Pharmacy Prior Authorization Criteria

Glycopyrrolate Oral Solution

Indications for Prior Authorization

Cuvposa (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).

Criteria

Brand Cuvposa, Generic glycopyrrolate oral solution

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of chronic severe drooling (sialorrhea)
AND
• Diagnosis of a neurologic condition (e.g., cerebral palsy) associated with chronic severe drooling (sialorrhea)
AND
• Patient is between 3 and 16 years of age
AND
• One of the following:
• Trial and failure, or intolerance to generic glycopyrrolate tablets [A]
OR
• One of the following:
• Patient is unable to swallow a solid dosage form (e.g., oral tablet) due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube
OR
• Dosage requirements cannot be met with a solid dosage form

Brand Cuvposa, Generic glycopyrrolate oral solution

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
• One of the following:
• Trial and failure, or intolerance to generic glycopyrrolate tablets [A]
OR
• One of the following:
• Patient is unable to swallow a solid dosage form (e.g., oral tablet) due to one of the following:
• Age
• Physical impairment (e.g., difficulties with motor or oral coordination)
• Dysphagia
• Patient is using a feeding tube or nasal gastric tube
OR
• Dosage requirements cannot be met with a solid dosage form

P & T Revisions

2025-04-18, 2025-03-13, 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

References

1. Glycopyrrolate Oral Solution Prescribing Information. Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY. January 2024.
2. Evatt ML. Oral glycopyrrolate for the treatment of chronic severe drooling caused by neurological disorders in children. Neuropsychiatr Dis Treat. 2011;7:543–7.
3. 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.
4. Cuvposa Prescribing Information. Merz Pharmaceuticals, LLC. Raleigh, NC. January 2023.

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End Notes

1. 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]

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Revision History

• 2025-04-18: 2025 annual review: Updated trial/failure requirement. Background updates.
• 2025-03-13: Addition of EHB formulary to guideline.
• 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

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