CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Abraxane (nab-paclitaxel) coverage guideline

Defines accepted indications, exclusions, contraindications, and coding for Abraxane (nab-paclitaxel) including FDA-approved and select off-label uses; indicates when Evolent will support use and documents documentation/evidence requirements and continuation criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAbraxane (nab-paclitaxel) coverage guideline

Policy CodePolicy N/A

Change TypeTemplate conversion / verbiage updates

Effective Date

Next Review Date

Key ActionPrescribers must support Abraxane use with FDA labeling, CMS‑approved compendia, NCCN, ASCO guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1179 Abraxane guideline.

1Supported primary indication (pancreatic adenocarcinoma)

4Cancer types not supported

1HCPCS drug code listed

Coverage Summary

Evolent has a mixed coverage stance for Abraxane (nab-paclitaxel). The policy supports Abraxane in combination with gemcitabine for pancreatic adenocarcinoma (neoadjuvant for borderline resectable/locally advanced disease and first or subsequent line therapy for recurrent/metastatic disease) consistent with cited randomized trial evidence. For multiple other cancer types — including breast cancer, cervical/endometrial/ovarian cancers, melanoma, and non‑small cell lung cancer — Abraxane and Abraxane‑based regimens are generally not supported due to lack of Level 1 evidence showing superiority to solvent‑based paclitaxel or recommended alternatives, except when the member has a history of severe allergic reaction/anaphylaxis to solvent‑based paclitaxel (Taxol) or docetaxel (Taxotere), in which case Abraxane would be supported.

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General coverage requirements

Abraxane use must be supported by recognized evidence sources; continuation requests for a not-approvable medication are exempt when specific conditions are met.

Use is supported by FDA approved product labeling, CMS‑approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Continuation request exemption

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Initial Therapy Criteria by Indication

Pancreatic adenocarcinoma

Supported uses in pancreatic adenocarcinoma per trials and guideline updates.

Abraxane in combination with gemcitabine may be used as neoadjuvant therapy for borderline resectable or locally advanced pancreatic adenocarcinoma

Abraxane in combination with gemcitabine may be used for first or subsequent line therapy for recurrent/metastatic pancreatic adenocarcinoma for members who have not received or progressed on prior Abraxane (nab-paclitaxel)

Breast cancer

Evolent position for breast cancer: Abraxane is restricted.

Supported only if: Member has a history of a severe allergic reaction/anaphylaxis to solvent-based paclitaxel (Taxol) or docetaxel (Taxotere)

Not supported otherwise: Otherwise, Abraxane and Abraxane-based regimens are NOT supported for adjuvant therapy of stages I-III breast cancer OR treatment of recurrent unresectable or metastatic breast cancer due to lack of Level 1 evidence showing superiority to solvent-based paclitaxel

Cervical, endometrial, and ovarian cancer

Evolent position for gynecologic malignancies: Abraxane is restricted.

Supported only if: Member has a history of a severe allergic reaction/anaphylaxis to solvent-based paclitaxel (Taxol) or docetaxel (Taxotere)

Not supported otherwise: Otherwise, Abraxane is NOT supported for treatment of cervical, endometrial, or ovarian cancer due to lack of Level 1 evidence showing superiority to solvent-based paclitaxel or docetaxel

Melanoma

Evolent position for unresectable/metastatic cutaneous melanoma: generally not supported with an exception.

Abraxane is NOT supported for treatment of unresectable/metastatic cutaneous melanoma due to lack of Level 1 evidence showing superiority to Evolent-recommended alternatives

Exception: Abraxane would be supported if member has history of severe allergic reaction/anaphylaxis to solvent-based paclitaxel

Non-small cell lung cancer (NSCLC)

Evolent position for NSCLC: not supported for initial or subsequent therapy except for hypersensitivity to solvent-based paclitaxel.

Abraxane +/- carboplatin +/- pembrolizumab (for squamous) / atezolizumab (for non-squamous) are NOT supported for initial or subsequent treatment of NSCLC based on KEYNOTE-407 and lack of Level 1 evidence showing superiority to solvent-based paclitaxel combinations

Exception: Abraxane would be supported if member has a history of a severe allergic reaction/anaphylaxis to solvent-based paclitaxel

Continuation Therapy Criteria

Continuation request exemption (details)

Continuation request exemption criteria for not-approvable medications (detailed branch).

Continuation exemption requirements

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization>30 days lapse
Additional medication(s) are not being added to the continuation request

Exclusions, Contraindications, and Non-Covered Uses

Contraindications

Absolute contraindications for Abraxane.

Neutrophil counts < 1,500 cells/mm3< 1,500 cells/mm3

Absolute contraindication

Severe hypersensitivity reactions to Abraxane (nab-paclitaxel) injectable suspension

Absolute contraindication

Exclusion criteria

Conditions and evidence standards that lead to non-coverage of Abraxane.

