CurrentAvMedPolicy N/A

Pharmacy prior authorization and step-edit for overactive bladder drugs

Form and clinical criteria governing prior authorization/step-edit requests for select overactive bladder (OAB) medications for AvMed members; applies to prescribers requesting fesoterodine, vibegron (Gemtesa), and mirabegron (Myrbetriq).

Policy Summary

PayerAvMed

PolicyPharmacy prior authorization and step-edit for overactive bladder drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of required trials/failures and supporting records (prescriber signature, member/prescriber details, drug name/strength/dosing, diagnosis).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3drugs listed on form

2diagnosis pathways

30min trial duration (days)

1/dayquantity limit

Coverage Criteria for Overactive Bladder Medications

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OAB (general adult): For diagnosis of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, member must have documentation of at least a 30-day trial and failure of TWO (2) of the following: oxybutynin IR/ER; darifenacin; tolterodine IR/ER; solifenacin tablets; trospium IR/ER.2 failed agents after >=30 days each

All criteria must be met and documentation provided.

inv-02: OAB with BPH (male patients) requirements

Covered when ALL of the following are met

OAB with BPH - mirabegron: If requesting mirabegron: for adult males on pharmacological therapy for benign prostatic hyperplasia, member must have documentation of at least a 30-day trial and failure of ONE of the following: doxazosin; silodosin; alfuzosin; tamsulosin; dutasteride and tamsulosin; terazosin.1 failed BPH agent after >=30 days

Applies specifically when requesting mirabegron.

OAB with BPH - vibegron: If requesting Gemtesa (vibegron): member must meet BOTH: (1) documentation of at least a 30-day trial and failure of ONE of the listed BPH agents (doxazosin; silodosin; alfuzosin; tamsulosin; dutasteride and tamsulosin; terazosin); AND (2) documentation of at least a 30-day trial and failure of mirabegron (generic Myrbetriq).1 failed BPH agent and failed mirabegron after >=30 days each

Sequential requirement for vibegron requests in males on BPH therapy.

Initial Therapy Requirements

inv-12: Initial pharmacologic therapy for OAB

For OAB in adults

Anticholinergic step requirement: Documented trial and failure of TWO of oxybutynin IR/ER, darifenacin, tolterodine IR/ER, solifenacin tablets, trospium IR/ER for >=30 days each before approving listed agents.

All checked therapies must be supported by documentation or pharmacy claims.

inv-13: Initial therapy requirements in males with BPH

For OAB in males with BPH when requesting mirabegron or vibegron

BPH agent requirement for mirabegron: Documented trial and failure of ONE BPH agent (doxazosin; silodosin; alfuzosin; tamsulosin; dutasteride and tamsulosin; terazosin) for >=30 days for mirabegron requests.

Applies to adult males on pharmacologic BPH therapy.

Sequential requirement for vibegron: For Gemtesa (vibegron), member must have failed ONE BPH agent (>=30 days) AND have documentation of a 30-day trial and failure of mirabegron (generic Myrbetriq) prior to approval.

Both conditions required.

Requirement	Details
OAB (general adult): prior anticholinergic trials
Member must have documentation of at least a 30-day trial and failure of TWO (2) of the following: oxybutynin IR/ER; darifenacin; tolterodine IR/ER; solifenacin tablets; trospium IR/ER.

Coding and Required Trial Durations

Diagnosis codeICD-10

ICD Code (if applicable)

Member to supply applicable ICD code on form

inv-05: Required trial duration — >= 30 days

Required trial duration>= 30 days per prior therapy (each trial)

Minimum number of anticholinergic trials for general OABTwo (2) distinct anticholinergic agents tried and failed for >=30 days each

Minimum BPH agent trial for OAB with BPH (mirabegron)One (1) BPH agent tried and failed for >=30 days

Sequential requirement for vibegron (Gemtesa)For vibegron requests in males on BPH therapy, must have failed one BPH agent (>=30 days) AND failed mirabegron after a >=30-day trial

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for fesoterodine (Toviaz), vibegron (Gemtesa), and mirabegron (Myrbetriq). Authorization may be delayed or denied if the request is incomplete, incorrect, or illegible.

Affected drugs: fesoterodine (Toviaz), vibegron (Gemtesa), mirabegron (Myrbetriq)
Fax prior authorization form to 1-305-671-0200
Quantity limit: 1 tablet per day (all strengths & medications)

Step Therapy

Step Therapy Requirement

Step therapy (step-edit) requires documented trials and failures of specified first-line agents prior to approval. Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes.

For OAB (general adult): documentation of at least a 30-day trial and failure of TWO of: oxybutynin IR/ER, darifenacin, tolterodine IR/ER, solifenacin, trospium IR/ER
For OAB with BPH (male patients requesting mirabegron): documentation of at least a 30-day trial and failure of ONE of: doxazosin, silodosin, alfuzosin, tamsulosin, dutasteride + tamsulosin, terazosin
For Gemtesa (vibegron) in males on BPH therapy: BOTH a 30-day trial/failure of ONE listed BPH agent AND documentation of at least a 30-day trial and failure of mirabegron (generic Myrbetriq)

Documentation Required

Required Documentation and Prescriber Signature

The prescribing physician must hand-sign and clearly print their name on the request form (preprinted stamps not valid). Authorization may be delayed if drug information (name/form/strength, dosing schedule, length of therapy), diagnosis, ICD code, weight (if applicable), or supporting documentation (labs, diagnostics, chart notes) are missing or illegible.

Prescriber signature: hand-signed (no preprinted stamps)
Include member and prescriber contact details (phone and fax)
Provide drug name/form/strength, dosing schedule, length of therapy, diagnosis and ICD code, and supporting documentation to substantiate trials/failures

Denial Risk

Incomplete or Illegible Submission Risk

Authorization may be delayed or denied if the form is incomplete, incorrect, illegible, or if supporting documentation (e.g., lab results, diagnostics, chart notes) is not provided. Samples used to initiate therapy do not satisfy step-edit or prior authorization requirements.

Incomplete or illegible submissions can delay or deny authorization
Ensure all requested fields are complete and legible before faxing
Samples do not meet step therapy/preauthorization criteria

Key Definitions

inv-11: Overactive Bladder (OAB) — Overactive bladder (OAB): symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

DefinitionOveractive bladder (OAB): symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

Typical initial managementBehavioral therapies and trial of anticholinergic agents or beta-3 agonists (as context in policy)

Applies toAdults with diagnosis of overactive bladder noted on the form

Background

Overactive bladder (OAB) is characterized by symptoms of urgency, urinary frequency, and urge urinary incontinence. Initial management typically begins with behavioral therapies and may include anticholinergic agents or beta-3 agonists. For adult males with concomitant benign prostatic hyperplasia (BPH), BPH-directed pharmacotherapy is often required before advancing to certain OAB-specific agents.

When evaluating prior authorization or step-edit requests for fesoterodine (Toviaz), vibegron (Gemtesa), or mirabegron (Myrbetriq), providers should be prepared to document prior trials and failures of first-line anticholinergic agents (or alpha/BPH agents in males) of at least 30 days each as specified by the criteria.