PD-L1, germline BRCA, first-line, or subsequent-therapy requirements.PD-L1 CPS ≥10 for pembrolizumab combination; CPS <10 or inability to receive PD-1/PD-L1 therapy and no germline BRCA1/2 pathogenic variant for specified first-line single-agent or carboplatin use
HER2-positive disease: Abraxane is used in combination with trastuzumab as fourth-line therapy or beyond.

Non-small cell lung cancer

Covered when the member is at least 18 years old and meets an applicable NSCLC pathway.

NSCLC treatment pathways

First-line locally advanced or metastatic disease: Used with carboplatin in a member who is not a candidate for curative surgery or radiation therapy.
First-line recurrent or advanced disease: Disease is recurrent, advanced, or metastatic, or involves mediastinal lymph node recurrence after prior radiation; treatment is first-line and uses the listed biomarker-directed, histology-specific combination or a single-agent or carboplatin regimen when PD-1/PD-L1 inhibitors are contraindicated.PD-L1 and biomarker thresholds as specified
Squamous histology may use carboplatin/pembrolizumab; non-squamous histology may use carboplatin/atezolizumab; tremelimumab/durvalumab/carboplatin excludes PD-L1 ≥50%.
Subsequent therapy: Treatment follows prior therapy and uses the listed biomarker-positive pathways, prior targeted-therapy pathways, PD-L1-positive actionable-biomarker-negative pathway, or single-agent therapy at first progression when not previously used.

Ovarian, fallopian tube, and primary peritoneal cancer

Covered when the member is at least 18 years old and meets the applicable ovarian, fallopian tube, or primary peritoneal cancer pathway.

Eligible histology and disease status: Member has grade 1 endometrioid carcinoma, carcinosarcoma, mucinous ovarian neoplasm, epithelial ovarian/fallopian tube/primary peritoneal cancer, clear cell ovarian carcinoma, or low-grade serous carcinoma; and has recurrent or persistent disease.
Platinum-resistant or platinum-sensitive disease: Platinum-resistant disease may be treated for progression on primary, maintenance, or recurrence therapy, stable or persistent disease when not on maintenance, or relapse within 6 months after complete remission. Platinum-sensitive disease may be treated after relapse at least 6 months after complete remission, excluding relacorilant combination.
Allowed regimens include single agent, carboplatin for confirmed taxane hypersensitivity, or relacorilant after up to three lines and prior bevacizumab when otherwise applicable.
Low-grade serous carcinoma: Member has recurrent disease and receives single-agent therapy, carboplatin for confirmed taxane hypersensitivity, or relacorilant after up to three lines and prior bevacizumab; disease is platinum-resistant when required.

Pancreatic cancer

Covered when the member is at least 18 years old and meets one of the following pancreatic cancer pathways.

Pancreatic cancer pathways

Gemcitabine combination: Member has adenocarcinoma, adenosquamous carcinoma, or squamous carcinoma and receives gemcitabine-based therapy for locally advanced or metastatic disease as first-line, induction followed by chemoradiation for locally advanced disease, subsequent therapy after progression, or subsequent therapy after recurrence following resection according to the specified timing and prior fluoropyrimidine requirements.
Neoadjuvant use requires resectable or biopsy-positive borderline resectable disease, or alternate therapy after minimal response or progression on first-line neoadjuvant therapy.
Gemcitabine and cisplatin: Used with gemcitabine and cisplatin for metastatic disease as first-line therapy.ECOG performance status 0–1
PAXG: Used with gemcitabine, cisplatin, and capecitabine as PAXG neoadjuvant therapy for resectable or biopsy-positive borderline resectable disease, or as alternate therapy after minimal response or progression on first-line neoadjuvant therapy.

Cutaneous and uveal melanoma

Covered when the member is at least 18 years old and meets the applicable melanoma pathway.

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.

Abraxane may substitute for paclitaxel or docetaxel after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.

Uveal melanoma: Used as a single agent for metastatic or unresectable disease.

Substitution for paclitaxel or docetaxel is permitted under the hypersensitivity or premedication contraindication condition.

