Medicare AdvantagePrior AuthMedium impact
Naglazyme® (galsulfase) (Revised)
Humana·KY, SC · Pediatrics, Genetics, Internal Medicine·Medicaid
Effective date
Jan 1, 2013
We identified it
Jun 25, 2026
Summary
This is a revised Naglazyme (galsulfase) prior authorization policy for Medicare and Medicaid (Kentucky and South Carolina) effective January 1, 2013, with the most recent revision dated March 25, 2026. The policy requires prior authorization for Naglazyme intravenous solution and establishes that the single approval criterion is a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). The policy includes detailed warnings about anaphylaxis, allergic reactions, immune-related reactions, cardiorespiratory risk, and infusion reactions requiring appropriate monitoring and pretreatment protocols.
Action Required
By April 1, 2026: Billing team must ensure all Naglazyme (galsulfase) claims for Medicaid members in Kentucky and South Carolina require prior authorization submission. Verify that the patient has documented diagnosis of MPS VI (Maroteaux-Lamy syndrome) before claim submission. Update billing system to flag any Naglazyme claims without prior authorization approval as requiring manual review. Educate clinical staff that infusion must include pretreatment with antihistamines and appropriate medical monitoring per policy guidelines. Contact Humana PAL at www.humana.com/PAL for specific medical and procedural coding information. Claims submitted without required prior authorization or appropriate diagnosis documentation will be denied.