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Health Plan Insights Health Plan Insights January 2020 Updates from December 2019 800.361.4542 | envisionrx.com Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any form or medium, without EnvisionRxOptions’ prior written consent. Recent FDA Approvals New Medications TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE Avsola Amgen Inc. Injection, Biosimilar to Remicade. For the treatment December 6, 2019 (infliximab-axxq) 100 mg/20 mL of/reducing the signs and symptoms of: Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis in combination with methotrexate, psoriatic arthritis, and plaque psoriasis. Vyondys 53 Sarepta Intravenous Solution, For the treatment of Duchenne muscular December 12, (golodirsen) Therapeutics, Inc. 50 mg/mL dystrophy (DMD) in patients who have a 2019 confirmed mutation of the DMD gene that is amenable to exon 53 skipping. Padcev Astellas Injection, For the treatment of adult patients with locally December 18, (enfortumab 20 mg/vial and 30 advanced or metastatic urothelial cancer who 2019 vedotin-ejfv) mg/vial have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. Conjupri CSPC Ouyi Tablets, For use alone or in combination with other (levamlodipine) Pharmaceutical 1.25 mg, 2.5 mg, and antihypertensive agents for the treatment of December 19, Co., Ltd. 5 mg hypertension, to lower blood pressure. 2019 Caplyta Intra-Cellular Capsules, For the treatment of schizophrenia in adults. December 20, (lumateperone) Therapies, Inc. 42 mg 2019 Tissue Blue Dutch Ophthalmic Ophthalmic Solution, To selectively stain the internal limiting December 20, (brilliant blue g) Research 0.025% membrane (ILM). 2019 Dayvigo Eisai R&D Tablets, For the treatment of adult patients with December 20, (lemborexant) Management Co., 5 mg and 10 mg insomnia, characterized by difficulties with 2019 Ltd sleep onset and/or sleep maintenance. Enhertu Daiichi Sankyo Injection, For the treatment of adult patients with December 20, (fam- 100 mg unresectable or metastatic HER2-positive 2019 trastuzumab breast cancer who have received two or more deruxtecan-nxki) prior anti-HER2-based regimens in the metastatic setting. Ubrelvy Allergan Tablets, For the acute treatment of migraine with or December 23, (ubrogepant) 10 mg and 50 mg without aura in adults. 2019 800.361.4542 | envisionrx.com 2 Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any form or medium, without EnvisionRxOptions’ prior written consent. New Combinations and Formulations TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE Nouress Avadel Legacy Injection, For use as an additive to amino acids December 13, 2019 (cysteine 50 mg/mL solutions to meet nutritional requirements of hydrochloride) neonates (preterm and term infants less than one month of age) requiring total parenteral nutrition. Arazlo Dow Topical Lotion, For the topical treatment of acne vulgaris in December 18, 2019 (tazarotene) Pharmaceuticals 0.045% patients 9 years of age and older. Genosyl Vero Biotech Gas Inhalation, To improve oxygenation and reduce the December 20, 2019 (nitric oxide) 20 ppm need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. New Generics APPROVAL GENERIC NAME TRADE NAME DOSAGE FORM MANUFACTURER(S) DATE Sucralfate Carafate Oral Suspension Amneal Pharmaceuticals LLC December 2, 2019 Fingolimod Gilenya Capsules Biocon Pharma Inc.; HEC Pharm USA Inc.; December 4, 2019 Hydrochloride Sun Pharmaceutical Industries, Inc. Everolimus Afinitor Tablets Teva Pharmaceuticals USA, Inc.; Par December 9, 2019 Pharmaceutical Inc. (excl. 10 mg) Sodium Teradecyl Sotradecol Injection Custopharm, Inc. December 9, 2019 Sulfate Etonogestrel and NuvaRing Vaginal Ring Amneal Pharmaceuticals LLC December 11, 2019 Ethinyl Estradiol Alvimopan Entereg Capsules Watson Laboratories Inc. December 19, 2019 Diazoxide Proglycem Oral Suspension E5 Pharma Inc. December 20, 2019 Apixaban Eliquis Tablets Mylan Pharmaceuticals Inc.; Micro Labs December 23, 2019 Limited Ziprasidone Geodon Injection Gland Pharma Limited December 26, 2019 Mesylate Mirabegron Myrbetriq Extended Release Sawai USA Inc. December 27, 2019 Tablets 800.361.4542 | envisionrx.com 3 Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any form or medium, without EnvisionRxOptions’ prior written consent. Pipeline New Medication Pipeline MECHANISM OF ANTICIPATED DRUG NAME GENERIC NAME ROUTE INDICATION(S) ACTION APPROVAL DATE Pedmark Sodium Intravenous Chelating