CurrentmhnPolicy CP.PMN.198

ENABLEX (PDF)

Defines medical necessity and prior authorization criteria for overactive bladder agents (mirabegron, fesoterodine, solifenacin, darifenacin, vibegron/Gemtesa and related formulations) across Commercial, ICHRA/HIM, and Medicaid lines of business. Includes initial and continuation criteria, step therapy/generic redirection, pediatric age limits, dosing maxima, contraindications, product availability and therapeutic alternatives.

Policy Summary

Payermhn

PolicyENABLEX (PDF)

Policy CodePolicy CP.PMN.198

Change TypeAdded vibegronbrand-to-generic redirectionadministrative updates

Effective DateMay 1, 2016

Next Review Date

Key ActionProviders must submit documentation supporting that the member meets all approval criteria for overactive bladder agents.

SourceLink

POLICY UPDATE CHANGES

Added vibegron (Gemtesa) to policy

Added brand-to-generic redirection for Myrbetriq and other products

Removed references to Enablex as branded product was discontinued

Added ICHRA/ H I M line of business

6Agents listed requiring prior authorization

12Approval duration (months)

2Required prior generic failures

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IL HIM step therapy bypass

Coverage Summary

This policy governs prior authorization for FDA‑approved overactive bladder agents including mirabegron (Myrbetriq, Myrbetriq Granules), fesoterodine (Toviaz), solifenacin (Vesicare, Vesicare LS), darifenacin, and vibegron (Gemtesa) and related formulations across Commercial, ICHRA/HIM, and Medicaid lines of business. It covers pediatric formulations and age/weight limits for neurogenic detrusor overactivity (e.g., Vesicare LS age 2–17, Myrbetriq Granules age 3–17, Myrbetriq age 3–17 with weight ≥ 35 kg, Toviaz age 6–17 with weight ≥ 25 kg), documents step therapy and brand‑to‑generic redirection requirements (with specified product exceptions and an IL HIM step therapy bypass per IL HB 5395 effective 1/1/2026), enforces that dosing not exceed the FDA‑approved maximum recommended dose or health plan quantity limits, lists hypersensitivity and product‑specific contraindications, and includes continuity of care and prior authorization procedural notes.

Key policy thresholds

Step therapy failures requiredFailure of 2 formulary generic overactive bladder agents (examples: fesoterodine, oxybutynin, solifenacin, tolterodine, trospium) for 30 days

Myrbetriq pediatric weight thresholdMember must weigh ≥ 35 kg for ages 3–17 when requesting mirabegron (Myrbetriq)

Toviaz pediatric weight thresholdMember must weigh ≥ 25 kg for ages 6–17 when requesting fesoterodine (Toviaz)

Approval durationAuthorizations are approved for 12 months for initial and continued therapy when criteria are met

Brand-to-generic redirectionFor brand Myrbetriq/Toviaz/Vesicare (and Vesicare LS age ≥18) member must use generic equivalent unless contraindicated or clinically significant adverse effects; IL HIM step therapy bypass effective 1/1/2026 per IL HB 5395

Initial Therapy Criteria

I. Initial Approval Criteria - Overactive Bladder

Covered when ALL of the following are met:

Diagnosis requirement: Diagnosis of overactive bladder, including neurogenic detrusor overactivity
Age requirement
- Adult: Age ≥ 18 years
- Pediatric neurogenic detrusor overactivity exceptions
  - Vesicare LS for age 2 to 17 years

Continuation Therapy Criteria

II. Continued Therapy - Overactive Bladder

Continued coverage when ALL of the following are met:

Continuity of care/member currently receiving or prior initial approval: Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
Positive response to therapy: Member is responding positively to therapy
Brand-to-generic redirection for continued therapy
- Vesicare continued redirection: If request is for brand Vesicare: member must use the generic version unless contraindicated or clinically significant adverse effects

Unapproved Indications / Exclusions

III. Diagnoses/Indications NOT authorized

Coverage not authorized for:

III. Diagnoses/Indications NOT authorized: Non-FDA approved indications not addressed in this policy unless sufficient documentation of efficacy and safety per the off-label use policy or evidence of coverage documents

References: CP.CPA.09 (commercial), HIM.PA.154 (ICHRA/HIM), CP.PMN.53 (Medicaid); evidence of coverage

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Providers must submit documentation (office chart notes, lab results, or other clinical information) that demonstrates the member meets all approval criteria for overactive bladder agents. Submit sufficient clinical information to support diagnosis, prior therapy, dosing, and any contraindications or adverse events referenced in the request.

Documentation Required

Document prior failures or contraindications

Document either failure of two formulary generic overactive bladder agents for 30 days each, or provide documentation of contraindication or clinically significant adverse effects that would bypass the step therapy requirement.

Note

Brand-to-generic redirection

Applicable Codes

No specific billing codes providedmixed

No codes listed

Clinical Evidence and References

References reviewed: multiple prescribing information documents for Myrbetriq/Myrbetriq Granules, Vesicare/Vesicare LS, Toviaz, Gemtesa, darifenacin, clinical database sources, and AUA/SUFU guidelines were cited and accessed on the dates shown in the policy reference list (accessed up to January–February 2026 as noted).

