CurrentUnitedHealthcarePolicy 2026 P 2179-9

Sucraid (sacrosidase) prior authorization and medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for Sucraid (sacrosidase) oral solution for treatment of congenital sucrase-isomaltase deficiency (CSID); applies to prescribing providers and members under UnitedHealthcare plans.

Policy Summary

PayerUnitedHealthcare

PolicySucraid (sacrosidase) prior authorization and medical necessity

Policy CodePolicy 2026 P 2179-9

Change TypeUpdated confirmatory testing and documentation requirements

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain and submit medical records confirming CSID diagnosis using endoscopic biopsy, SI gene testing, or carbon-13 sucrose breath test and document specialist prescribing or consultation.

SourceLink

POLICY UPDATE CHANGES

Added carbon-13 sucrose breath test as an acceptable confirmatory diagnostic test.

Requirement for submission of medical records documenting diagnosis and confirmation of diagnosis.

Updated confirmation of diagnosis requirements for initial authorization and simplified reauthorization criteria.

3 monthsinitial authorization duration

12 monthsre-authorization duration

2026-04-01effective date

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Coverage Criteria for Sucraid (sacrosidase)

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization Criteria

Documented diagnosis: Submission of medical records documenting a diagnosis of congenital sucrase-isomaltase deficiency (CSID).
Confirmatory testing (one required)
- Endoscopic biopsy criteria: Endoscopic small bowel biopsy showing: normal small bowel morphology; absent or markedly reduced sucrase activity; isomaltase activity varying from 0 to full activity; reduced maltase activity; and either normal lactase activity OR both reduced lactase and sucrase:lactase ratio < 1.0.
- Genetic testing: Molecular genetic testing of the sucrase-isomaltase (SI) gene indicating a pathogenic isomaltase gene variant.
- 13C sucrose breath test: Carbon-13 sucrose breath test (13C SBT) showing cumulative 13CO2 exhalation over 90 minutes below the 10th percentile (<3.9% for men; <5.2% for women).
Specialist involvement: Prescribed by or in consultation with a gastroenterologist or rare disease specialist.
Dietary management: Will be used with a sucrose-free, low starch diet.
Authorization will be issued for 3 months.

ref

Reauthorization

Reauthorization covered when ALL of the following are met:

Reauthorization Criteria

Clinical response: Documentation of positive clinical response to Sucraid therapy (examples: reduced abdominal pain, bloating, gas, vomiting; reduced number of stools per day; reduced number of symptomatic days).
Specialist involvement: Prescribed by or in consultation with a gastroenterologist or rare disease specialist.
Dietary management: Will be used with a sucrose-free, low starch diet.

ref

The product labeling for Sucraid (sacrosidase) does not evaluate use in secondary (acquired) sucrase deficiency. This policy reflects that distinction and does not extend the labeled indication for Sucraid to treatment of secondary sucrase deficiency.

Treatment of secondary (acquired) sucrase deficiency is not supported by this policy because the effects of Sucraid in that population have not been evaluated in the product information. Requests for Sucraid to treat acquired sucrase deficiency will not meet the covered indication criteria in this policy.

Coding and Diagnostic Cutoffs

Relevant coding notesmixed

No codes listed

13C sucrose breath test cutoff — cumulative 13CO2 exhalation over 90 minutes

Threshold definitionCumulative 13CO2 exhalation over 90 minutes below the 10th percentile

Male cutoff< 3.9% cumulative 13CO2 exhalation over 90 minutes

Female cutoff< 5.2% cumulative 13CO2 exhalation over 90 minutes

Test nameCarbon-13 sucrose breath test (13C SBT)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Initial prior authorization required

Prior authorization/medical necessity review required for initial prescriptions. Initial approvals are issued for 3 months when all initial criteria are met.

Affected medication: Sucraid (sacrosidase) oral solution
Initial authorization duration: 3 months
Policy number: 2026 P 2179-9

Prior Authorization

Reauthorization prior authorization requirements

Reauthorization requires documentation of a positive clinical response to therapy and that the prescription is by or in consultation with a gastroenterologist or rare disease specialist. Reauthorizations are issued for 12 months when criteria are met.

Documentation: reduced symptoms (e.g., abdominal pain, bloating, gas, vomiting), fewer stools per day, reduced symptomatic days
Reauthorization duration: 12 months

Background on Sucraid (sacrosidase)

Sucraid (sacrosidase) is an oral enzyme replacement therapy indicated for the treatment of sucrase deficiency as part of congenital sucrase-isomaltase deficiency (CSID). The product labeling explicitly notes that the effects have not been evaluated in secondary (acquired) sucrase deficiency.

Definitions

CSID definition — congenital sucrase-isomaltase deficiency description and treatment context

DefinitionCongenital sucrase-isomaltase deficiency (CSID) — a condition characterized by sucrase deficiency; Sucraid (sacrosidase) is an oral enzyme replacement therapy indicated for treatment of sucrase deficiency as part of CSID.

Treatment contextSucraid (sacrosidase) used as enzyme replacement therapy for sucrase deficiency in CSID.

LimitationsEffects of Sucraid have not been evaluated in patients with secondary (acquired) sucrase deficiency.

Documentation Required

Required documentation for initial authorization

Submission of medical records documenting a diagnosis of congenital sucrase-isomaltase deficiency (CSID) and confirmatory diagnostic testing is required. Acceptable confirmatory tests include endoscopic small bowel biopsy showing absent or markedly reduced sucrase activity (with the specified lactase/isomaltase findings), molecular genetic testing identifying a pathogenic SI gene variant, or a 13C sucrose breath test with cumulative 13CO2 exhalation below the 10th percentile (<3.9% for men; <5.2% for women). Prescriptions must be by or in consultation with a gastroenterologist or rare disease specialist and therapy must be used with a sucrose-free, low-starch diet.

Required documentation: medical records confirming CSID diagnosis and one acceptable confirmatory test (biopsy, SI gene testing, or 13C sucrose breath test)
Prescriber requirement: gastroenterologist or rare disease specialist (or in consultation)
Concurrent management: sucrose-free, low-starch diet