Pharmacy Prior Authorization Criteria
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WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT (51) International Patent Classification: (71) Applicant: JUNO THERAPEUTICS, INC. [US/US]; 400 A 61K 35/1 7 (20 15.0 1) A 61P 35/00 (2006 .0 1) Dexter Ave. N., Suite 1200, Seattle, WA 98109 (US). (21) International Application Number: (72) Inventor: ALBERTSON, Tina; 400 Dexter Ave. N., Suite PCT/US2018/035755 1200, Seattle, WA 98109 (US). (22) International Filing Date: (74) Agent: AHN, Sejin et al; Morrison & Foerster LLP, 1253 1 0 1 June 2018 (01 .06.2018) High Bluff Drive, Suite 100, San Diego, CA 92130-2040 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/5 14,774 02 June 2017 (02.06.2017) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/5 15,530 05 June 2017 (05.06.2017) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/521,366 16 June 2017 (16.06.2017) u s HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/527,000 29 June 2017 (29.06.2017) u s KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 62/549,938 24 August 2017 (24.08.2017) u s MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/580,425 0 1 November 2017 (01 .11.2017) u s OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 62/593,871 0 1 December 2017 (01 .12.2017) u s SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/596,764 08 December 2017 (08.12.2017) u s TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
Accepted Manuscript
Zurich Open Repository and Archive University of Zurich Main Library Strickhofstrasse 39 CH-8057 Zurich www.zora.uzh.ch Year: 2020 JAK efficacy in Crohn’s disease Rogler, Gerhard Abstract: Inhibition of Janus kinases in Crohn’s disease (CD) patients has shown conflicting results in clinical trials. Tofacitinib, a pan-JAK inhibitor showed efficacy in ulcerative colitis (UC) and has been approved for the treatment of patients with moderate to severe UC. In contrast, studies in patients suffering from CD were disappointing and the primary endpoint of clinical remission could notbemet in the respective phase II induction and maintenance trials. Subsequently, the clinical development of tofacitinib was discontinued in CD. In contrast, efficacy of filgotinib, a selective JAK1 inhibitor, inCD patients was demonstrated in the randomized, double-blinded, placebo-controlled phase II FITZROY study. Upadacitinib also showed promising results in a phase II trial in moderate to severe CD. Subse- quently phase III programs in CD have been initiated for both substances, which are still ongoing. Several newer molecules of this class of orally administrated immunosuppressants are tested in clinical programs. The concern of side effects of systemic JAK inhibition is addressed by either exclusively intestinal action or higher selectivity (Tyk2 inhibitors). In general, JAK inhibitors constitute a new promising class of drugs for the treatment of CD. DOI: https://doi.org/10.1093/ecco-jcc/jjz186 Posted at the Zurich Open Repository and Archive, University of Zurich ZORA URL: https://doi.org/10.5167/uzh-178518 Journal Article Accepted Version Originally published at: Rogler, Gerhard (2020). JAK efficacy in Crohn’s disease. -
JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors
Drugs https://doi.org/10.1007/s40265-020-01261-8 CURRENT OPINION JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors Miguel Nogueira1 · Luis Puig2 · Tiago Torres1,3 © Springer Nature Switzerland AG 2020 Abstract Despite advances in the treatment of psoriasis, there is an unmet need for efective and safe oral treatments. The Janus Kinase– Signal Transducer and Activator of Transcription (JAK–STAT) pathway plays a signifcant role in intracellular signalling of cytokines of numerous cellular processes, important in both normal and pathological states of immune-mediated infamma- tory diseases. Particularly in psoriasis, where the interleukin (IL)-23/IL-17 axis is currently considered the crucial pathogenic pathway, blocking the JAK–STAT pathway with small molecules would be expected to be clinically efective. However, relative non-specifcity and low therapeutic index of the available JAK inhibitors