October 2015, Volume 7, Issue 1 The Prescriber e-Letter October 2015, Volume 7, Issue 1 Topical Corticosteroids (cont.) Neuraminidase inhibitors The neuraminidase inhibitors zanamivir (Relenza®) and The prior authorization process for topical corticosteroids oseltamivir (Tamiflu®) are approved by the U.S. Food and was implemented on October 26, 2015. The PA status of the Drug Administration (FDA) for the prophylaxis and individual products is outlined below. treatment of influenza and have demonstrated activity against both influenza A and influenza B. These agents interfere with PA No PA the release of progeny influenza virus from infected cells, Class I. Super Potent thereby preventing new rounds of infection. A 2003 meta- Clobetasol propionate cream, Betamethasone augmented gel analysis of 17 treatment and seven prevention trials ointment (Temovate®) Betamethasone dipropionate lotion, concluded that these drugs reduced the median duration of Clobetasol propionate foam (Olux®) ointment symptoms by approximately one day and may reduce the Clobetasol propionate foam / Betamethasone dipropionate, odds of developing influenza by 70 to 90%. However, recent emollient (Olux-E®) augmented ointment (Diprolene®)# trials and meta-analyses have demonstrated conflicting Clobetasol propionate lotion, Clobetasol propionate/emollient results on the ability of these agents to reduce influenza- shampoo, spray (Clobex®) (Temovate E®) related complications. Therefore, prior authorization will be Halobetasol cream, ointment Clobetasol propionate gel, solution ® # required for quantities greater than one treatment course per (Ultravate ) Clobetasol propionate shampoo kit season. Diflorasone ointment Fluocinonide 0.1% cream (Vanos®) Flurandrenolide tape (Cordran®) The prior authorization process for neuraminidase inhibitors Halobetasol / lactic acid (Ultravate was implemented on October 26, 2015, and is outlined X®) below. All agents require a PA from June 1 to September 30. From October 1 to May 31, a PA will be required for doses Class II. Potent exceeding the quantity limit as noted in the table below. Amcinonide ointment Betamethasone dipropionate cream Zanamivir requires PA for members <5 years of age. Desoximetasone 0.25% cream, Betamethasone dipropionate, ointment, spray, 0.05% gel augmented cream (Diprolene AF®)# (Topicort®) Betamethasone dipropionate, Drug PA for Quantity Limits ® # ® Diflorasone cream/emollient augmented lotion (Diprolene ) Zanamivir (Relenza ) > 20 inhalations/season ® ® (Apexicon-E ) Fluocinonide cream, gel, ointment, Oseltamivir 30 mg (Tamiflu ) > 20 capsules/season Halcinonide cream, ointment solution Oseltamivir 45 mg and 75 mg > 10 capsules/season (Halog®) Mometasone ointment (Elocon®) (Tamiflu®) Triamcinolone 0.5% ointment Oseltamivir 6 mg/mL > 180 mL/season ® Class III. Upper Mid-Strength Potent suspension (Tamiflu ) Amcinonide cream Amcinonide lotion Betamethasone valerate foam Betamethasone valerate ointment (Luxiq®) Fluocinonide / emollient Topical Corticosteroids Desoximetasone 0.05% cream, Fluticasone ointment ® ointment (Topicort ) Triamcinolone 0.1% ointment, 0.5% ® Topical corticosteroids are FDA-approved for the treatment Diflorasone cream (Psorcon ) cream of a variety of dermatological conditions. The topical Class IV. Mid-Strength Potent corticosteroids were subdivided in the former classification Clocortolone cream (Cloderm®) Fluocinolone ointment (Synalar®)# system of four groups: low potency, medium potency, high Fluocinolone ointment kit (Synalar®) Hydrocortisone valerate ointment potency and very high potency. The USA classification Triamcinolone 0.05% ointment Mometasone cream, solution system subdivides topical corticosteroids into seven classes, Triamcinolone spray (Kenalog®) (Elocon®)# with group one being super potent and group seven being Triamcinolone 0.1% cream least potent. MassHealth has determined that more costly topical corticosteroids will require PA, including all brand- name and generic products that are more costly than comparable alternatives. The Prescriber e-Letter is an update designed to enhance the transparency and efficiency of the MassHealth drug prior-authorization (PA) process and the MassHealth Drug List. Each issue highlights key clinical information and updates to the MassHealth Drug List. The Prescriber E-Letter was prepared by the MassHealth Drug Utilization Review Program and the MassHealth Pharmacy Program. The Prescriber e-Letter October 2015, Volume 7, Issue 1 Topical Corticosteroids (cont.) Class V. Lower Mid-Strength Potent Hydrocortisone solution Hydrocortisone