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New Drug Arrivals Q 4 – Monograph Summary

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New Drug Arrivals Q 4 – Monograph Summary Centene Pharmacy & Therapeutics Committee New Drug Arrivals Summary 4Q18 – Survey Meeting Review Type (RT) Descriptions 1, 2, 3, or 5 Review type 1 (RT1): New Drug Review Full review of new chemical or biologic agents Review type 2 (RT2): New Indication Review Abbreviated review of new dosage forms of existing agents that are approved for a new indication or use Review type 5 (RT5): Abbreviated Reviews for Intravenous Chemotherapy Agents Abbreviated review for intravenous chemotherapy agents which are usually covered under the medical benefit Type Drug Name FDA-Approved Indication(s) RT1 Avatrombopag (Doptelet®) Doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. RT1 Baricitinib Olumiant is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or (Olumiant® ) more tumor necrosis factor (TNF) antagonist therapies (TNFi). RT1 Elagolix (Orilissa®) For the management of moderate-to-severe pain associated with endometriosis RT1 Ivosidenib For the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as (Tibsovo®) detected by an FDA-approved test RT1 Migalastat (Galafold™) Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. RT1 Moxidectin Moxidectin is an anthelmintic indicated for the treatment of onchocerciasis due to Onchocerca volvulus in patients aged 12 years and older. RT1 Patisiran (Onpattro™) Onpattro is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. RT1 Pegvaliase-pqpz Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine (Palynziq™) concentrations greater than 600 µmol/L on existing management. RT1 Sodium zirconium Lokelma is indicated for the treatment of hyperkalemia in adults. cyclosilicate (Lokelma®) RT1 Tafenoquine For the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for (Krintafel®) acute P. vivax infection. RT2 Certolizumab pegol New/Revised Indication(s) (Cimzia®) Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy RT2 Denosumab New/Revised Indication(s) (Prolia®) For the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. RT2 Enzalutamide (Xtandi®) Treatment of patients with castration-resistant prostate cancer (CRPC) RT2 Epoetin alfa-epbx Retacrit is an FDA-approved biosimilar agent to Epogen® (epoetin alfa) and Procrit® (epoetin alfa) with the same indications. (Retacrit™ ) RT2 Glycopyrronium Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older (Qbrexza™) RT2 IncobotulinumtoxinA Treatment of chronic sialorrhea in adult patients (Xeomin®) RT2 Lenvatinib (Lenvima®) First-line treatment of patients with unresectable hepatocellular carcinoma. RT2 Pegfilgrastim-jmdb Fulphila is a biosimilar to Neulasta® and has the same indication as Neulasta: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients (Fulphila™ ) with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. RT2 Ribociclib Revised indication: Use in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)- (Kisqali®) positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. New indication: Use in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy. RT2 Rituximab Rituxan is indicated for the treatment of adult patients with moderate-to-severe pemphigus vulgaris (PV). (Rituxan®) RT2 Tofacitinib New/Revised Indication(s) (Xeljanz®) For the treatment of adult patients with moderately to severely active ulcerative colitis (UC) RT5 Mogamulizumab-kpkc Poteligeo indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic (Poteligeo®) therapy. ©2018 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. .
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