ModifiedEmblemHealthPolicy MG.MM.PH.66

Abraxane (paclitaxel protein-bound particles) Intravenous

Clinical coverage criteria, dosing/authorization limits, and indications for intravenous Abraxane (albumin‑bound paclitaxel) for EmblemHealth members. Affects providers requesting preauthorization for Abraxane across multiple cancer indications.

Policy Summary

PayerEmblemHealth

PolicyAbraxane (paclitaxel protein-bound particles) Intravenous

Policy CodePolicy MG.MM.PH.66

Change TypeCoverage criteria and dosing revisions

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical evidence that the member meets indication‑specific criteria, including biomarker and performance status documentation.

SourceLink

POLICY UPDATE CHANGES

Updated dosing limits and added lengths of authorization for several indications including NSCLC combinations and multiple neoadjuvant settings.

Extensive additions and clarifications to NSCLC coverage criteria including combinations with pembrolizumab, atezolizumab, tremelimumab/durvalumab, and molecular biomarker-specific pathways.

Breast cancer initial criteria updated to add 'unless clinically contraindicated' and expand settings for use (including PD-L1, BRCA, HER2 scenarios).

Ovarian, endometrial, pancreatic, biliary tract, small bowel, and other tumor-specific criteria were added/modified with specifics on platinum sensitivity, neoadjuvant use, and histologic subtypes.

Updated multiple disease-specific criteria clarifying use as single agent or in combination with carboplatin, performance status requirements, and biomarker-driven considerations.

Removed several prior restrictive statements requiring single-agent use or limiting stage-specific use for certain cancers (examples include melanoma, uterine cancer, bladder cancer items).

Clarified actionable molecular genomic biomarkers to include EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET exon 14 skipping mutation, RET, and ERBB2 (HER2).

Added JCODE J9259 Injection, paclitaxel protein-bound particles (American regent) not therapeutically equivalent to j9264,1 mg.

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6 monthsstandard length of authorization

900/21dNSCLC dosing limit

2800/84dBreast/ovarian/pancreatic cap

300/28dKaposi sarcoma dosing

9Actionable biomarkers listed

J9264Primary HCPCS code

Coverage Criteria and Clinical Logic

Indication-specific coverage criteria

Indication-specific coverage criteria. Covered when the following tumor-type–specific conditions are met (consolidated):

