Genitourinary System

Tier 1 products are covered with no authorization necessary.

Tier 2 authorization criteria

• Trials of all Tier 1 medication that yielded inadequate clinical response or adverse effects, OR
• A unique FDA approved indication not covered by Tier 1 products.

Tier 3 Authorization Criteria:

• Trials of all Tier 2 medications that yielded inadequate clinical response or adverse effects, OR
• A unique FDA approved indication not covered by lower Tiered products.

desmopressin acetate sublingual tablets (Nocdurna®) Approval Criteria:

• An FDA approved diagnosis of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void; AND   
• All other causes of nocturia have been ruled out or adequately treated [e.g., benign prostatic hyperplasia (BPH), overactive bladder (OAB), obstructive sleep apnea (OSA)]; AND  
• The prescriber must confirm the member has a 6-month history of at least two nocturic episodes per night; AND
• Member has failed behavior modifications including reducing caffeine intake, alcohol intake, and nighttime fluid intake; AND   
• Member must have failed a trial of DDAVP® (desmopressin acetate tablets) or have a patient-specific, clinically significant reason why the standard tablet formulation cannot be used; AND  
• The prescriber must be willing to measure serum sodium levels prior to starting treatment and document levels are acceptable; AND  
• The prescriber must agree to monitor serum sodium levels within the first week and approximately one month after starting treatment, and periodically during treatment; AND   
• The prescriber must confirm the member is not taking loop diuretics; AND    
• The prescriber must confirm the member does not have renal impairment with an estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2; AND   
• Initial approvals will be for the duration of 3 months; for continued authorization the prescriber must provide the following:
  
  • Documentation that serum sodium levels are acceptable to the prescriber; AND
  • Documentation that the member is responding to treatment; AND   
• Approvals will be limited to the 27.7mcg dose for female members; AND    
• A quantity limit of 30 tablets per 30 days will apply.  

desmopressin acetate (Noctiva™) Approval Criteria:  

• An FDA approved diagnosis of nocturia due to nocturnal polyuria in adults; AND
• All other causes of nocturia have been ruled out or adequately treated [e.g., benign prostatic hyperplasia (BPH), overactive bladder (OAB), obstructive sleep apnea (OSA)]; AND
• The prescriber must confirm the member has a 6-month history of at least two nocturic episodes per night; AND
• Member has failed behavior modifications including reducing caffeine intake, alcohol intake, and nighttime fluid intake; AND
• Member must have failed a trial of DDAVP® (desmopressin) tablets or have a patient-specific, clinically significant reason why the tablet formulation cannot be used; AND
• The prescriber must be willing to measure serum sodium levels within seven days of anticipated start of treatment and document levels are acceptable; AND
• The prescriber must agree to monitor serum sodium levels within one month of starting treatment or increasing the dose; AND
• The prescriber must confirm the member is not taking any of the following:
  • Other medications via the nasal route; OR
  • Loop diuretics; AND 
• The prescriber must confirm the member does not have renal impairment with estimated glomerular filtration rate (eGFR) below 50mL/min/1.73m2; AND
• Initial approvals will be for the duration of 3 months, and for continued authorization the prescriber must provide the following:
  • Documentation that serum sodium levels are acceptable to the prescriber; AND
  • Documentation that the member is responding to treatment; AND
• A quantity limit of one bottle (3.8g) per 30 days will apply.

• An FDA approved indication of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency; and
• Member must be 18 years of age or older; and
• A patient-specific, clinically significant reason why all lower tiered medications are not appropriate for the member must be provided; and
• A quantity limit of 30 tablets per 30 days will apply. 

Oxybutynin 2.5mg Tablet Approval Criteria:

• An FDA approved diagnosis; and
• A patient-specific, clinically significant reason why the member cannot use other appropriate Tier-1 products, including splitting an oxybutynin 5mg tablet to achieve a 2.5mg dose, must be provided. 

Oxytrol (oxybutynin 3.9mg/day patch) Special PA Tier approval criteria: 

• An FDA approved diagnosis of overactive bladder; AND
• A patient-specific, clinically significant reason why all lower tiered medications are not appropriate for the member; AND
• A quantity limit of 8 patches every 30 days will apply.