Clinical Policy: Fesoterodine (Toviaz) Reference Number: ERX.ST.16 Effective Date: 09.01.17 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log

See Important Reminder at the end of this policy for important regulatory and legal information.

Description Fesoterodine (Toviaz®) is a muscarinic antagonist.

FDA approved indication Toviaz is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria

It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Toviaz is medically necessary when the following criteria are met:

I. Initial Approval Criteria A. Step Therapy for Toviaz (must meet all): 1. Age ≥ 18 years; 2. Previous use of 2 formulary generic overactive bladder agents, each trialed for 30 days, unless all are contraindicated or clinically significant adverse effects are experienced; 3. Previous use of Myrbetriq and Vesicare, each trialed for 30 days, unless both are contraindicated or clinically significant adverse effects are experienced; 4. One of the aforementioned trials occurred within the past 6 months, unless all are contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 8 mg per day (1 tablet per day). Approval duration: 12 months

II. Continued Therapy A. Step Therapy for Toviaz (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or member has previously met initial approval criteria; 2. If request is for a dose increase, new dose does not exceed 8 mg per day (1 tablet per day). Approval duration: 12 months

III. Appendices/General Information Appendix A: Abbreviation/Acronym Key ER: extended release FDA: Food and Drug Administration IR: immediate release

Appendix B: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/ Maximum Dose Oxybutynin (Ditropan®, Adults IR: 20 mg/day Ditropan XL®) ER: 30 mg/day

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Drug Dosing Regimen Dose Limit/ Maximum Dose Immediate release (IR): Usual dose is 5 mg PO 2-3 times per day. The maximum dose is 5 mg PO 4 times per day. Extended release (ER): Initially, 5-10 mg PO once daily. Dosage may be adjusted weekly by 5-mg increments based on efficacy and tolerability. Tolterodine (Detrol®, Adults 4 mg/day Detrol LA®) IR: 2 mg PO twice daily. The dose may be lowered to 1 mg PO twice daily based on individual response and tolerability. ER: 4 mg PO once daily. Trospium (Sanctura®, Adults 60 mg/day Sanctura XR®) IR: 20 mg PO twice daily. ER: 60 mg PO once daily in the morning. Darifenacin (Enablex) Adults: Initially, 7.5 mg PO once daily. 15 mg/day The dose may be increased to 15 mg PO once daily after 2 weeks based on individual response. Myrbetriq® (mirabegron) Adults: 25 mg PO once daily; Based on 50 mg/day individual patient efficacy and tolerability the dose may be increased to 50 mg PO once daily Vesicare® (solifenacin) Adults: 5 mg PO once daily. The dose 10 mg/day may be increased to 10 mg PO once daily if needed and tolerated.

IV. Dosage and Administration Indication Dosing Regimen Maximum Dose Overactive bladder Adults: Initially, 4 mg PO once daily. The dose 8 mg/day may be increased to 8 mg PO once daily based upon response and tolerability.

V. Product Availability Extended-release tablets: 4 mg and 8 mg

VI. References 1. Toviaz Prescribing Information. New York, NY: Pfizer Inc.; January 2014. Available at: http://www.toviaz.com/. Accessed July 7, 2017. 2. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non- neurogenic) in adults: AUA/SUFU guideline. Published 2012; Amended 2014. Available at: http://www.auanet.org/guidelines/overactive-bladder-(oab)-(aua/sufu-guideline-2012-amended- 2014). Accessed July 6, 2017. 3. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.; 2017. Available at: http://www.clinicalpharmacology-ip.com/.

Reviews, Revisions, and Approvals Date P&T Approval Date Policy split from ERX.NSST.12 Overactive bladder agents 07/17 08/17 (retired) and converted to new template. Added trial duration of 30 days and that one of the trials occurred within the last 6

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Reviews, Revisions, and Approvals Date P&T Approval Date months; Modified generic FDA approved max dose statement to reflect specific max dose of drug. Updated references.

Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information.

This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members.

This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions.

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