CurrentAvMedPolicy N/A

Paclitaxel protein‑bound (Abraxane) medical prior authorization

Defines prior authorization, initial and reauthorization clinical criteria, and documentation requirements for non‑preferred paclitaxel protein‑bound (Abraxane®) for AvMed medical (Part B) benefit; applies to providers requesting outpatient administration.

Policy Summary

PayerAvMed

PolicyPaclitaxel protein‑bound (Abraxane) medical prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionProvider must obtain prior authorization for non-preferred Abraxane (HCPCS J9264) and submit supporting clinical documentation, including prior regimen history and biomarker results when required.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization duration

6 monthsReauthorization duration

J9264Abraxane HCPCS

J9267Preferred paclitaxel HCPCS

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization: The requesting provider is an oncologist; use of the requested oncology therapy is documented in FDA labeling for the specific indication OR an accepted off-label indication found in specified compendia (AHFS, NCCN Category 1 or 2A, Elsevier Clinical Pharmacology, Micromedex DrugDex Class I/IIa/IIb, Lexi-Drugs Level A) OR justified medical necessity (experimental/investigational uses per the chemotherapy administration policy are excluded); submit chart notes/literature supporting medical necessity as applicable.

Chart documentation required; see chemotherapy administration policy for experimental/investigational definitions.

Biomarker/Genetic Requirement: If a biomarker/genetic component is required for the drug's site of action, submit all genetic mutation/receptor/biomarker/laboratory documentation using an FDA-approved test including results and the test utilized.

Attach genetic/biomarker test reports.

Step Therapy / Prior Treatment:

Policy Summary

PayerAvMed

PolicyPaclitaxel protein‑bound (Abraxane) medical prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Member has tried and failed guideline- and FDA label-recommended first-line agents OR has documented intolerance, FDA-labeled contraindication, or hypersensitivity to first-line therapies; provider must submit documentation of failure/intolerance/contraindication to preferred agents prior to approval of the non-preferred product.

Does not apply for pancreatic cancer, ampullary adenocarcinoma, and biliary tract cancers; step therapy applies to overlapping compendia-supported indications/regimens.

Prior Chemotherapy Documentation: Provider lists all previous chemotherapy regimens and dates (attach chart notes).

Complete regimen history must be provided.

Dose and Quantity: Requested dose/quantity must meet ONE of the following: (1) quantity requested is in accordance with FDA-approved labeling (including applicable age/weight conditions), OR (2) requested dose is higher than FDA maximum and prescriber has submitted clinical literature and medical documentation supporting safety and efficacy of the higher dose (e.g., guideline evidence or peer-reviewed trials).

Chart documentation required when requesting doses above FDA labeling.

Brand vs Generic: If requesting the brand formulation when a generic is available, provider must submit documentation confirming treatment failure, contraindication, or intolerance to the generic product.

Evidence of failure/intolerance to generic required.

Continuation Therapy

Covered when ALL of the following are met for reauthorization:

Reauthorization - General: Member is currently receiving the medication; all initial authorization criteria continue to be met.

Reauthorization period: 6 months.

Reauthorization - Step Therapy Documentation: Provider must submit documentation of contraindication, failure, or intolerance to any of the preferred agents prior to continued approval of the non-preferred product (see initial authorization for details).

Step therapy applies to overlapping compendia-supported indications/regimens.

Disease Status: Member requires continuation of therapy and is NOT experiencing disease progression.

Documentation (imaging/clinic notes) supporting lack of progression should be provided.

Ongoing Support: Ongoing treatment is consistent with FDA labeling or compendia support.

Provide references if continuing off-label per compendia.

Safety/Toxicity: Member is NOT experiencing an FDA-labeled limitation of use or toxicity related to the medication.

Provide relevant lab results or toxicity assessments.

Dose Consistency: The quantity (dose) requested is in accordance with FDA-approved labeling (or higher dose is supported by literature per initial authorization requirements).

Dose requests outside FDA labeling require supporting literature and documentation.

Experimental/investigational use, as defined by the referenced chemotherapy administration policy, precludes medical necessity for requests for non-preferred paclitaxel protein‑bound (Abraxane®). When a request is submitted on a medical prior authorization form, the provider must support a medical‑necessity rationale with chart notes or literature; however, any use characterized as experimental or investigational under the chemotherapy policy cannot be approved.

