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Margenza (margetuximab-cmkb) (Revised)
Act
by Nov 1, 2025
Effective date
Nov 1, 2025
Identified
Sep 23, 2026
Summary
This is a revised Humana Medicaid (Indiana) prior authorization policy for Margenza (margetuximab-cmkb), an intravenous anti-HER2 therapy for metastatic breast cancer. The policy requires prior authorization and establishes four mandatory clinical criteria: metastatic HER2-positive breast cancer diagnosis, documented HER2-neu positivity, prior receipt of two anti-HER2 therapies (one in metastatic setting), and use in combination with specified chemotherapy agents. Claims will be denied if the member experiences disease progression on Margenza.
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What to do
by Nov 1, 2025 · 7 steps
01Billing team must implement prior authorization requirements for Margenza (HCPCS J9355) for all Indiana Medicaid claims.
02Update billing software to require prior authorization before claim submission for J9355.
03Create or update authorization request forms to capture: member's diagnosis of metastatic breast cancer, HER2-neu positive status documentation (IHC 3+, IHC 2+ with ISH confirmation, or ISH dual-probe results per 2018 ASCO-CAP guidelines), documentation of two prior anti-HER2 therapies with at least one in metastatic setting, and confirmation of concurrent chemotherapy use (gemcitabine, eribulin, vinorelbine, or capecitabine).
04Train providers and front desk staff that this policy applies only to Indiana Medicaid members.
05Implement claims denial logic for members with documented disease progression on Margenza.
06Failure to obtain prior authorization will result in claim denials.
07Claims submitted without evidence of meeting all four criteria will be rejected.
Codes mentioned
J9355
Original notice
Margenza (margetuximab-cmkb) (Revised)
mcp.humana.com · Always check the source before changing claims.
Related changes
See all Humana changes →Margenza (margetuximab-cmkb) (Revised)MediumEffective Nov 1, 2025 · MedicaidMargenza (margetuximab-cmkb) (Revised)MediumEffective Nov 1, 2025 · MedicaidMargenza (margetuximab-cmkb) (Revised)MediumNo effective date · MedicaidMargenza (margetuximab-cmkb) (Revised)MediumEffective Sep 24, 2025 · MedicaidBrowse every Humana change in the policy list