SUCRAID (sacrosidase)

SUCRAID (sacrosidase)

Self-Administration – oral solution

Diagnosis considered for coverage:

• Congenital Sucrase-Isomaltase Deficiency (CSID): Indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

Coverage Criteria:

For diagnosis of CSID:

• Diagnosis of sucrase deficiency (which is part of congenital sucrose-isomaltase deficiency [CSID]); AND
• Disease is confirmed by ONE of the following:
  • Disaccharidase assay via a small bowel biopsy 
  • Carbon -13 sucrose breath test 
  • Molecular genetic testing confirms mutation in the SI gene 
  • Stool pH less than 6, an increase in breath hydrogen of greater than 10 parts-per-million (ppm) when challenged with sucrose after fasting and a negative lactose breath test; AND 
• Prescribed by or in consultation with a gastroenterologist or geneticist

Reauthorization Criteria: 

For diagnosis of CSID:

• Patient demonstrates positive clinical response to therapy (e.g., decrease in symptoms of abdominal pain, cramps, bloating or gas; decrease in number and frequency of stools per day)

Dosing:

• Patients weighing 15 kg and less: 
  • The recommended dosage is 1 mL (8,500 International Units) administered orally with each meal or snack
• Patients weighing more than 15 kg: 
  • The recommended dosage is 2 mL (17,000 International Units) administered orally with each meal or snack

Coverage Duration:

• Initial: 12 months
• Reauthorization: 24 months

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Patients with CSID cannot metabolize sucrose or starch, and they experience symptoms such as diarrhea, abdominal pain, bloating, and abdominal distention from the excessive fermentation of undigested carbohydrates. 
• Sucraid does not enable the metabolism of starch, so CSID patients still need to avoid starch in order to avoid digestive problems while taking Sucraid.
• No other product has been approved by the FDA to treat CSID. In some CSID patients, the disease can be managed by diet, by avoiding sucrose and sucrose-containing foods and medicines, as well as by avoiding starch.

Policy Updates:

• 06/01/2024 – New policy for Sucraid approved by WHA P&T Committee. (P&T, 05/21/2024)

References:

1. Sucraid Prescribing Information. QOL Medical, LLC. Vero Beach, FL. May 2022. 
2. Congenital Sucrase-Isomaltase Deficiency (CSID). International Foundation for Gastrointestinal Disorders. Available at https://iffgd.org/gi-disorders/congenital-sucrase-isomaltase-deficiency-csid/. Accessed October 24, 2022. 
3. Smith, H., Romero, B., et al. The patient journey to diagnosis and treatment of congenital sucrase-isomaltase deficiency. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8298246/. Accessed October 24, 2022. 
4. Chey, W., Cash, B., et al. Congenital Sucrase-Isomaltase Deficiency: What, When, and How? Gastroenterology and Hepatology. October 2020. Available at https://www.gastroenterologyandhepatology.net/files/2020/10/gh1020sup5-1.pdf. Accessed October 24, 2022.