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Genitourinary System

Tier 1 products are covered with no authorization necessary.

Tier 2 Prior Authorization criteria

  • FDA approved diagnosis.
  • Recent 4-week trial of at least two Tier 1 medications from different pharmacological classes within the last 90 days.
  • Documented adverse effect, drug interaction, or contraindication to all available Tier 1 products.

Tier 3 Prior Authorization Criteria

  • FDA approved diagnosis of BPH.
  • Trial of at least two Tier 1 medications from different pharmacological classes.
  • A 4-week trial of each Tier 2 medication within the past 5 months.
  • Documented adverse effect, drug interaction, or contraindication, or lack of efficacy to all available Tier 1 and Tier 2 products.
  • Authorizations for tadalafil (Cialis®) will be granted for 5mg tablets only.

TIER 1

TIER 2

TIER 3

  • alfuzosin (Uroxatrol®)
  • doxazosin (Cardura®)
  • dutasteride (Avodart®)
  • finasteride (Proscar®)
  • tamsulosin (Flomax®)
  • terazosin (Hytrin®)
  • doxazosin (Cardura XL®)
  • dutasteride/tamsulosin (Jalyn®)
  • silodosin (Rapaflo®)
  • tadalafil (Cialis®)
  • finasteride/tadalafil (Entadfi™) 

 

Entadfi™ (Finasteride 5mg/Tadalafil 5mg) Approval Criteria:

  • An FDA approved diagnosis of benign prostatic hyperplasia (BPH); AND
  • A patient-specific, clinically significant reason why all lower tiered medications are not appropriate for the member must be provided; AND
  • A patient-specific, clinically significant reason why the member cannot use the individual components (finasteride and tadalafil) must be provided; AND
  • A quantity limit of 30 capsules per 30 days will apply; AND
  • Maximum treatment duration of 26 weeks will apply.   

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.
  • For use of Myrbetriq® (mirabegron) in combination with VESIcare® (solifenacin), the member must have failed monotherapy with either mirabegron or solifenacin (minimum 4-week trial) defined by continued symptoms of urge urinary incontinence, urgency, and urinary frequency. Current tier structure rules will also apply.

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.
Gemtesa® (Vibegron) Approval Criteria:
  • 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. 
Bladder Control Medications
Tier 1 Tier 2 Tier 3 Special PA
  • fesoterodine (Toviaz™) - Brand Preferred
  • oxybutynin (Ditropan®)
  • oxybutynin ER tabs (Ditropan XL®)
  • oxybutynin gel (Gelnique®)
  • solifenacin (VESIcare®)Δ
  • solifenacin oral susp (VESIcare LS™)α
  • trospium (Sanctura®)
  • tolterodine (Detrol®)
  • tolterodine ER tabs (Detrol LA®)
  • darifenacin (Enablex®)
  • mirabegron (Myrbetriq™)Δ tablets and granulesβ
  • trospium ER (Sanctura XR™)
  • desmopressin acetate SL tablets (Nocdurna®)
  • oxybutynin 2.5mg tablet
  • oxybutynin patch (Oxytrol®)   
  • vibergron (Gemtesa®)+  

ER = extended-release; PA = prior authorization; SL = sublingual; susp = suspension

Tier structure based on supplemental rebate participation and/or National Average Drug Acquisition

Costs (NADAC), Wholesale Acquisition Costs (WAC), or State Maximum Allowable Costs (SMAC).

ΔUnique criteria specific to use of Myrbetriq® (mirabegron) in combination with VESIcare® (solifenacin) applies.

αAn age restriction of 2 to 10 years of age will apply for VESIcare LS™. Members older than 10 years of age will require a patient-specific, clinically significant reason why the oral tablet formulation cannot be used. 

βThe Myrbetriq® granule formulation is covered for members 3 years of age or older weighing <35kg. Members weighing ≥35kg will require a patient-specific, clinically significant reason why the granule formulation is needed in place of the regular tablet formulation. Current Tier-3 criteria applies.

Filspari™ (Sparsentan) Approval Criteria:

  • An FDA approved indication to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression; AND
  • The diagnosis of primary IgAN must be confirmed by the following:
    • Kidney biopsy; AND
    • Secondary causes of IgAN have been ruled out (i.e., IgA vasculitis; IgAN secondary to virus, inflammatory bowel disease, autoimmune disease, or liver cirrhosis; IgA-dominant infection-related glomerulonephritis); AND
  • Member must be 18 years of age or older; AND
  • Must be prescribed by a nephrologist (or an advanced care practitioner with a supervising physician who is a nephrologist); AND
  • Member must be at risk of rapid disease progression as demonstrated by ≥1 of the following, despite 3 months of maximal supportive care:
    • Urine protein-to-creatinine (UPCR) ratio ≥1.5g/g; OR
    • Proteinuria >0.75g/day; AND
  • Member must be on a stable dose of a maximally tolerated angiotensin convert enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) for at least 3 months, unless contraindicated or intolerant; AND
  • Prescriber must verify the member will discontinue use of renin-angiotensin-aldosterone system (RAAS) inhibitors and endothelin receptor antagonists (ERAs) prior to initiating treatment with Filspari™; AND
  • Member must not be taking strong CYP3A4 inhibitors (e.g., itraconazole) or strong CYP3A4 inducers (e.g., rifampin) concomitantly with Filspari™; AND
  • Member must not be taking H2 receptor blockers or proton pump inhibitors (PPIs) concomitantly with Filspari™; AND
  • If member is using antacids, they must agree to separate antacid and Filspari™ administration by 2 hours; AND
  • Prescriber, pharmacy, and member must be enrolled in the Filspari™ Risk Evaluation and Mitigation Strategy (REMS) program and maintain enrollment throughout therapy; AND
  • A quantity limit of 30 tablets per 30 days will apply.
 

If you have questions please call the Pharmacy Help Desk at (800) 522-0114 option 4 or (405) 522-6205 option 4.

Last Modified on Mar 01, 2024
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