Medicare AdvantagePrior AuthMedium impact
Xenpozyme™ (olipudase alfa) intravenous solution (Revised)
Humana·KY, SC · Infectious Disease, Genetics, Pediatrics +2 more·Medicaid
Effective date
Nov 30, 2022
We identified it
Jun 25, 2026
Summary
This is a revised Humana prior authorization policy for Xenpozyme (olipudase alfa) for treating non-CNS manifestations of Acid Sphingomyelinase Deficiency (ASMD). The policy was updated May 27, 2026 and applies to Medicare, Medicaid-Kentucky, and Medicaid-South Carolina. Prior authorization is required for all claims, with approval granted for one plan year at initial authorization and renewal.
Action Required
By June 30, 2026: Billing team must implement prior authorization requirements for all Xenpozyme (olipudase alfa) IV claims for Kentucky and South Carolina Medicaid members and Medicare beneficiaries. (1) Update billing system to flag all Xenpozyme claims requiring prior auth submission to Humana. (2) Verify patients meet all four criteria before claim submission: confirmed ASMD diagnosis via enzymatic assay or SMPD1 genetic testing, documentation of non-CNS manifestations (splenomegaly, hepatomegaly, interstitial lung disease, thrombocytopenia), and confirmation that infusion will occur in setting with CPR equipment available. (3) Providers must document black box warning acknowledgment and monitoring for severe hypersensitivity reactions and infusion-associated reactions. (4) Ensure ALT/AST lab work is current per schedule (within 1 month pre-initiation, within 72 hours pre-infusion during escalation, or prior to next scheduled infusion after missed dose). (5) For female patients of reproductive potential, document effective contraception counseling and 14-day post-discontinuation contraception requirement. (6) Notify providers to use www.humana.com/PAL for applicable preauthorization codes. Claims submitted without prior authorization will be denied.