Background

Background: This clinical policy establishes prior authorization criteria for FDA‑approved overactive bladder agents, including pediatric formulations, aligning coverage with FDA indications, step therapy and brand‑to‑generic redirection requirements, dosing maxima, contraindications, and continuity of care provisions.

Revision History

01.13.25added

Added vibegron (Gemtesa) to policy; Gemtesa added with indications and dosing; additional indication added for adult males on pharmacologic therapy for BPH (01.13.25).

01.28.25revised

Added brand-to-generic redirection for Myrbetriq and other products; for brand Myrbetriq added redirection to generic mirabegron and added step therapy bypass for Illinois HIM per IL HB 5395 (01.28.25/02Q2025).

2Q2024removed

Policy Summary

Payermhn

PolicyENABLEX (PDF)

Policy CodePolicy CP.PMN.198

Change TypeAdded vibegronbrand-to-generic redirectionadministrative updates

Effective DateMay 1, 2016

Next Review Date

Key ActionProviders must submit documentation supporting that the member meets all approval criteria for overactive bladder agents.

SourceLink

On This Page

Myrbetriq Granules for age 3 to 17 years

Myrbetriq (mirabegron) weight rule: Myrbetriq for age 3 to 17 years AND member weighs ≥ 35 kg35 kg

Toviaz weight rule: Toviaz for age 6 to 17 years AND member weighs ≥ 25 kg25 kg

Step therapy requirement: Failure of 2 formulary generic overactive bladder agents for 30 days, unless clinically significant adverse effects or contraindicationsFailure of 2 generics for 30 days

For Illinois HIM requests, step therapy requirements do not apply as of 2026-01-01 per IL HB 5395

Brand-to-generic redirection requirements (apply where product-specific)

Vesicare brand redirection: If request is for brand Vesicare: member must use the generic version unless contraindicated or clinically significant adverse effects
Vesicare LS adult redirection: If request is for Vesicare LS and age ≥ 18 years: member must use generic solifenacin tablet unless contraindicated or clinically significant adverse effects
For Illinois HIM requests, this step therapy requirement does not apply as of 2026-01-01 per IL HB 5395
Toviaz redirection: If request is for Toviaz: member must use generic fesoterodine unless contraindicated or clinically significant adverse effects
Myrbetriq redirection: If request is for brand Myrbetriq: member must use generic mirabegron unless contraindicated or clinically significant adverse effects

Dose maximum constraint: Dose does not exceed the FDA-approved maximum recommended dose or health plan approved quantity limit for the relevant drugFDA max or plan limit

I. Initial Approval Criteria - Other diagnoses/indications

If request does not match primary criteria:

Recent label change guidance: If the drug recently (within 6 months) underwent a label change not reflected in this policy, follow the applicable no coverage or non-formulary policy for the line of business6 months
References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
Off-label use guidance: If requested use is not listed under section III and criterion 1 above does not apply, refer to the off-label use policy for the line of business
References: CP.CPA.09, HIM.PA.154, CP.PMN.53

Vesicare LS adult continued redirection: If request is for Vesicare LS and age ≥ 18 years: member must use generic solifenacin tablet unless contraindicated or clinically significant adverse effects

For Illinois HIM requests, this step therapy requirement does not apply as of 2026-01-01 per IL HB 5395

Toviaz continued redirection: If request is for Toviaz: member must use generic fesoterodine unless contraindicated or clinically significant adverse effects

Myrbetriq continued redirection: If request is for brand Myrbetriq: member must use generic mirabegron unless contraindicated or clinically significant adverse effects

Dose increase limit: If request is for a dose increase, new dose does not exceed the FDA-approved maximum recommended dose or health plan approved quantity limit for the relevant drugFDA max or plan limit

II. Continued Therapy - Other diagnoses/indications

If continued use is for other indications:

Recent label change guidance for continued therapy: If the drug recently (within 6 months) underwent a label change not reflected in this policy, follow the applicable no coverage or non-formulary policy for the line of business6 months
References: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
Off-label guidance for continued therapy: If requested use is not listed under section III and criterion 1 above does not apply, refer to the off-label use policy for the line of business
References: CP.CPA.09, HIM.PA.154, CP.PMN.53

For the listed branded products, the prescriber must either prescribe the generic equivalent or document why the generic is contraindicated or has caused clinically significant adverse effects. For Illinois HIM requests the step therapy/generic redirection requirements do not apply as of 1/1/2026 per IL HB 5395.

Vesicare → generic solifenacin (member must use generic version unless contraindicated)
Vesicare LS (age ≥ 18 years) → generic solifenacin tablet (member must use generic unless contraindicated)
Toviaz → generic fesoterodine (member must use generic unless contraindicated)
Myrbetriq (brand) → generic mirabegron (member must use generic unless contraindicated)
IL HB 5395 effective date: 1/1/2026 (Illinois HIM step therapy bypass)

Billing Rule

Dose and quantity limits

Requested dose must not exceed the FDA‑approved maximum recommended dose or the health plan approved quantity limit for the requested drug. Any dose increase must adhere to these maximum dose limits.

Prior Authorization

Approval duration

Authorizations are approved for 12 months for both initial and continued therapy when the approval criteria are met.

Removed references to Enablex as branded product was discontinued (administrative update during 2Q 2024 annual review).

03.26.26revisedLatest

Added ICHRA/HIM line of business during 2Q 2026 annual review (03.26.26).