Nexviazyme® (avalglucosidase alfa-ngpt)

Nexviazyme (avalglucosidase alfa‑ngpt) is covered only for the FDA‑approved indication of late‑onset Pompe disease in patients aged ≥1 year (excluded: patients <1 year, infantile‑onset, and other non‑approved uses). Coverage requires confirmed diagnosis by deficient acid α‑glucosidase activity or molecular testing showing biallelic pathogenic/likely pathogenic GAA variants, prescription by or consultation with a geneticist, neurologist, metabolic disorder subspecialist or lysosomal storage disorder specialist, documentation of age/weight/diagnosis and applicable safety criteria, and adherence to weight‑based IV dosing every 2 weeks (40 mg/kg if <30 kg; 20 mg/kg if ≥30 kg) with authorization up to 12 months.

"Nexviazyme (avalglucosidase alfa-ngpt) is indicated for the treatment of individuals with late-onset Pompe disease (lysosomal acid α-glucosidase deficiency)."