Endometrial carcinoma

Covered when the member is at least 18 years old and meets all specified endometrial carcinoma criteria.

Endometrial carcinoma: Used as single-agent subsequent therapy for recurrent disease when Abraxane has not previously been used.

Treatment is not covered for locoregional recurrence when there has been no prior radiation to the recurrence site or only previous vaginal brachytherapy, or after surgical exploration when disease is confined to the vagina or paravaginal soft tissue.

Biliary tract cancers

Covered when the member is at least 18 years old and meets one of the following biliary tract cancer pathways.

Advanced or metastatic disease: Used with gemcitabine for unresectable, gross residual R2, or metastatic disease as primary treatment or subsequent treatment after progression on or after systemic therapy.
Resectable locoregionally advanced gallbladder cancer: Used with gemcitabine as neoadjuvant therapy for resectable locoregionally advanced gallbladder cancer when there is an incidental suspicious mass found during surgery without hepatobiliary surgery expertise, a qualifying pathologic finding such as cystic duct node positivity or T1b or greater disease or T1a with positive margins, or a mass on imaging.

Small bowel adenocarcinoma

Covered when the member is at least 18 years old and meets all small bowel adenocarcinoma criteria.

Small bowel adenocarcinoma: Member has advanced or metastatic disease and receives single-agent therapy or gemcitabine combination as initial therapy after prior adjuvant FOLFOX or CAPEOX within the past 12 months or because of contraindication, with pMMR/MSS disease, or receives subsequent therapy if Abraxane has not previously been given.pMMR/MSS when required; prior FOLFOX/CAPEOX within 12 months or contraindication for the initial-therapy pathway

Substitution for paclitaxel or docetaxel is permitted after hypersensitivity despite premedication or when standard hypersensitivity premedication is contraindicated.

Endometrial carcinoma

Covered for endometrial carcinoma when the applicable criteria are met.

Allowed pathway
- Subsequent single-agent therapy for recurrent disease when Abraxane has not previously been used.
- Substitution for paclitaxel or docetaxel because of hypersensitivity despite premedication or contraindication to standard hypersensitivity premedication.

Biliary tract cancers

Covered for biliary tract cancers when all required disease and treatment criteria are met.

Biliary tract cancer pathways

Advanced or metastatic disease pathway: Combination with gemcitabine for unresectable, gross residual R2, or metastatic disease; treatment may be primary or subsequent after progression on or after systemic therapy.
Resectable locoregionally advanced gallbladder pathway: Combination with gemcitabine as neoadjuvant therapy for resectable locoregionally advanced gallbladder cancer and a qualifying suspicious mass, pathologic finding, or imaging finding.
Taxane substitution: Substitution for paclitaxel or docetaxel because of hypersensitivity despite premedication or contraindication to standard hypersensitivity premedication.

Small bowel adenocarcinoma

Covered for small bowel adenocarcinoma when the applicable pathway is met.

Member has advanced or metastatic disease and receives single-agent therapy or therapy with gemcitabine.
Receives initial therapy after prior FOLFOX or CAPEOX adjuvant therapy within the past 12 months or because of contraindication and has pMMR/MSS disease.
Receives subsequent therapy if Abraxane was not previously given.
Substitution for paclitaxel or docetaxel because of hypersensitivity despite premedication or contraindication to standard hypersensitivity premedication.

Kaposi sarcoma

Covered for Kaposi sarcoma when all applicable disease and treatment conditions are met.

Kaposi sarcoma pathways

Relapsed or refractory advanced disease: Member is intolerant to paclitaxel and receives subsequent therapy for relapsed or refractory advanced disease that has progressed on or not responded to first-line systemic therapy and has progressed on alternate first-line systemic therapy.
Use single-agent therapy when the member does not have HIV and combine with antiretroviral therapy for members with HIV.
KSHV-associated inflammatory cytokine syndrome: Receives alternative systemic therapy with rituximab for Kaposi-sarcoma-associated herpesvirus inflammatory cytokine syndrome.
Taxane substitution: Substitution for paclitaxel or docetaxel because of hypersensitivity despite premedication or contraindication to standard hypersensitivity premedication.

