Sucraid – NC Standard

• Sucraid® (sacrosidase)

• As an oral replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucraseisomaltase deficiency. 

Initial Coverage

1. The patient is at least 5 months of age; AND
2. The patient has a documented diagnosis of Congenital Sucrase-Isomaltase Deficiency (CSDI) (medical record documentation required); AND
3. ONE of the following (medical record documentation required):
   1. ALL of the following:
      1. The patient has a positive stool pH (pH < 6.0); AND
      2. The patient has a positive sucrose breath test (increase in breath hydrogen of > 10ppm when challenged with sucrose after fasting); AND 
      3. The patient has a negative lactose breath test; OR 
   2. The patient has a positive measurement of intestinal disaccharides upon small bowel biopsy; OR
   3. The patient has a positive SI genetic test; AND
4. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, geneticist, metabolic specialist); AND 
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 30 days (1 month)

Continuation Coverage 

1. The patient has been previously approved for Sucraid (sacrosidase) with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. The patient has had an improvement in the symptoms associated with CSID (i.e., gas, bloating, diarrhea, vomiting) (medical record documentation required); AND
3. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist, geneticist, metabolic specialist).

Duration of Approval: 365 days (1 year) 

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

All information referenced is from FDA package insert unless otherwise noted below.

November 2022: Criteria update: Formatting changes and review.

June 2021: Criteria update: Continuation duration of approval increased to 1 year.

April 2021: Original utilization management criteria issued.