Sucraid (sacrosidase oral solution) — Medica
Congenital Sucrase-Isomaltase Deficiency
Initial criteria
- Diagnosis is established by ONE of the following (i or ii):
- i. Endoscopic biopsy of the small bowel with disaccharidase levels consistent with congenital sucrose-isomaltase deficiency as evidenced by ALL of the following (a–d): decreased (usually absent) sucrase level (>25 U/g protein normal), decreased or normal isomaltase (palatinase) level (>5 U/g protein normal), decreased maltase level (>100 U/g protein normal), and decreased or normal lactase level (>15 U/g protein normal); OR
- ii. Molecular genetic test demonstrating homozygous or compound heterozygous pathogenic or likely pathogenic sucrase-isomaltase gene variant;
- AND prior to starting therapy, patient had symptomatic congenital sucrose-isomaltase deficiency (e.g., diarrhea, bloating, abdominal cramping);
- AND medication is prescribed by or in consultation with a geneticist, gastroenterologist, metabolic disorder subspecialist, or a physician who specializes in the treatment of congenital diarrheal disorders.
Approval duration
1 year