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Health Plan Insights Health Plan Insights August 2020 Updates from July 2020 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 ByfavoTM Acacia Pharma, Injection, for IV use For the induction and maintenance of procedural July 2, 2020 (remimazolam) Inc. Eq 20 mg/vial sedation in adults undergoing procedures lasting 30 minutes or less. RukobiaTM ViiV Healthcare Extended-Release For use in combination with other antiretroviral(s), July 2, 2020 (fostemsavir) Tablets, for the treatment of HIV-1 infection in heavily 600 mg treatment-experienced adults with multidrug- resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. QwoTM Endo Aesthetics Injection for SQ For the treatment of moderate to severe cellulite July 6, 2020 (collagenase LLC use, in the buttocks of adult women. clostridium 0.92 mg and 1.84 histolyticum-aaes) mg Hulio® Mylan Injection for SQ For the treatment of Rheumatoid Arthritis, July 6, 2020 (adalimumab-fkjp) Pharmaceuticals use, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Inc. 40 mg/0.8 mL and Ankylosing Spondylitis, Adult Crohn’s Disease, 20 mg/0.4 mL Ulcerative Colitis, and Plaque Psoriasis. Inqovi® Otsuka Tablets, For the treatment of adult patients with July 7, 2020 (decitabine and Pharmaceutical 35 mg/100 mg myelodysplastic syndromes (MDS), including cedazuridine) Company, Ltd. previously treated and untreated, de novo and secondary MDS with the following FrenchAmerican-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. XywavTM Jazz Oral Solution, For the treatment of cataplexy or excessive July 21, 2020 (calcium, Pharmaceuticals, 0.5 mg/mL daytime sleepiness (EDS) in patients 7 years of magnesium, Inc. age and older with narcolepsy. potassium, and sodium oxybates) 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. TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE XeglyzeTM Dr. Reddy’s Lotion, For the treatment of head lice infestation in July 24, 2020 (abametapir) Laboratories, SA 0.74% patients 6 months of age and older. XEGLYZE should be used in the context of an overall lice management program. Monjuvi® MorphoSys US Injection for IV use, For the treatment of adult patients with relapsed July 31, 2020 (tafasitamab-cxix) Inc. 200 mg per vial or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). New Combinations and Formulations TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE TralementTM American Regent, Injection, for IV use, For use in adult and pediatric patients weighing July 2, 2020 (trace elements: Inc. Each mL contains at least 10 kg as a source of zinc, copper, zinc sulfate, cupric zinc 3 mg, copper 0.3 manganese, and selenium for parenteral sulfate, mg, manganese 55 nutrition when oral or enteral nutrition is not manganese sulfate mcg, and selenium possible, insufficient, or contraindicated. and selenious 60 mcg acid) Bendamustine Slayback Injection, For: (1) Chronic lymphocytic leukemia (CLL). July 2, 2020 Hydrochloride Pharmaceuticals 100 mg/m2 Efficacy relative to first line therapies other LLC than chlorambucil has not been established. (2) Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. UpneeqTM RVL Ophthalmic Solution, For the treatment of acquired blepharoptosis in July 8, 2020 (oxymetazoline Pharmaceuticals, 1% adults. hydrochloride) Inc. Carbon Dioxide, Nexair LLC Medical Gas For human and animal drug use. July 18, 2020 USP Wynzora® MC2 Therapeutics, Topical Cream, For the topical treatment of plaque psoriasis in July 20, 2020 (calcipotriene and Inc. 0.005%/0.064% patients 18 years of age and older. betamethasone dipropionate) 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. TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE Breztri AstraZeneca Inhalation Aerosol, For the maintenance treatment of patients with July 23, 2020 AerosphereTM Pharmaceuticals 160 mcg/9 