Disease progression while receiving Abraxane or an Abraxane-containing regimen

Dosing exceeds single dose limit of Abraxane 260 mg/m2 if given every 3 weeksAbraxane 260 mg/m2 q3w

Exclusion for dosing exceeding single-dose limit

Investigational use/off-label indication not supported by sufficient evidence or not generally accepted by the medical community

Evidence insufficiency criteria: Evidence insufficiency may include inadequate representativeness of patient/cancer characteristics, inadequate regimen representation, lack of clinically meaningful outcomes (ASCO e.g., HR < 0.80 and OS/PFS benefit >= 3 months), inappropriate study design, reliance solely on case reports or abstractsHR < 0.80; OS/PFS >= 3 months for meaningful benefit

Defines sufficiency of evidence

Continuation requests for a medication that would otherwise be not approvable are exempt from denial provided ALL of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and additional medication(s) are not being added to the continuation request.

Evidentiary sufficiency for coverage requires support from CMS‑recognized compendia or acceptable peer‑reviewed literature. Evidence is considered insufficient when clinical characteristics or the regimen are not adequately represented, outcomes are not clinically meaningful (ASCO examples: hazard ratio < 0.80 and OS/PFS benefit ≥ 3 months), study design is inappropriate, or the data rely solely on case reports or abstracts without full peer‑reviewed publication.

Provider Actions & Prior Authorization

Prior Authorization

Evolent authorization required

Evolent authorization is required to process medication requests. Medications that have not been authorized by Evolent may be deemed not approvable and therefore may not be reimbursable.

Documentation Required

Support with recognized evidence sources

Prescribers must support Abraxane use with one of the following evidence sources: FDA-approved product labeling, CMS‑approved compendia, National Comprehensive Cancer Network (NCCN) guidelines, American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Documentation Required

Continuation request requirements

Continuation requests for a not-approvable medication are exempt only if ALL of the following are documented:

Member has not experienced disease progression on the requested medication
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Denial Risk

Exclusion risk for investigational/off-label use

Claims for investigational or off-label indications that lack sufficient supporting evidence are excluded and at risk for denial. Evidence-insufficiency considerations include representativeness of patient/cancer characteristics, regimen representation, lack of clinically meaningful outcomes (ASCO definitions such as HR < 0.80 and OS/PFS benefit ≥ 3 months), inappropriate study design, and reliance solely on case reports or abstracts.

Billing Rule

Dose limit enforcement

Claims with dosing that exceed the single dose limit for Abraxane should be excluded/denied.

J9264

Clinical Evidence & Rationale

KEYNOTE-355Trials cited — informs non-support for breast cancer (comparable outcomes vs solvent-based paclitaxel)

IMpassion130Trials cited — referenced in breast cancer evidence base

KEYNOTE-407Trials cited — informs non-support for NSCLC (equivalent PFS/OS vs solvent-based paclitaxel)

VonHoff2013Trial cited — supports pancreatic use with gemcitabine

The policy basis references randomized clinical trials and guideline updates. Key trials and references informing positions include Von Hoff et al supporting nab‑paclitaxel plus gemcitabine in pancreatic cancer and trials such as KEYNOTE‑355/IMpassion130 and KEYNOTE‑407 informing non‑support positions for breast cancer and NSCLC respectively. Evolent requires that requests be supported by FDA labeling, CMS compendia, NCCN/ASCO guidance, or peer‑reviewed literature meeting CMS Chapter 15 standards.

Consistent with the evidence and guideline updates, the policy emphasizes a preference for solvent‑based paclitaxel (Taxol) over Abraxane except when a patient has a documented severe hypersensitivity/anaphylaxis to solvent‑based paclitaxel or docetaxel, in which case Abraxane would be supported.

The policy uses ASCO definitions for clinically meaningful outcomes when assessing evidence strength (for example, ASCO recommends thresholds such as a hazard ratio < 0.80 and survival benefit for OS/PFS of at least 3 months).

Background

This guideline defines accepted indications and exclusions for Abraxane (nab‑paclitaxel) based on FDA labeling, CMS‑approved compendia, NCCN and ASCO guidelines, and peer‑reviewed evidence. It specifies supported uses (notably combination with gemcitabine for pancreatic adenocarcinoma) and documents non‑support positions across several tumor types where Level 1 evidence of superiority is lacking.

Evolent expresses a clear preference for solvent‑based paclitaxel formulations (Taxol) except when a patient has a documented history of a severe allergic reaction/anaphylaxis to solvent‑based paclitaxel or docetaxel, in which case Abraxane is a supported alternative. The document cites randomized trials and guideline publications (e.g., KEYNOTE‑series trials, IMpassion130, Von Hoff et al) and references FDA prescribing information and compendia as sources.

Continuation request exemption: A not‑approvable medication may be continued if the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

Sufficient evidence: Evidence that supports coverage must come from CMS‑recognized compendia or acceptable peer‑reviewed literature. ASCO clinical meaningfulness thresholds are used as examples of adequate benefit (e.g., HR < 0.80 and OS/PFS benefit ≥ 3 months). Evidence may be insufficient if patient/regimen characteristics are not represented, outcomes are not clinically meaningful, study design is inappropriate, or data are limited to case reports or abstracts.