Ampullary adenocarcinoma

Covered for ampullary adenocarcinoma when all required criteria are met.

Ampullary adenocarcinoma: Used 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, substituted for paclitaxel or docetaxel because of hypersensitivity despite premedication or contraindication to standard hypersensitivity premedication.

High-risk localized features 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 treatment and disease criteria are met.

Cervical cancer pathways

Used as single-agent subsequent therapy for persistent, recurrent, or metastatic small-cell neuroendocrine carcinoma of the cervix.
Used as single-agent subsequent therapy for recurrent or metastatic cervical cancer.
Substitution for paclitaxel or docetaxel because of hypersensitivity despite premedication or contraindication to standard hypersensitivity premedication.

Vaginal cancer

Covered for vaginal cancer when both treatment and disease criteria are met.

Vaginal cancer pathways

Used as single-agent subsequent therapy for recurrent or metastatic disease.
Substitution for paclitaxel or docetaxel because of hypersensitivity despite premedication or contraindication to standard hypersensitivity premedication.

Renewal criteria

Renewal requires all listed criteria.

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

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

For endometrial carcinoma, Abraxane may be covered as single-agent subsequent therapy for recurrent disease when it has not been used previously. For locoregional recurrence, coverage is limited: treatment is not covered when there has been no prior radiation therapy to the recurrence site or when the only prior radiation was vaginal brachytherapy. The exclusion also applies after surgical exploration when disease is confined to the vagina or paravaginal soft tissue.

For ovarian, fallopian tube, and primary peritoneal cancer, Abraxane is not covered for immediate treatment of biochemical relapse alone, defined as a rising CA-125 without radiographic evidence of disease. The member must have recurrent or persistent disease and meet the applicable histology, platinum-sensitivity, prior-treatment, and regimen requirements.

For the specified first-line NSCLC regimen using tremelimumab, durvalumab, and carboplatin, members with tumor PD-L1 expression of at least 50% are excluded. The request must otherwise satisfy the applicable disease status, treatment-line, histology, biomarker, and combination-regimen requirements.

Coverage is excluded for endometrial carcinoma locoregional recurrence when the member has had no prior radiation therapy to the recurrence site or only previous vaginal brachytherapy. It is also excluded after surgical exploration when disease is confined to the vagina or paravaginal soft tissue.

Billing, Diagnosis, Biomarkers, and Authorization Parameters

Covered HCPCS CodeHCPCSCovered

J9264

Injection, paclitaxel protein-bound particles, 1 mg

Abraxane NDCNDCCovered

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

Triple-Negative Breast Cancer PD-L1 Thresholds

Pembrolizumab combinationPD-L1 CPS ≥10 for PD-L1-positive triple-negative breast cancer

First-line single-agent therapyPD-L1 CPS <10, or the member is not a candidate for PD-1/PD-L1 inhibitor therapy, with no germline BRCA1/2 pathogenic variant

First-line carboplatin combinationPD-L1 CPS <10, or the member is not a candidate for PD-1/PD-L1 inhibitor therapy, with no germline BRCA1/2 pathogenic variant

NSCLC PD-L1 Thresholds and Definitions

Tremelimumab/durvalumab/carboplatinExcluded when PD-L1 expression is ≥50%

Authorization, Documentation, and Denial Conditions

Prior Authorization

Initial Prior Authorization

Prior authorization is required. Initial authorization is generally valid for 6 months (180 days), unless a shorter indication-specific duration applies.

Member must be at least 18 years of age.
Authorization is subject to the applicable initial-approval criteria and dosing limits.

Prior Authorization

Limited-Duration Gastrointestinal Cancer Authorization

Authorization is limited to a maximum of 24 weeks of therapy (18 doses) for specified gastrointestinal cancer regimens.

Ampullary adenocarcinoma: neoadjuvant therapy.
Biliary tract cancers, including gallbladder cancer: neoadjuvant therapy.
Pancreatic cancer: neoadjuvant or induction therapy.