ALL of the following

Breast cancer
- Patient is ≥18 years of age; AND prior therapy: patient failed combination chemotherapy for metastatic disease or relapsed within 6 months of adjuvant therapy; AND previous chemotherapy included an anthracycline unless clinically contraindicated; AND disease is recurrent or metastatic OR inflammatory breast cancer with no response to preoperative systemic therapy; AND disease is HER2-negative; AND used as a single agent OR in combination with carboplatin in patients with high tumor burden, rapidly progressing disease, or visceral crisis; AND disease is hormone receptor–positive and patient is refractory to endocrine therapy or has a visceral crisis; AND used in one of the following settings: first-line therapy if no germline BRCA1/2 mutation; second-line if not a candidate for fam-trastuzumab-deruxtecan-nxki; third-line and beyond.
- Patient has triple-negative breast cancer (TNBC): used as single agent OR combined with carboplatin in patients with high tumor burden, rapidly progressing disease, or visceral crisis; AND used in one of the following: first-line therapy if PD-L1 CPS <10 and no germline BRCA1/2 mutation; OR subsequent therapy; OR used in combination with pembrolizumab for PD-L1 positive (PD-L1 CPS ≥10) disease.
- Patient has HER2-positive disease: used as fourth-line therapy and beyond in combination with trastuzumab.
- May be substituted for paclitaxel or docetaxel if the patient had hypersensitivity reactions despite premedication or has contraindications to standard hypersensitivity premedication.
Non‑Small Cell Lung Cancer (NSCLC)
- Used as first-line therapy for locally advanced or metastatic disease in combination with carboplatin in patients not candidates for curative surgery or radiation; OR
- Used for recurrent, advanced, or metastatic disease (excluding locoregional recurrence or isolated symptomatic local disease) or mediastinal lymph node recurrence after prior radiation; AND used as first-line therapy in patients meeting one of the following: (1) PS 0–1, tumors negative for actionable molecular biomarkers* and PD-L1 <1%; (2) PS 0–2, tumors negative for actionable molecular biomarkers* and PD-L1 ≥1%; (3) PS 0–1 and positive for certain molecular mutations (EGFR exon 20, KRAS G12C, BRAF V600E, NTRK1/2/3 fusion, MET exon 14 skipping, RET rearrangement, or ERBB2/HER2).
- When used in combination regimens: in squamous histology may be combined with carboplatin and pembrolizumab; in non-squamous histology may be combined with carboplatin and atezolizumab; may be used in combination with tremelimumab + durvalumab + carboplatin (excluding patients with PD-L1 ≥50% for that regimen).
- Used in patients with contraindications to PD-1/PD-L1 inhibitors (or as single agent when indicated): used with carboplatin in patients with PS 0–2 or as single agent for PS 2; applicable to tumors negative for actionable molecular biomarkers and varying PD-L1 strata as above.
Pancreatic adenocarcinoma
- Must be used in combination with gemcitabine; AND disease is locally advanced or metastatic; AND used as first-line therapy OR induction therapy followed by chemoradiation (locally advanced only) OR subsequent therapy after progression on a fluoropyrimidine‑based therapy.
- For recurrent disease post-resection: used ≥26 months after completion of primary therapy OR used <6 months from completion of primary therapy if the prior regimen was fluoropyrimidine‑based.
- Used as neoadjuvant therapy when patient has resectable or biopsy‑positive borderline resectable disease; OR used in combination with gemcitabine and cisplatin for metastatic disease in patients with ECOG PS 0–1 as first‑line therapy.
Melanoma / Uveal melanoma
- Cutaneous melanoma: used as single agent or in combination with carboplatin for metastatic or unresectable disease; may be used as subsequent therapy for disease progression, intolerance, or projected risk of progression with BRAF‑targeted therapy.
- Uveal melanoma: used as single agent for distant metastatic disease; patient has tried paclitaxel and could not tolerate it due to documented hypersensitivity despite recommended premedication or has medical contraindication to premedication; used as subsequent therapy for recurrent disease.
Kaposi sarcoma
- Used as subsequent therapy in patients intolerant to paclitaxel; AND disease is relapsed/refractory advanced cutaneous, oral, visceral, or nodal disease; AND disease has progressed on or not responded to first‑line systemic therapy and on alternate first‑line systemic therapy; AND either: used as single agent for patients without HIV; OR used in combination with antiretroviral therapy (ART) for patients with HIV.
Biliary tract cancers (Gallbladder / Intra‑/Extra‑hepatic cholangiocarcinoma)
- Used in combination with gemcitabine; AND patient has unresectable, resected gross residual (R2), or metastatic disease and may be used as primary or subsequent treatment after progression on or after systemic therapy; OR
- Used for resectable locoregionally advanced gallbladder cancer as neoadjuvant therapy in specific operative/pathologic scenarios (e.g., incidental suspicious mass during surgery without hepatobiliary expertise, incidental pathologic finding such as cystic duct node positive, or mass on imaging).
Small bowel adenocarcinoma
- Patient has advanced or metastatic disease; AND used as single agent or in combination with gemcitabine; AND used as initial therapy after prior adjuvant FOLFOX/CAPEOX within past 12 months or when contraindicated; OR used as subsequent therapy if not previously given.
Ampullary adenocarcinoma
- Used in combination with gemcitabine; AND patient has pancreatobiliary or mixed type disease; AND used as neoadjuvant therapy for localized high‑risk disease (equivocal/indeterminate imaging, markedly elevated CA19‑9 or CEA, large primary tumor or regional nodes, excessive weight loss, extreme pain), OR used as first‑line therapy for unresectable localized or metastatic disease, OR used as subsequent therapy for progression.
Gynecologic cancers
- Cervical cancer: used as single agent as subsequent therapy for persistent, recurrent, or metastatic disease including small cell neuroendocrine carcinoma of the cervix (NECC).
- Vaginal cancer: used as single agent as subsequent therapy for recurrent or metastatic disease.
General renewal criteria
- Coverage may be renewed if patient continues to meet the above indication criteria; AND there is tumor response with stabilization or decrease in tumor size/spread; AND absence of unacceptable toxicity (examples: ANC <1,500/mm3, sensory neuropathy, sepsis, pneumonitis, severe hypersensitivity, significant myelosuppression).