have delayed their integration into the therapeutic armamentarium of psoriasis. Current research appears to be focused on Tyrosine kinase 2 (TYK2), the frst described member of the JAK family. Data from the Phase II trial of BMS-986165—a selective TYK2 inhibitor—in psoriasis have been published and clinical results are encouraging, with a large Phase III programme ongoing. Further, the selective TYK2 inhibitor PF-06826647 is being tested in moderate-to-severe psoriasis in a Phase II clinical trial. Brepocitinib, a potent TYK2/JAK1 inhibitor, is also being evaluated, as both oral and topical treatment. Results of studies with TYK2 inhibitors will be important in assessing the clinical efcacy and safety of these drugs and their place in the therapeutic armamentarium of psoriasis. -
JAK-Inhibitors for the Treatment of Rheumatoid Arthritis: a Focus on the Present and an Outlook on the Future
biomolecules Review JAK-Inhibitors for the Treatment of Rheumatoid Arthritis: A Focus on the Present and an Outlook on the Future 1, 2, , 3 1,4 Jacopo Angelini y , Rossella Talotta * y , Rossana Roncato , Giulia Fornasier , Giorgia Barbiero 1, Lisa Dal Cin 1, Serena Brancati 1 and Francesco Scaglione 5 1 Postgraduate School of Clinical Pharmacology and Toxicology, University of Milan, 20133 Milan, Italy; [email protected] (J.A.); [email protected] (G.F.); [email protected] (G.B.); [email protected] (L.D.C.); [email protected] (S.B.) 2 Department of Clinical and Experimental Medicine, Rheumatology Unit, AOU “Gaetano Martino”, University of Messina, 98100 Messina, Italy 3 Experimental and Clinical Pharmacology Unit, Centro di Riferimento Oncologico di Aviano (CRO), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Pordenone, 33081 Aviano, Italy; [email protected] 4 Pharmacy Unit, IRCCS-Burlo Garofolo di Trieste, 34137 Trieste, Italy 5 Head of Clinical Pharmacology and Toxicology Unit, Grande Ospedale Metropolitano Niguarda, Department of Oncology and Onco-Hematology, Director of Postgraduate School of Clinical Pharmacology and Toxicology, University of Milan, 20162 Milan, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-090-2111; Fax: +39-090-293-5162 Co-first authors. y Received: 16 May 2020; Accepted: 1 July 2020; Published: 5 July 2020 Abstract: Janus kinase inhibitors (JAKi) belong to a new class of oral targeted disease-modifying drugs which have recently revolutionized the therapeutic panorama of rheumatoid arthritis (RA) and other immune-mediated diseases, placing alongside or even replacing conventional and biological drugs. -
Summary Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 211675Orig1s000 SUMMARY REVIEW Cross Discipline Team Leader Review NDA 211675 Division Director Sununa1y Rinvoq (upadacitinib) for RA Office Director Sununary AbbVie , Inc. DHHS/FDA/CDER/ODEII/DPARP Cross-Discipline Team Leader Review Division Director Summary Office Director Summary Date July 11 , 201 9 Rachel Glaser, MD, Clinical Team Leader, DPARP From Sally Seymour, MD, Director, DP ARP Marv Thanh Hai, MD, Acting Director, ODEII Cross-Discipline Team Leader Review Subject Division Director Summaiy Office Director Summary NDA/BLA # and Supplement# 211675 Applicant AbbVie fuc Date of Submission December 18, 201 8 PDUFA Goal Date AUITTlSt 18, 201 9 Proprietary Name RINVOO Established or Proper Name Uoadacitinib Dosa2e Form(s) 15 mg extended release tablets Applicant Proposed (b)(4 Indication(s )/Population(s) Applicant Proposed Dosing 15 mg orally administered once daily Reoimen(s) Recommendation on Regulatory Approval Action Recommended Treatment of adults with moderately to severely active lndication(s)/Population(s) (if rheumatoid ai1hritis who have had an inadequate aoolicable) resoonse or intolerance to methotrexate Recommended Dosing 15 mg orally administered once daily Re2imen(s) (if aoolicable) CDER Cross Discipline Team Leader Review Template 1 Version date: October 10, 2017fo r all NDAs and BLAs Reference ID: 4478224 Cross Discipline Team Leader Review NDA 211675 Division Director Summary Rinvoq (upadacitinib) for RA Office Director Summary AbbVie, Inc. DHHS/FDA/CDER/ODEII/DPARP 1. Benefit-Risk Assessment Benefit-Risk Assessment Framework Rheumatoid arthritis (RA) is a serious medical condition that affects over 1.3 million Americans. RA is a chronic progressive disease that primarily affects the joints, but can involve other organs. -
