CurrentNeighborhood Health Plan of Rhode IslandPolicy Evolent Clinical Guideline 3000 for Abraxane (nab-paclitaxel)

Evolent Clinical Guideline 3000 for Abraxane (nab-paclitaxel)

Defines accepted indications, limitations, and authorization requirements for Abraxane (nab‑paclitaxel) for Neighborhood Health Plan of Rhode Island members as processed by Evolent. Applies to network ordering providers requesting coverage for this drug.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEvolent Clinical Guideline 3000 for Abraxane (nab-paclitaxel)

Policy CodePolicy Evolent Clinical Guideline 3000 for Abraxane (nab-paclitaxel)

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit prior authorization with documentation of indication and supporting evidence (FDA label, CMS compendia, NCCN/ASCO, or peer‑reviewed literature) and prior exposure status for continuation requests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J9264HCPCS

Commercial; Exchange; MedicaidLines of business

260 mg/m2Max single dose

<1,500 /mm3Neutrophil threshold

Pancreatic adenocarcinoma

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Coverage Criteria for Abraxane (nab-paclitaxel)

Pancreatic adenocarcinoma — supported use

Covered when ALL of the following are met

Pancreatic adenocarcinoma indication: Member has pancreatic adenocarcinoma AND regimen is nab-paclitaxel in combination with gemcitabine for neoadjuvant therapy of borderline resectable or locally advanced disease OR for first or subsequent line therapy for recurrent/metastatic disease

For subsequent line use, member must not have received or progressed on prior nab-paclitaxel

Non‑supported tumor types

Not supported except for allergy/anaphylaxis to solvent-based agents

Tumor types with non‑support: Abraxane (nab-paclitaxel) is not supported for adjuvant/neoadjuvant or metastatic breast cancer (stages I-III or recurrent/metastatic), cervical cancer, endometrial cancer, ovarian cancer, unresectable/metastatic melanoma, or initial/subsequent treatment of non-small cell lung cancer (NSCLC)

Use of Abraxane may be supported if there is a documented severe allergic reaction/anaphylaxis to solvent-based paclitaxel (Taxol) or docetaxel (Taxotere)

Coverage will be denied when there is documented disease progression while receiving Abraxane (nab-paclitaxel) or an Abraxane-containing regimen. Requests will also be excluded if the requested dosing exceeds the policy's single-dose limit of 260 mg/m2 when given every 3 weeks. Investigational use or off-label indications that lack sufficient evidence as defined in the guideline (i.e., not supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature meeting CMS criteria) are not covered.

Evolent does not support routine use of Abraxane (nab-paclitaxel) for the following tumor types: breast cancer (adjuvant/neoadjuvant stages I–III or recurrent/metastatic), cervical cancer, endometrial cancer, ovarian cancer, unresectable/metastatic cutaneous melanoma, and non‑small cell lung cancer (NSCLC) for initial or subsequent treatment. This position reflects a lack of Level 1 evidence demonstrating superior outcomes compared with solvent-based paclitaxel (Taxol) or docetaxel (Taxotere). Use in these indications may be considered only when there is a documented severe allergic reaction/anaphylaxis to solvent-based paclitaxel or docetaxel, or when sufficient supporting evidence from recognized sources is provided.

Regimens and Indications Supported

Regimen	Indication	Coverage stance
nab-paclitaxel in combination with gemcitabine
Pancreatic adenocarcinoma — neoadjuvant therapy for borderline resectable or locally advanced disease; first or subsequent line therapy for recurrent/metastatic disease (provided member has not received/progressed on prior nab-paclitaxel)
Covered

Regimen	Indication / context	Coverage stance
Abraxane +/- carboplatin +/- pembrolizumab (Keytruda) or atezolizumab; Abraxane-based regimens
Breast cancer — adjuvant/neoadjuvant or metastatic (stages I-III or recurrent/metastatic); Non-Small Cell Lung Cancer (initial or subsequent treatment)
Not supported except when member has documented severe allergic reaction/anaphylaxis to solvent-based paclitaxel (Taxol) or docetaxel (Taxotere)