Regimens, Combinations, and Dosing Patterns

Regimen	Indication / Patient selection	Performance status / Biomarker notes	Authorization length / limits
nab-paclitaxel + carboplatin
First-line therapy for locally advanced or metastatic NSCLC in patients not candidates for curative surgery or radiation; also for recurrent/advanced/metastatic disease
PS 0-1 for many combination pathways; PD-L1 and actionable molecular biomarker status determine specific pathways (eg, PD-L1 <1% vs >=1%; actionable biomarkers include EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET exon 14, RET, ERBB2)
When combined with pembrolizumab or tremelimumab+durvalumab: max 12 weeks (12 doses) for specified combos; when combined with atezolizumab: up to 18 weeks (18 doses); dosing limits per revision (see policy)

Regimen	Indication / Patient selection	Dosing schedule (selected)	Authorization length / limits
nab-paclitaxel + gemcitabine
Locally advanced or metastatic pancreatic adenocarcinoma; used as first-line, induction followed by chemoradiation (locally advanced), subsequent therapy after progression on fluoropyrimidine-based therapy, or neoadjuvant for resectable/borderline disease
125 mg/m2 IV days 1, 8, and 15 of a 28-day cycle (common schedule); neoadjuvant: 125 mg/m2 days 1,8,15 for 6 cycles
Neoadjuvant/induction regimens in combination with gemcitabine may be limited to up to 24 weeks (18 doses) per revision

Regimen	Indication / Patient selection	Biomarker / sequencing notes	Dosing schedule (selected)
nab-paclitaxel (single-agent)
Breast cancer: single agent for metastatic, recurrent, or inflammatory disease meeting eligibility (eg, failed combination chemo or relapsed within 6 months of adjuvant therapy; prior anthracycline unless contraindicated)
Used in HER2-negative disease pathways and across lines (first-line if no germline BRCA1/2; second-line if not candidate for trastuzumab-deruxtecan; third-line and beyond). For TNBC may combine with pembrolizumab if PD-L1 positive (PD-L1 CPS >=10). HER2-positive disease: combination with trastuzumab in later lines per policy
Single-agent dosing: 260 mg/m2 IV every 21 days OR 100–125 mg/m2 IV days 1, 8, and 15 of a 28-day cycle

Setting / Regimen	Typical adult dosing	Cycle length	Notes
Single-agent (common)
260 mg/m2 IV on day 1
Every 21 days
Alternative weekly schedule: 100–125 mg/m2 IV on days 1, 8, and 15 of a 28-day cycle

Regimen	Combination partner(s)	PS / biomarker restrictions	Authorization length / renewal
nab-paclitaxel + carboplatin + pembrolizumab
Pembrolizumab (for squamous histology typically) with carboplatin and nab-paclitaxel
Patients with PS 0-1; tumor PD-L1 and actionable biomarker status guide use; contraindications to PD-1/PD-L1 agents alter pathway
Coverage provided up to a maximum of 12 weeks (12 doses) for specified combinations (per revision) and may NOT be renewed beyond defined maximums

Regimen	Indication / Patient selection	Biomarker / partner notes	Dosing schedule (selected)
nab-paclitaxel (single-agent) or + carboplatin
Ovarian, fallopian tube, primary peritoneal cancer: single agent or combined with carboplatin depending on histology, platinum-sensitivity, and confirmed taxane hypersensitivity
Use and partner selection guided by platinum-resistant vs platinum-sensitive status and taxane hypersensitivity; pembrolizumab or trastuzumab may be used per biomarker where specified
Single-agent: 260 mg/m2 IV day 1 q21d OR 100–125 mg/m2 days 1,8,15 q28d; combination schedules commonly 100–125 mg/m2 days 1,8,15 of 28-day cycle or 125 mg/m2 days 1 and 8 of a 21-day cycle depending on partner

