Pharmacy Prior Authorization Criteria

Overactive Bladder Agents - Step Therapy

Indications for Prior Authorization

Gelnique (oxybutynin chloride)

• For diagnosis of Overactive Bladder Symptoms
  Indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Oxytrol (oxybutynin transdermal system)

• For diagnosis of Overactive Bladder Symptoms
  Indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.

Oxytrol For Women (oxybutynin patch)

• For diagnosis of Overactive Bladder Symptoms
  Indicated for the treatment of overactive bladder in women with symptoms of urge urinary incontinence, urgency, and frequency.

Gemtesa (vibegron)

• For diagnosis of Overactive Bladder Symptoms
  Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

• For diagnosis of Overactive Bladder Symptoms
  Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH)

Vesicare LS (solifenacin) Oral Suspension

• For diagnosis of Neurogenic Detrusor Overactivity
  Indicated for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older.

Toviaz (fesoterodine fumarate)

• For diagnosis of Overactive Bladder
  Indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.

• For diagnosis of Neurogenic Detrusor Overactivity
  Indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.

Criteria

Gelnique, Gemtesa, Oxytrol, Oxytrol For Women, Toviaz

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), contraindication, or intolerance to two of the following: [3]
• Myrbetriq tablets
• generic darifenacin ER
• generic oxybutynin IR/ER
• generic solifenacin
• generic tolterodine IR/ER
• generic trospium IR/ER
• generic fesoterodine ER

Vesicare LS

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• Trial and failure (of a minimum 30-day supply), contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to one of the following:
• generic oxybutynin IR/ER tablets
• generic oxybutynin syrup

P & T Revisions

2025-02-17, 2024-03-04, 2023-02-28, 2022-10-18, 2022-08-04, 2022-03-03, 2021-09-17, 2021-06-28, 2021-03-04, 2020-01-31, 2019-11-18

References

1. Gelnique Prescribing Information. Allergan USA, Inc. Irvine, CA. March 2019.
2. Oxytrol Prescribing Information. Allergan USA, Inc. Irvine, CA. May 2024.
3. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU Guideline on the Diagnosis and Treatment of Idiopathic Overactive Bladder. J Urol. 2024;212(1):11-20. Available at: https://www.auajournals.org/doi/10.1097/JU.0000000000003985. Accessed January 29, 2025.
4. Gemtesa Prescribing Information. Urovant Sciences, Inc. December 2024.
5. Vesicare LS Prescribing Information. Astellas Pharma US, Inc. Northbrook, IL. October 2022.
6. Toviaz Prescribing Information. Pfizer Inc. New York, NY. November 2021.
7. Oxytrol for Women. Allergan USA, Inc., Madison, NJ. August 2016.
8. Sandhu JS, Bixler BR, Dahm P, et al. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH): AUA Guideline amendment 2023. J Urol. 2023;10. Available at: https://www.auanet.org/guidelines-and-quality/guidelines/benign-prostatic-hyperplasia-(bph)-guideline. Accessed January 29, 2025.

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Revision History

• 2025-02-17: 2025 Annual Review. No criteria changes. Added new Gemtesa indication for OAB in adults males with BPH. Updated References.
• 2024-03-04: 2024 annual review. Added Oxytrol for Women as target to the guideline, removed Oxybutyinin Oral Solution as target from guideline. Updated GPIs and references.
• 2023-02-28: Added new brand Oxybutynin oral solution to criteria. Added FDA approved indication criterion. Updated references.
• 2022-10-18: Added Toviaz as a target to guideline. Updated background and references.
• 2022-08-04: Updated ST to include generic fesoterodine as ST1 alt for gemtesa, gelnique and oxytrol.
• 2022-03-03: Annual review - updated references.
• 2021-09-17: Criteria update to state Myrbetriq "tablets".
• 2021-06-28: Updated prerequisite options for Gemtesa/Gelnique/Oxytrol ST to include Myrbetriq, generic darifenacin ER and generic solifenacin
• 2021-03-04: Added Gemtesa and Vesicare LS. Added ER formulations as options for tolterodine and trospium. Added "minimum 30-day supply" language to T/F requirement. Updated background and references.
• 2020-01-31: Annual review - updated references.
• 2019-11-18: Removed Vesicare as target from existing guideline as it will be managed via the Generic-first Program.

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