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J9264

Injection, paclitaxel protein-bound particles, 1 mg

Covered HCPCS CodesHCPCSCovered

J9264

Injection, paclitaxel protein-bound particles, 1 mg

Maximum single dose (q3w) — dosing limit

Maximum single dose (q3w)260 mg/m2 — dosing that exceeds this single‑dose limit when given every 3 weeks is an exclusion

ApplicabilityApplies to Abraxane (nab‑paclitaxel) administered on a q3w (every 3 weeks) schedule

Exclusion consequenceRequests for dosing above 260 mg/m2 (q3w) are considered excluded from coverage

Related exclusionAlso excluded: disease progression while receiving Abraxane or an Abraxane‑containing regimen

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Requests for Abraxane (nab‑paclitaxel) must be submitted to Evolent for review and authorization prior to initiation except where continuation exemption criteria apply.

Continuation exemption applies when: member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse >30 days of an active authorization; no additional medications are being added to the continuation request.

Prior Authorization

Preferred Alternatives and Allergy Exception

Abraxane is generally not preferred when solvent‑based paclitaxel (Taxol) or docetaxel (Taxotere) are appropriate and supported by evidence. Abraxane may be authorized as an alternative only when there is documentation of a severe hypersensitivity reaction or anaphylaxis to solvent‑based paclitaxel or docetaxel, or when clinical circumstances make solvent‑based formulations unsuitable.

Preferred alternatives include solvent‑based paclitaxel (Taxol) or docetaxel (Taxotere) and other Evolent‑recommended regimens (see Evolent Pathways).
Allergy exception: must document history of severe allergic reaction/anaphylaxis to solvent‑based Taxol (paclitaxel) or Taxotere (docetaxel).

Line of Therapy Positioning

first-line | subsequent

Pancreatic regimen lines: nab-paclitaxel + gemcitabine may be used as neoadjuvant therapy for borderline resectable or locally advanced pancreatic adenocarcinoma OR as first or subsequent line therapy for recurrent/metastatic pancreatic adenocarcinoma provided the member has not received or progressed on prior nab-paclitaxel

neoadjuvant | adjuvant | subsequent

Breast cancer neoadjuvant/adjuvant guidance: Abraxane is not supported for neoadjuvant or adjuvant treatment of stages I-III breast cancer or for treatment of recurrent unresectable or metastatic breast cancer due to lack of Level 1 evidence showing superiority to solvent-based paclitaxel; exception allowed for documented severe hypersensitivity/anaphylaxis to solvent-based paclitaxel or docetaxel

References include KEYNOTE-355 and other trials cited by policy

Background and Rationale

Abraxane is an albumin-bound formulation of paclitaxel developed to avoid solvent-based carriers used with traditional paclitaxel formulations. Evolent supports Abraxane when the indication and regimen are justified by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, or adequate peer‑reviewed evidence that meets CMS criteria. For pancreatic adenocarcinoma, nab-paclitaxel in combination with gemcitabine is an accepted regimen for neoadjuvant therapy of borderline resectable or locally advanced disease and for first or subsequent line treatment of recurrent/metastatic disease when prior nab-paclitaxel exposure/progression rules are met.

Definitions and Evidence Standards

Sufficient evidence — acceptable evidence sources and standards

Acceptable evidence sourcesFDA approved product labeling; CMS‑recognized compendia; NCCN or ASCO clinical guidelines; or peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 criteria

Peer‑reviewed literature standardsMust meet CMS Chapter 15 criteria (representative patient characteristics, regimen representation, clinically meaningful outcomes, and appropriate study design)

Clinically meaningful outcomesASCO‑recommended thresholds (e.g., hazard ratio <0.80 and recommended survival benefit for OS/PFS of at least 3 months) used to judge sufficiency of evidence

Lower‑weight evidenceNon‑randomized trials with substantial subject numbers may provide supportive evidence; case reports and abstracts without full peer‑reviewed articles generally are insufficient