Opfolda — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following: (A) Eligible for continuation of therapy AND prescriber states patient has been treated with requested agent within past 90 days and at risk if therapy changed OR (B) ALL of the following:
• Patient has a diagnosis of late-onset Pompe disease (acid maltase deficiency; glycogen storage disease type II) confirmed by ONE of the following: (A) Genetic analysis confirms biallelic mutation in GAA gene OR (B) Deficient acid alpha-glucosidase enzyme activity in dried blood spots, leukocytes, skin fibroblasts, and/or skeletal muscle tissue
• Patient is not improving on current enzyme replacement therapy (ERT)
• Patient weighs ≥ 40 kg
• Requested agent will be taken in combination with Pombiliti
• If FDA labeled indication, ONE of the following: (A) Patient’s age is within FDA labeling OR (B) Support for use in patient's age for requested indication