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PHARMACY PRE-AUTHORIZATION CRITERIA DRUG (S) Clobetasols (clobetasol propionate 0.05%) Clobetasol (liquid, ointment, cream, lotion, solution, gel, shampoo, foam) Clobex (lotion, shampoo, spray) Olux Foam Temovate (ointment, cream, gel) POLICY # 13142 INDICATIONS Clobetasol Propionate is FDA approved for short-term relief of inflammation and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses. Clobex lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older and for the treatment of moderate to severe plaque psoriasis. CRITERIA ConnectiCare considers Clobetasol Propionate foam, liquid, ointment, cream, lotion, solution, gel, shampoo, or spray to be medically necessary when the following criteria are met: 1. Patient is diagnosed with a corticosteroid responsive skin disorder AND 2. Patient has had adequate trials (of 2 weeks’ duration) of any two of the following • Amcinonide • Betamethasone Dipropionate • Desoximetasone • Fluocinonide • Halcinonide • Halobetasol • Triamcinolone OR • Patient is being treated by a gynecologist for Lichen Sclerosus. (not FDA-approved, but sufficient evidence to support its use) ConnectiCare considers Clobex Lotion to be medically necessary for patients 18 years of age and older who meet all of the following criteria: 1. Patient has clinically documented inflammatory or pruritic dermatoses OR 2. Patient has clinically diagnosed moderate to severe plaque psoriasis AND 3. Patient has a documented intolerance to, or treatment failure of an adequate trial of clobetasol (Temovate) cream, gel, ointment, or solution for scalp application PHARMACY PRE-AUTHORIZATION CRITERIA DRUG (S) Clobetasols (clobetasol propionate 0.05%) Policy #13142 LIMITATIONS Quantities of clobetasol cream, ointment, solution, gel, and shampoo will be limited to 240 grams/month. Approval will be limited to 6 months. If the above criteria are met authorization for Clobex Lotion is limited to no more than 118 ml’s over 1 month, and Olux Foam will be limited to no more than 1 cannister (100 gm) over 1 month. Treatment will be limited to: • 2 consecutive weeks for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses • And up to 2 additional weeks for moderate to severe plaque psoriasis that have not sufficiently improved after the initial 2 weeks of treatment • Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary REFERENCES • • • • Facts & Comparisons Online Clobex Lotion full prescribing information. Galderma Laboratories, Fort Worth, Texas. Olux full prescribing information. Connetics Corporation, Palo Alto, CA. Olux-E full prescribing information. Connetics Corporation, Palo Alto, CA. P&T REVIEW HISTORY 9/07, 6/08, 9/09, 9/10, 12/11, 10/12, 10/13, 10/14, 11/15, 5/16, 8/16 REVISION RECORD 8/16, 11/16