Prior Authorization/Step Therapy Program

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1 Prior Authorization/Step Therapy Program This program encourages safe, cost-effective medication use by allowing coverage when certain conditions are met. A clinical team of physicians and pharmacists develops and approves the clinical programs and criteria by reviewing FDA-approved labeling, scientific literature and nationally recognized guidelines. Prior Authorization Diclofenac Gel: Solaraze/ generic diclofenac gel Actinic Keratosis Addyi Afrezza Androgens/ Anabolic Steroids Antifungal Agents Fluorouracil Cream: Carac, Fluorouracil Cream, Fluoroplex, Efudex, Efudex Cream Kit, Tolak Imiquimod Cream: Aldara, Zyclara Ingenol Gel: Picato Addyi Afrezza Anadrol-50, Androderm, Androgel/ generic testosterone, Android/generic methyltestosterone, Androxy, Aveed, Axiron/generic testosterone solution, danazol, Delatestryl/generic testosterone enanthate, Depo-Testosterone/generic testosterone cypionate, Fortesta, Methitest, Natesto, Oxandrin, Striant, Testim, Testopel, Testred/generic methyltestosterone, Vogelxo Cresemba, Noxafil, Vfend/voriconazole product labeling, clinical studies and/or clinical guidelines. product labeling, clinical studies and/or clinical guidelines. Encourages appropriate use as well as the usage of cost-effective, preferred rapid-acting insulin product(s). A quantity limit is applied to these agents. Helps ensure that patients are appropriately selected and treated according to parameters defined in product labeling, clinical evidence and/or clinical guidelines. Upon meeting criteria, the preferred topical agent, Androgel 1.62% is typically required before non-preferred topical products. A quantity limit is applied to all topical and injectable testosterone products. Both brand and generic agents are targeted. Helps ensure appropriate selection of patients for treatment when prescribed for indications approved in product labeling. Both brand and generic agents are targeted. Antifungal Agents - Onychomycosis (formerly Topical Antifungal Agents) Jublia, Kerydin, Onmel, Penlac/ciclopirox, Sporanox labeling and/or clinical trials and to discourage cosmetic use. Ensures appropriate use in patients with fungal nail infections that cannot be treated with terbinafine or itraconazole. Bonjesta/Diclegis Diclegis Helps ensure appropriate use based on FDA labeling, guidelines and/or clinical studies. Circadian Rhythm Disorders Combination GI Protectants (Pain Management) Hetlioz Duexis, Vimovo, Yosprala Helps ensure appropriate selection of patients for therapy according to product labeling, clinical guidelines and/or clinical studies and according to dosing Encourages use of target agents when prescriber has provided documentation that the use of individual ingredients within the target combination agent as separate dosage forms is not clinically appropriate. BCBSTX Prior Authorization/Step Therapy Program 1 of 6

2 Prior Authorization (continued) Doxycycline/Minocycline Erectile Dysfunction Hyperpolarization- Activated Cyclic Nucleotide-Gated (HCN) Channel Blocker Insulin Agents Doxycycline products: Acticlate/ generic doxycycline, Adoxa, Doryx (and generic equivalents), Doryx MPC (and generic equivalents), Doxycycline, Monodox, Oracea, Targadox, Vibramycin Minocycline products: Minocin, minocycline tablet, Minocycline SR (and generic equivalents), Solodyn (and generic equivalents), Ximino Caverject, Cialis, Edex, Levitra, Muse, Staxyn, Stendra, Viagra/sildenafil Corlanor Admelog, Apidra, Humalog, Humalog Junior KwikPen, Humalog KwikPen U200, Humalog Mix 75/25, Humalog Mix 50/50, Humulin R U-100, Humulin N, Humulin 70/30 labeling, clinical studies and/or clinical guidelines and encourages use of first-line generic agents and topical acne products before use of targeted products, when appropriate. labeling, clinical guidelines and/or clinical studies. If prescribed for benign prostatic hyperplasia (BPH), encourages the use of a generic alpha blocker prior to consideration of Cialis at the recommended FDA-approved dose. A quantity limit is applied to these agents. product