Policy and Therapy Background

Abraxane is an intravenous, albumin-bound formulation of paclitaxel used as cytotoxic chemotherapy for multiple solid tumors and Kaposi sarcoma. Depending on the covered indication, it may be administered as monotherapy, as part of a combination regimen, or as a substitute for paclitaxel or docetaxel when hypersensitivity persists despite premedication or standard hypersensitivity premedication is contraindicated. Coverage is based on the member’s disease extent, treatment line, prior therapy, biomarkers, histology, and planned regimen.

Clinical and Billing Definitions

Actionable Biomarkers

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

Testing methodsComplete molecular assessment may be performed using biopsy and/or plasma testing

Treatment selectionIf a clinically actionable marker is found, it is reasonable to start therapy based on the identified marker; if results are unknown, members are treated as though they do not have driver oncogenes

PD-1/PD-L1 Inhibitor Considerations

Autoimmune diseaseActive or previously documented autoimmune disease may be a contraindication to PD-1/PD-L1 inhibitor treatment

Immunosuppressive therapyCurrent use of immunosuppressive agents may be a contraindication

Initial Approval Framework

General initial eligibility

Initial approval requires all of the following.

Adult eligibility: Member is at least 18 years of age and meets an applicable covered indication and medical-necessity pathway.18 years

Initial authorization

Initial authorization requires all applicable disease-specific criteria.

Disease-specific initial authorization: Member has one of the covered malignancies and meets the corresponding disease status, treatment-line, single-agent or combination-regimen, and substitution requirements described in the applicable coverage section.

Detailed pathways are specified for endometrial, biliary tract, small bowel, Kaposi sarcoma, ampullary, cervical, and vaginal cancers.

Continuation and Renewal Framework

Renewal authorization

Renewal may be approved every 6 months unless the indication is specifically nonrenewable.

Continuation authorization: Prior authorization may be renewed every 6 months (180 days), subject to indication-specific nonrenewal restrictions and ongoing medical-necessity criteria.180 days

Renewal is not permitted for the specified NSCLC regimens, ampullary adenocarcinoma neoadjuvant therapy, biliary tract cancer neoadjuvant therapy, pancreatic neoadjuvant or induction therapy, or pancreatic PAXG therapy.

Continuation and renewal

Renewal is permitted only when all continuation criteria are met.

Continuation therapy: Continued indication-specific eligibility, unexpired authorization duration, disease stabilization or reduction in tumor or tumor spread, and no unacceptable toxicity.

Unacceptable toxicity includes severe myelosuppression, sensory neuropathy, sepsis, pneumonitis, severe hypersensitivity including anaphylaxis, and hepatic impairment.

Taxane Substitution Rules

Step	Requirement	Failure criteria	Coverage
1	Abraxane may be substituted for paclitaxel or docetaxel when the member has experienced hypersensitivity reactions despite premedication or has a contraindication to standard hypersensitivity premedication.	Hypersensitivity to paclitaxel or docetaxel despite premedication, or contraindication to standard hypersensitivity premedication.	Covered when the substitution criteria are met.

Indication-Specific Dosing Limits

Abraxane Quantity Limit

Quantity limit300 billable units

Time periodPer 28 days

Billing basisHCPCS units

Abraxane Quantity Limit for NSCLC

Quantity limit900 billable units

Time periodPer 21 days

IndicationNon-small cell lung cancer (NSCLC)

Administration Setting

Note

Use the covered infusion setting

Administer intravenous paclitaxel albumin-bound in an infusion center. The policy identifies the covered product as intravenous therapy and does not state a more specific site-of-care restriction.

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 documentation showing an allowed cancer indication and the applicable disease, treatment-line, regimen, and combination-therapy requirements.

SourceLink

On This Page

PD-L1 ≥1% for the specified prior PD-1/PD-L1 inhibitor pathway

Applicable pathways include BRAF V600E, NTRK1/2/3, MET exon 14 skipping, ERBB2 (HER2), EGFR variants, ALK, RET, and ROS1, with applicable prior targeted-therapy requirements.

