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Medical Necessity Criteria for Pharmacy Edits, 5.01.605

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Medical Necessity Criteria for Pharmacy Edits, 5.01.605 PHARMACY / MEDICAL UTILIZATION MANAGEMENT GUIDELINE – 5.01.605 Medical Necessity Criteria for Pharmacy Edits Effective Date: Nov. 5, 2021* RELATED GUIDELINES / POLICIES: Last Revised: Aug. 31, 2021 5.01.520 Antidepressants: Pharmacy Medical Necessity Criteria for Brands Replaces: N/A 5.01.521 Pharmacologic Treatment of Neuropathy, Fibromyalgia, and Seizure Disorders 5.01.529 Management of Opioid Therapy 5.01.541 Medical Necessity Exception Criteria for Closed Formulary Benefits and for Dispense as Written (DAW) Exception Reviews 5.01.547 Medical Necessity Criteria and Dispensing Quantity Limits for Exchange *View the current version Formulary Benefits 5.01.552 Hetlioz® (tasimelteon) Select a hyperlink below to be directed to that section. COVERAGE GUIDELINE | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY ∞ Clicking this icon returns you to the hyperlinks menu above. Introduction Pharmacy prior authorization helps members receive the most appropriate therapy. The program also helps reduce unnecessary prescription drug use, waste, and error. Before a medication can be covered, certain medical criteria need to be met. This helps ensure medications are safe and effective for a particular condition while offering the greatest value. This policy describes coverage criteria for drugs in the plan’s pharmacy prior authorization program. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Index of Drugs, Drug Classes, and Disease States The Pharmacy Benefit medications in the following hyperlink table are affected by the Company’s Pharmacy Prior Authorization program: Drug / Drug Class Indications Individual Agents Adapalene Products, Brand and Generic Acne Differin®, Plixda™, generic adapalene, (all prescription strengths and formulations) ADHD Drugs, Brands ADHD Adhansia XR™, Adzenys ER, Adzenys XR-ODT™, Aptensio XR™; Azstarys™, Cotempla XR-ODT™; Daytrana®; Dyanavel™XR, Evekeo®, Jornay PM®, Methylphenidate ER 72mg®, Mydayis®, Qelbree™, Quillichew ER™, Quillivant XR®; Relexxii®, Ritalin LA® 10mg, 60mg; Vyvanse®; Zenzedi™ Allergic Conjunctivitis Allergies Alocril®, Alomide®, Bepreve®, Lastacaft®, Pataday®, Pazeo®, Zerviate™ Alpha Adrenergic Agonist Blepharoptosis, Lucemyra™, Upneeq™ Opioid withdrawal Angiotensin II Receptor Blockers, Brands Hypertension, Edarbi®, Edarbyclor®, Teveten/HCT® Cardiovascular Disease Antibiotics Cystic fibrosis Cayston® Antifungals Aspergillosis, Brexafemme®, Cresemba®, Noxafil®, Tolsura® Blastomycosis, Histoplasmosis, Mucormycosis, VVC Antihypertensive/Diuretic Edema, Carospir® hypertension, severe heart failure Antiparasitic Agents Tuberculosis Daraprim®, Pyrimethamine Antiprotozoal Agents Diarrhea Alinia® Antipsychotics (Second Generation, Psychoses, Bipolar Caplyta™, Fanapt®, Latuda®, Rexulti®, “Atypicals”), Brands Disorder, MDD, etc. Saphris®, Secuado®, Versacloz™, Vraylar®, Nuplazid®, Abilify MyCite® Page | 2 of 86 ∞ Drug / Drug Class