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Paclitaxel albumin-bound (Abraxane) — Medicare Advantage medical policy

Medicare Advantage medical policy governing prior authorization and coverage criteria for paclitaxel albumin-bound (Abraxane) for oncology indications across specified Medicare Advantage jurisdictions; applies to providers requesting medical benefit coverage.

Policy Summary

PayerEmblemHealth

PolicyPaclitaxel albumin-bound (Abraxane) — Medicare Advantage medical policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date11/30/2022

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the listed clinical criteria and dosing for the applicable indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+distinct cancer indications with approval criteria listed

1 yearstandard approval duration for indications

Medicare Advantageapplicable lines of business

Requires prior PD‑1dMMR/MSI‑H progression requirement

Dose optionsapproved dosing regimens

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Coverage restrictedexplicit non‑recommended coverage statement

Recommended Authorization Criteria

Small Bowel Adenocarcinoma — Initial Authorization

Initial Authorization — Approve for 1 year if the patient meets ALL of the following:

Initial Authorization Criteria

Patient is ≥ 18 years of age.
The patient has advanced or metastatic small bowel adenocarcinoma.
If the disease is deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H), the patient has progressed on Keytruda (pembrolizumab intravenous infusion), Opdivo (nivolumab intravenous infusion), or Jemperli (dostarlimab intravenous infusion).

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for medical benefit coverage. Approval is provided if the patient meets the applicable Recommended Authorization Criteria and Dosing. Documentation should demonstrate that the conditions of coverage are met.

Prior authorization recommended for medical benefit coverage of Abraxane
Approvals provided for durations listed in the Criteria (typically 1 year)
Documentation must support that all conditions in the Criteria are met

Prior Authorization

Prior Authorization Conditions

Prior authorization is required and approval is recommended for 1 year when all of the following conditions are met: patient is ≥ 18 years of age; patient has advanced, unresectable or metastatic disease as specified in the indication; and any indication‑specific conditions (e.g., prior systemic therapy or progression on listed agents) are satisfied.

Approve for 1 year when all listed criteria for the selected indication are met (age ≥18, disease status, and indication‑specific requirements)

Step Therapy

Step Therapy for dMMR/MSI‑H Tumors

For dMMR/MSI‑H tumors (for example small bowel adenocarcinoma with dMMR/MSI‑H), the patient must have progressed on pembrolizumab (Keytruda), nivolumab (Opdivo), or dostarlimab (Jemperli) prior to approval.

Step therapy required for dMMR/MSI‑H: progression on Keytruda, Opdivo, or Jemperli is required before approval

Documentation Required

Supporting Documentation

Required clinical documentation should include patient age, disease status (advanced, unresectable or metastatic where applicable), tumor dMMR/MSI‑H status when relevant, and evidence of prior therapies or progression on listed agents per the indication-specific Criteria.

Document patient age (≥18)
Document disease status (advanced, unresectable or metastatic as applicable)
Document tumor dMMR/MSI‑H status when applicable
Document prior systemic therapies or progression on listed agents (e.g., pembrolizumab, nivolumab, dostarlimab) when required

Denial Risk

Not Recommended for Non‑listed Indications

Coverage is not recommended for indications or circumstances that are not listed in the Recommended Authorization Criteria; such requests may be denied.

Requests outside the listed indications are not recommended for approval

Key Terms and Drug Definition

Paclitaxel albumin-bound — definition and dosing

AgentPaclitaxel albumin-bound (Abraxane), an albumin-bound formulation of paclitaxel used as a microtubule inhibitor for multiple oncology indications.

Approved formulation / routesIntravenous (albumin-bound paclitaxel formulation).

Label-referenced dosing options100 mg/m2 IV three times per 21-day cycle; 125 mg/m2 IV three times per 28-day cycle; 260 mg/m2 IV once every 21 days.

Common regimen combinations (documented)Used in combination with carboplatin for NSCLC, with gemcitabine for pancreatic and biliary tract cancers, and with trastuzumab or pembrolizumab for select breast cancer subtypes per NCCN guidance.

Substitution for hypersensitivityMay be substituted for paclitaxel or docetaxel due to hypersensitivity or medical necessity (per NCCN guidance referenced).

Clinical Background

Paclitaxel albumin‑bound (Abraxane) is an albumin‑bound formulation of paclitaxel used as a microtubule inhibitor across multiple malignancies. This policy supports prior authorization for medical‑benefit use and provides recommended authorization criteria by indication; approval is contingent on meeting the specific clinical criteria described for each tumor type. Dosing schedules and line‑of‑therapy requirements differ by indication and are specified within the individual coverage sections.

Policy Revision Timeline

2018-07-11created

Policy created as a Medicare Advantage medical policy (initial creation).

2019-11-06revised

Reviewed and revised original policy in accordance with Local Coverage Article A52448 and Oncology - Abraxane Utilization Review Policy.

2019-12-16revised

Completed 2019 monthly monitoring process with revisions per Local Coverage Determination L33394 and companion articles; non-clinical update added Medicare coverage guidance language.

Policy Summary

PayerEmblemHealth

PolicyPaclitaxel albumin-bound (Abraxane) — Medicare Advantage medical policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date11/30/2022

Next Review DateN/A

Key ActionObtain prior authorization and document that the patient meets the listed clinical criteria and dosing for the applicable indication.

SourceLink

On This Page

dMMR / MSI‑H — definition and policy relevance

DefinitionDeficient mismatch repair (dMMR) / microsatellite instability‑high (MSI‑H) describes a tumor phenotype referenced in the policy as a criterion affecting prior therapy requirements for certain indications.

Policy consequenceIf disease is dMMR/MSI‑H for small bowel adenocarcinoma, the patient must have progressed on pembrolizumab, nivolumab, or dostarlimab prior to approval.

Required prior PD‑1/PD‑L1 agents (examples)Keytruda (pembrolizumab), Opdivo (nivolumab), Jemperli (dostarlimab) — progression on one of these is required when dMMR/MSI‑H is present for the listed indication.

ApplicabilityReferenced specifically in the Small Bowel Adenocarcinoma criteria as condition C when granting 1‑year approvals.

2020-01-30revised

Non-clinical update adding policy statement note regarding potential differences from NCDs/LCDs and companion articles.

2020-12-16revised

Added new approval conditions and guideline-based updates including NSCLC (MET exon 14, RET), removed urothelial carcinoma, updated breast cancer age requirement and dosing language.

2021-12-21revised

Policy revisions including dosing and indication updates reflected in 2021 changes (see history entries).

2022-03-17revised

Revised dosing options (including biliary tract dosing) and added/updated several indications such as ampullary and cervical cancers; clarified NSCLC requirements and added targeted mutation examples.

2022-11-30revisedLatest

Policy updated with comprehensive 11/30/2022 effective revisions consolidating prior changes and aligning with referenced NCCN and CMS guidance; policy effective date recorded as 11/30/2022.