Regimen	Histology / Indication	PS / biomarker considerations	Typical dosing / notes
nab-paclitaxel + carboplatin +/- PD-1/PD-L1 inhibitor
NSCLC — combination with carboplatin and pembrolizumab for squamous histology or carboplatin and atezolizumab for non-squamous; alternative combos include tremelimumab+durvalumab+carboplatin in select patients
Pathway selection depends on PS (eg PS 0-1 vs 0-2), PD-L1 expression (eg <1% vs >=1%) and actionable molecular biomarkers; some combos exclude PD-L1 >=50% patients per revision
Dosing examples: 100 mg/m2 IV days 1,8,15 q21d for combination regimens; authorization length limits apply (eg 12–18 weeks depending on combo)

Regimen	Indication / Patient selection	Platinum-sensitivity / prior therapy	Dosing / notes
nab-paclitaxel (single-agent) or + carboplatin
Recurrent ovarian, peritoneal, or fallopian tube cancer — selection depends on platinum-resistant vs platinum-sensitive disease and taxane hypersensitivity
Platinum-resistant: single-agent use for progression or stable/persistent disease; Platinum-sensitive: may be combined with carboplatin for relapse >=26 months after remission or per specified timing
Single-agent dosing: 260 mg/m2 q21d OR 100–125 mg/m2 days 1,8,15 q28d; combination schedules per regimen (eg 125 mg/m2 days 1,8,15 q28d or 125 mg/m2 days 1 and 8 q21d)

Regimen	Indication / Patient selection	Sequencing / prior therapy requirements	Dosing / authorization limits
nab-paclitaxel (single-agent)
Kaposi sarcoma — used as subsequent therapy in patients intolerant to paclitaxel; single-agent for HIV-negative patients or with ART for patients with HIV
Used after progression on or nonresponse to first-line systemic therapy or alternate first-line systemic therapy; prior paclitaxel intolerance documented despite premedication when applicable
Kaposi dosing: fixed 100 mg IV days 1,8,15 of a 28-day cycle; policy documents a dose cap of 300 billable units per 28 days and typical authorization lengths per standard policy (6 months) with renewal contingent on response/toxicity

Codes, Dosing Limits, and Diagnoses

Kaposi Sarcoma dosing limitsmixedCovered

300 billable units / 28 days

Kaposi sarcoma dosing limit

NSCLC dosing limitsmixedCovered

900 billable units / 21 days	NSCLC dosing limit (also listed per 28 days)
900 billable units / 28 days	NSCLC dosing limit

Breast and related indications dosing limitsmixedCovered

2800 billable units / 84 days

Breast, small bowel adenocarcinoma, pancreatic adenocarcinoma, ovarian/fallopian/primary peritoneal, endometrial carcinoma dosing cap

Melanoma dosing limitsmixedCovered

1200 billable units / 28 days

Cutaneous & uveal melanoma dosing limit

Applicable CPT/HCPCS CodesHCPCSCovered

J9264

Injection,paclitaxel protein-bound particles,1 mg; 1 billable unit = 1 mg

Applicable NDCsNDCCovered

00480-3290-01	Paclitaxel protein-bound part 100 mg (teva pharmaceuticals)
00517-4300-01	Paclitaxel protein-bound part 100 mg (American regent)
00781-3531-91	Paclitaxel protein-bound part 100 mg (sandoz)
60505-6230-04	Paclitaxel protein-bound part 100 mg (apotex)
68817-0134-50	Abraxane 100 mg powder for injection; single-use vial (b-m squibb us)

Applicable ICD‑10 Diagnoses (selected excerpts)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 the gallbladder
C24.0	Malignant neoplasm of extrahepatic bile duct
C24.1	Malignant neoplasm of ampulla of Vater

1–10 of 29

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ICD-10 Diagnoses (partial)ICD-10

C50.421	Malignant neoplasm of upper-outer quadrant of right male breast
C50.422	Malignant neoplasm of upper-outer quadrant of left male breast
C50.429	Malignant neoplasm of upper-outer quadrant of unspecified male breast
C50.511	Malignant neoplasm of lower-outer quadrant of right female breast
C50.512	Malignant neoplasm of lower-outer quadrant of left female breast
C50.519	Malignant neoplasm of lower-outer quadrant of unspecified female breast
C50.521	Malignant neoplasm of lower-outer quadrant of right male breast
C50.522	Malignant neoplasm of lower-outer quadrant of left male breast
C50.529	Malignant neoplasm of lower-outer quadrant of unspecified male breast
C50.611	Malignant neoplasm of axillary tail of right female breast