Uses that meet the chemotherapy administration policy definition of experimental/investigational are considered not medically necessary and will preclude authorization. Providers seeking coverage must document that the requested oncology therapy is consistent with FDA labeling, an accepted compendium listing, or a justified medical‑necessity rationale that is not experimental or investigational per the chemotherapy policy.

Initial Authorization Criteria

Initial Authorization

Initial authorization requirements

Provider and Indication: The requesting provider is an oncologist; indication is supported by FDA labeling OR an accepted off-label compendium OR documented medical necessity (experimental/investigational uses per chemotherapy policy preclude medical necessity).

Ensure diagnosis is documented and attach supporting literature or chart notes as applicable.

Biomarker/Genetic Testing: When a biomarker/genetic component is required for drug activity, submit/attach all genetic mutation, receptor, biomarker, and laboratory documentation using an FDA-approved test including both results and which test was utilized.

Failure to provide these results may delay or preclude approval.

Prior Treatment Failure: Member has tried and failed current treatment-guideline and FDA label-recommended first-line agents OR has documented intolerance, FDA-labeled contraindication, or hypersensitivity to first-line therapies.

Provider must submit documentation of failure/intolerance/contraindication to preferred agents prior to approval of the non-preferred product.

Exception for Specific Cancers: Step therapy requirement does NOT apply for pancreatic cancer, ampullary adenocarcinoma, and biliary tract cancers.

Document indication to justify exception.

Chemotherapy History: List all previous chemotherapy regimens and dates (attach chart notes).

Provide dates/cycles completed for each regimen.

Dose Compliance: Requested dose must either be: (a) in accordance with FDA-approved labeling (including age/weight conditions), OR (b) higher than FDA maximum with prescriber-submitted clinical literature and medical documentation supporting safety and efficacy of the higher dose.

Chart documentation of the above is required with the request.

Brand Formulation Request: If requesting the brand formulation when a generic is available, provider must submit documentation confirming treatment failure, contraindication, or intolerance to the generic product.

Provide evidence of failure/intolerance to generic.

Continuation / Reauthorization Criteria

Reauthorization

Reauthorization requirements

Continuation of Initial Criteria: All initial authorization criteria continue to be met; provider must supply documentation demonstrating continued fulfillment of initial requirements.

Reauthorization interval: 6 months.

Step Therapy Documentation: Provider must submit documentation of contraindication, failure, or intolerance to any preferred agents prior to continued approval of the non-preferred product (step therapy applies to overlapping compendia-supported indications/regimens).

See initial authorization section for requirements.

No Disease Progression: Member requires continuation of therapy and is NOT experiencing disease progression.

Provide clinical documentation (e.g., imaging, clinician notes).

Consistent with FDA/Compendia: Ongoing treatment is consistent with FDA labeling or compendia support.

If off-label, provide compendia citation supporting use.

No Labeled Toxicity or Limitation: Member is NOT experiencing an FDA-labeled limitation of use or medication-related toxicity that would preclude continuation.

Provide labs or toxicity monitoring data as appropriate.

Dose Within Labeling: Quantity (dose) requested is in accordance with FDA-approved labeling (or if outside labeling, supported by previously submitted literature).

Dose changes outside labeling require supporting documentation.

Coding

Non-Preferred HCPCSHCPCSCovered

J9264

Paclitaxel protein‑bound particles (Abraxane®)

Preferred HCPCSHCPCSCovered

J9267

Paclitaxel injection

Provider Actions & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for non-preferred paclitaxel protein-bound particles (Abraxane®) (HCPCS J9264). Submit requests via the Medical Prior Authorization/Step-Edit Request form. Incomplete, incorrect, or illegible information (including missing provider signature, phone/fax, or member/diagnosis details) may delay review or result in denial.

