Sucraid — Medical Mutual

Initial criteria

• Diagnosis is established by ONE of the following: i. Patient has endoscopic biopsy of the small bowel with disaccharidase levels consistent with congenital sucrose-isomaltase deficiency as evidenced by ALL of the following: a) Decreased (usually absent) sucrase (normal reference: > 25 U/g protein); AND b) Decreased or normal isomaltase (palatinase) [normal reference: > 5 U/g protein]; AND c) Decreased maltase (normal reference: > 100 U/g protein); AND d) Decreased or normal lactase (normal reference: > 15 U/g protein); OR ii. Patient has a molecular genetic test demonstrating homozygous or compound heterozygous pathogenic or likely pathogenic sucrase-isomaltase gene variant
• Prior to starting therapy with Sucraid, patient had symptomatic congenital sucrose-isomaltase deficiency (e.g., diarrhea, bloating, abdominal cramping)
• Sucraid is prescribed by or in consultation with a geneticist, gastroenterologist, a metabolic disorder sub-specialist, or a physician who specializes in the treatment of congenital diarrheal disorders

Reauthorization criteria

• Diagnosis is established by ONE of the following: i. Patient has endoscopic biopsy of the small bowel with disaccharidase levels consistent with congenital sucrose-isomaltase deficiency as evidenced by ALL of the following: a) Decreased (usually absent) sucrase (normal reference: > 25 U/g protein); AND b) Decreased or normal isomaltase (palatinase) [normal reference: > 5 U/g protein]; AND c) Decreased maltase (normal reference: > 100 U/g protein); AND d) Decreased or normal lactase (normal reference: > 15 U/g protein); OR ii. Patient has a molecular genetic test demonstrating homozygous or compound heterozygous pathogenic or likely pathogenic sucrase-isomaltase gene variant
• Prior to starting therapy with Sucraid, patient had symptomatic congenital sucrose-isomaltase deficiency (e.g., diarrhea, bloating, abdominal cramping)
• Sucraid is prescribed by or in consultation with a geneticist, gastroenterologist, a metabolic disorder sub-specialist, or a physician who specializes in the treatment of congenital diarrheal disorders
• The prescriber reports a response to therapy, such as significantly fewer total stools; significantly greater number of hard and formed stools; fewer watery, soft stools; or fewer symptoms including abdominal bloating, excess gas, and abdominal pain

Approval duration

6 months