Oxistat (Oxiconazole) Cream P&T Approval Date 8/2014, 8/2015, 7/2016, 8/2017, 9/2018, 9/2019, 10/2020 Effective Date 2/1/2021; Oxford Only: 2/1/2021

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

Program Number 2020 P 2034-8 Program Prior Authorization/Medical Necessity Medication Oxistat (oxiconazole) cream P&T Approval Date 8/2014, 8/2015, 7/2016, 8/2017, 9/2018, 9/2019, 10/2020 Effective Date 2/1/2021; Oxford only: 2/1/2021

1. Background:

Oxistat (oxiconazole) cream is indicated for patients with tinea dermal infections including tinea versicolor (i.e., pityriasis versicolor) a common superficial fungal infection. Tinea versicolor often presents as hypopigmented, hyperpigmented, or erythematous macules on the trunk and proximal upper extremities. The causative organisms are yeasts in the genus Malassezia (formerly known as Pityrosporum). Most tinea dermal infections are treatable with over-the-counter medications. Coverage of Oxistat cream will only be provided for tinea versicolor infections after meeting these requirements.

2. Coverage Criteria a:

A. Oxistat cream will be approved based on all of the following:

1. Diagnosis of tinea versicolor

-AND-

2. History of failure, contraindication, or intolerance to one of the following topical antifungal agents:

a. ketoconazole 2% cream (generic Nizoral) b. ciclopirox 0.77% cream (generic Loprox)

Authorization will be issued for 12 months.

a State mandates may apply. Any federal regulatory requirements and the member specific benefit plan coverage may also impact coverage criteria. Other policies and utilization management programs may apply.

3. Additional Clinical Rules:

• Supply limits and/or Step Therapy may be in place • Notwithstanding Coverage Criteria, UnitedHealthcare may approve initial and re- authorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Use of automated approval and re-approval processes varies by program and/or therapeutic class.

4. References:

1. Oxistat [package insert]. Melville, NY: E. Fougera & CO; February 2019. 2. Ketoconazole [package insert]. Melville, NY: E. Fougera & CO; August 2020. 3. Loprox [package insert]. Fairfield, NJ: Medimetriks Pharmaceuticals, Inc; November 2018.

Program Prior Authorization/Medical Necessity - Oxistat Change Control Date Change 8/2014 New program. 9/2014 Administrative change - Tried/Failed exemption for State of New Jersey removed. 8/2015 Annual review. Updates to background section and references. 7/2016 Annual review. Provided clarity to step 1 and step 2 medications. Updated clinical rules and requirements. Added Maryland Continuation of Care statement. Updated references. Added Indiana and West Virginia coverage information. 11/2016 Administrative change. Added California coverage information. 8/2017 Annual review. State mandate reference language updated. 9/2018 Annual review. Updated references. 9/2019 Annual review. Updated references; added automation language. 10/2020 Annual review. Updated references.