PD-L1-positive tumors

Defined as PD-L1 expression ≥1% for the specified subsequent-therapy pathway

Testing contextComplete biomarker testing is required when applicable; testing may use biopsy and/or plasma samples

Authorization Duration

Standard authorization6 months (180 days) initially and generally for renewal

Specified gastrointestinal indicationsUp to 24 weeks or 18 doses for ampullary adenocarcinoma neoadjuvant therapy, biliary tract cancer neoadjuvant therapy, and pancreatic cancer neoadjuvant or induction therapy

Pancreatic PAXG therapyUp to 24 weeks or 12 doses

Specified NSCLC regimens12 weeks or 12 doses for tremelimumab/durvalumab/carboplatin or pembrolizumab/carboplatin

NSCLC atezolizumab regimen18 weeks or 18 doses with atezolizumab and carboplatin

Severe Neutropenia

Severe neutropenia thresholdAbsolute neutrophil count <1,500 cells/mm³

Toxicity categorySevere neutropenia is an example of severe myelosuppression and unacceptable toxicity

Renewal impactUnacceptable toxicity precludes renewal

Prior Authorization

Limited-Duration NSCLC Authorization

For specified NSCLC combinations, authorization is limited to the regimen-specific treatment duration and dose count.

NSCLC with tremelimumab, durvalumab, and carboplatin, or with pembrolizumab and carboplatin: up to 12 weeks or 12 doses.
NSCLC with atezolizumab and carboplatin: up to 18 weeks or 18 doses.

Prior Authorization

Renewal Authorization

Renewal may generally be requested every 6 months (180 days), unless an indication-specific exception applies.

Renewal requires continued compliance with the applicable indication criteria, duration limits, documented response, and absence of unacceptable toxicity.
The nonrenewable indications listed below cannot generally be renewed.

Documentation Required

Initial Authorization Requirements

Initial authorization requires the applicable disease indication, treatment regimen, treatment setting, and supporting clinical documentation.

Document the diagnosis and relevant disease status, including stage, recurrence, resectability, metastatic status, or locally advanced disease, as applicable.
Identify the requested treatment line and regimen, including required concomitant drugs and whether therapy is single-agent, combination, neoadjuvant, induction, first-line, or subsequent therapy.
For breast cancer, document the applicable subtype, hormone-receptor/HER2 status, prior endocrine or chemotherapy treatment, visceral crisis or disease burden when relevant, and treatment line.
For NSCLC, document histology, disease setting, treatment line, actionable-biomarker status, PD-L1 status when relevant, prior targeted or immunotherapy, and any contraindication to PD-1/PD-L1 therapy.
For ovarian, fallopian tube, or primary peritoneal cancer, document histology, recurrence or persistence, platinum sensitivity or resistance, prior therapy, and the requested combination.
For pancreatic, biliary, ampullary, small-bowel, cervical, vaginal, endometrial, Kaposi sarcoma, melanoma, and other covered indications, document the disease-specific criteria and prior-therapy requirements.

Prior Authorization

Renewal Authorization Criteria

Renewal authorization requires ongoing medical necessity and documentation that the member continues to benefit from treatment within the authorized duration.

The member continues to meet the relevant indication-specific criteria, including concomitant-therapy and performance-status requirements, excluding prerequisite-therapy requirements.
The requested renewal does not exceed the applicable authorization duration or dose limit.
There is disease response, defined as stabilization of disease or a decrease in tumor size or tumor spread.
There is no unacceptable toxicity from Abraxane.

Note

Prior Authorization Factors

Prior authorization is applied after considering the indication, safety and efficacy, drug cost, and potential for misuse or abuse.

Indication: considered for prior authorization.
Safety and efficacy: considered for prior authorization.
Cost of the drug: considered for prior authorization.
Potential for misuse or abuse: not a priority for prior authorization.

Documentation Required

Clinical Documentation

Submit clinical records that establish the diagnosis and the disease and treatment characteristics required by the applicable indication.