1–10 of 43

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Covered J-codes / coding updateHCPCS

J9259	Injection, paclitaxel protein-bound particles (American regent) not therapeutically equivalent to J9264, 1 mg
J9264	Injection, paclitaxel protein-bound particles, 1 mg (listed as reference)

Age requirement — patient is 18 years of age or older

Minimum agePatient is 18 years of age or older

Breast cancer eligibility noteAge requirement applies to breast cancer coverage criteria where listed (must be ≥18)

General policy applicabilityAge ≥18 requirement applies across indicated tumor-specific coverage criteria unless otherwise specified for Medicare members

Laboratory threshold — absolute neutrophil count threshold referenced

Absolute neutrophil count (ANC) threshold

Prior Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. The treating physician or primary care provider must submit clinical evidence that the member meets the indication-specific criteria and that prior therapies/sequence requirements have been met. Failure to submit required documentation will prevent approval.

Prior authorization standard length: coverage will be provided for six months and may be renewed unless a specific indication limit applies.
Requests exceeding published maximum lengths (see indication-specific limits below) require justification and may be denied.

Prior Authorization

Prior Authorization: Indication, Prior Therapies, and Renewal Evidence

Indication-specific prior authorization must document diagnosis, line of therapy, prior agents tried (or documented intolerance/hypersensitivity), and biomarker/testing results when applicable. Renewal requests must include evidence of tumor response (stable disease or reduction) and absence of unacceptable toxicity.

Document prior use of standard agents (e.g., paclitaxel) or provide documented intolerance/hypersensitivity if using nab-paclitaxel instead.

Biomarker and Molecular Testing Requirements

PD-L1 — CPS and % expression thresholds used in decision branches (e.g., CPS <10, CPS >=10, <1%, >=1%, >=50%)

PD-L1 CPS <10Breast TNBC first-line pathway: PD-L1 CPS <10 (and no germline BRCA1/2) guides single-agent or carboplatin use

PD-L1 CPS ≥10 / PD-L1 positiveBreast TNBC: PD-L1 CPS ≥10 (PD-L1 positive) is referenced for combination with pembrolizumab

PD-L1 % expression thresholdsNSCLC branches reference PD-L1 <1%, PD-L1 ≥1%, and PD-L1 ≥50% across decision pathways

Actionable molecular genomic biomarkers — enumerated list used to route therapy choices

Enumerated actionable biomarkersEGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET exon 14 skipping, RET rearrangement, ERBB2 (HER2)

Role in NSCLC

Terms and Background

Abraxane (albumin‑bound paclitaxel) is an intravenous formulation of paclitaxel bound to albumin nanoparticles. It is a microtubule inhibitor used across multiple solid tumor indications including breast cancer, non‑small cell lung cancer, pancreatic adenocarcinoma, melanoma, ovarian and biliary tract cancers, Kaposi sarcoma, and small bowel adenocarcinoma, and is described in the policy as having indication‑specific dosing, combination partners, and sequencing requirements.

Abraxane — definition as albumin-bound paclitaxel and mechanism class

Abraxane definitionAbraxane is albumin-bound paclitaxel, a microtubule inhibitor preventing microtubule depolymerization

Mechanism classClassified as a microtubule inhibitor (paclitaxel protein-bound formulation)

Route of administrationIntravenous formulation used across multiple solid tumor indications

Genomic Aberration Targeted Therapies — listing genomic contexts referenced

Genomic aberration contexts listed

Document Changes and Revision Timeline

Material changes include updated dosing limits and added explicit lengths of authorization for several indications. Notably, several NSCLC platinum/ICI combinations were assigned maximum authorization periods (for example, 12 weeks for some tremelimumab/durvalumab/carboplatin or pembrolizumab combinations and 18 weeks for atezolizumab‑containing regimens), and select neoadjuvant/induction uses were set to 24 weeks with non‑renewal.

The coding section was updated to add a second J‑code. J9259 (Injection, paclitaxel protein‑bound particles, American Regent) was added alongside the primary code J9264, and the dosing chart and related coding entries were updated accordingly.

