Bladder relaxant (antimuscarinic and beta-3 agonist) prior authorization
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Defines prior authorization requirements, preferred vs non-preferred products, age/weight-specific approvals, and quantity/exception processes for bladder relaxant medications for Georgia Medicaid Fee-for-Service members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Bladder Relaxants
Vesicare LS approvals
Covered when specific pediatric criteria are met
Documentation should support age and diagnosis of NDO and prior inadequate response/allergy/contraindication/drug-drug interaction/intolerable side effect to oxybutynin for ages 5–17.
Myrbetriq Granules approvals
Covered when age, weight, diagnosis, and prior therapy criteria are met
Documentation should support age, weight, diagnosis of NDO, and prior inadequate response/allergy/contraindication/drug interaction/intolerable side effect to Vesicare LS.
Requires documentation of prior inadequate response/allergy/contraindication/drug interaction/intolerable side effect to both oxybutynin and Vesicare LS.
Gelnique
Letter of medical necessity must describe inability to swallow oral forms and why Oxytrol Rx is unsuitable.
All Other Non-Preferred Products
Document prior trials and reason for failure (ineffectiveness, allergy, contraindication, interaction, or intolerable side effect).
A quantity-level limitation applies to Oxytrol Rx (oxybutynin patch). One replacement patch may be approved when the member’s original Oxytrol Rx patch has been lost or damaged.
Product Listings and Coding
| Fesoterodine ER | Fesoterodine ER |
| Oxybutynin chloride IR tablets | Oxybutynin chloride IR tablets |
| Oxybutynin chloride oral syrup | Oxybutynin chloride oral syrup |
| Oxybutynin chloride ER tablets | Oxybutynin chloride ER tablets |
| Oxytrol Rx (oxybutynin patch) | Oxytrol Rx (oxybutynin patch) |
| Solifenacin tablets | Solifenacin tablets |
| Vesicare LS (solifenacin oral suspension) | Vesicare LS (solifenacin oral suspension) |
| Darifenacin ER | Darifenacin ER |
| Flavoxate | Flavoxate |
| Gelnique (oxybutynin gel) | Gelnique (oxybutynin gel) |
Prior Authorization, Documentation, and Step Therapy
Prior authorization required; authorization length 1 year
Prior authorization is required for select bladder relaxant products; Vesicare LS is listed as preferred but still requires prior authorization. Authorized coverage is granted for up to 1 year. PA requests may be initiated by calling OptumRx at 1-866-525-5827.
Step therapy: try and fail preferred products first
Non-preferred bladder relaxant products are approvable only after the member has tried and experienced ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects to at least two preferred products (only one may be an oxybutynin product).
- At least two preferred products must have documented trial and failure; only one trial may be an oxybutynin product.
Submit LOM explaining why Oxytrol Rx is inappropriate for swallowability
For Gelnique requests when a member cannot swallow oral dosage forms, the prescriber must submit a written letter of medical necessity explaining why the preferred product Oxytrol Rx is not appropriate for the member.
- Letter must state reasons Oxytrol Rx is not appropriate for the member unable to swallow oral forms.
Document age, weight, NDO diagnosis and prior inadequate response for pediatric approvals
To support approvals for Vesicare LS and Myrbetriq Granules for pediatric neurogenic detrusor overactivity (NDO), include documentation of the member's age, weight (when applicable), diagnosis of NDO, and prior inadequate response, allergy, contraindication, drug-drug interaction, or intolerable side effect to the specified agents.
- Vesicare LS: document age (2–4 yrs or 5–17 yrs) and NDO diagnosis; for 5–17 yrs document prior inadequate response/allergy/contraindication/drug interaction/intolerable side effect to oxybutynin.
- Myrbetriq Granules: document age (3–4 yrs or 5–17 yrs), weight ≥ 35 kg, NDO diagnosis, and prior inadequate response/allergy/contraindication/drug interaction/intolerable side effect to required prior agents (Vesicare LS and/or oxybutynin as specified).
Denial risk if required step-therapy trials not documented
Requests for non-preferred products may be denied if the required trials of preferred products are not documented — specifically, lack of documentation that the member tried and experienced ineffectiveness, allergy, contraindication, drug-drug interaction, or intolerable side effects to at least two preferred products (only one may be an oxybutynin product) risks denial.
Background
Neurogenic detrusor overactivity (NDO) in pediatric patients is specifically addressed for select formulations in this policy. Treatment selection depends on patient age, weight, and prior response or tolerability to preferred agents such as oxybutynin and Vesicare LS, with topical or alternative formulations considered for members unable to use oral dosage forms.
For Vesicare LS, approvals are age- and diagnosis-specific: it is approvable for members 2 to 4 years of age with a diagnosis of NDO, and for members 5 to 17 years of age with NDO who have experienced an inadequate response, allergy, contraindication, drug–drug interaction, or intolerable side effect to oxybutynin. For Myrbetriq Granules, pediatric approvals require both an age/weight threshold (3 to 4 years of age and weighing ≥ 35 kg) and documented prior inadequate response or intolerance to specified agents (Vesicare LS for younger children; oxybutynin and Vesicare LS for older children).
Definitions
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