WHA
 

Glycopyrrolate products - PA, NF

Indications for Prior Authorization

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

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

Glycopyrrolate injections
  • For diagnosis of peptic ulcer (adults)
    Indicated as adjunctive therpay for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated

  • For diagnosis of anesthesia (all ages)
    Indicated for: 1) for reduction of salivary, tracheobronchial, and pharyngeal secretions, reduction of volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation, 2) intraoperatively to counteract surgically or drug-induced or vagal reflex-associated arrhythmias, 3) for protection against peripheral muscarinic effects of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing agents.

Criteria

Brand Glycate, Brand Glycopyrrolate tablet, Robinul, Robinul Forte, Brand Glycopyrrolate injection, generic glycopyrrolate injection

Prior Authorization (Initial Authorization)

Length of Approval: 3 Months [A]
For diagnosis of Peptic Ulcer

  • 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
  • Trial and failure, or intolerance to generic glycopyrrolate tablets
    • AND
  • Prescribed by or in consultation with a gastroenterologist
Brand Glycate, Brand Glycopyrrolate tablet, Robinul, Robinul Forte, Brand Glycopyrrolate injection, generic glycopyrrolate injection

Prior Authorization (Reauthorization)

Length of Approval: 3 Months [A]
For diagnosis of Peptic Ulcer

  • 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

  • Guideline ID
    GL-597229

  • Formulary
    premium

  • Effective date
    Jun 1, 2026

  • P&T approval date

P & T Revisions

2026-04-29, 2026-04-01, 2025-12-18, 2025-04-21, 2024-03-13, 2023-05-03, 2022-10-17, 2022-06-01, 2022-05-09, 2022-04-06, 2022-03-18

  1. Vakil NB. Peptic ulcer disease: Treatment and secondary prevention. UpToDate. Available by subscription at: http://www.uptodate.com/. Accessed March 30, 2026.
  2. Vakil NB. Approach to refractory peptic ulcer disease. UpToDate. Available by subscription at: http://www.uptodate.com/. Accessed March 30, 2026.
  3. Robinul/Robinul Forte Prescribing Information. Casper Pharma, LLC. East Brunswick, NJ. October 2022.
  4. Glycate Prescribing Information. Intra-Sana Laboratories LLC. Las Vegas, NV. January 2026.
  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. [1-2]
  • 2026-04-29: Addition of Brand/generic glycopyrrolate injection for use in peptic ulcer as a target drug.
  • 2026-04-01: 2026 Annual Review - removed Dartisla ODT and background updates
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-04-21: 2025 Annual Review - For Dartisla ODT, for the trial of generic glycopyrrolate tablets, updated bypass language criteria and updated references
  • 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