Pharmacy Prior Authorization Criteria

Glycopyrrolate Tablets - PA, NF

Indications for Prior Authorization

Dartisla ODT (glycopyrrolate), Robinul/Robinul Forte (glycopyrrolate tablet)

• For diagnosis of Peptic Ulcer, Adjunct
  Indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer.

  Limitations of Use: Dartisla ODT/Robinul/Robinul Forte are not indicated as monotherapy for treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.

Glycate (glycopyrrolate tablet)

• For diagnosis of Peptic Ulcer, Adjunct
  Indicated for use as adjunctive therapy in the treatment of peptic ulcer.

Criteria

Dartisla ODT, Brand Glycate, Brand Glycopyrrolate tablet, Robinul, Robinul Forte

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [A]

• Diagnosis of peptic ulcer as confirmed by endoscopy
AND
• One of the following: [2]
• Patient is receiving concomitant treatment therapy with a proton-pump inhibitor (PPI) (e.g., lansoprazole, omeprazole)
OR
• Both of the following:
• Patient has a contraindication or intolerance to PPIs
AND
• Patient is receiving concomitant treatment therapy with an H2-receptor antagonist (e.g., famotidine, nizatidine)
AND
• One of the following:
• Trial and failure, or intolerance to generic glycopyrrolate tablets
OR
• Patient is unable to swallow tablets (Applies to Dartisla ODT only)
AND
• Prescribed by or in consultation with a gastroenterologist

Dartisla ODT, Brand Glycate, Brand Glycopyrrolate tablet, Robinul, Robinul Forte

Prior Authorization (Reauthorization)

Length of Approval: 3 Months [A]

• One of the following:
• Patient's peptic ulcer has not healed as confirmed by endoscopy
OR
• Patient has a new peptic ulcer as confirmed by endoscopy
AND
• One of the following: [2-3]
• Patient is receiving concomitant treatment therapy with a proton-pump inhibitor (PPI) (e.g., lansoprazole, omeprazole)
OR
• Both of the following:
• Patient has a contraindication or intolerance to PPIs
AND
• Patient is receiving concomitant treatment therapy with an H2-receptor antagonist (e.g., famotidine, nizatidine)
AND
• Patient experienced a reduction in peptic ulcer symptoms while on therapy
AND
• Other correctable factors (e.g., medication noncompliance, NSAID use, H. pylori infection, etc.) have been addressed
AND
• Prescribed by or in consultation with a gastroenterologist

Dartisla ODT

Non Formulary (Initial Authorization)

Length of Approval: 3 Months [A]

• Diagnosis of peptic ulcer as confirmed by endoscopy
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following: [2]
• Patient is receiving concomitant treatment therapy with a proton-pump inhibitor (PPI) (e.g., lansoprazole, omeprazole)
OR
• Both of the following:
• Patient has a contraindication or intolerance to PPIs
AND
• Patient is receiving concomitant treatment therapy with an H2-receptor antagonist (e.g., famotidine, nizatidine)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
• Trial and failure, or intolerance to generic glycopyrrolate tablets
OR
• Patient is unable to swallow tablets
AND
• Prescribed by or in consultation with a gastroenterologist

Dartisla ODT

Non Formulary (Reauthorization)

Length of Approval: 3 Months [A]

• Submission of medical records (e.g., chart notes) confirming one of the following:
• Patient's peptic ulcer has not healed as confirmed by endoscopy
OR
• Patient has a new peptic ulcer as confirmed by endoscopy
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following: [2-3]
• Patient is receiving concomitant treatment therapy with a proton-pump inhibitor (PPI) (e.g., lansoprazole, omeprazole)
OR
• Both of the following:
• Patient has a contraindication or intolerance to PPIs
AND
• Patient is receiving concomitant treatment therapy with an H2-receptor antagonist (e.g., famotidine, nizatidine)
AND
• Submission of medical records (e.g., chart notes) confirming patient has experienced a reduction in peptic ulcer symptoms while on therapy
AND
• Submission of medical records (e.g., chart notes) confirming that other correctable factors (e.g., medication noncompliance, NSAID use, H. pylori infection, etc.) have been addressed
AND
• Prescribed by or in consultation with a gastroenterologist

P & T Revisions

2024-03-13, 2023-05-03, 2022-10-17, 2022-06-01, 2022-05-09, 2022-04-06, 2022-03-18

References

1. Dartisla ODT Prescribing Information. Edenbridge Pharmaceuticals, LLC. Parsippany, NJ. October 2023.
2. Vakil NB. Peptic ulcer disease: Treatment and secondary prevention. UpToDate. Available by subscription at: http://www.uptodate.com/. Accessed February 26, 2024.
3. Vakil NB. Approach to refractory peptic ulcer disease. UpToDate. Available by subscription at: http://www.uptodate.com/. Accessed February 26, 2024.
4. Robinul/Robinul Forte Prescribing Information. Casper Pharma, LLC. East Brunswick, NJ. October 2022.
5. Glycate Prescribing Information. Intra-Sana Laboratories LLC. Las Vegas, NV. August 2021.

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End Notes

1. Leading organizations and guidelines for peptic ulcer disease do not recommend glycopyrrolate as an option for the management of peptic ulcer. Due to the limited data available, Dartisla ODT treatment duration is based on current treatment guidance with antisecretory therapy which recommends initial treatment with a PPI for a maximum of 12 weeks, and an additional maximum 12 weeks for refractory ulcers, after which surgery should be considered. [2-3]

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Revision History

• 2024-03-13: 2024 annual review. Updated references.
• 2023-05-03: Annual review - updated background and references.
• 2022-10-17: Added Glycate and brand glycopyrrolate tablet to guideline.
• 2022-06-01: Created NF criteria for Dartisla ODT.
• 2022-05-09: Added Robinul/Robinul Forte to guideline. Removed drug name from reauth criteria. Updated background and references.
• 2022-04-06: Updated reauthorization to include criterion on correctable factors have been addressed.
• 2022-03-18: New program

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