labeling, clinical studies and/or clinical guidelines, and according to dosing Encourages the use of preferred insulin products unless not clinically appropriate. A quantity limit is applied to these agents. Keveyis Keveyis Multisource Brand AirDuo Respiclick Encourages the use of a cost-effective generic over the requested agent. Narcolepsy Neprilysin Inhibitor Northera Opioid Antidote Opioid Induced Constipation Ophthalmic Immunomodulators Oral Immunotherapy Pseudobulbar Affect Rayos Regranex Nuvigil/armodafanil, Provigil/modafanil Entresto Northera Evzio* Movantik, Relistor Restasis, Xiidra Grastek, Oralair, Ragwitek Nuedexta Rayos Regranex Encourages appropriate use when prescribed according to product labeling for patients age 17 and older. A quantity limit encourages Both brand and generic agents are targeted. labeling, clinical studies and/or clinical guidelines. labeling, clinical studies and/or clinical guidelines. labeling, clinical studies and/or clinical guidelines. labeling, clinical studies and/or clinical guidelines. A quantity limit encourages Helps ensure appropriate selection of patients according to FDA-approved labeling and/or clinical guidelines. BCBSTX Prior Authorization/Step Therapy Program 2 of 6

3 Prior Authorization (continued) Selective Serotonin Inverse Agonist (SSIA) Therapeutic Alternatives Topical Doxepin Topical Lidocaine Transmucosal Immediate Release Fentanyl Nuplazid Absorica, Allzital, Amrix, Ativan, Auvi-Q, Azelex, Bupap, Cambia, Cardizem CD, Carospir, Cuprimine, Daraprim, Dexpak, Durlaza, Fexmid/generic cyclobenzaprine, Fortamet/metformin extended-release, Glumetza/metformin extended-release, Kadian, Kazano, levorphanol, Librax, Locort, Lorzone, Naprelan, Nesina, Noritate, Oseni, Pandel, Primlev, Sitavig, Spritam, Tivorbex, Vanatol LQ, Vanos, Vivlodex, Zegerid/OmePPI/omeprazolesodium bicarbonate, Zipsor, Zodex Pak, Zonacort, Zorvolex, Zyflo, Zyflo CR/ zileuton CR Doxepin cream, Prudoxin, Zonalon Lidoderm/lidocaine patch, lidocaine ointment Abstral, Actiq /fentanyl lozenge, Fentora, Lazanda, Subsys Helps ensure the appropriate use of cost-effective, clinically appropriate, preferred alternatives over other high-cost agents. labeling and/or clinical guidelines, and according to dosing recommended in product labeling. Helps ensure the appropriate use of cost-effective, clinically appropriate, preferred alternatives over other high-cost agents. Encourages appropriate use for the treatment of breakthrough pain in cancer patients who are opioid-tolerant. A quantity limit is applied to these agents. Both brand and generic agents are targeted. URAT1 Inhibitor Duzallo, Zurampic Vitamin B12 Deficiency Nascobal Helps ensure appropriate selection of patients for treatment according to product Specialty Prior Authorization Benlysta Benlysta product labeling and/or clinical studies and/or clinical guidelines, and according to dosing Biologic Immunomodulators (Rheumatoid Arthritis/Psoriasis) Cerdelga Cystic Fibrosis Emflaza Enzyme Deficiency Erythropoiesis Stimulating Agents (ESAs) Actemra subcutaneous, Cimzia, Cosentyx, Enbrel, Entyvio, Humira, Humira starter kit, Inflectra, Kevzara, Kineret, Orencia subcutaneous, Renflexis, Siliq, Simponi, Stelara, Stelara IV, Taltz, Tremfya, Xeljanz, Xeljanz XR Cerdelga Kalydeco, Orkambi Emflaza Kuvan Aranesp, Epogen, Mircera, Procrit Encourages use of first-line agents prior to the use of preferred biologic immunomodulators. Also encourages use of preferred biologic immunomodulators, Enbrel, Humira, Simponi and Stelara, before use of a non preferred biologic immunomodulator. A quantity limit encourages FDA approved dosing. Helps ensure appropriate selection of patients for treatment when prescribed for indications in product labeling. Encourages appropriate selection of cystic fibrosis patients for treatment according to product labeling, clinical studies, and/or clinical guidelines while following dosing Encourages use in patients with phenylketonuria (PKU) who are unable to maintain phenylalanine levels within the recommended range despite compliance with dietary restrictions. A quantity limit encourages Encourages appropriate use of ESAs to ensure that hemoglobin levels are within an acceptable range. BCBSTX Prior Authorization/Step Therapy Program 3 of 6