Diagnosis and histology, including the relevant cancer subtype.
Stage, recurrence, metastatic or locally advanced status, resectability, and treatment setting.
Prior treatment history, treatment response or progression, and requested line of therapy.
Biomarker and molecular-test results, including the testing method and whether tissue biopsy and/or plasma testing was used.
For NSCLC, complete actionable-biomarker assessment should address EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, NRG1, and ERBB2 (HER2), with PD-L1 results when applicable.
Document hypersensitivity reactions despite premedication or contraindications to standard hypersensitivity premedication when Abraxane is substituted for paclitaxel or docetaxel.
Document contraindications to PD-1/PD-L1 inhibitors when that exception is used, such as active or documented autoimmune disease, immunosuppressive therapy, or relevant oncogenic drivers.

Documentation Required

Renewal Clinical Documentation

Renewal submissions must include updated clinical evidence supporting continued treatment.

Current disease status and response, including stabilization or reduction in tumor size or spread.
Current treatment regimen, concomitant therapy, treatment duration, and whether the applicable duration limit has been reached.
Updated toxicity assessment, including myelosuppression, sensory neuropathy, sepsis, pneumonitis, severe hypersensitivity, hepatic impairment, or other unacceptable toxicity.
Documentation that all continuing indication-specific criteria remain satisfied.

Billing Rule

CMS Coverage Policies

Medicare Part B claims must comply with applicable CMS coverage and claims-payment requirements in addition to any plan criteria.

Apply the Medicare Benefit Policy Manual, Pub. 100-2, Chapter 15, §50, for outpatient Part B drugs.
Follow applicable National Coverage Determinations, Local Coverage Determinations, and Local Coverage Articles for coverage, diagnosis codes, benefit eligibility, and claims payment.
CMS coverage policies may result in requirements different from the non-Medicare criteria in this policy.

Denial Risk

Nonrenewable Indications

The following initial authorization periods generally cannot be renewed.

NSCLC in combination with tremelimumab, durvalumab, and carboplatin; pembrolizumab and carboplatin; or atezolizumab and carboplatin.
Ampullary adenocarcinoma neoadjuvant therapy.
Biliary tract cancer, including gallbladder cancer, neoadjuvant therapy.
Pancreatic cancer neoadjuvant or induction therapy.
Pancreatic cancer in combination with cisplatin, capecitabine, and gemcitabine as a component of PAXG.

Billing Rule

Dosing Limit Exceeded

Claims may be denied when the requested billable units exceed the applicable indication-specific limit.

Kaposi sarcoma: 300 billable units per 28 days.
NSCLC: 900 billable units per 21 days.
Cervical cancer, biliary tract cancers, vaginal cancer, and ampullary adenocarcinoma: 900 billable units per 28 days.
Breast cancer, small-bowel adenocarcinoma, pancreatic cancer, ovarian/fallopian tube/primary peritoneal cancer, and endometrial carcinoma: 2,800 billable units per 84 days.
Cutaneous or uveal melanoma: 1,200 billable units per 28 days.

Denial Risk

Medical-Necessity Criteria Not Met

Authorization may be denied when the requested use does not satisfy the applicable disease, treatment-setting, biomarker, prior-therapy, regimen, or safety requirements.

The member is under age 18 or the diagnosis is not a covered indication.
Required disease stage, recurrence, metastatic status, resectability, histology, or treatment line is not documented.
Required prior therapy, treatment response or progression, performance status, or concomitant therapy is absent.
Required biomarker, molecular-testing, PD-L1, hormone-receptor, HER2, mismatch-repair, or platinum-sensitivity information is missing or inconsistent with the requested regimen.
The requested regimen, substitution, or treatment setting is not listed in the applicable indication criteria.
A nonrenewable indication is submitted for renewal, or the authorization duration or dosing limit has been exceeded.
The requested use is excluded because of a specified locoregional recurrence setting or other indication-specific exclusion.

Denial Risk

Excluded Endometrial Recurrence Setting

Abraxane is not authorized for certain endometrial-carcinoma locoregional recurrence scenarios.

