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Kristalose® - NC Standard
Restricted Product(s)
Restriction applies to brand and generic products
- Kristalose® powder packets
FDA Approved Use
- For the treatment of constipation.
Criteria for Approval of Restricted Product(s)
- The patient has a diagnosis of constipation; AND
- The patient has tried and failed Lactulose solution (i.e. Constulose, Enulose); OR
- The provider gives a written statement demonstrating that the patient is likely to undergo harm by utilizing a solution as opposed to the requested powder packets; AND
- For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
Duration of Approval: 365 days (1 year)
References
All information referenced is from FDA package insert unless otherwise noted below.
Policy Implementation/Update Information
Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.
December 2023: Criteria update: Formatting updates only
May 2021: Criteria update: Annual criteria review. Format updates only.
July 2019: Original utilization management criteria issued.
Disclosures:
BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. Blue Cross NC is an independent licensee of the Blue Cross and Blue Shield Association. All other marks are the property of their respective owners.
Blue Cross and Blue Shield of North Carolina does not discriminate on the basis of race, color, national origin, sex, age or disability in its health programs and activities. Learn more about our non-discrimination policy and no-cost services available to you.
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