Topical Acne Policy Number: C4190-A

CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 4/1/2012 3/1/2019 3/1/2020 J CODE TYPE OF CRITERIA LAST P&T APPROVAL NA RxPA Q2 2019

PRODUCTS AFFECTED: Acanya GEL 1.2-2.5% Benzoyl Peroxide GEL 6.5% Clinoin CREA 1.25-0.025- Aczone GEL 5% Benzoyl Peroxide GEL 8% 1% Aczone GEL 7.5% Benzoyl Peroxide- Dapsone GEL 5% Aktipak PACK 5-3% Erythromycin GEL 5-3% Duac GEL 1.2-5% Azelex CREA 20% BP Foam FOAM 5.3% Ery PADS 2% Benzac AC Wash LIQD 5% BP Foam FOAM 9.8% Erygel GEL 2% BenzaClin GEL 1-5% BP Wash LIQD 2.5% Erythromycin GEL 2% BenzaClin with Pump GEL BP Wash LIQD 7% Erythromycin PADS 2% 1-5% BPO GEL 4% Erythromycin SOLN 2% Benzamycin GEL 5-3% BPO GEL 8% Evoclin FOAM 1% BenzEFoam FOAM 5.3% Cleocin-T GEL 1% Evoclin FOAM 1% BenzEFoam FOAM 5.3% Cleocin-T LOTN 1% Inova 4/1 Acne Control BenzEFoamUltra FOAM Cleocin-T SOLN 1% Therapy KIT 4 & 1 & 5% 9.8% Cleocin-T SWAB 1% Inova 8/2 Acne Control BenzePrO Creamy Wash Clindacin ETZ KIT 1% Therapy KIT 8 & 2 & 5% LIQD 7% Clindacin ETZ SWAB 1% Inova KIT 4 & 5% BenzePrO FOAM 5.3% Clindacin Pac KIT 1% Inova KIT 8 & 5% BenzePrO Foaming Cloths Clindacin-P SWAB 1% Neuac GEL 1.2-5% MISC 6% Clindagel GEL 1% Neuac KIT 1.2-5% BenzePrO Short Contact Clindamycin Phos-Benzoyl Onexton GEL 1.2-3.75% FOAM 9.8% Perox GEL 1.2-2.5% Onexton GEL 1.2-3.75% Benziq GEL 5.25% Clindamycin Phos-Benzoyl PR Benzoyl Peroxide Wash Benziq LS GEL 2.75% Perox GEL 1-5% LIQD 7% Benziq Wash LIQD 5.25% Clindamycin Phosphate Riax FOAM 5.5% Benzoyl Perox- FOAM 1% Riax FOAM 9.5% Hydrocortisone LOTN 5- Clindamycin Phosphate Vanoxide-HC LOTN 5-0.5% 0.5% GEL 1% Zacare KIT 4 & 0.2% Benzoyl Peroxide FOAM Clindamycin Phosphate Zacare KIT 8 & 0.2% 9.8% LOTN 1% Zaclir Cleansing LOTN 8% Benzoyl Peroxide Forte- HC Clindamycin Phosphate LOTN 7.5-1% SWAB 1%

DRUG CLASS: Topical Acne Products

ROUTE OF ADMINISTRATION: External

PLACE OF SERVICE: Retail Pharmacy

Molina Healthcare, Inc. confidential and proprietary © 2018 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 1 of 4 AVAILABLE DOSAGE FORMS: see above

FDA-APPROVED USES: Topical treatment of acne vulgaris

COMPENDIAL APPROVED OFF-LABELED USES: None

COVERAGE CRITERIA: INITIAL AUTHORIZATION

DIAGNOSIS: acne vulgaris

REQUIRED MEDICAL INFORMATION: A. ACNE VULGARIS: 1. Documentation of diagnosis of acne vulgaris AND 2. Documentation of an adequate trial (at least 4 weeks) or labeled contraindication to ALL of following topical treatments: benzoyl peroxide, topical clindamycin or erythromycin, topical adapalene (Differin gel 0.1% OTC ONLY) AND 3. Documentation of an adequate trial (at least 4 weeks) of two products [(benzoyl peroxide, topical clindamycin or erythromycin, topical adapalene (Differin gel 0.1% OTC ONLY)] used within combination AND 4. Documentation member will be using requested product in combination with at least one other topical agent for the treatment of acne AND 5. FOR COMBINATION PRODUCTS REQUESTS: combination products are not covered; Notify prescriber that separate topical products are formulary and are covered when valid prescriptions are presented to the pharmacy.

DURATION OF APPROVAL: Initial authorization: 6 months, Continuation of therapy: 12 months

QUANTITY: Differin gel 0.1% 45 grams/30 days, Benzoyl Peroxide Wash 240grams/30 days

PRESCRIBER REQUIREMENTS: None

AGE RESTRICTIONS: benzoyl peroxide 2.5% and adapalene 1% gel is > 9 years of age, all others > 12 years of age

GENDER: Male and female

CONTINUATION OF THERAPY: A. ACNE VULGARIS: 1. Continues to meet initial criteria

CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: All other uses of topical acne products are considered experimental/investigational and therefore, will follow Molina’s Off-Label policy.

OTHER SPECIAL CONSIDERATIONS: Isotretinoin and topical retinoids have a separate policy for alternative acne treatments

APPENDIX: Guidelines of care for the management of acne vulgaris- J Am Acad Dermatol http://dx.doi.org/10.1016/j.jaad.2015.12.037

REFERENCES:

1. Zaenglein, A., Pathy, A., Schlosser, B., Alikhan, A., Baldwin, H., Berson, D., Bowe, W., Graber, E., Harper, J., Kang, S., Keri, J., Leyden, J., Reynolds, R., Silverberg, N., Stein Gold, L., Tollefson, M., Weiss, J., Dolan, N., Sagan, A., Stern, M., Boyer, K. and Bhushan, R. (2016).

Guidelines of care for the management of acne vulgaris. Journal of the American Academy of Dermatology, 74(5), pp.945-973.e33.