Policy Summary

PayerEmblemHealth

PolicyAbraxane (paclitaxel protein-bound particles) Intravenous

Policy CodePolicy MG.MM.PH.66

Change TypeCoverage criteria and dosing revisions

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical evidence that the member meets indication‑specific criteria, including biomarker and performance status documentation.

SourceLink

On This Page

Used as subsequent therapy: may be used as single agent (if not previously given) in patients with PS 0–2 for first progression after initial systemic therapy; and used based on mutation status (e.g., BRAF V600E, NTRK fusions, MET exon 14 skipping, RET rearrangement) or after prior targeted therapies for certain aberrations (e.g., selected EGFR, ALK, ROS1 alterations).

Actionable molecular genomic biomarkers include EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET exon 14 skipping, RET rearrangement, and ERBB2 (HER2). If tissue is insufficient, repeat biopsy and/or plasma testing should be done; if not feasible, treat as though driver oncogenes are absent. Contraindications to PD-1/PD-L1 inhibitors may include active autoimmune disease or use of immunosuppressive agents; some oncogenic drivers (e.g., sensitizing EGFR, ALK) are associated with less benefit from PD-1/PD-L1 inhibitors.

Renewal denial example lists neutrophil counts of < 1,500 cells/mm3 as unacceptable toxicity

Renewal requirement impactANC <1,500 cells/mm3 cited among examples of unacceptable toxicity that would preclude renewal

Documentation implicationProviders should submit recent ANC when requesting renewal to demonstrate ANC ≥1,500 cells/mm3

Lengths of authorization — specific new authorization lengths for NSCLC and select regimens

NSCLC — tremelimumab + durvalumab + carboplatin or pembrolizumab + carboplatinCoverage provided for up to a maximum of 12 weeks of therapy (12 doses) and may NOT be renewed

NSCLC — atezolizumab + carboplatinCoverage provided for up to a maximum of 18 weeks of therapy (18 doses) and may NOT be renewed

Selected neoadjuvant uses (Ampullary, Gallbladder, Pancreatic induction)Coverage provided for up to a maximum of 24 weeks of therapy (18 doses) and may NOT be renewed

Relapse timing for platinum-sensitive disease — timing threshold (>= 26 months) noted

Platinum-sensitive relapse timingRelapse 26 months after complete remission (≥ 26 months) defines platinum-sensitive disease for certain regimens

Use implicationPlatinum-sensitive patients with relapse ≥26 months may be eligible for combination with carboplatin when taxane hypersensitivity is present

Documentation implicationProvider should document timing of relapse relative to prior complete remission to support regimen selection

Renewal criteria: patient continues to meet initial criteria; tumor response with stabilization or decrease in tumor size/spread; absence of unacceptable toxicity (examples: ANC <1,500/mm3, sensory neuropathy, sepsis, pneumonitis, severe hypersensitivity, myelosuppression).

Prior Authorization

Prior Authorization for Updated Dosing and Lengths

Updated dosing limits and lengths of authorization are enforced. Prior authorization requests must conform to the revised maximum dosing/authorization durations; requests that exceed these dosing limits or lengths should be denied or require clinical justification.

Examples of non-renewable, indication-specific maximums: certain NSCLC combinations (12 weeks/12 doses or 18 weeks/18 doses), neoadjuvant therapies for ampullary/gallbladder/pancreatic indications (up to 24 weeks/18 doses) — renewal may NOT be allowed for those specific neoadjuvant indications per policy.
When requesting quantities or durations beyond policy maximums, include clinical rationale and supporting documentation.

Billing Rule

Billing and Diagnosis Documentation (J-code / NDC)

J-code and NDC billing information must be provided on the claim and in the clinical documentation. EmblemHealth requires submission of the applicable HCPCS J-code(s) and NDC(s) to properly identify product and dosing.

Primary HCPCS: J9264 = Injection, paclitaxel protein-bound particles, 1 mg (1 billable unit = 1 mg).
Note addition: J9259 may be present in history; confirm product therapeutic equivalence before billing (some J-codes represent non-equivalent products).
Include applicable NDC(s) when available (e.g., 68817-0134-50 Abraxane 100 mg; other listed NDCs per policy).
Include the ICD-10 diagnosis code(s) that support the indication (see policy ICD-10 list).

