ModifiedCentenePolicy CP.PMN.198

Clinical Policy: Overactive Bladder Agents

Prior authorization and medical necessity criteria for mirabegron, fesoterodine, solifenacin, darifenacin, and vibegron for overactive bladder across Centene lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Overactive Bladder Agents

Policy CodePolicy CP.PMN.198

Change TypeFormulary additions, brand-to-generic redirection, pediatric extensions, state-specific bypass

Effective DateMay 1, 2016

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, age/weight criteria, and failure of two formulary generics (30 days each) or medical justification for brand use.

SourceLink

POLICY UPDATE CHANGES

Added Gemtesa (vibegron) to the policy.

Added redirection from brand Myrbetriq to generic mirabegron.

Added requirement for medical justification for inability to use generic for requests for brand Vesicare or Enablex; removed Enablex branded references when discontinued.

Added pediatric indications/extensions for certain agents (Myrbetriq Granules, Toviaz).

Added step therapy bypass for Illinois HIM per IL HB 5395.

Added fesoterodine and solifenacin as examples of formulary generic OAB agents.

5agents requiring prior authorization

12 moapproval duration (initial/continuation)

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Coverage Criteria for Overactive Bladder Agents

Initial Therapy Criteria

Covered when ALL of the following are met for Initial Approval:

Initial Approval - Overactive Bladder: Member has a diagnosis of overactive bladder, including neurogenic detrusor overactivity; AND member meets age/weight criteria (age ≥18 years, or pediatric age/weight criteria when applicable: Vesicare LS age 2–17 years; Myrbetriq Granules age 3–17 years; Myrbetriq age 3–17 years and ≥35 kg; Toviaz age 6–17 years and ≥25 kg) AND failure of 2 formulary generic overactive bladder agents (e.g., fesoterodine, oxybutynin, solifenacin, tolterodine, trospium) for 30 days each unless contraindicated or clinically significant adverse effects occur (Illinois HIM requests: step therapy does not apply as of 1/1/2026 per IL HB 5395) AND when requesting a branded product the member must use the generic version unless contraindicated or clinically significant adverse effects are experienced (product-specific generic substitution requirements apply: Vesicare → generic solifenacin, Toviaz → generic fesoterodine, Myrbetriq (brand) → generic mirabegron) AND requested dose does not exceed FDA‑approved maximum or the health plan approved quantity limit.Failure of 2 formulary generics; 30 days each

Approval duration: 12 months

Continuation Therapy Criteria

Covered when ALL of the following are met for Continuation/Renewal:

Continuation Approval - Overactive Bladder: Member is currently receiving the medication via the Centene benefit or previously met initial approval criteria OR member is covered under continuity-of-care provisions per state addenda; AND member is responding positively to therapy; AND when requesting a branded product the member must use the generic version unless contraindicated or clinically significant adverse effects are experienced (product-specific generic substitution requirements apply: Vesicare → generic solifenacin, Toviaz → generic fesoterodine, Myrbetriq (brand) → generic mirabegron) AND if request is for a dose increase the new dose does not exceed the FDA‑approved maximum or health plan approved quantity limit.Documented positive response to therapy

Approval duration: 12 months; Illinois HIM requests: step therapy notes apply per state-specific exceptions where indicated

Coverage actions and updates

Policy implements formulary redirection and criteria-based coverage for OAB agents; updates include additions and constraints below.

Brand-to-generic redirection: Requests for branded products (for example, Vesicare or Myrbetriq) require use of the formulary generic version unless contraindicated or clinically significant adverse effects are documented; members may be redirected to generic equivalents and requests must not exceed health plan approved quantity limits.

Added requirement for medical justification for inability to use generic; Enablex references removed when discontinued

Pediatric indications: Certain products have pediatric extensions and were added with corresponding criteria (examples: Myrbetriq Granules and Toviaz pediatric indications for neurogenic detrusor overactivity); follow product-specific age and weight criteria in the policy.

Specific age/weight criteria are detailed in initial approval criteria

State exceptions: Illinois HIM receives a step therapy bypass per IL HB 5395; applicability limited to the specified state and line of business.

