CurrentViva HealthPolicy IC-0072

Ixempra (ixabepilone) (Intravenous) — Prior Authorization Coverage Criteria

Prior authorization policy for intravenous ixabepilone (Ixempra) for treatment of advanced, recurrent, or metastatic breast cancer, governing coverage, dosing limits, and renewal for Viva Health members in North Carolina.

Policy Summary

PayerViva Health

PolicyIxempra (ixabepilone) (Intravenous) — Prior Authorization Coverage Criteria

Policy CodePolicy IC-0072

Change TypeNo material change

Effective DateSep 4, 2025

Next Review DateSep 4, 2025

Key ActionObtain prior authorization (initially valid for 6 months) and renew every 6 months with documentation of continued response and absence of unacceptable toxicity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial prior authorization validity

90maximum billable HCPCS units per 21 days

40 mg/m2recommended dose every 21 days

J9207HCPCS code

>=18minimum patient age

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Medicare MAC jurisdictions referenced

Coverage Criteria for Ixabepilone (Ixempra)

Initial Therapy Criteria

Covered when ALL of the following are met

Age and hypersensitivity: Patient is at least 18 years of age; no history of severe hypersensitivity to agents containing Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil)

Disease indication: Used for recurrent unresectable (local or regional) or metastatic (stage IV [M1]) disease OR inflammatory breast cancer with no response to preoperative systemic therapy; OR used for locally advanced or metastatic disease after prior therapy failures as specified

HER2-negative pathway: HER2-negative disease confirmed by an FDA-approved or CLIA-compliant test; used as a single agent. For hormone-receptor positive disease: use for visceral crisis or endocrine therapy–refractory disease; first-line if no germline BRCA1/2 mutation and/or HER2 IHC 0+, 1+, or 2+/ISH negative; second-line if not a candidate for fam-trastuzumab deruxtecan; third-line and beyond otherwise. For triple‑negative breast cancer (TNBC): first-line if PD‑L1 CPS <10 and no germline BRCA1/2 mutation; otherwise used as subsequent therapy.

HER2-positive pathway: HER2-positive disease confirmed by an FDA-approved or CLIA-compliant test; used in combination with trastuzumab as fourth-line therapy and beyond; OR used in combination with capecitabine or as single agent after capecitabine failure when anthracycline and taxane have failed or are contraindicated

Organ function when combined with capecitabine: If used in combination with capecitabine, AST and ALT must be <= 2.5 x ULN and bilirubin <= 1 x ULNAST/ALT <= 2.5 x ULN; bilirubin <= 1 x ULN

History of severe hypersensitivity to agents containing Cremophor® EL or its derivatives (for example, polyoxyethylated castor oil) is an exclusion for ixabepilone therapy and will preclude coverage under this policy.

Renewal of prior authorization may be denied if there is unacceptable toxicity. Examples of unacceptable toxicity include peripheral neuropathy (sensory and motor), severe myelosuppression (e.g., neutropenia, leukopenia, anemia, thrombocytopenia), toxicity in patients with hepatic impairment, hypersensitivity reactions (including anaphylaxis), or cardiac adverse reactions (such as myocardial ischemia or ventricular dysfunction).

Regimen	Dose / Schedule	HCPCS (billing unit)	NDCs
Ixabepilone (Ixempra) — single-agent regimen
40 mg/m2 IV over 3 hours every 21 days until disease progression or unacceptable toxicity (BSA capped at 2.2 m2)
J9207 — Injection, ixabepilone, 1 mg (1 billable unit = 1 mg)
Ixempra 15 mg single-dose vial: 70020-1910-xx; Ixempra 45 mg single-dose vial: 70020-1911-xx

Coding: HCPCS, NDCs, and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9207

Injection, ixabepilone, 1 mg

NDCsNDC

70020-1910-xx	Ixempra 15 mg single-dose vial NDC
70020-1911-xx	Ixempra 45 mg single-dose vial NDC