mcg/4.8 chronic obstructive pulmonary disease (budesonide, LP mcg per inhalation (COPD). glycopyrrolate, and formoterol fumarate) Cyclophosphamide Ingenus Injection, for IV use For the treatment of Malignant Diseases: July 30, 2020 Pharmaceuticals malignant lymphomas: Hodgkin's disease, LLC lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma; multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary, retinoblastoma, breast carcinoma. New Generics APPROVAL GENERIC NAME TRADE NAME DOSAGE FORM MANUFACTURER(S) DATE Deferasirox Jadenu Sprinkle Oral Granules Alkem Laboratories Ltd. July 14, 2020 Metyrosine Demser Capsules Amneal Pharmaceuticals LLC July 24, 2020 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. Pipeline New Medication Pipeline MECHANISM OF ANTICIPATED DRUG NAME GENERIC NAME ROUTE INDICATION(S) ACTION APPROVAL DATE Botreso TBD Oral TBD Treatment of the 2Q 2020 signs and symptoms of benign prostatic hyperplasia Roctavian Valoctocogene Intravenous Gene therapy Hemophilia A 08/21/2020 Roxaparvovec TRC101 Veverimer Oral Acid binder Metabolic acidosis 08/22/2020 XaraColl Bupivacaine Implant Amide anesthetic Post-operative pain 08/26/2020 Winlevi Cortexolone 17a- Topical Antiandrogens Acne vulgaris 08/27/2020 Propionate SA237 Satralizumab Subcutaneous Interleukin 6 Neuromyelitis optica 08/2020 receptor (IL-6R) antagonist CC-486 Azacitidine Oral Antimetabolites Acute myeloid 09/03/2020 leukemia Lucassin Terlipressin Acetate Intravenous Vasopressin agonist Hepatorenal 09/12/2020 syndrome Ryoncil Remestemcel-L Intravenous Stem cell therapy Graft versus host 09/30/2020 disease Coronavirus disease 2019 (COVID-19) NETMedix Copper Cu-64 Intravenous Diagnostic For scintigraphic 09/2020 Dotatate radiopharmaceutical localization of neuroendocrine tumors GLPG0634 Filgotinib Oral Janus kinase (JAK) Rheumatoid arthritis 3Q 2020 inhibitor Ulcerative colitis Crohn's disease Ankylosing Spondylitis Psoriatic arthritis REGN-EB3 TBD Intravenous Antiviral antibodies Ebola virus disease 10/25/2020 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 Bronchitol Mannitol Inhaled Mucolytic Cystic fibrosis 11/01/2020 Bronchiectasis SPN-812 Viloxazine Oral Norepinephrine Attention deficit 11/08/2020 Hydrochloride reuptake inhibitor hyperactivity disorder ALKS 3831 Olanzapine; Oral Opioid antagonist Schizophrenia 11/15/2020 Samidorphan Atypical Bipolar disorder I or antipsychotic II AR19 Amphetamine Oral CNS stimulant Attention deficit 11/15/2020 hyperactivity disorder JCAR017 Lisocabtagene Intravenous Chimeric antigen B-cell lymphoma 11/16/2020 Maraleucel receptor T-cell (CAR-T) immunotherapy Cellular immunotherapy Zokinvy Lonafarnib Oral Farnesyltransferase Progeria Hepatitis D 11/20/2020 inhibitor BLU-667 Pralsetinib Oral RET inhibitor Non-small cell lung 11/23/2020 cancer Xofluza (oral Baloxavir marboxil Oral Endonuclease Acute uncomplicated 11/23/2020 suspension) inhibitor influenza/ Prophylaxis of influenza RM-493 Setmelanotide Subcutaneous Peptide Obesity 11/27/2020 melanocortin receptor agonist Danyelza Naxitamab Injectable Anti-GD2 antibody Neuroendocrine 11/30/2020 tumors Hetlioz (liquid) Tasimelteon TBD Melatonin receptor Sleep disorders 12/01/2020 agonist associated with Smith-Magenis syndrome ALN-GO1 Lumasiran Subcutaneous Antisense Primary 12/03/2020 oligonucleotide hyperoxaluria BCX7353 Berotralstat Oral Plasma kallikrein Prophylaxis against 12/03/2020 inhibitor angioedema attacks in hereditary angioedema 800.361.4542 | envisionrx.com 6 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 FG-4592 Roxadustat Oral Hypoxia-inducible Anemia due to 12/20/2020 factor (HIF) kidney disease stabilizer Relugolix Relugolix Oral Gonadotropin- Prostate cancer 12/20/2020 releasing hormone Uterine fibroids (GnRH) antagonist RVT-901 Vibegron Oral Beta adrenergic
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