4 Specialty Prior Authorization (continued) Growth Hormone/ Egrifta H.P. Acthar (Pituitary Hormone) Hepatitis B & C Hereditary Angioedema Huntington s Disease Hypercholesterolemia Idiopathic Pulmonary Fibrosis (IPF) Inherited Autoinflammatory Disorders Injectable Atopic Dermatitis Agents Korlym Multiple Sclerosis Myalept Natpara Ocalvia Osteoporosis Otezla Pulmonary Arterial Hypertension (PAH) Egrifta, Genotropin, Humatrope, Norditropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Zomacton, Zorbtive H.P. Acthar Gel Daklinza, Epclusa, Harvoni, Mavyret, Olysio, Pegasys, PegIntron, Sovaldi, Technivie, Viekira PAK, Viekira XR, Vosevi, Zepatier Haegarda Austedo, Xenazine/tetrabenazine Juxtapid, Kynamro, Praluent, Repatha Esbriet, Ofev Arcalyst, Ilaris Dupixent Korlym Ampyra Myalept Natpara Ocalvia Forteo, Tymlos Otezla Adcirca, Adempas, Letairis, Opsumit, Orenitrum, Revatio, Tracleer, Tyvaso, Uptravi, Ventavis Encourages appropriate use for patients diagnosed with growth hormone deficiencies. Upon meeting criteria, use of the preferred growth hormone Omnitrope is typically required before non-preferred products. Also helps ensure appropriate use of Egrifta in treatment of patients with HIV lipodystrophy. A quantity limit for Egrifta encourages Helps ensure that patients are appropriately selected for therapy according to product labeling, clinical guidelines and/or clinical evidence. Verifies that appropriate FDA-approved dosing is used for specified indications. FDA-approved and/or clinically supported indications including, but not limited to, infantile spasms. Helps ensure that patients are appropriately selected and treated for an appropriate duration of therapy according to parameters defined in product labeling, clinical evidence and/or clinical guidelines. Upon meeting criteria, use of the preferred agent by genotype is typically required before non-preferred products in treatment of Hepatitis C. Helps ensure appropriate selection of patients for treatment when prescribed for indications approved in product labeling. Encourages appropriate selection of patients for treatment of chorea associated with Huntington s disease. A quantity limit encourages Helps ensure appropriate use of Juxtapid and Kynamro in treatment of patients with homozygous familial hypercholesterolemia (HoFH). Helps encourage appropriate selection of HoFH, heterozygous familial hypercholesterolemia (HeFH) or secondary prevention patients for treatment according to clinical studies and/or peer reviewed evidence for Praluent and Repatha. A quantity limit encourages FDA-approved dosing. Helps ensure appropriate selection of patients for treatment when prescribed for indications in product labeling. Encourages use for FDA-approved indications and discourages use in place of anakinra for rheumatoid arthritis, and off-label uses. A quantity limit encourages Helps ensure patients prescribed therapy meet selection requirements defined in product Encourages appropriate selection of patients for treatment according to product labeling, clinical studies and/or clinical guidelines and according to dosing Encourages appropriate use in ambulatory patients with multiple sclerosis. A quantity limit encourages Helps ensure that patients prescribed therapy are appropriately selected according to FDA product labeling and/or clinical studies. product labeling, clinical studies and/or clinical guidelines. A quantity limit encourages Ensures appropriate selection of patients for treatment according to product labeling and/or clinical guidelines and/or clinical studies. Also helps ensure appropriate dosing as determined by FDA product labeling or as supported by guidelines and/or clinical evidence. This program also encourages the use of the preferred agent where appropriate, per labeling. A quantity limit encourages Helps ensure the appropriate use of cost-effective, clinically appropriate, preferred alternatives over other high-cost agents. labeling, clinical studies and/or clinical guidelines. Upon meeting criteria, use of generic sildenafil is typically required before the brands Adcirca or Revatio unless the patient is already stabilized on the brand drug. A quantity limit encourages Both brand and generic agents are targeted. BCBSTX Prior Authorization/Step Therapy Program 4 of 6