Documentation Required

Documentation Required for Review

Clinical evidence submission requirements: supply supporting clinical documentation including history, prior lines of therapy, response to prior treatments, performance status, and any relevant biomarker test results. Lack of this information will prevent authorization.

Submit prior therapy records (dates, agents, reason for discontinuation/progression or documented intolerance).
Document line/sequence of therapy (first-line, subsequent) and rationale for use in the requested line.
Include performance status and tumor response assessments (imaging reports, RECIST or provider summary).

Documentation Required

Supporting Clinical Documentation and Biomarker Testing

Supporting clinical documentation must demonstrate the disease setting, prior therapies and responses, platinum-sensitivity when applicable, and biomarker status for indications where actionable genomic biomarkers affect therapy selection.

For NSCLC and other tumor types where actionable biomarkers alter therapy, document testing results for EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET exon 14 skipping, RET, and ERBB2 (HER2) when applicable.
If testing is not feasible, document rationale; if unknown, treat as lacking driver oncogenes per policy guidance.

Step Therapy

Step Therapy and Sequencing Requirements

Step therapy and sequencing rules apply. The policy requires documentation of prior lines and responses; some indications require prior paclitaxel unless there is documented intolerance or hypersensitivity.

When policy specifies first-line vs subsequent therapy, include documentation showing the patient’s prior systemic therapies and reasons for selection of nab‑paclitaxel.
If using nab‑paclitaxel because of paclitaxel intolerance, include documentation of hypersensitivity despite recommended premedication or a documented medical contraindication to standard premedication.
Kaposi sarcoma: use as subsequent therapy in patients intolerant to paclitaxel; document relapsed/refractory advanced disease and progression on or lack of response to first-line systemic therapy. For HIV-positive patients, document concomitant ART when applicable.

Denial Risk

Denial Risk: Use Inconsistent with Policy

Use inconsistent with specified performance or regimen requirements may lead to denial. Approvals are contingent upon meeting the exact criteria for indication, sequence, dosing, duration, biomarker status, and documentation.

Denial triggers include: lack of required prior therapy documentation, absence of indicated biomarker testing where required, requests exceeding dosing or authorization length limits without justification, or use in an unlisted indication.
Clinical exceptions must be justified with detailed provider rationale and supporting evidence.

Testing for these actionable molecular genomic biomarkers directs NSCLC treatment pathway selection and sequencing

Testing expectationIf insufficient tissue for testing, repeat biopsy or plasma testing should be done; treat as no driver oncogene if testing not feasible

EGFR, ALK, ROS1, BRAF, PD-L1 listed as genomic contexts

Genomic contexts listedEGFR, ALK, ROS1, BRAF, PD-L1 are presented as genomic/biomarker contexts in dosing/administration and biomarker sections

Associated targeted agents contextDosing/administration maps genomic aberrations to example targeted therapies (e.g., EGFR to osimertinib, ALK to alectinib)

Testing guidanceDocument advises repeat biopsy/plasma testing if inadequate tissue for full panel

List of specific mutations/rearrangements referenced (EGFR exon20, KRAS G12C, BRAF V600E, NTRK fusions, MET exon14, RET, ERBB2)

Specific mutations/rearrangements enumeratedEGFR exon 20, KRAS G12C, BRAF V600E, NTRK1/2/3 fusions, MET exon 14 skipping, RET rearrangement, ERBB2 (HER2)

Use implicationPresence of these mutations guides eligibility for mutation-specific NSCLC pathways and combination choices

Prior targeted therapy considerationSome patients with these mutations who received prior targeted therapy have alternative eligibility rules

PD-L1 CPS and % expression referenced across branches

PD-L1 CPS thresholds for breastPD-L1 CPS <10 used to define first-line TNBC single-agent/carboplatin pathway; PD-L1 CPS ≥10 (PD-L1 positive) referenced for pembrolizumab combination

PD-L1 % thresholds in NSCLCPD-L1 <1% and PD-L1 ≥1% referenced to stratify NSCLC pathways; PD-L1 ≥50% noted in some branches

