MEDICATION COVERAGE POLICY PHARMACY AND THERAPEUTICS ADVISORY COMMITTEE POLICY Eye & Ear Anti-Inflammatory P & T DATE 12/10/2019 Disorders THERAPEUTIC CLASS Topical Anti-Inflammatory Agents REVIEW HISTORY 12/18, 9/17, 2/08, 9/10, LOB AFFECTED Medi-Cal (MONTH/YEAR) 11/15, 12/16 This policy has been developed through review of medical literature, consideration of medical necessity, generally accepted medical practice standards, and approved by the HPSJ Pharmacy and Therapeutic Advisory Committee. OVERVIEW Eye and ear infections are among the most common reasons for patient self-referral. A wide variety of conditions can lead to ocular and ophthalmic inflammation. Inflammation of the eye is mostly caused by allergens, bacteria, and viral infections. On the other hand, ear infections are mostly caused by bacterial infections, although viral infections are also possible. Most infections are mild. However, severe cases can rapidly progress to permanent visual/hearing loss if not cared for properly. This review will examine the recommended use of topical anti- inflammatory agents and their coverage criteria. Available Agents: (Current as of 10/2019) AVG FORM. COST GENERIC NAME AVAILABLE STRENGTHS NOTES LIMITS PER 30 (BRAND NAME) DAYS OPHTHALMIC AGENTS CORTICOSTEROIDS 0.1% SOLUTION -- $54.76 -- MAXIDEX 0.1% SUSPENSION NF $88.31 -- DEXAMETHASONE DEXYCU 9% SUSPENSION NF (MAXIDEX, OZURDEX) OZURDEX 0.7 MG IMPLANT NF -- -- DIFLUPREDNATE 0.05% EMULSION NF -- -- (DUREZOL) IMPLANT: FLUOCINOLONE 0.19 MG NF -- -- (ILUVIEN, RETISERT) 0.59 MG NF -- -- FLUOROMETHOLONE 0.1% -- $60.62 -- SUSPENSION FLUOROMETHOLONE FML S.O.P. 0.1 % OINTMENT -- $135.65 -- (FML, FLAREX, FML FORTE, FLAREX 0.1% ACETATE FML LIQUIFILM) NF -- -- SUSPENSION FML FORTE 0.25% SUSPENSION -- $149.29 -- LOTEMAX 0.5% GEL PA $159.54 LOTEMAX 0.5% OINTMENT PA -- RESTRICTED TO PATIENTS WITH LOTEPREDNOL GLAUCOMA OR AGE (LOTEMAX, ALREX) LOTEMAX 0.5% SUSPENSION PA $209.86 10 OR LESS; MUST BE PRESCRIBED BY ALREX 0.2% SUSPENSION PA $199.16 OPHTHALMOLOGIST PREDNISOLONE SODIUM PREDNISOLONE -- $45.29 -- (OMNIPRED, PRED FORTE, PHOSPHATE 1% DROPS PREDNISOLONE ACETATE 1% PRED MILD) -- $53.18 -- DROPS PRED MILD 0.12% SUSPENSION -- $129.19 -- TRIAMCINOLONE 4 MG/ML INTRAVITREAL NF -- -- (TRIESENCE) SUSPENSION NSAIDs Coverage Policy – Eye & Ear Inflammatory Disorders Page 1 BROMFENAC SODIUM 0.09% SOLUTION NF -- -- ( PROLENSA, XIBROM ) DICLOFENAC -- 0.1% SOLUTION -- $15.56 (VOLTAREN) FLURBIPROFEN - 0.03% SOLUTION -- $6.55 (OCUFEN) KETOROLAC 0.4% SOLUTION -- $47.11 -- (ACULAR LS, ACULAR, 0.5 % SOLUTION -- $37.11 -- ACUVAIL) ACUVAIL 0.45% SOLUTION NF -- -- NEPAFENAC ILEVRO 0.3% SUSPENSION NF -- -- (ILEVRO, NEVANAC) NEVANAC 0.1 % SUSPENSION NF -- -- ANTIBIOTICS AZITHROMYCIN AZASITE 1% SOLUTION NF -- -- (AZASITE) BACITRACIN 500 UNITS/GRAM OINTMENT -- $80.89 -- BESIFLOXACIN BESIVANCE 0.6% SUSPENSION NF -- -- (BESIVANCE) CIPROFLOXACIN CILOXAN 0.3% OINTMENT NF -- -- (CILOXAN) 0.3% SOLUTION -- $13.54 -- ERYTHROMYCIN 0.5% OINTMENT -- $15.65 -- GATIFLOXACIN 0.5% SOLUTION NF -- -- (ZYMAR) GENTAMICIN 0.3% OINTMENT -- $13.46 -- (GARAMYCIN, GENTAK) 0.3% SOLUTION -- $6.07 -- STEP THERAPY TO TREATMENT MOXIFLOXACIN FAILURE OF OFLOXACIN OR 0.5 % DROPS ST $86.40 (VIGAMOX) CIPROFLOXACIN OPTHALMIC SUSPENSION IN THE LAST 90 DAYS. OFLOXACIN 0.3% SOLUTION -- $15.59 -- (OCUFLOX) SULFACETAMIDE 10% OINTMENT -- $49.45 -- (BLEPH-10) 10% SOLUTION -- $43.48 -- TOBRAMYCIN TOBREX 0.3% OINTMENT -- $206.45 -- (TOBREX) 0.3% SOLUTION -- $12.58 -- BACITRACIN/ 500UNITS/10,000 UNITS POLYMYXIN B -- $21.40 -- OINTMENT (POLYCIN) BACITRACIN/POLYMYXIN/ 400UNITS/10,000UNITS/3.5MG NEOMYCIN -- $40.60 -- OINTMENT (NEO-POLYCIN) BACITRACIN/POLYMYXIN/ 400UNITS/10,000UNITS/ NEOMYCIN/HC -- $43.08 -- 3.5MG/1% OINTMENT (NEO-POLYCIN HC) GENTAMICIN/ 0.3%/0.6% OINTMENT -- -- -- PREDNISOLONE 0.3%/1% SUSPENSION -- -- -- (PRED-G) 3.5MG/10,000 UNITS/0.1% NEOMYCIN/POLYMYXIN/ -- $16.93 -- OINTMENT DEXAMETHASONE 3.5MG/10,000 UNITS/0.1% (MAXITROL) -- $16.15 -- SOLUTION NEOMYCIN/ POLYMYXIN 1.75MG/10,000UNITS/0.025 MG -- $40.60 -- B/GRAMICIDIN SOLUTION (NEOSPORIN) NEOMYCIN/POLYMYXIN/ 3.5MG/400-10,000 U/ 10MG/ML HC -- $119.97 -- SUSPENSION (CORTISPROIN) POLYMYXIN B/ 10,000 UNITS/1 MG SOLUTION -- $9.66 -- TRIMETHOPRIM Coverage Policy – Eye & Ear Inflammatory Disorders Page 2 (POLYTRIM) TOBRADEX 0.3%/0.1% -- $197.71 -- TOBRAMYCIN/ OINTMENT DEXAMETHASONE TOBRADEX ST 0.3%/0.05% NF (TOBRADEX) OINTMENT 0.3%/0.1% SOLUTION -- $85.36 -- TOBRAMYCIN/ LOTEPREDNOL ZYLET 0.5/0.3% SUSPENSION NF -- -- (ZYLET) 10%/0.23% SOLUTION - $26.06 -- SULFACETAMIDE/PREDNI BLEPHAMIDE 10%/0.2% -- $192.42 -- SOLONE ACETATE SUSPENSION (BLEPHAMIDE SOP, BLEPHAMDIE S.O.P. 10/ 0.2% BLEPHAMIDE) -- $129.19 -- OINTMENT ANTIFUNGALS NATAMYCIN 5% SUSPENSION -- -- -- (NATACYN) ANTIVIRALS TRIFLURIDINE $113.20 0.1% SOLUTION -- -- (VIROPTIC) GANCICLOVIR (ZIRGAN) 0.15% GEL NF -- -- H1-ANTIAGONISTS ALCAFTADINE -- 0.25% SOLUTION NF -- (LASTACAFT) EMEDASTINE 0.05% SOLUTION NF -- -- (EMADINE) MAST-CELL INHIBITORS CROMOLYN SODIUM 4% SOLUTION -- $13.07 -- (OPTICROM) LODOXAMIDE 0.1% SOLUTION NF -- -- (ALOMIDE) NEDOCROMIL 2% SOLUTION NF -- -- (ALOCRIL) H1-ANTAGONIST/MAST-CELL INHIBITORS AZELASTINE 0.05% SOLUTION ST $55.32 STEP THERAPY TO KETOTIFEN (OPTIVAR) ALCAFTADINE 0.25% SOLUTION NF -- (LASTACAFT) BEPOTASTINE 1.5% SOLUTION NF -- -- (BEPREVE) BROMFENAC 0.09% SOLUTION NF $202.00 (XIBROM) EPINASTINE 0.05% SOLUTION NF -- -- (ELESTAT) KETOTIFEN 0.025% SOLUTION QL $7.55 LIMIT 10 ML PER MONTH (ALAWAY, ZADITOR) OLOPATADINE RESERVED FOR TREATMENT FAILURE (PATADAY, PATANOL, TO AZELASTINE AND EITHER 0.1% DROPS PA,QL $85.20 PAZEO) KETOTIFEN OR NAPHCON-A. LIMIT 5ML PER 30 Coverage Policy – Eye & Ear Inflammatory Disorders Page 3 PATANOL 0.1% DROPS NF $259.80 0.2% DROPS NF $136.95 -- PATADAY 0.2% DROPS NF $199.33 -- PAZEO 0.7% SOLUTION NF $196.86 -- CALCINEURIN INHIBITOR RESTASIS 0.05% DROPERETTE PA $427.30 RESERVED FOR TREATMENT FAILURE CYCLOSPORINE RESTASIS 0.05% MULTIDOSE TO OPHTHALMIC LUBRICANTS IN THE PA $ 474.44 (RESTASIS) VIALS LAST 6 MONTHS LFA-1 ANTAGONIST LIFITEGRAST 5% SOLUTION NF $446.79 -- (XIIDRA) OPHTHALMIC LUBRICANTS AND IRRIGATIONS HYDROXYPROPYL CELLULOSE 5 MG INSERT NF -- -- (LACRISERT) PROPYLENE GLYCOL/PEG 400 0.4%/0.3% DROPS -- $6.72 -- (SYSTANE, LUBRICANT EYE) GLYCERIN/PROPYLENE GLYCOL ARTIFICIAL TEAR DROPS -- $2.50 -- (ADVANCED EYE RELIEF, 0.1%/0.3% ARTIFICIAL TEARS) MINERAL OIL/PETROLATUM WHITE OINTMENT OINTMENT -- $5.82 -- (ARTIFICIAL TEARS, REFRESH P.M.) 0.25%, 1%, 1.5% GEL CARBOXYMETHYL- 0.25%, 0.5 %, 0.7% , 1% -- -- -- CELLULOSE SOLUTION (GEN TEAL, REFRESH REFRESH LIQUIGEL 1% GEL OPTIVE, TEARS AGAIN) -- $10.39 -- DROPS HYPROMELLOSE 0.2% DROPS -- -- (PURE AND GENTLE EYE 0.3% DROPS -- -- -- DROPS) DEXTRAN 70/ HYPROMELLOSE (ARTIFICIAL TEARS, 0.1%-0.3% DROPS -- -- -- TEARS PURE, TEARS NATURALE FREE) PEG 400/ HYPROMELLOSE/ 1%-0.2%-0.2% DROPS -- $1.03 -- GLYCERIN (ARTIFICIAL TEARS) POLYVINYL ALCOHOL (HYPO TEARS, LIQUI 1.4% DROPS -- $3.14 -- TEARS, MURINE TEARS, TEARS AGAIN) POLYVINYL ALCOHOL/POVIDONE 0.5%/0.6% DROPS -- -- -- (ARTIFICIAL TEARS, REFRESH) VASO-CONSTRICTORS CLEAR EYES REDNESS RELIEF SOLUTION (NAPHAZOLINE NF -- -- NAPHAZOLINE 0.125%/ GLYCERIN 