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.
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