ModifiedUnitedHealthcarePolicy 2025 P 3187-2

Mirabegron (generic Myrbetriq®) - Step Therapy - UnitedHealthcare Commercial Plans

UnitedHealthcare step therapy program requiring trial of two specified alternatives (oxybutynin and solifenacin) prior to coverage of generic mirabegron for adults with overactive bladder; applies to commercial plans with program- and state-specific variations.

Policy Summary

PayerUnitedHealthcare

PolicyMirabegron (generic Myrbetriq®) - Step Therapy - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 3187-2

Change TypeNew step therapy program; annual review with updated references

Effective DateNov 16, 2025

Next Review Date

Key ActionPrior authorization required for generic mirabegron; ensure documentation of trials/failures or contraindications to both oxybutynin and solifenacin before seeking approval.

SourceLink

POLICY UPDATE CHANGES

New step therapy program requiring trial of oxybutynin and solifenacin prior to mirabegron coverage was created (program start noted 6/2024, new program 9/2025).

Annual review conducted with updated references (AUA/SUFU guideline and EAU guideline citations updated).

2Required prior medications

12Authorization duration (months)

1Program number

Summary of Change

Mirabegron is indicated for treatment of overactive bladder symptoms in adults and may be used alone or with solifenacin. The step therapy program encourages use of lower-cost alternatives by requiring trials of oxybutynin and solifenacin prior to coverage of generic mirabegron. P&T approval dates include 6/2024 and 9/2025, and this is a material change introducing a new step therapy program.

Key dates & program summary

Effective date2025-11-16

Last review2025-09-01

P&T approval(s)6/2024; 9/2025

Program scopeUnitedHealthcare step therapy program requiring trial of oxybutynin and solifenacin prior to coverage of generic mirabegron for adults with overactive bladder; applies to commercial plans with program- and state-specific variations.

Coverage Stance & Criteria

Covered with criteria: generic mirabegron will be covered only after required criteria are met (step therapy prior authorization).

Authorization - Initial Therapy

Mirabegron (generic only) will be approved when ALL of the following are met:

ALL of the following

Patient is an adult with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
ALL of the following
- Oxybutynin (generic Ditropan or Ditropan XL)
- Solifenacin (generic Vesicare)

Authorization Duration

Authorization will be issued for 12 months

Relevant Codes & Diagnosis

Relevant diagnosis coding (referenced)ICD-10

Populate referenced diagnosis codes (ICD-10) for overactive bladder from policy references/guidelines and claims logic — not specified in brief/source; providers should supply appropriate OAB diagnosis codes when submitting authorization requests.

Prior Authorization & Billing Actions

Step Therapy

Step therapy prior authorization required

Prior authorization required for generic mirabegron; member must have documentation/history of failure, contraindication, intolerance, or inadequate response to both oxybutynin and solifenacin prior to approval.

Documentation Required

Supporting documentation for automated approval

UnitedHealthcare may approve initial and reauthorization based on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; providers should ensure claims/medication history accurately reflect trials and failures.

Billing Rule

Brand Myrbetriq exclusion noted

Brand Myrbetriq is typically excluded from coverage; ensure generic mirabegron is billed when authorization is sought.

UnitedHealthcare step therapy program requires trials of two specified alternatives (oxybutynin and solifenacin) prior to coverage of generic mirabegron for adults with overactive bladder; program and state-specific variations and federal or plan mandates may apply, and brand Myrbetriq is typically excluded. Providers should refer to supporting documentation, referenced guidelines, and prior claims/medication history used for automated approvals.

Definitions and Supporting References

Step Therapy: A utilization management program that requires trial of specified lower-cost alternatives prior to coverage of a requested medication.

Source	Detail
P&T Approval Date	6/2024; 9/2025
Myrbetriq PI	Astellas Pharma US, Inc; April 2021
Guideline citation	AUA/SUFU guideline published April 23, 2024; EAU 2024 guideline referenced

Policy Update Changes

6/2024addedLatest

P&T approval and creation of new step therapy program requiring trials of oxybutynin and solifenacin prior to coverage of mirabegron (program start noted 6/2024; new program effective 9/2025).

9/2025revised

Annual review conducted with updated references (AUA/SUFU 2024 and EAU 2024 guideline citations updated).

What Providers Must Do

Prior Authorization

Prior authorization & documentation required

Ensure prior authorization is requested for generic mirabegron and document trials of oxybutynin and solifenacin (history of failure, contraindication, intolerance, or inadequate response). Bill generic mirabegron (not brand Myrbetriq) when seeking approval.

Request prior authorization for generic mirabegron (program effective 11/16/2025).
Document trials/failures, contraindications, or intolerances to both oxybutynin (Ditropan/ Ditropan XL) and solifenacin (Vesicare).
Provide accurate claim/medication history and relevant ICD-10 diagnosis codes to support automated approval.
Bill the generic NDC (brand Myrbetriq typically excluded).

Actionable dates and thresholds