Medicare AdvantagePrior AuthMedium impact
Onivyde (liposomal irinotecan) (Revised)
Humana·FL, KY, SC, VA · Oncology, Pharmacy·Medicaid
Effective date
May 27, 2026
We identified it
Jun 25, 2026
Summary
Humana revised its Onivyde (liposomal irinotecan) prior authorization policy effective May 27, 2026, affecting coverage for metastatic pancreatic adenocarcinoma in first-line and subsequent therapy scenarios. The policy clarifies that Onivyde must be used in combination therapy (not monotherapy) and establishes specific criteria for approval across Medicare and four Medicaid state programs (Florida, Kentucky, South Carolina, Virginia). Billing teams must ensure prior authorization is obtained before dispensing and verify member eligibility under the stated clinical criteria.
Action Required
By May 27, 2026: Billing and pharmacy teams must implement prior authorization requirements for Onivyde (liposomal irinotecan, HCPCS J9261) across affected plans. Pharmacy staff must verify that: (1) member has metastatic adenocarcinoma of pancreas diagnosis; (2) Onivyde is being used in combination therapy only (not monotherapy—Exclusion #1); (3) for first-line therapy, combination includes oxaliplatin, fluorouracil, and leucovorin; (4) for subsequent therapy, member previously received gemcitabine-based or fluoropyrimidine-based therapy with documented disease progression, and combination includes fluorouracil and leucovorin. Do NOT approve if member has experienced disease progression on prior Onivyde therapy (Exclusion #2). Update pharmacy billing system to flag claims for prior authorization submission. Obtain approvals before claim submission to prevent denials. Train pharmacy and billing staff on clinical criteria. This applies to Medicare, Medicaid-Florida, Medicaid-Kentucky, Medicaid-South Carolina, and Medicaid-Virginia members only.