5 Specialty Prior Authorization (continued) Self-administered Oncology Short Bowel Syndrome Strensiq Tardive Dykinesia Thrombopoietin Receptor Agonists Urea Cycle Disorders Xyrem Afinitor, Afinitor Disperz, Alecensa, Alunbrig, Bosulif, Cabometyx, Calquence, Caprelsa, Cometriq, Cotellic, Erivedge, Farydak, Gilotrif, Gleevec/imatinib, Hexalen, Hycamtin, Ibrance, Iclusig, Idhifa, Imbruvica, Inlyta, Iressa, Jakafi, Kisqali, Kisqali Femara Pack, Lenvima, Lonsurf, Lynparza, Lysodren, Matulane, Mekinist, Nerlynx, Nexavar, Ninlaro, Odomzo, Pomalyst, Revlimid, Rubraca, Rydapt, Sprycel, Stivarga, Sutent, Sylatron, Tafinlar, Tagrisso, Tarceva, Targretin/bexarotene, Tasigna, Temodar/temozolomide, Thalomid, Tretinoin, Tykerb, Venclexta, Verzenio, Votrient, Xalkori, Xeloda/ capecitabine, Xtandi, Zejula, Zelboraf, Zolinza, Zykadia, Zydelig, Zytiga Gattex Strensiq Ingrezza Nplate, Promacta Buphenyl/sodium phenylbutyrate, Ravicti Xyrem labeling, clinical studies and/or clinical guidelines. A quantity limit encourages Helps ensure appropriate use of Gattex in the treatment of patients with short bowel syndrome (SBS). product labeling and/or clinical studies and/or clinical guidelines, and according to dosing product labeling and/or clinical studies and/or clinical guidelines, and according to dosing Encourages appropriate, approved use for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) in those who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. A quantity limit encourages Helps ensure appropriate use of Buphenyl and Ravicti in patients with the following urea cycle disorders: carbamoylphosphate synthetase I deficiency (CPSID), ornithine transcarbamylase deficiency (OTCD), argininosuccinic acid synthetase deficiency (ASSD), argininosuccinic acid lyase deficiency (ASLD) or arginase deficiency (ARGD), who are not able to manage the disease by a protein restricted diet or with essential amino acid supplementation alone. Encourages appropriate use in patients age 16 and older for the treatment of cataplexy and as a second-line agent to a stimulant for patients with a diagnosis of narcolepsy with excessive daytime sleepiness. A quantity limit encourages Step Therapy Antidepressants Aplenzin, Celexa, Cymbalta, desvenlafaxine ER tabs, Desvenlafaxine fumarate, Duloxetine, Effexor, Effexor XR, Fetzima, fluoxetine 60 mg tabs, Fluvoxamine ER, Forfivo XL, Irenka, Khedezla, Lexapro, maprotiline, Oleptro, Paxil, Paxil CR, Pexeva, Pristiq, Prozac, Prozac Weekly, Remeron, Remeron SolTab, Trintellix, venlafaxine ER tabs, Viibryd, Viibryd Starter Kit, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zoloft Encourages use of cost-effective generic antidepressants for patients with new prescriptions for brand agents. The criteria also encourages use of first-line generic agents before Cymbalta when prescribed for neuropathic pain or fibromyalgia. Atopic Dermatitis Elidel, Eucrisa, Protopic/tacrolimus Encourages use of topical corticosteroid or topical corticosteroid combination preparations prior to, or concurrent with, brands Elidel, Eucrisa or Protopic. BCBSTX Prior Authorization/Step Therapy Program 5 of 6

6 Step Therapy (continued) Atypical Antipsychotics Diabetes (GLP-1 Receptor Agonists) Fibrates Gabapentin ER Glucose Test Strips Insulin Combination Agents Lipid Management Methotrexate Injectable Ophthalmic Prostaglandins Phosphate Binder Topical Non-Steroidal Anti-Inflammatory Drug Abilify, Abilify Discmelt, Abilify Maintena, Aristada, clozapine ODT, Clozaril, Fanapt, FazaClo, Geodon, Invega, Invega Sustenna, Invega Trinza, Latuda, Rexulti, Risperdal, Risperdal M-Tab, Risperdal Consta, Risperidone ODT, Saphris, Seroquel, Seroquel XR, Versacloz, Vraylar, Zyprexa, Zyprexa Relprevv, Zyprexa Zydis Adlyxin, Bydureon, Bydureon Bcise, Byetta, Ozempic, Tanzeum, Trulicity, Victoza