Indications Individual Agents Antitubercular Agents Tuberculosis Sirturo® Atopic Dermatitis Atopic Dermatitis Elidel®, Eucrisa®, Protopic® Brand Oral Antibiotics and Their Generics Acne; Rosacea; Acticlate®, Adoxa®, Avidoxy, Doryx®, Doryx® Infections MPC, Doxycycline IR-DR, Helidac®, Minocin®, Minolira®, Minolira® ER, Monodox®, Morgidox®, Omeclamox-Pak®, Oracea®, Pylera®, Seysara™, Solodyn®, Solosec®, Talicia®, Targadox™, Ximino™, Xyrosa Brand Single-Source Oral NSAIDs Pain, Inflammation All Single-Source Brands Brand Topical Acne or Rosacea Agents Acne; Rosacea Acanya®, Aczone®, Aklief®, Aktipak®, Altreno™, Amzeeq™, Arazlo™, Atralin®, Avage®, Avita®, Azelex®, Benzamycinpak®, Clindagel®, Clindamycin/Benzoyl Peroxide, Clindamycin Phosphate, Dapsone, Epiduo®, Epiduo Forte®, Fabior®, Finacea®, Onexton®, Retin-A®, Retin-A Micro®, Retin-A Micro Pump®, Tazorac®, Tretin-X®, Twyneo®, Veltin®, Winlevi™, Zilxi™ Brand Topical Rosacea Agent Rosacea Soolantra® Calcimimetics Hyper- Generic cinacalcet, Sensipar® parathyroidism; Parathyroid carcinoma Calcium Channel Blockers Hypertension, Azor®, Caduet®, Conjupri®, Exforge®, Cardiovascular Exforge® HCT, Lotrel®, Prestalia®, Tarka®, Disease Tribenzor®, Twynsta® Chelating Agents Wilson’s disease, Generic penicillamine, Clovique™, Cuprimine®, Cystinuria Depen®, generic trientine, Syprine® Combination Medications (Misc.) Various Consensi® Constipation IBS-C, CIC, OIC Amitiza® Linzess®, Motegrity™, Movantik®, Pizensy™, Trulance®, Zelnorm® Corticosteroids, Topical Brand Various Anti-Itch Lotion®, Anti-Itch Spray®, Anti-Itch Plus Cream®, Aveeno®, Bryhali™, Capex Shampoo®, Clocortolone Pivalate®, Cloderm®, Cordran®, Cortizone®, Dermasorb TA®, Duobrii™, First-Hydrocortisone®, Halog®, Impoyz®, Lexette®, Locoid Lipocream®, Noble Formula HC®, Nucort®, Olux®, Olux-E®, Pandel®, Pediaderm HC®, Pediaderm TA®, Page | 3 of 86 ∞ Drug / Drug Class Indications Individual Agents Sernivo®, Synalar®, Texacort®, Topicort®, Ultravate®, Verdeso® Crohn’s Disease Agents Crohn’s disease Entocort® EC, Ortikos™ Chronic Kidney Disease Treatment Kidney disease Farxiga®, Kerendia® Cystic Fibrosis Cystic fibrosis Bronchitol®, Pulmozyme® Diabetic Test Strips Diabetes Non-One Touch (manufactured by LifeScan) and non-Contour (manufactured by Ascensia) branded test strips Dry Eye Treatment Dry eyes Cequa™, Xiidra® Anticonvulsants Partial-onset Aptiom®, Banzel®, Topiramate Extended- seizure, Release, Briviact®, Diacomit®, Epidiolex®, Fintepla®, Fycompa®, Nayzilam®, Oxtellar Dravet Syndrome, XR®, Peganone®, Qudexy XR®, Sabril®, Lennox-Gastaut Spritam®, Sympazan®, Trokendi XR®, Syndrome, Valtoco®, vigabatrin, Vigadrone®, Vimpat®, Refractory complex Xcopri® partial seizures, Infantile Spasms Gabapentin Products, Brand Neuralgia, Sleep- Gralise®, Horizant® related movement disorders Gastrointestinal Stimulants Gastroparesis Gimoti™ GnRH Receptor Antagonist Products Endometriosis, Oriahnn®, Orilissa® Uterine fibroids Heart Failure Agents Heart Failure Corlanor®, Entresto®, Farxiga®, Verquvo™ Hypnotics, Non-Benzodiazepine, Brands Insomnia Edluar®, Zolpimist™, Belsomra®, Dayvigo® Human Nerve Growth