Pharmacy Prior Authorization Criteria

Glycopyrrolate Oral Solution

For diagnosis of Chronic Severe Drooling (Sialorrhea)
Indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy).

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Diagnosis of a neurologic condition (e.g., cerebral palsy) associated with chronic severe drooling (sialorrhea)

AND

AND

Patient requires liquid formulation due to dosing or inability to take tablet formulation

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

Patient demonstrates a positive clinical response to therapy (e.g., reduction in drooling severity compared to baseline)

AND

Patient requires liquid formulation due to dosing or inability to take tablet formulation

2024-04-18, 2022-10-17, 2022-03-02, 2021-12-13, 2021-11-04, 2021-09-29, 2021-08-24, 2021-03-15, 2020-08-05, 2020-04-07, 2019-08-29

Glycopyrrolate Oral Solution Prescribing Information. Northstar Rx LLC. Memphis, TN. October 2023.
Evatt ML. Oral glycopyrrolate for the treatment of chronic severe drooling caused by neurological disorders in children. Neuropsychiatr Dis Treat. 2011;7:543–7.
Cuvposa/Glycopyrrolate Center for Drug Evaluation and Research Summary Review. Food and Drug Administration Web site. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022571Orig1s000SumR.pdf. Accessed March 22, 2024.
Cuvposa Prescribing Information. Merz Pharmaceuticals, LLC. Raleigh, NC. January 2023.

Prior to the approval of glycopyrrolate oral solution, glycopyrrolate tablets were frequently and extensively used off-label in children to treat chronic drooling due to neurological conditions. [2, 3]

2024-04-18: 2024 annual review: Updated reauth language to replace "documentation of" with "patient demonstrates". Added to reauth trial/failure requirement through generic glycopyrrolate tablets mirroring initial criteria. Background updates.
2022-10-17: Added brand Cuvposa to guideline.
2022-03-02: New program
2021-12-13: 2022 Formulary Note update - no changes to criteria
2021-11-04: 2022 Formulary Note Addition - No Changes to criteria
2021-09-29: 2022 Formulary Note Addition - No Changes to criteria
2021-08-24: 2022 Medicare Implementation - No Changes
2021-03-15: 2021 Annual Review, no changes to criteria.
2020-08-05: 2021 Guideline Loading created from HPMS Submission file
2020-04-07: Annual Review: Removed Brand Robinul, Robinul Forte (obsolete 4/7/20); updated background and references
2019-08-29: 2020 Migration upload of new guideline for Oral Glycopyrrolate Products