Antara, Fenoglide, Fibricor, Lipofen, Lofibra, Tricor, Triglide, Trilipix Gralise, Horizant All non-preferred brand test strips and disks Soliqua, Xultophy Advicor, Altoprev, Crestor, Flolipid, Lescol, Lescol XL, Lipitor, Liptruzet, Livalo, Mevacor, Pravachol, Simcor, Vytorin, Zocor Otrexup, Rasuvo Bimatoprost, Lumigan, Rescula, Travatan Z, Travoprost, Vyzulta, Xalatan, Zioptan Auryxia, Fosrenol/lanthanum carbonate, Renagel, Renvela/ sevelamer carbonate, Velphoro Flector, Pennsaid/diclofenac, Voltaren/diclofenac Encourages the use of cost-effective generic atypical antipsychotic agents over brand atypical antipsychotic agents, as well as accommodates the use of brand agents when generic agents cannot be used due to previous trial, documented intolerance, FDA labeled contraindication or hypersensitivity. Encourages appropriate use for patients with a diagnosis of type 2 diabetes mellitus who are concurrently receiving or have tried an agent containing metformin, sulfonylurea, insulin or insulin/glp-1. A quantity limit encourages Encourages the use of cost-effective generic fenofibrate. Helps ensure appropriate selection of patients for therapy according to product labeling, clinical studies or clinical guidelines and according to dosing Encourages use of cost-effective preferred glucose test strip products before non-preferred products. A quantity limit is applied to all glucose test strips. Helps ensure appropriate selection of patients based on product labeling and/or clinical guidelines and/or clinical studies. Encourages use of cost-effective generic HMG CoA reductase inhibitor (HMG) agents prior to the use of non-preferred brand HMG or HMG combination agents for the management of high blood cholesterol. Encourages the use of generic methotrexate injectable agents over brand agents Otrexup and Rasuvo. Encourages the use of cost-effective generic ophthalmic prostaglandin. Encourages the appropriate use of cost-effective calcium containing phosphate binder agents over non-calcium containing agents. Helps ensure appropriate use of noncalcium containing agents due to documented intolerance, FDA-labeled contraindication, hypersensitivity or when calcium containing binders are clinically inappropriate. Encourages use of cost-effective generic prescription oral non-steroidal anti-inflammatory drug (NSAID) products. Specialty Step Therapy Infertility Iron Chelator Multiple Sclerosis Bravelle, Gonal F, Gonal F RFF Ferriprox Extavia, Zinbryta Encourages use of the preferred agent Follistim AQ prior to the use of non preferred agents. A quantity limit encourages Helps ensure appropriate use for transfusional iron overload due to thalassemia syndromes after the use of deferasirox, based on FDA-approved labeling, clinical studies and/or treatment guidelines. Encourages use of preferred agents prior to use of non-preferred agents. Coverage is allowed for only one disease-modifying agent at a time. A quantity limit encourages These programs are included in the standard utilization management package and apply for some standard pharmacy benefit plans. Not all drug categories are included in all plans, based on the member s drug list. Refer to the member s benefit materials or call the Pharmacy Program number on the back of the member s Blue Cross and Blue Shield of Texas ID card to determine whether a particular category is part of the member s benefit. The erectile dysfunction prior authorization program and infertility step therapy program do not apply to all pharmacy benefit plans. * Due to Substance Abuse Parity, some members may not need to submit a PA request for Evzio to be considered for coverage. This list is subject to change without notice. Call to confirm the status of a particular drug. Third-party brand names are the property of their respective owners. Blue Cross and Blue Shield of Texas, a Division of Health Care Service Corporation, a Mutual Legal Reserve Company, an Independent Licensee of the Blue Cross and Blue Shield Association BCBSTX Prior Authorization/Step Therapy Program 6 of 6

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