Health Plan Insights September 2020 Updates from August 2020 Confidential – Do not copy or distribute. 800-361-4542 | elixirsolutions.com 1 Recent FDA Approvals New Medications TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE Blenrep GlaxoSmithKline Injection, For the treatment of adult patients with August 5, 2020 (belantamab 2.5 mg/kg relapsed or refractory multiple myeloma who mafodotin-blmf) have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Lampit Bayer Healthcare Tablets, For use in pediatric patients (birth to less than August 6, 2020 (nifurtimox) 30 mg and 120 18 years of age and weighing at least 2.5 kg) mg for the treatment of Chagas disease (American Trypanosomiasis), caused by Trypanosoma cruzi. Olinvyk Trevena, Inc. Injection, For use in adults for the management of August 7, 2020 (oliceridine) 1 mg/mL acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Evrysdi Genentech, Inc. Oral Solution, For the treatment of spinal muscular atrophy August 7, 2020 (risdiplam) 0.75 mg/mL (SMA) in patients 2 months of age and older. Viltepso NS Pharma, Inc. Injection, For the treatment of Duchenne muscular August 12, 2020 (viltolarsen) 50 mg/mL dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enspryng Genentech, Inc. Injection, For the treatment of neuromyelitis optica August 14, 2020 (satralizumab- 120 mg/mL spectrum disorder (NMOSD) in adult patients mwge) who are anti-aquaporin-4 (AQP4) antibody positive. Confidential – Do not copy or distribute. 800-361-4542 | elixirsolutions.com 2 TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE Kesimpta Novartis Injection, For the treatment of relapsing forms of August 20, 2020 (ofatumumab) Pharmaceutical 20 mg/0.4 mL multiple sclerosis (MS), to include clinically Corporation isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Winlevi Cassiopea Inc. Cream, For the topical treatment of acne vulgaris in August 26, 2020 (clascoterone) 1% patients 12 years of age and older. Sogroyo Novo Nordisk Inc. Injection, For the replacement of endogenous growth August 28, 2020 (somapacitan- 6.7 mg/mL hormone (GH) in adults with growth hormone beco) deficiency (GHD). New Combinations and Formulations TRADE NAME DOSAGE FORM APPROVAL MANUFACTURER INDICATION(S) (generic name) STRENGTH DATE Vasopressin AM Regent IV Solution, To increase blood pressure in adults with August 3, 2020 (vasopressin) 20 units/mL vasodilatory shock who remain hypotensive despite fluids and catecholamines. Xtandi Atellas Tablets, For the treatment of patients with: (1) August 4, 2020 (enzalutamide) 40 mg and 80 mg castration-resistant prostate cancer; (2) metastatic castration-sensitive prostate cancer. Cystadrops Recordati Rare Ophthalmic For the treatment of corneal cystine crystal August 19, 2020 (cysteamine) Diseases Solution, deposits in adults and children with 3.8 mg/mL cystinosis. Xaracoll Innocoll Implant, For use in adults for placement into the August 28, 2020 (bupivacaine Pharmaceuticals 300 mg surgical site to produce postsurgical hydrochloride) analgesia for up to 24 hours following open inguinal hernia repair. New Generics APPROVAL GENERIC NAME TRADE NAME DOSAGE FORM MANUFACTURER(S) DATE Ciprofloxacin and Ciprodex Otic Dr. Reddy's Laboratories Ltd. August 10, 2020 Dexamthasone Suspension/Drops Confidential – Do not copy or distribute. 800-361-4542 | elixirsolutions.com 3 Pipeline New Medication Pipeline ANTICIPATED MECHANISM OF DRUG NAME GENERIC NAME ROUTE INDICATION(S) APPROVAL ACTION DATE Lucassin Terlipressin Acetate Intravenous Vasopressin agonist Hepatorenal syndrome 09/12/2020 Ryoncil Remestemcel-L Intravenous Stem cell therapy Graft versus host 09/30/2020 disease 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 disease 11/13/2020 inhibitors ALKS 3831 Olanzapine; Oral Opioid antagonist Schizophrenia Bipolar 11/15/2020 Samidorphan Atypical antipsychotic disorder I or II AR19 Amphetamine Oral CNS stimulant Attention deficit 11/15/2020 hyperactivity disorder JCAR017 Lisocabtagene Intravenous Chimeric antigen Diffuse large B cell 11/16/2020 Maraleucel receptor T-cell (CAR- lymphoma T) immunotherapy Cellular immunotherapy Zokinvy Lonafarnib Oral Farnesyltransferase Progeria 11/20/2020 inhibitor Xofluza Baloxavir marboxil Oral Endonuclease Prophylaxis of influenza 11/23/2020 inhibitor RM-493 Setmelanotide Subcutaneous Peptide melanocortin Obesity 11/27/2020 receptor agonist Danyelza Naxitamab Injectable Anti-GD2 antibody Neuroendocrine tumors 11/30/2020 (NETs) Hetlioz Tasimelteon Oral Melatonin receptor Sleep disorders 12/01/2020 agonist associated with Smith- Magenis syndrome ALN-GO1 Lumasiran Subcutaneous Antisense Primary hyperoxaluria 12/03/2020 oligonucleotide Confidential – Do not copy or distribute. 