Covered ICD-10 Diagnosis Codes (selected; full list in document)ICD-10Covered

C50.011	Malignant neoplasm of nipple and areola, right female breast
C50.012	Malignant neoplasm of nipple and areola, left female breast
C50.019	Malignant neoplasm of nipple and areola, unspecified female breast
C50.021	Malignant neoplasm of nipple and areola, right male breast
C50.022	Malignant neoplasm of nipple and areola, left male breast
C50.029	Malignant neoplasm of nipple and areola, unspecified male breast
C50.111	Malignant neoplasm of central portion of right female breast
C50.112	Malignant neoplasm of central portion of left female breast
C50.119	Malignant neoplasm of central portion of unspecified female breast
C50.121	Malignant neoplasm of central portion of right male breast

1–10 of 13

1/2

Covered Diagnosis CodesICD-10Covered

C50.929	Malignant neoplasm of unspecified site of unspecified male breast
Z85.3	Personal history of malignant neoplasm of breast

Medicare Part B Covered Diagnosis Codesmixed

No codes listed

Maximum HCPCS units per dosing interval

Maximum HCPCS units per 21 days90 billable units every 21 days

HCPCS billing unit1 billable unit = 1 mg (see J9207)

Dosing intervalEvery 21 days

Dose per administration

Dose per administration40 mg/m2 IV over 3 hours every 21 days

BSA cap for calculationsBSA capped at 2.2 m2 for dose calculations

Provider Actions, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization must be obtained prior to initiation of therapy. Initial authorizations are valid for 6 months. Authorizations may be renewed every 6 months; renewal requires submission of documentation demonstrating continued medical necessity (see documentation and renewal criteria).

Initial prior authorization validity: 6 months.
Renewal: May be renewed every 6 months; renewal requires documentation of continued benefit and absence of unacceptable toxicity (see Renewal Criteria).

Documentation Required

Required Clinical Documentation

Providers must submit clinical documentation to support the medical necessity of therapy. Required documentation must be available at the time of initial request and for renewals.

Pathology report or test results confirming HER2 status (IHC/ISH) and hormone receptor (ER/PR) status using an FDA-approved or CLIA-compliant assay where applicable.

Line-of-Therapy Rules

first-line | second-line | third-line | salvage

Line of therapy options: Ixabepilone may be used as first-line, second-line, third-line, or salvage therapy depending on HER2 status, germline BRCA1/2 mutation status, PD‑L1 (CPS), prior anthracycline and taxane exposure or resistance, and candidacy for alternative agents (e.g., fam‑trastuzumab deruxtecan).

Required Biomarker and Tumor Status Information

HER2

HER2-negative criteriaIHC 0 or 1+ OR dual-probe ISH Group 5 (HER2/CEP17 ratio <2.0 AND average HER2 copy number <4.0) OR concurrent ISH/IHC patterns consistent with Groups 2–4 as specified

HER2-positive criteriaIHC 3+ OR ISH with HER2/CEP17 ratio ≥2.0 AND average HER2 copy number ≥4.0 OR other concurrent ISH/IHC combinations meeting positive group definitions

Testing requirementHER2 status must be confirmed by an FDA‑approved or CLIA‑compliant assay

ER/PR

ER/PR negativeSample considered ER/PR negative if <1% tumor cell nuclei stain

ER-low-positive1%–10% of nuclei stain (ER-low-positive) — biologic behavior may be more similar to ER-negative

Definitions and Abbreviations

Anthracycline resistance

Anthracycline resistance definitionProgression while on anthracycline therapy or within 6 months in the adjuvant setting or within 3 months in the metastatic setting

Context for useRequired to establish prior therapy failure before combination use with capecitabine or single‑agent use after capecitabine

DocumentationPrior treatment dates and progression timing should be documented in clinical record

Taxane resistance

Taxane resistance definitionProgression while on taxane therapy or within 12 months in the adjuvant setting or within 4 months in the metastatic setting

ImplicationMay qualify patient for ixabepilone when further anthracycline therapy is contraindicated or after prior taxane exposure

Background

Ixabepilone is a microtubule-stabilizing agent used in the treatment of advanced, unresectable, or metastatic breast cancer including inflammatory breast cancer and disease following specific prior therapy failures. Use must respect universal safety criteria — notably absence of a history of severe hypersensitivity to agents containing Cremophor® EL or derivatives — and renewal requires documented disease response and absence of unacceptable toxicity.