agent Chemotherapy-induced 2H 2019 Thiosulfate ototoxicity Tazemetostat Tazemetostat Oral EZH2 inhibitor Soft tissue sarcoma 01/23/2020 Dificid (oral Fidaxomicin Oral Narrow-spectrum Clostridium difficile 01/24/2020 suspension) macrocyclic antibiotic associated diarrhea Palforzia TBD Oral Allergen Allergy to peanuts 01/2020 immunotherapy BLU-285 Avapritinib Oral Receptor tyrosine Gastrointestinal cancer 02/14/2020 kinase inhibitor ETC-1002 Bempedoic Acid Oral ATP citrate lyase Hypercholesterolemia 02/21/2020 inhibitor Barhemsys Amisulpride Intravenous Atypical antipsychotic Postoperative nausea 02/26/2020 and vomiting Bempedoic Acid / Bempedoic Acid; Oral Intestinal cholesterol Hypercholesterolemia 02/26/2020 Ezetimibe Ezetimibe absorption inhibitor, ATP citrate lyase inhibitor ALD403 Eptinezumab Intravenous Calcitonin gene- Migraine 02/2020 related peptide inhibitor Empa + Lina + Met Empagliflozin; Oral Biguanides, Sodium- Diabetes Mellitus 02/2020 XR Linagliptin; glucose linked Metformin transporter 2 inhibitor, Dipeptidyl peptidase-4 inhibitor Teprotumumab Teprotumumab Intravenous Insulin-like growth Thyroid eye disease 03/08/2020 factor-1 receptor antagonist ITCA 650 Exenatide Implant Glucagon-like Diabetes Mellitus 03/09/2020 peptide-1 agonist Fintepla Fenfluramine Oral Serotonin reuptake Dravet syndrome 03/25/2020 inhibitor Lennox-Gastaut syndrome 800.361.4542 | envisionrx.com 4 Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any form or medium, without EnvisionRxOptions’ prior written consent. MECHANISM OF ANTICIPATED DRUG NAME GENERIC NAME ROUTE INDICATION(S) ACTION APPROVAL DATE Ozanimod Ozanimod Oral Sphingosine 1- Relapsing multiple 03/25/2020 phosphate receptor sclerosis modulators HTX-011 Bupivacaine; Injectable Nonsteroidal anti- Post-operative pain 03/26/2020 Meloxicam inflammatory drugs, Amide anesthetic Triferic Ferric Intravenous Iron supplement Anemia in end stage 03/28/2020 Pyrophosphate renal disease Citrate BHV-3000 Rimegepant Oral Calcitonin gene- Migraine 1Q 2020 related peptide inhibitor Bronchitol Mannitol Inhaled Mucolytic Cystic fibrosis, 1Q 2020 Bronchiectasis LCI699 Osilodrostat Oral Aldosterone synthase Cushing's disease in 1Q 2020 inhibitor adult patients PRO 140 Leronlimab Subcutaneous Entry inhibitor HIV infection 1Q 2020 MenQuadfi Meningococcal Intramuscular Meningitis B vaccine Meningococcal disease 04/25/2020 Conjugate Vaccine Ongentys Opicapone Oral Catechol-O- Motor deficit 04/26/2020 methyltransferase inhibitor Sarclisa Isatuximab Intravenous Anti-CD38 antibody Multiple myeloma 04/30/2020 Prostate cancer Non- small cell lung cancer Remimazolam Remimazolam Intravenous Benzodiazepine Sedation 04/2020 Dasotraline Dasotraline Oral Serotonin, Binge eating disorder 05/14/2020 norepinephrine and dopamine reuptake inhibitor RG7916 Risdiplam Oral Splicing modulator Spinal muscular atrophy 05/24/2020 Amphora Citric Acid; L- Intravaginal pH buffer Pregnancy prevention 05/25/2020 Lactic Acid; Potassium Bitartrate 800.361.4542 | envisionrx.com 5 Confidential - Document has confidential information and may not be copied, published or distributed, in whole or in part, in any form or medium, without EnvisionRxOptions’ prior written consent. MECHANISM OF ANTICIPATED DRUG NAME GENERIC NAME ROUTE INDICATION(S) ACTION APPROVAL DATE INCB054828 Pemigatinib Oral Fibroblast growth Biliary tract cancer 05/30/2020 factor receptor inhibitor IMMU-132 Sacituzumab Intravenous Cytotoxic agent, Anti- Hormone receptor 06/02/2020 Govitecan Trop2 antibody positive breast cancer Inebilizumab Inebilizumab Intravenous Anti-CD19 antibody Neuromyelitis optica 06/2020 Orilissa Elagolix Oral Luteinizing hormone Uterine fibroids 2Q 2020 releasing hormone antagonist Selumetinib Selumetinib Oral MEK inhibitor Neurofibromatosis 2Q 2020 Sulphate Bimatoprost SR Bimatoprost Ophthalmic Prostaglandin analog Glaucoma or Ocular 1H 2020 Implant Hypertension VP-102 Cantharidin Topical Blistering agent Molluscum contagiosum 07/13/2020 Verruca vulgaris (common warts) UX007 Triheptanoin Oral Lipid replacement Long-chain fatty acid 07/31/2020 therapy oxidation disorders, Glucose transporter-1 deficiency AGN-150998 Abicipar Pegol Ophthalmic Vascular endothelial Wet age-related macular 07/2020 growth factor inhibitor degeneration Viaskin Peanut TBD Topical Allergen Allergy to peanuts 08/05/2020 immunotherapy TRC101 Veverimer Oral Acid binder Metabolic acidosis
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