Affected code: HCPCS J9264 (Paclitaxel protein-bound particles, Abraxane®) — Non‑preferred (Authorization Required)
Fax completed form to 1-877-535-1391
Prescribing physician must sign and clearly print name (preprinted stamps not valid)

Step Therapy

Step Therapy and Failure Documentation

Member must have tried and failed current treatment-guideline and FDA label–recommended first-line agents, or have documented intolerance, FDA‑labeled contraindication, or hypersensitivity. Step therapy requirements do not apply for pancreatic cancer, ampullary adenocarcinoma, and biliary tract cancers. If requesting brand when a generic is available, document failure/intolerance/contraindication to the generic.

Step therapy applies to all overlapping compendia‑supported indications/regimens
List all previous chemotherapy regimens and dates (attach chart notes)
If exempt indication (pancreatic, ampullary adenocarcinoma, biliary tract cancers) — note on request

Documentation Required

Required Supporting Documentation

Provider must submit supporting documentation for each clinical criterion checked. Documentation must include relevant lab results, diagnostics, chart notes, genetic/biomarker testing (if applicable), and any literature or rationale for off‑label or higher‑than‑label dosing. For genetic/biomarker requirements, include the FDA‑approved test name and results. Chart documentation supporting dose justification or higher‑than‑label dosing must be attached.

Attach lab results, diagnostics, and chart notes supporting each criterion checked
If biomarker/genetic component is required: submit test name, method, and results (FDA‑approved test)
If requesting dose above FDA labeling: attach clinical literature, practice guidelines, or peer‑reviewed trial evidence supporting safety/efficacy
If requesting brand over generic: submit documentation confirming failure/intolerance/contraindication to generic

Denial Risk

Incomplete/Incorrect Information Warning

Missing, illegible, or incomplete information (including unsigned forms, absent provider contact information, or omitted supporting documentation) may delay review or result in denial of the authorization request.

Ensure provider signature is present and legible (preprinted stamps are not valid)
Ensure phone and fax numbers are correct on the form
Requests lacking required documentation may be denied or delayed

Step Therapy Requirements

Step	Requirement
1	Provider must submit documentation of contraindication, failure, or intolerance to preferred agents prior to approval of the non‑preferred product; member must have tried and failed guideline/FDA‑label first‑line agents or have documented intolerance, FDA‑labeled contraindication, or hypersensitivity. (Step therapy does not apply for pancreatic cancer, ampullary adenocarcinoma, and biliary tract cancers.)

Step

Requirement

Provider must submit documentation of contraindication, failure, or intolerance to preferred agents prior to approval of the non‑preferred product; member must have tried and failed guideline/FDA‑label first‑line agents or have documented intolerance, FDA‑labeled contraindication, or hypersensitivity. (Step therapy does not apply for pancreatic cancer, ampullary adenocarcinoma, and biliary tract cancers.)

Site of Care

Billing Rule

Specify infusion site and provide NPI/DEA or select specialty pharmacy

Indicate the location/site of drug administration and provide the NPI or DEA number of the administering location, or indicate that the medication will be dispensed via a specialty pharmacy.

Enter administering location on the form and provide NPI or DEA #
Alternatively, check ‘Specialty Pharmacy’ if product is dispensed through a specialty pharmacy

Definitions

Off‑label use supported by compendia — accepted sources

Accepted compendia — NCCNNational Comprehensive Cancer Network's Drugs & Biologics Compendium (use must be consistent with NCCN recommendations carrying a Category 1 or 2A level of evidence)

Accepted compendia — AHFSAmerican Hospital Formulary Service Drug Information (Supportive)

Accepted compendia — ElsevierElsevier Gold Standard's Clinical Pharmacology (Supportive)

Accepted compendia — MicromedexThompson Micromedex DrugDex ® (Class I, IIa, or IIb)

Accepted compendia — Lexi-DrugsWolters Kluwer Lexi-Drugs ® (Level A)

Use when FDA labeling not availableOff-label indications supported by any of the listed compendia may be accepted when documented in the most recent edition and consistent with the compendium's recommended level of evidence.

Background

Paclitaxel protein‑bound (Abraxane®) is identified in this policy as a non‑preferred formulation of paclitaxel used for oncologic indications and is billed under HCPCS code J9264. Requests for this formulation require documentation consistent with the initial authorization requirements, including provider specialty, indication support (FDA labeling or accepted compendia), and any required biomarker/genetic test results; note that experimental/investigational uses per the chemotherapy administration policy are not eligible for medical necessity.