CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Sucraid (sacrosidase) oral solution prior authorization and quantity limits

Defines prior authorization clinical criteria and quantity limits for Sucraid (sacrosidase) oral solution for treatment of congenital sucrase-isomaltase deficiency (CSID). Applies to initial prior authorization requests and specifies documentation required for approval and monthly/3-month supply limits by product presentation.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySucraid (sacrosidase) oral solution prior authorization and quantity limits

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required for Sucraid; approval requires documentation of CSID diagnosis and confirmatory testing (small bowel biopsy OR genetic testing OR sucrose hydrogen breath test).

POLICY UPDATE CHANGES

No material clinical or coverage changes.

3Acceptable diagnostic confirmations

2Product presentations listed

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Defines prior authorization clinical criteria and quantity limits for Sucraid (sacrosidase) oral solution for treatment of congenital sucrase-isomaltase deficiency (CSID). Applies to initial prior authorization requests and specifies documentation required for approval and monthly/3-month supply limits by product presentation.

Initial Prior Authorization Criteria

Initial Prior Authorization / Coverage Criteria

Covered when ALL of the following are met:

ALL of the following

The patient has a diagnosis of congenital sucrase-isomaltase deficiency (CSID).
Confirmation of diagnosis (at least one):
- Small bowel biopsy confirming sucrase deficiency.
- Genetic testing confirming pathogenic variants consistent with congenital sucrase-isomaltase deficiency.
- Sucrose hydrogen breath test consistent with congenital sucrase-isomaltase deficiency.

Continuation Therapy Criteria

Note: This policy defines initial prior authorization criteria and enforces quantity limits for ongoing supply. Initial approval requires documentation per the scope_summary; quantity limits are applied by product presentation for monthly and 3-month supply periods.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for Sucraid. Approval requires documentation of a diagnosis of congenital sucrase-isomaltase deficiency (CSID) and confirmatory testing with one of the following: small bowel biopsy OR genetic testing OR sucrose hydrogen breath test.

Billing Rule

Quantity limits by product presentation and supply period

Quantity limits apply and differ by product presentation and supply period. Pharmacies may fill per package size up to these limits; fill days used allow time for refill processing.

Multiple-dose bottle (4 oz / 118 mL): Month limit = 354 mL per 25 days; 3-month limit = 1062 mL per 75 days.
Single-use container carton (150 x 2 mL = 300 mL): Month limit = 300 mL per 21 days; 3-month limit = 900 mL per 63 days.

Clinical Evidence and Background

Background: Sucraid (sacrosidase) oral solution is FDA-indicated as oral replacement therapy for the genetically determined sucrase deficiency that is part of congenital sucrase-isomaltase deficiency (CSID). The policy aligns coverage to require confirmatory diagnostic testing prior to approval and enforces quantity limits by product presentation to control supply.

Evidence: Primary reference: Sucraid package insert, QOL Medical, LLC; 2022.

Definition: CSID — Congenital sucrase-isomaltase deficiency, a genetically determined sucrase deficiency.