Pombiliti™ (cipaglucosidase alfa-atga)

Pombiliti (cipaglucosidase alfa‑atga) is covered only as adjunctive therapy with Opfolda for adults (≥18 years and ≥40 kg) with laboratory- or genetically confirmed late‑onset Pompe disease and is excluded for patients <18 years, <40 kg, or those who are improving on prior ERT. Authorization requires ≥1 year of prior Lumizyme or Nexviazyme without objective improvement (e.g., FVC or 6MWT), prescribing/consultation by a geneticist, neurologist, metabolic/lysosomal storage disorder specialist, documentation of diagnosis and prior ERT failure, dosing at 20 mg/kg IV every other week, and is approved for 12 months.

"Laboratory evidence of deficient acid alpha-glucosidase activity in blood, fibroblasts, or muscle tissue."

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