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Health Plan Insights July 2020 Updates from June 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 Oxygen Air Liquide Inhalation gas Medical gas June 2, 2020 (oxygen) Canada Inc. Nyvepria Hospira Inc. Injection, To decrease the incidence of infection, as June 10, 2020 (pegfilgrastim- 6 mg/0.6 mL manifested by febrile neutropenia, in patients apgf) with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Semglee Mylan Injection, To improve glycemic control in adults and June11, 2020 (insulin glargine) Pharmaceuticals 100 units/mL pediatric patients with type 1 diabetes mellitus Inc. and in adults with type 2 diabetes mellitus. Uplinza Viela Bio, Inc. Injection, For the treatment of neuromyelitis optica June 11, 2020 (inebilizumab- 100 mg/10 mL spectrum disorder (NMOSD) in adult patients cdon) who are anti-aquaporin-4 (AQP4) antibody positive. Zepzelca Jazz Injection, For the treatment of adult patients with June 15, 2020 (lurbinectedin) 4 mg/vial metastatic small cell lung cancer (SCLC) with disease progression on or after platinum- based chemotherapy. Lyumjev Eli Lilly and Co. Injection, To improve glycemic control in adults with June 15, 2020 (insulin lispro- 100 units/mL and diabetes mellitus. aabc) 200 units/mL Nitrogen, NF Air Liquide Inhalation Gas Medical gas June 29, 2020 (nitrogen) Canada Inc. Phesgo Genentech Inc. Injection, For use in combination with chemotherapy for June 29, 2020 (pertuzumab, 1,200 mg/600 (1) the neoadjuvant treatment of adult patients trastuzumab, mg/30,000 units and with HER2-positive, locally advanced, hyaluronidase- 600 mg/600 inflammatory, or early stage breast cancer zzxf) mg/20,000 units (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; (2) the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. 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 Dojolvi Ultragenyx Oral Liquid, For use as a source of calories and fatty acids June 30, 2020 (triheptanoin) Pharmaceuticals 35% for the treatment of pediatric and adult patients Inc. with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD). New Combinations and Formulations TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE Tivicay PD Viiv Healthcare Tablets for Oral For use in combination with other antiretroviral June 12, 2020 (dolutegravir Suspension, agents for the treatment of HIV-1 infection in sodium) eq 5 mg adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or - experienced but INSTI- naïve) aged at least 4 weeks and weighing at least 3 kg. Tazverik Epizyme Inc. Tablets, For the treatment of: (1) Adults and pediatric June 18, 2020 (tazemetostat) 200 mg patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection; (2) Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA- approved test and who have received at least 2 prior systemic therapies; (3) Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. Gimoti Evoke Nasal Spray, For the relief of symptoms in adults with acute June 19, 2020 (metoclopramide) Pharmaceuticals eq15 mg base/spray and recurrent diabetic gastroparesis. Inc. Fintepla Zogenix Inc. Oral Solution, For the treatment of seizures associated with June 25, 2020 (fenfluramine) eq 2.2 mg base/mL Dravet syndrome in patients 2 years of age and older. Mycapssa Chiasma Delayed-Release For long-term maintenance treatment in June 26, 2020 (octreotide) Capsules, acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. 