Factor Neurotrophic Oxervate™ keratitis Parkinson’s Disease Agents Parkinson’s disease Apokyn®, Inbrija™, Kynmobi™, Nourianz™, Ongentys™ Ibsrela® (tenapanor) IBS-C Ibsrela® Inhaled Corticosteroids Asthma Alvesco®, Asmanex® HFA, Asmanex® Twisthaler®, Pulmicort Flexhaler® Inherited Metabolic Disorders Tyrosinemia Generic nitisinone, Nityr™, Orfadin® Page | 4 of 86 ∞ Drug / Drug Class Indications Individual Agents Intranasal Corticosteroid Products, Brands Allergic Rhinitis Beconase AQ®, Nasonex®, Omnaris®, Qnasl®, Veramyst®, Xhance®, Zetonna® Nasal Polyps Iron Replacement Products Iron Deficiency Accrufer™ Irritable Bowel Syndrome with Diarrhea IBS-D Viberzi® (IBS-D) Agents Peanut Immunotherapy Peanut Allergies Palforzia™ Progressing Autosomal Dominant Autosomal Jynarque™ Polycystic Kidney Disease (ADPKD) dominant polycystic kidney disease (ADPKD) Muscle Relaxants Spasticity Ozobax Nonsteroidal Anti-inflammatory Drugs Pain and Cambia®, Duexis®, Ketorolac Nasal Spray, (NSAIDs) and Combinations Inflammation Naproxen/Esomeprazole, Sprix®, Vimovo® Ophthalmic Prostaglandin Analogs, Brands Glaucoma Lumigan®, Travatan Z®, Vyzulta™, Xelpros™ and Zioptan® Oral Corticosteroids, Brand Inflammation Alkindi® Sprinkle, Cortef®, Dxevo®, Hemady®, Medrol®, Orapred ODT®, Pediapred®, Taperdex®, Zcort® Overactive Bladder Agents Overactive bladder Gemtesa®, Myrbetriq®, Oxytrol®, Toviaz® Proton Pump Inhibitors Acid reflux, Aciphex®, Aciphex® Sprinkle, Dexilant®, Nexium®, generic omeprazole/sodium Ulcers bicarbonate, Prevacid®, Prevacid® Solutab, Prilosec®, Protonix®, Zegerid® Pseudobulbar Affect Pseudobulbar Nuedexta® Affect Qbrexza™ (glycopyrronium cloth) Hyperhidrosis Qbrexza™ Rho Kinase Inhibitor Elevated intraocular Rhopressa®, Rocklatan™ pressure Rifamycin Antibiotics Traveler’s Diarrhea, Xifaxan®, Aemcolo™ Hepatic Encephalopathy, IBS-D Samsca® (tolvaptan) Hypervolemic or Generic tolvaptan, Samsca® euvolemic hyponatremia Page | 5 of 86 ∞ Drug / Drug Class Indications Individual Agents Tardive Dyskinesia & Huntington’s Disease Tardive Dyskinesia, Ingrezza®, Austedo®, Xenazine® Huntington’s Disease Testosterone Replacement Low Testosterone Androderm®, AndroGel®, Fortesta®, Jatenzo®, Natesto™, Striant®, Testim®, Testosterone gel (brand), Vogelxo™ Topical Antibiotic Impetigo Xepi™ Treatment of Nausea/Vomiting Nausea/Vomiting Bonjesta®, Diclegis® Tryptophan Hydroxylase Inhibitor Carcinoid Xermelo® Syndrome Diarrhea Ulcerative Colitis Agents Ulcerative colitis Apriso®, Asacol® HD, Colazal®, Delzicol®, Dipentum®, Giazo®, Lialda®, Pentasa®, Uceris® The Pharmacy Benefit medications in the following hyperlink table are affected by the Company’s quantity limits: Drug / Drug Class Indications Individual Agents Continuous Glucose Monitoring (CGM) Diabetes Dexcom G6® Sensor, Dexcom G6® Transmitter, Supplies management Freestyle® Libre Sensor, Freestyle® Libre 2 Sensor Santyl® (collagenase) Wound Santyl® debridement Short-Acting Beta Agonists Asthma Albuterol HFA inhaler, Levalbuterol HFA inhaler, ProAir® Digihaler™, ProAir® HFA, ProAir® Respiclick, Proventil®
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