cream, lotion, Fluocinolone cream kit (Synalar®) Betamethasone valerate cream ointment Fluocinolone shampoo (Capex®) Desonide lotion, ointment Combination Products Fluticasone lotion (Cutivate®) Fluocinolone 0.01% cream Betamethasone/calcipotriene Hydrocortisone/pramoxine foam Hydrocortisone probutate cream Fluocinolone 0.025% cream ® ® # ointment, scalp suspension (Pandel ) (Synalar ) ® (Taclonex ) Fluticasone cream (Cutivate®)# Neomycin/fluocinolone cream, Hydrocortisone butyrate/emollient cream kit Hydrocortisone butyrate cream, #This designates a brand-name drug with FDA “A”-rated generic ointment, solution Hydrocortisone valerate cream equivalents. PA is required for the brand, unless a particular form of that Prednicarbate cream, ointment drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated (Dermatop®)# generic equivalent. Triamcinolone 0.1% lotion, 0.025% ointment Class VI. Mild Potent Fluocinolone solution kit (Synalar®) Alclometasone cream, ointment Desonide gel (Desonate®) Betamethasone valerate lotion Desonide cream Fluocinolone body oil, scalp oil (Derma-smoothe-FS®)# Fluocinolone solution (Synalar®)# Fluticasone cream, ointment (Cutivate®)# Triamcinolone 0.025% cream, lotion Recent MassHealth Drug List Updates Drug/Drug Class Addition/Deletion/Change Rationale Antihypertensives Change in PA status; does not Given a recent decrease in the cost of the associated generic require PA irbesartan, irbesartan/hydrochlorothiazide, valsartan and valsartan/hydrochlorothiazide products, these agents no Irbesartan/hydrochlorothiazide longer require PA. (Avalide®)# Irbesartan (Avapro®)# Valsartan (Diovan®)# Valsartan/hydrochlorothiazide (Diovan HCT®)# #This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. Change in PA status; requires PA Given the significant increase in the cost of generic captopril, captopril/ hydrochlorothiazide and nadolol, these agents will Captopril require PA due to the availability of less costly alternatives. Captopril/hydrochlorothiazide Nadolol (Corgard®) Anti-inflammatory Ophthalmic Change in PA status; does not Given the rising cost of generic alternatives, fluorometholone Agents require PA acetate and prednisolone sodium phosphate no longer require PA. Fluorometholone acetate (Flarex®) Prednisolone sodium phosphate 1% ophthalmic solution 2 The Prescriber e-Letter October 2015, Volume 7, Issue 1 Antiviral Agents Change in PA status; requires PA PA will be required for quantities greater than one treatment for exceeding new quantity limits course per season. This will allow for the evaluation of the Zanamivir (Relenza®) –PA < 5 level of risk for complications of influenza infection for years of age and > 20 greater quantities. inhalations/season Oseltamivir 30 mg (Tamiflu®) –PA These agents require PA for all quantities from June 1to > 20 capsules/season September 30. From October 1 to May 31, a PA is required Oseltamivir 45 mg and 75 mg for doses exceeding the quantity limit as outlined. Zanamivir (Tamiflu®) –PA > 10 requires PA for members <5 years of age. capsules/season Oseltamivir 6 mg/mL suspension (Tamiflu®) –PA > 180 mL/season Dermatological Agents Change in PA status; does not Ammonium lactate is indicated for dry skin dermatitis and require PA congenital ichthyosis of the skin and is a brand-name drug with FDA “A”-rated generic equivalents. These agents no Ammonium lactate (Lac-Hydrin®)# longer require PA. Ammonium lactate (LAClotion®)# #This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. Insulin Products Addition; requires PA Insulin glargine 300 units/mL prefilled syringe is a higher potency formulation of insulin glargine. This agent requires a Insulin glargine prefilled syringe PA based on established medical necessity for the prefilled (Toujeo®) pen. Addition; requires PA Insulin human inhalation powder is a rapid-acting insulin indicated to improve glycemic control in adult patients with Insulin human inhalation powder diabetes mellitus. This agent requires PA based on established (Afrezza®) medical necessity for the formulation. Headache Therapy Agents Change in PA status; requires PA Butalbital-containing agents are FDA-approved to treat for all ages and quantities tension-type headaches. Due to the increased cost and the availability of butalbital/acetaminophen/caffeine as a less Butalbital 50 mg/acetaminophen costly alternative, butalbital/acetaminophen and 325 mg butalbital/aspirin/caffeine/codeine requires PA for all ages Butalbital/aspirin/caffeine/codeine and quantities. (Fiorinal®/Codeine) Kinase Inhibitors Change in PA status; requires PA Everolimus, everolimus