Added step therapy bypass for IL HIM per IL HB 5395

Non‑FDA approved indications referenced in provider requests are not authorized under this policy unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policy. Follow the member's line‑of‑business off‑label requirements: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid) when submitting justification for off‑label use.

References to the branded product Enablex were removed from this policy because the branded product has been discontinued. Providers should reference the remaining listed agents and generics when submitting prior authorization requests.

Requests that exceed the health plan's approved quantity limits may not be approved. When requesting quantities above plan limits, include documentation supporting medical necessity and adherence to dosing guidance; lack of justification may result in denial or redirection to plan‑approved quantities.

Drug List and Product Coding

Prior authorization drug listNDC

NDC not listed	mirabegron (Myrbetriq, Myrbetriq Granules)
NDC not listed	fesoterodine (Toviaz)
NDC not listed	solifenacin (Vesicare, Vesicare LS)
NDC not listed	darifenacin
NDC not listed	vibegron (Gemtesa)

Available drug productsNDC

NDC	Vibegron (Gemtesa) tablets: 75 mg (product availability listed)

Age and weight thresholds for pediatric/weight-based indications

Myrbetriq (mirabegron) — pediatric tabletAge ≥3 years AND weight ≥35 kg for pediatric use; adults ≥18 years for standard indication

Myrbetriq GranulesAge ≥3 years (pediatric indication); weight‑based dosing per granules formulation (see dosing table)

Toviaz (fesoterodine) — pediatric extensionAge 6 to 17 years AND weight >25 kg for pediatric indication

Vesicare LS (solifenacin oral suspension)Age ≥2 years for pediatric neurogenic detrusor overactivity

Weight-based pediatric dosing examplesMyrbetriq Granules: 11 to <22 kg = 3 mL (24 mg) QD; 22 to <35 kg = 4 mL (32 mg) QD; ≥35 kg = 6 mL (48 mg) QD

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for mirabegron (Myrbetriq®, Myrbetriq® Granules), fesoterodine (Toviaz®), solifenacin (Vesicare®, Vesicare LS™), darifenacin, and vibegron (Gemtesa®).

Affected products listed above require prior authorization.

Step Therapy

Step Therapy — Fail Two Generics Prior to Brand

For initial approval, member must have failed two formulary generic overactive bladder agents (examples: fesoterodine, oxybutynin, solifenacin, tolterodine, trospium) for at least 30 days each unless clinically significant adverse effects occur or all are contraindicated. For Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395 (effective 01/01/2026).

Failure = inadequate response or intolerable adverse effects after ≥30 days on each of two formulary generics.
IL HIM step therapy bypass effective 01/01/2026 per IL HB 5395.

Background on Overactive Bladder

Overactive bladder (OAB) is characterized by urinary urgency, increased urinary frequency, and often urge urinary incontinence. Treatment options include oral antimuscarinics and beta‑3 adrenergic agonists which are FDA‑approved for adults and, for select products, pediatric or neurogenic detrusor overactivity indications. Clinical selection and authorization depend on the member's diagnosis (including neurogenic detrusor overactivity where applicable), age and weight thresholds for pediatric approvals, prior therapy history, and tolerability.

Agent Definitions and Specific Product Notes

Neurogenic detrusor overactivity (NDO)

DefinitionNeurogenic detrusor overactivity is a form of overactive bladder associated with neurologic conditions and is included within the policy's OAB diagnosis criteria

Agents with pediatric NDO indicationsMyrbetriq (mirabegron), Myrbetriq Granules, Toviaz (fesoterodine), Vesicare LS (solifenacin) are indicated for neurogenic detrusor overactivity in pediatric patients per specified age/weight thresholds

Policy placementRequests for NDO must meet the policy's diagnosis and applicable age/weight criteria listed under Initial Approval

Gemtesa (vibegron)

Product identityGemtesa = vibegron 75 mg tablet (FDA‑approved dosing: 75 mg PO QD)

Policy inclusionGemtesa was added to the policy (RT4) and is included on the formulary/prior authorization list