PD-L1 testing rolePD-L1 results direct whether immunotherapy combinations (e.g., pembrolizumab, atezolizumab) are appropriate

germline BRCA1/2 — referenced as biomarker for certain breast/ovarian regimens

germline BRCA1/2 notedGermline BRCA1/2 is referenced in breast cancer pathways to define first-line vs later-line therapy

Breast therapy implicationFirst-line therapy permitted if no germline BRCA1/2 mutation; BRCA status influences sequencing and eligibility

Documentation implicationProviders should document germline BRCA1/2 testing status when relying on this branch

EGFR — actionable biomarker reference

EGFR included as actionable biomarkerEGFR (including multiple sensitizing and uncommon mutations) is listed among actionable genomic biomarkers guiding NSCLC pathways

Testing expectationIf insufficient tissue, repeat biopsy or plasma testing should be performed for EGFR and other markers

Impact on immunotherapySome EGFR alterations are associated with less benefit from PD-1/PD-L1 inhibitors and are noted as contraindications to immunotherapy combinations

KRAS (including G12C) — actionable biomarker reference

KRAS (including G12C) listedKRAS (including G12C) is listed as an actionable molecular biomarker influencing NSCLC treatment pathways

Pathway relevanceKRAS G12C positivity places patients into molecular-positive pathways with PS-dependent regimen options

Testing and sequencingKRAS testing is expected as part of the actionable biomarker panel to inform sequencing and eligibility

ALK, ROS1, BRAF V600E, NTRK, MET exon 14 skipping, RET, ERBB2(HER2) — grouped actionable biomarkers

Grouped actionable biomarkersALK, ROS1, BRAF V600E, NTRK1/2/3 fusions, MET exon 14 skipping, RET rearrangement, ERBB2 (HER2) are grouped as actionable biomarkers

Clinical implicationPresence of these biomarkers guides eligibility for mutation-specific NSCLC pathways and may affect immunotherapy combination choices

Testing guidancePolicy recommends comprehensive testing for these markers or repeat/plasma testing if initial tissue insufficient

EGFR, ALK, ROS1, BRAF, PD-L1 and others are presented in the dosing/administration genomic aberration targeted therapies mapping

Example targeted agentsDosing section maps mutations to example targeted agents (e.g., EGFR → osimertinib; BRAF V600E → dabrafenib + trametinib)

PurposeThese genomic contexts inform selection of targeted therapy pathways referenced in the policy

ICD-10 diagnosis code examples for malignant neoplasms

ICD-10 diagnosis examplesIncludes malignant neoplasm codes such as C25.x (pancreas), C34.x (lung), C50.x (breast), C46.x (Kaposi sarcoma), C17.x (small intestine), C23–C24 (gallbladder/biliary tract)

Provider documentationProviders should supply the appropriate ICD-10 diagnosis code corresponding to the covered tumor type when requesting authorization

Partial list noteDocument contains an extensive ICD-10 list; examples above are selected excerpts from the policy

actionable molecular biomarkers enumerated — short list reference

Short actionable biomarker listKey actionable biomarkers enumerated include EGFR, KRAS G12C, BRAF V600E, NTRK1/2/3 fusions, MET exon 14 skipping, RET, ERBB2 (HER2)

PurposeThese biomarkers are used to route NSCLC patients into specific treatment pathways and sequencing decisions

Testing recommendationComprehensive testing or repeat/plasma testing is recommended if tissue is insufficient

Enumerated biomarker set (EGFR, KRAS, ALK, ROS1, BRAF, NTRK, MET ex14, RET, ERBB2)

Enumerated biomarker setEGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET exon 14 skipping, RET, ERBB2 (HER2)

Use in policyListed repeatedly across NSCLC and other tumor-specific branches to determine eligibility and sequencing

Action requiredProviders should include biomarker test results or documentation of why testing was not feasible with authorization requests

Performance status references (PS 0-1, PS 0-2, PS 2) used as regimen modifiers

Performance status modifiersPS 0-1, PS 0-2, and PS 2 are referenced as modifiers directing regimen choice (e.g., PS 0-1 for combination regimens; PS 2 may limit to single-agent use)

NSCLC examplePS 0-1 vs 0-2 distinctions determine eligibility for platinum + immunotherapy combinations or single-agent use

Documentation implicationProviders must document ECOG/PS score to support regimen selection and renewals