Covered Regimens and Billing

Regimen summary	Dose / Schedule	HCPCS billed	NDCs (vials)
Ixabepilone (Ixempra) — breast cancer regimen
40 mg/m2 IV over 3 hours every 21 days until progression or unacceptable toxicity (BSA calculations capped at 2.2 m2)
J9207 — Injection, ixabepilone, 1 mg (billable unit = 1 mg)
15 mg vial NDC: 70020-1910-xx; 45 mg vial NDC: 70020-1911-xx

Revision History

Dates Reviewed: 09/2025policy_reviewLatest

Policy reviewed and last review date recorded (09/04/2025).

Dates Reviewed: 09/2024policy_review

Policy reviewed (09/2024) as part of routine updates to coverage criteria and appendices.

Dates Reviewed: 05/2023policy_review

Policy Summary

PayerViva Health

PolicyIxempra (ixabepilone) (Intravenous) — Prior Authorization Coverage Criteria

Policy CodePolicy IC-0072

Change TypeNo material change

Effective DateSep 4, 2025

Next Review DateSep 4, 2025

Key ActionObtain prior authorization (initially valid for 6 months) and renew every 6 months with documentation of continued response and absence of unacceptable toxicity.

SourceLink

On This Page

Duration of therapyContinue until disease progression or unacceptable toxicity

Treatment history documenting prior systemic therapies, dates, responses, and reason for discontinuation (e.g., progression, toxicity, contraindication).

Documentation of current disease status (recurrent unresectable, metastatic, inflammatory breast cancer, or other covered indication) and measurable/assessable disease for renewal assessments.

Performance status and any concomitant therapies (including use with capecitabine or trastuzumab when applicable).

For renewals: evidence of disease response (stabilization or decrease in tumor size/spread) and documentation of absence of unacceptable toxicity.

Billing Rule

Required Diagnosis Coding

Submit diagnosis coding that supports the indication being treated. Use covered diagnosis codes from Appendix 1 when applicable.

Primary diagnosis codes to support coverage consideration: C50.929 (Malignant neoplasm of unspecified site of unspecified male breast) or Z85.3 (Personal history of malignant neoplasm of breast) as applicable per Appendix 1.
Ensure diagnosis codes on the prior authorization request and subsequent claims match the clinical documentation and indication.

Step Therapy

Sequencing and Line-of-Therapy Considerations

Sequencing and line-of-therapy rules in the policy must be followed when requesting authorization. Requests should state the intended line of therapy and provide documentation of prior lines, eligibility for alternatives, and any contraindications.

HER2-negative disease: single-agent use, with specific rules for first-line (if no germline BRCA mutation and/or HER2 IHC 0/1/2+ ISH negative), second-line (if not a candidate for fam-trastuzumab deruxtecan), or third-line and beyond as specified in the policy.
Triple-negative breast cancer (TNBC): first-line use if PD-L1 CPS <10 and no germline BRCA mutation, or subsequent therapy as indicated.
HER2-positive disease: use in combination with trastuzumab for fourth-line therapy and beyond when indicated.
Locally advanced/metastatic disease: combination with capecitabine or single-agent after capecitabine failure where policy specifies; anthracycline and taxane resistance definitions must be documented when required.

Denial Risk

Triggers for Denial or Non-Renewal

Prior authorization may be denied or not renewed if clinical or safety contraindications are present or required documentation is incomplete.

History of severe hypersensitivity to Cremophor® EL or derivatives (e.g., polyoxyethylated castor oil) is a contraindication and may lead to denial.
If used in combination with capecitabine: abnormal hepatic tests (AST or ALT >2.5 x ULN or bilirubin >1 x ULN) may trigger denial or non-renewal due to increased safety risk.
Lack of required documentation (e.g., missing HER2/ER/PR test results, absent prior therapy history, or no evidence of disease response for renewals) may result in denial or non-renewal.
Evidence of unacceptable toxicity (e.g., significant peripheral neuropathy, severe myelosuppression, hepatic impairment, hypersensitivity/anaphylaxis, cardiac adverse reactions) may preclude renewal.