Do not authorize therapy for locoregional recurrence when there has been no prior radiation therapy to the recurrence site or only prior vaginal brachytherapy.
Do not authorize therapy after surgical exploration for locoregional recurrence when disease is confined to the vagina or paravaginal soft tissue.

Denial Risk

Indication-Specific Criteria Not Met

Indication-specific criteria must be satisfied for the requested cancer and regimen; otherwise the request may be denied.

Breast cancer: required subtype, prior therapy, treatment line, endocrine-resistance or visceral-crisis status, HER2/ hormone-receptor status, and applicable BRCA or PD-L1 criteria must be documented.
NSCLC: required disease setting, histology, treatment line, biomarker results, PD-L1 status, prior targeted or immunotherapy, and regimen must be documented.
Ovarian, fallopian tube, or primary peritoneal cancer: required histology, recurrence or persistence, platinum sensitivity/resistance, prior therapy, and combination criteria must be met.
Pancreatic, biliary, ampullary, small-bowel, cervical, vaginal, endometrial, Kaposi sarcoma, and melanoma requests must meet their respective disease-specific stage, regimen, treatment-line, and prior-therapy criteria.
The requested therapy must not be used for an excluded biochemical relapse, unsupported treatment setting, or other expressly excluded circumstance.

Denial Risk

Unsupported Taxane Substitution

Substitution of Abraxane for paclitaxel or docetaxel requires documentation that standard therapy cannot be used safely because of hypersensitivity or premedication limitations.

Document a hypersensitivity reaction that occurred despite appropriate premedication; or
Document a contraindication to standard hypersensitivity premedication.

Denial Risk

Endometrial Carcinoma Exclusion

Endometrial carcinoma authorization requires single-agent use as subsequent therapy for recurrent disease when Abraxane has not previously been used, subject to the specified recurrence exclusions.

Document recurrent disease and the requested subsequent-therapy setting.
Do not authorize the excluded locoregional recurrence scenarios described above.
Taxane substitution still requires documented hypersensitivity despite premedication or a contraindication to standard premedication.

Denial Risk

Renewal Requirements Not Met

Renewal may be denied when continuing criteria, authorized duration, response, or toxicity requirements are not satisfied.

The member no longer meets the applicable indication-specific criteria or required concomitant-therapy/performance-status criteria.
The requested duration exceeds the Section I limit or the indication is nonrenewable.
There is no documented disease stabilization or decrease in tumor size or spread.
Unacceptable toxicity is present, including severe neutropenia with absolute neutrophil count below 1,500 cells/mm³, thrombocytopenia, sensory neuropathy, sepsis, pneumonitis, severe hypersensitivity or anaphylaxis, or hepatic impairment.

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

Genomic-Driver Targeted Therapy

DefinitionTherapies selected according to the relevant genomic alteration and applicable treatment guidelines

Guideline referenceRefer to guidelines for appropriate use

Examples of relevant alterationsEGFR, ALK, RET, ROS1, BRAF, NTRK1/2/3, MET, NRG1, and ERBB2 (HER2) alterations are addressed in the policy pathways

Indication Markers

FDA Approved Indication(s)Marked with a dagger (†)

Compendia Recommended Indication(s)Marked with a double dagger (‡)

Orphan drug indicationSeparately marked with the orphan-drug symbol (Ф)

J9264 Billing Unit

HCPCS codeJ9264

Code descriptionInjection, paclitaxel protein-bound particles, 1 mg

Billable-unit equivalenceOne billable unit equals 1 mg

Abraxane Quantity Limits

Quantity limit900 billable units

Time periodPer 28 days

Covered indicationsCervical cancer, biliary tract cancers, vaginal cancer, and ampullary adenocarcinoma

Abraxane Quantity Limits

Quantity limit2,800 billable units

Time periodPer 84 days

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

Abraxane Quantity Limit for Melanoma

Quantity limit1,200 billable units

Time periodPer 28 days

Covered indicationsCutaneous and uveal melanoma