0.2%) Coverage Policy – Eye & Ear Inflammatory Disorders Page 4 (CLEAR EYES REDNESS GOODSENSE REDNESS RELIEF RELIEF, GOODSENSE PLUS SOLUTION (NAPHAZOLINE NF -- -- REDNESS RELIEF PLUS, 0.03%/ GLYCERIN 0.5% ) VASOCLEAR) 0.1% SOLUTION -- $5.34 -- OXYMETAZOLINE 0.025 % SOLUTION NF -- -- (VISINE-LR) PHENYLEPHRINE 2.5% SOLUTION -- -- -- (ALTAFRIN, MYDFRIN, 10% SOLUTION -- -- -- NEOFRIN) TETRAHYDROZOLINE (OPTI-CLEAR, VISINE 0.05% SOLUTION NF -- -- ADVANCED RELIEF) NAPHAZOLINE/PHENIRAM 0.025%-0.3% SOLUTION -- $5.95 -- INE (NAPHCON-A, OPCON-A, 0.027%-0.315% SOLUTION -- $3.81 -- VISINE-A) TOPICAL ANESTHETIC LIDOCAINE 3.5% GEL NF -- -- (AKTEN) PROPARACAINE 0.5% SOLUTION -- $25.93 -- (ALCANINE, PARCAINE) TETRACAINE (ALTACAINE, TETCAINE, 0.5% SOLUTION NF -- -- TETRAVISC, TETRAVISC FORTE) PROPARACAINE/FLUORES CEIN 0.25%-0.5% SOLUTION NF -- -- (FLUCAINE) MISCELLANEOUS CYSTEAMINE 0.44 % DROPS NF -- (CYSTARAN) -- 2 % DROPS NF -- -- SODIUM CHLORIDE 5 % DROPS NF -- (MURO-128) -- 5 % OINTMENT NF -- -- OTIC AGENTS ANTIBIOTICS 0.2% SOLUTION NF -- -- CIPROFLOXACIN OTIPRIO 6% INTRATYMPANIC (CETRAXAL, OTIPRIO) NF -- -- SUSPENSION OFLOXACIN 0.3% SOLUTION -- $21.43 -- (FLOXIN OTIC) 3.5MG/10,000 UNITS/1% NEOMYCIN/ -- $47.58 -- SOLUTION POLYMYXIN B/HC 3.5MG/10,000 UNITS/1% ( CORTISPORIN OTIC ) -- $51.92 -- SUSPENSION CIPROFLOXACIN/ FLUOCINOLONE 0.3-0.25% SOLUTION NF -- -- (OTOVEL OTIC) CIPROFLOXACIN/HC 0.2%-1% SUSPENSION NF $276.51 -- Coverage Policy – Eye & Ear Inflammatory Disorders Page 5 (CIPRO HC) RESERVED FOR TREATMENT FAILURE CIPROFLOXACIN/ TO OFLOXACIN AND DEXAMETHASONE 0.3%-1.7% SUSPENSION PA $204.57 NEOMYCIN/ POLYMYXIN/HC (CIPRODEX OTIC) IN THE LAST 30 DAYS. NEOMYCIN/COLISTIN/HC/ THONZONIUM 0.33%-0.3%-1%-0.05% NF -- -- (COLY-MYCIN S, SUSPENSION CORTISPORIN TC) ANTI-INFECTIVES ACETIC ACID 2% SOLUTION -- $16.25 -- (VOSOL) ACETIC ACID/ALUMINUM 2% SOLUTION -- $61.22 -- ACETATE ACETIC ACID 2 % SOLUTION -- $16.19 (VOSOL) ACETIC ACID/HYDROCORTISONE 1%/2% SOLUTION -- $129.32 -- (VOSOL-HC) CRESYL ACETATE CRESYLATE 25% SOLUTION NF -- -- (CRESYLATE) CORTICOSTEROIDS FLUOCINOLONE 0.01% OIL NF $170.82 -- (DERMOTIC) PA = Prior Authorization; QL = Quantity Limit; NF = Non-Formulary EVALUATION CRITERIA FOR APPROVAL/EXCEPTION CONSIDERATION Below are the coverage criteria and required information for each agent. These coverage criteria have been reviewed approved by the HPSJ Pharmacy & Therapeutics