Note

Medicare/NCD/LCD Applicability

Medicare Part B coverage determinations may be governed by CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs). Providers must follow applicable Medicare policies when requesting coverage or submitting claims for Medicare beneficiaries.

The information in this policy is intended for non‑Medicare coverage determinations; for Medicare Part B drugs consult the Medicare Benefit Policy Manual (Pub. 100-02), Chapter 15, §50 and relevant NCDs/LCDs/LCAs.
Search for applicable Medicare coverage documents: https://www.cms.gov/medicare-coverage-database/search.aspx.
Claims for Medicare Part B drugs must comply with any applicable NCD/LCD/LCA; failure to follow these CMS determinations may affect coverage. Medicare Part B covered diagnosis codes (applicable to existing NCD/LCD/LCA): N/A as noted in Appendix 2.

Note

Provider action placeholder: ensure all required items above are provided with the authorization request and retained in the medical record. Include explicit statements of line of therapy and rationale when applicable.

Include copies of pathology and molecular testing reports with the initial request.
Document prior systemic therapies with dates and reasons for discontinuation (progression, toxicity, or contraindication).
For renewals, include imaging or clinical assessment demonstrating stabilization or improvement and documentation of toxicity assessment.

ER/PR positive>10% of nuclei stain = ER-positive

germline BRCA1/2

germline BRCA1/2 testingGermline BRCA1/2 status is required to inform line-of-therapy decisions (presence may alter first-line use)

DocumentationTest must be performed and documented per clinical records (FDA/CLIA guidance applicable for other biomarkers)

Effect on sequencingPresence of germline BRCA1/2 mutation may preclude first-line use in some pathways

PD-L1 (CPS)

PD-L1 (CPS) threshold for first-line TNBCCPS <10 required for first-line use in triple‑negative breast cancer (TNBC)

Role in pathwayGuides whether ixabepilone may be used first-line in TNBC when no germline BRCA1/2 mutation is present

Testing standardPD-L1 CPS should be reported numerically to determine eligibility

DocumentationDocument prior taxane regimen and timing of progression relative to treatment

C50.929

C50.929Malignant neoplasm of unspecified site of unspecified male breast

Use in coverage determinationInclude this code when applicable for male breast malignancy claims

Appendix referenceListed in Appendix 1 - Covered Diagnosis Codes

Z85.3

Z85.3Personal history of malignant neoplasm of breast

Use in coverage determinationSubmit when patient has prior history of breast malignancy per Appendix 1

Appendix referenceListed in Appendix 1 - Covered Diagnosis Codes

Policy reviewed (05/2023) as part of ongoing document maintenance.

Dates Reviewed: 05/2022policy_review

Policy reviewed (05/2022) as part of ongoing document maintenance.

Dates Reviewed: 05/2021policy_review

Policy reviewed (05/2021) as part of ongoing document maintenance.

Dates Reviewed: 05/2020policy_review

Policy reviewed (05/2020) as part of ongoing document maintenance.

Dates Reviewed: 05/2019policy_review

Policy reviewed (05/2019) as part of ongoing document maintenance.

Dates Reviewed: 04/2018policy_review

Policy reviewed (04/2018) as part of ongoing document maintenance.

Dates Reviewed: 04/2017policy_review

Policy reviewed (04/2017) as part of ongoing document maintenance.

Dates Reviewed: 04/2016policy_review

Policy reviewed (04/2016) as part of ongoing document maintenance.

Dates Reviewed: 05/2015policy_review

Policy reviewed (05/2015) as part of ongoing document maintenance.

Dates Reviewed: 06/2014policy_review

Policy reviewed (06/2014) as part of ongoing document maintenance.

Dates Reviewed: 11/2013policy_review

Policy reviewed (11/2013) as part of ongoing document maintenance.

Dates Reviewed: 02/2013policy_review

Policy reviewed (02/2013) as part of ongoing document maintenance.

Date of Origin: 01/01/2012policy_origin

Policy originally created (01/01/2012).