FDA-approved, for example:

• Neurogenic detrusor overactivity
• 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

Non-FDA-approved, for example:

• Postoperative pain related to catheter placement

Note: The above lists may not include all FDA-approved and non-FDA approved indications.

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.
• Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
• 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.
• For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
• Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

darifenacin > one unit/day

• Documentation of all of the following is required:
  • appropriate diagnosis; and 
  • one of the following: 
    • clinical rationale why the dose cannot be consolidated; or
    • clinical rationale why the member requires dosing at intervals exceeding what is recommended by the FDA. 

Gemtesa, and trospium extended-release

• Documentation of all of the following is required:
  • appropriate diagnosis; and 
  • inadequate response or adverse reaction to two or contraindication to all of the following: darifenacin, fesoterodine, Myrbetriq, oxybutynin extended-release tablet, solifenacin, tolterodine extended-release; and
  • one of the following: 
    • requested quantity is ≤ one unit/day; or
    • for requested quantity > 1 unit/day, one of the following:
      • clinical rationale why the dose cannot be consolidated; or
      • clinical rationale why the member requires dosing at intervals exceeding what is recommended by the FDA.

SmartPA: Claims for Gemtesa, and trospium extended-release for a quantity of ≤ one unit/day will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims within the last 365 days for two of the following: darifenacin, fesoterodine, Myrbetriq, oxybutynin extended-release tablet, solifenacin, tolterodine extended-release. ^†

Nocdurna

• Documentation of all of the following is required:
  • appropriate diagnosis; and 
  • member is ≥ 18 years of age; and  
  • one of the following:
    • inadequate response or adverse reaction to desmopressin acetate tablets; or
    • medical necessity for the sublingual tablet instead of the tablet formulation available without prior authorization; and
  • appropriate dosing; and
  • one of the following: 
    • requested quantity is ≤ one unit/day; or
    • for requested quantity > one unit/day, one of the following: 
      • clinical rationale why the dose cannot be consolidated; or
      • clinical rationale why the member requires dosing at intervals exceeding what is recommended by the FDA. 

SmartPA: Claims for Nocdurna for a quantity of ≤ one unit/day 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 within the last 365 days for desmopressin tablets. ^†

oxybutynin 2.5 mg immediate-release tablet, oxybutynin solution

• Documentation of all of the following is required: 
  • appropriate diagnosis; and
  • member is ≥ six years of age; and
  • medical necessity for use of the requested agent instead of formulations available without prior authorization; and
  • appropriate dosing; and
  • for oxybutynin 2.5 mg immediate-release tablet, one of the following:
    • requested quantity is ≤ three units/day; or
    • for requested quantity > three units/day, one of the following:
      • clinical rationale why the dose cannot be consolidated; or
      • clinical rationale why the member requires dosing at intervals exceeding what is recommended by the FDA.

Oxytrol for Women

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • an intolerable adverse reaction to Oxytrol (oxybutynin transdermal system); and
  • one of the following: 
    • requested quantity is ≤ eight patches/28 days; or
    • for requested quantity > eight patches/28 days, clinical rationale why the member requires dosing at intervals exceeding what is recommended by the FDA; and
  • one of the following:
    • an intolerable adverse reaction to oral extended-release oxybutynin; or
    • medical necessity for the use of transdermal formulation as noted by one of the following: 
      • member utilizes tube feeding (G-tube/J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow.    

Vesicare LS

• Documentation of all of the following is required:
  • appropriate diagnosis; and 
  • prescriber is a urologist or consult notes from a urology office are provided; and  
  • one of the following:
    • member is ≥ two years of age and < five years of age; or
    • inadequate response, adverse reaction, or contraindication to oxybutynin syrup; and
  • appropriate dosing.

^† 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.