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. New Generics APPROVAL GENERIC NAME TRADE NAME DOSAGE FORM MANUFACTURER(S) DATE Halobetasol Ultravate Lotion Topical Lotion Perrigo June 3, 2020 Propionate Betamethasone Sernivo Topical Spray Taro Pharmaceuticals, Inc. June 17, 2020 Diproptionate Methylphenidate Cotempla XR-ODT Extended-Release Orally Actavis Elizabeth, LLC June 19, 2020 Hydrochloride Disintegrating Tablets Pantoprazole Sodium Protonix For Delayed-Release Oral Sun Pharmaceutical June 30, 2020 Suspension Industries Ltd. 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 GENERIC MECHANISM OF ANTICIPATED DRUG NAME ROUTE INDICATION(S) NAME ACTION APPROVAL DATE VP-102 Cantharidin Topical Blistering agent Molluscum 07/13/2020 contagiosum RVL-1201 Oxymetazoline Ophthalmic Anti-inflammatory Blepharoptosis 07/16/2020 Hydrochloride agent JZP-258 Sodium Oral CNS depressant Narcolepsy Idiopathic 07/21/2020 oxybate; hypersomnia (IH) Potassium oxybate; Calcium oxybate; Magnesium oxybate GSK2857916 Belantamab Intravenous Cytotoxic agent Multiple myeloma 07/2020 Mafodotin Anti-B-cell maturation antigen (BCMA) antibody Viaskin Peanut TBD Topical Allergen Allergy to peanuts 08/05/2020 immunotherapy Olinvo Oliceridine Intravenous Opioid agonist Acute pain 08/07/2020 KTE-X19 TBD Intravenous Chimeric antigen Mantle cell lymphoma 08/10/2020 receptor T-cell (CAR-T) immunotherapy Pedmark Sodium Intravenous Chelating agent Chemotherapy- 08/10/2020 Thiosulfate induced ototoxicity Valrox Valoctocogene Intravenous Gene therapy Hemophilia A 08/21/2020 Roxaparvovec TRC101 Veverimer Oral Acid binder Metabolic acidosis 08/22/2020 RG7916 Risdiplam Oral Splicing modulator Spinal muscular 08/24/2020 atrophy XaraColl Bupivacaine Implant Amide anesthetic Post-operative pain 08/26/2020 Winlevi Cortexolone Topical Antiandrogens Acne vulgaris 08/27/2020 17a-Propionate 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. GENERIC MECHANISM OF ANTICIPATED DRUG NAME ROUTE INDICATION(S) NAME ACTION APPROVAL DATE MOR208 Tafasitamab Intravenous Anti-CD19 antibody Diffuse large B cell 08/30/2020 lymphoma 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 Intravenous Vasopressin agonist Hepatorenal syndrome 09/12/2020 Acetate Ryoncil Remestemcel-L Intravenous Stem cell therapy Graft versus host 09/30/2020 disease 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 REGN-EB3 TBD Intravenous Antiviral antibodies Ebola virus disease 10/25/2020 Bronchitol Mannitol Inhaled Mucolytic Cystic fibrosis 11/01/2020 SPN-812 Viloxazine Oral Norepinephrine Attention deficit 11/08/2020 Hydrochloride reuptake inhibitor hyperactivity disorder BIVV009 Sutimlimab Intravenous Complement Cold agglutinin 11/13/2020 inhibitors disease ALKS 3831 Olanzapine; Oral Opioid antagonist Schizophrenia 11/15/2020 Samidorphan Atypical antipsychotic 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 11/20/2020 inhibitor 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. GENERIC MECHANISM OF ANTICIPATED DRUG NAME ROUTE INDICATION(S) NAME ACTION APPROVAL DATE BLU-667 Pralsetinib Oral RET inhibitor Non-small cell lung 11/23/2020 cancer Xofluza (oral Baloxavir Oral Endonuclease Acute uncomplicated 11/23/2020 suspension) marboxil inhibitor influenza RM-493 Setmelanotide Subcutaneous Peptide Obesity 11/27/2020 melanocortin receptor agonist Danyelza Naxitamab Injectable Anti-GD2 antibody Neuroendocrine 11/30/2020 tumors (NETs) ALN-GO1 Lumasiran Subcutaneous Antisense Primary hyperoxaluria 12/03/2020 oligonucleotide BCX7353 Berotralstat Oral Plasma kallikrein Prophylaxis against 12/03/2020 inhibitor angioedema attacks in hereditary angioedema FG-4592 Roxadustat Oral Hypoxia-inducible Anemia due to kidney 12/20/2020 factor (HIF) disease stabilizer RVT-901 Vibegron Oral Beta adrenergic Overactive bladder 12/26/2020
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