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Drug Category: Renal and Urinary

Medication Class/Individual Agents: Urinary Dysfunction Agents

I. Prior-Authorization Requirements

 Urinary Dysfunction Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

darifenacin Enablex PA  
desmopressin-DDAVP DDAVP # test  
desmopressin-Nocdurna Nocdurna PA  
desmopressin-Noctiva Noctiva PA  
fesoterodine Toviaz BP PA  
flavoxate test  
mirabegron extended-release Myrbetriq PA  
oxybutynin extended-release tablet Ditropan XL # test  
oxybutynin gel Gelnique PA  
oxybutynin immediate-release tablet, syrup test  
oxybutynin transdermal system Oxytrol PA  
oxybutynin transdermal system-Oxytrol for Women Oxytrol for Women test  
solifenacin Vesicare BP PA  
tolterodine extended-release 2 mg Detrol LA # PA   - > 30 units/month
tolterodine extended-release 4 mg Detrol LA # test  
tolterodine immediate-release Detrol # test  
trospium extended-release test  
trospium immediate-release test  

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

  • First-line treatment options according to the 2014 American Urological Association guidelines and 2010 clinical guidelines for nocturia are behavioral therapy.
  • Literature does not support the use of one antimuscarinic agent or beta adrenergic receptor agonist over another.
  • Once daily dosing with extended-release agents tend to have less antimuscarinic side effects than the immediate-release products.

 

References:
1. American Urological Association Guideline. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) In Adults: AUA/SUFU Guideline [guideline on the Internet]. 2014 May [cited 2016 Sep 28]. Available from: https://www.auanet.org/common/pdf/education/clinical-guidance/Overactive-Bladder.pdf.
2. The Committee for Establishment of the Clinical Guidelines for Nocturia of the Neurogenic Bladder Society (2010), Clinical guidelines for nocturia. International Journal of Urology, 17: 397–409.

 
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void
  • Overactive bladder with symptoms of urinary frequency, urgency, or incontinence

 Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

 

darifenacin and fesoterodine

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • one of the following:
      • an inadequate response or adverse reaction to either oxybutynin extended-release or tolterodine extended-release; or
      • contraindication to both oxybutynin extended-release and tolterodine extended-release; and
    • quantity requested is for ≤ 30 tablets/month.

SmartPA: Claims for darifenacin and fesoterodine for a quantity of ≤ 30 tablets/month will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims in the past 365 days for oxybutynin extended-release or tolterodine extended-release.

 

Gelnique and Oxytrol

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • an intolerable adverse reaction to OTC Oxytrol; and
    • one of the following:
      • an intolerable adverse reaction to oral extended-release oxybutynin; or
      • medical necessity for a transdermal formulation; and
    • for Oxytrol, quantity requested is for  8 patches/30 days.

 

Myrbetriq and solifenacin

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • one of the following:
      • an inadequate response or adverse reaction to either darifenacin or fesoterodine; or
      • contraindication to both darifenacin and fesoterodine; and
    • quantity requested is for ≤ 30 tablets/month.

SmartPA: Claims for Myrbetriq and solifenacin for a quantity of ≤ 30 tablets/month will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims in the past 365 days for darifenacin or fesoterodine.

 

Nocdurna

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • member is ≥ 18 years of age; and 
    • appropriate dosing; and 
    • one of the following:
      • an inadequate response or adverse reaction to desmopressin acetate tablets; or
      • clinical rationale why desmopressin acetate tablets may not be appropriate.

SmartPA: Claims for Nocdurna for a quantity of ≤ 30 tablets/month will usually process at the pharmacy without a PA request if the member is ≥ 18 years of age and has a history of paid MassHealth pharmacy claims in the past 365 days for desmopressin tablets.

 

Noctiva

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • member is ≥ 50 years of age; and 
    • prescriber is a urology specialist or consult notes are provided; and 
    • one of the following:
      • an inadequate response or adverse reaction to desmopressin acetate tablets; or
      • clinical rationale why desmopressin acetate tablets may not be appropriate.

  

tolterodine extended-release 2 mg (> 30 units/month)

  • Documentation of all of the following is required:
    • appropriate diagnosis; and 
    • medical necessity for additional medication exceeding the quantity limits.

  

 Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 11/2009

Last Revised Date: 07/2019


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Last updated 07/15/19