800-361-4542 | elixirsolutions.com 4 ANTICIPATED MECHANISM OF DRUG NAME GENERIC NAME ROUTE INDICATION(S) APPROVAL ACTION DATE Orladeyo 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) stabilizer disease Relugolix Relugolix Oral Gonadotropin- Prostate cancer 12/20/2020 releasing hormone (GnRH) antagonist RVT-901 Vibegron Oral Beta adrenergic Overactive bladder 12/26/2020 agonist symptoms Ontinua ER Arbaclofen Oral GABA receptor Spasticity in multiple 12/29/2020 agonist sclerosis KX2-391 Tirbanibulin Topical Tubulin inhibitor Src Actinic keratosis 12/30/2020 kinase inhibitor Tanezumab Tanezumab Subcutaneous Anti-NGF antibody Osteoarthritis pain 12/2020 Inclisiran Inclisiran Subcutaneous PCSK9 inhibitor Atherosclerotic vascular 4Q 2020 disease risk due to hypercholesterolemia TSR-042 Dostarlimab Injectable Programmed cell Endometrial cancer 4Q 2020 death 1 (PD-1) inhibitor MK-1242 Vericiguat Oral Guanylate cyclase Heart failure 01/20/2021 stimulants LY03005 Ansofaxine Oral Norepinephrine- Major depressive 01/2021 Hydrochloride dopamine reuptake disorder inhibitor (NDRI) Serotonin- norepinephrine reuptake inhibitor (SNRI) StrataGraft TBD Other Organ replacement Burns 02/02/2021 Evinacumab Evinacumab Intravenous Anti-angiopoietin-like Homozygous familial 02/11/2021 protein 3 (ANGPTL3) hypercholesterolemia antibody Confidential – Do not copy or distribute. 800-361-4542 | elixirsolutions.com 5 ANTICIPATED MECHANISM OF DRUG NAME GENERIC NAME ROUTE INDICATION(S) APPROVAL ACTION DATE TGR-1202 Umbralisib Oral Phosphoinositide 3- Marginal zone 02/15/2021 kinase (PI3K) inhibitor lymphoma Trilaciclib Trilaciclib Intravenous CDK4/6 dual inhibitor Small cell lung cancer 02/15/2021 Amondys 45 Casimersen Intravenous Antisense Duchenne muscular 02/25/2021 oligonucleotide dystrophy Defencath Taurolidine; Heparin Other Anti-infective Catheter related 02/28/2021 Heparins and bloodstream infections heparinoid-like agents Oraxol Encequidar; Oral Mitotic inhibitor P- Breast cancer 02/28/2021 Paclitaxel glycoprotein (P-gp) pump inhibitor Ygalo View Melflufen Intravenous Alkylating agent Multiple myeloma 02/28/2021 Comments MSC2156119J Tepotinib Oral C-Met inhibitor Non-small cell lung 02/2021 View Comments cancer P1101 Ropeginterferon alfa- Subcutaneous Pegylated interferons Polycythaemia Vera 02/2021 2b BIIB037 Aducanumab Intravenous Amyloid beta protein Alzheimer's disease 03/07/2021 inhibitor ZP4207 Dasiglucagon Subcutaneous Glucagon analog Improve glycemic control 03/27/2021 in type 1 and/or type 2 diabetes Tivozanib Tivozanib Oral Vascular endothelial Kidney cancer 03/31/2021 growth factor receptor (VEGFR) inhibitor Ryplazim Plasminogen Intravenous Enzyme replacement Hypoplasminogenemia 03/2021 therapy ACT-128800 Ponesimod Oral Sphingosine 1- Relapsing multiple 1Q 2021 phosphate (S1P) sclerosis receptor modulators Cabenuva Cabotegravir; Intramuscular Non-nucleoside HIV-1 infection* 1Q 2021 Rilpivirine reverse transcriptase inhibitor (NNRTI) Integrase strand Confidential – Do not copy or distribute. 800-361-4542 | elixirsolutions.com 6 ANTICIPATED MECHANISM OF DRUG NAME GENERIC NAME ROUTE INDICATION(S) APPROVAL ACTION DATE transfer inhibitor (INSTI) Relugolix Relugolix Oral Gonadotropin- Uterine fibroids 06/01/2021 releasing hormone (GnRH) antagonist TGR-1202 Umbralisib Oral Phosphoinositide 3- Follicular lymphoma 06/15/2021 kinase (PI3K) inhibitor TransCon hGH Lonapegsomatropin Subcutaneous Growth hormone Pediatric growth 06/25/2021 hormone deficiency Estelle Drospirenone; Oral Estrogens Progestins Pregnancy prevention 2Q 2021 Estetrol Ibsrela Tenapanor Oral Sodium-hydrogen Hyperphosphatemia in 2Q 2021 exchanger (NHE) end stage renal disease inhibitor NexoBrid TBD Topical Proteolytic enzymes Wound debridement 2Q 2021 Orelvo Voclosporin Oral Immunosuppressant Lupus nephritis