Switching Between Janus Kinase Inhibitor Upadacitinib and Adalimumab Following Insufficient Response: Efficacy and Safety In
Ann Rheum Dis: first published as 10.1136/annrheumdis-2020-218412 on 4 November 2020. Downloaded from Rheumatoid arthritis CLINICAL SCIENCE Switching between Janus kinase inhibitor upadacitinib and adalimumab following insufficient response: efficacy and safety in patients with rheumatoid arthritis Roy M Fleischmann ,1 Ricardo Blanco ,2 Stephen Hall,3 Glen T D Thomson,4 Filip E Van den Bosch,5,6 Cristiano Zerbini,7 Louis Bessette,8,9 Jeffrey Enejosa,10 Yihan Li,10 Yanna Song,10 Ryan DeMasi,10 In- Ho Song10 Handling editor Josef S ABSTRACT Key messages Smolen Objectives To evaluate efficacy and safety of immediate switch from upadacitinib to adalimumab, or ► Additional material is What is already known about this subject? published online only. To view, vice versa, in patients with rheumatoid arthritis with non- ► In patients with rheumatoid arthritis, a treat- please visit the journal online response or incomplete- response to the initial therapy. to- target strategy is recommended, in which (http:// dx. doi. org/ 10. 1136/ Methods SELECT-COMP ARE randomised patients to therapy is optimised every 3–6 months until annrheumdis- 2020- 218412). upadacitinib 15 mg once daily (n=651), placebo (n=651) remission, or low disease activity, is achieved. or adalimumab 40 mg every other week (n=327). A For numbered affiliations see Recent treatment recommendations suggest the treat-to- target study design was implemented, with end of article. addition of a biological or targeted- synthetic blinded rescue occurring prior to week 26 for patients disease- modifying antirheumatic drug in Correspondence to who did not achieve at least 20% improvement in both patients who do not achieve treatment goals, Dr Roy M Fleischmann, The tender and swollen joint counts (’non-responders’) and and switches between mechanisms of action University of Texas at week 26 based on Clinical Disease Activity Index Southwestern Medical Center, occur commonly in clinical practice. -
BCBSVT Specialty Drug List Effective 2021.07.01.Xlsx
Effective Date: 07/01/2021 SPECIALTY DRUG LIST Revised Date: 05/07/2021 DOSAGE EXCLUDED ON NATIONAL DRUG CLASS DRUG NAME GENERIC NAME FORM PERFORMANCE FORMULARY ANEMIA ARANESP SOLN DARBEPOETIN ALFA SOLN INJ ANEMIA ARANESP SOSY DARBEPOETIN ALFA SOLN PREFILLED SYRINGE ANEMIA EPOGEN SOLN EPOETIN ALFA INJ X ANEMIA PROCRIT SOLN EPOETIN ALFA INJ X ANEMIA REBLOZYL SOLR LUSPATERCEPT-AAMT FOR SUBCUTANEOUS INJ ANEMIA RETACRIT SOLN EPOETIN ALFA-EPBX INJ ANTI-GOUT AGENT KRYSTEXXA SOLN PEGLOTICASE INJ (FOR IV INFUSION) ANTI-INFECTIVE PREVYMIS SOLN LETERMOVIR IV SOLN ANTI-INFECTIVE PREVYMIS TABS LETERMOVIR TAB ASTHMA CINQAIR SOLN RESLIZUMAB IV INFUSION SOLN ASTHMA FASENRA SOSY BENRALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE ASTHMA FASENRA PEN SOAJ BENRALIZUMAB SUBCUTANEOUS SOLN AUTO-INJECTOR ASTHMA NUCALA SOAJ MEPOLIZUMAB SUBCUTANEOUS SOLUTION AUTO-INJECTOR ASTHMA NUCALA SOLR MEPOLIZUMAB FOR INJ ASTHMA NUCALA SOSY MEPOLIZUMAB SUBCUTANEOUS SOLUTION PREF SYRINGE ASTHMA XOLAIR SOLR OMALIZUMAB FOR INJ ASTHMA XOLAIR SOSY OMALIZUMAB SUBCUTANEOUS SOLN PREFILLED SYRINGE CARDIOVASCULAR VYNDAMAX CAPS TAFAMIDIS CAP CARDIOVASCULAR VYNDAQEL CAPS TAFAMIDIS MEGLUMINE (CARDIAC) CAP CENTRAL NERVOUS SYSTEM AGENTS AUSTEDO TABS DEUTETRABENAZINE TAB CENTRAL NERVOUS SYSTEM AGENTS ENSPRYNG SOSY SATRALIZUMAB-MWGE SUBCUTANEOUS SOLN PREF SYRINGE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ CAPS TASIMELTEON CAPSULE CENTRAL NERVOUS SYSTEM AGENTS HETLIOZ LQ SUSP TASIMELTEON ORAL SUSP CHEMOTHERAPY PROTECTANT AMIFOSTINE SOLR AMIFOSTINE CRYSTALLINE FOR INJ CHEMOTHERAPY PROTECTANT ELITEK -
Prescribing Information
HIGHLIGHTS OF PRESCRIBING INFORMATION DOSAGE FORMS AND STRENGTHS These highlights do not include all the information needed to use Extended-release tablets: 15 mg (3) RINVOQ safely and effectively. See full prescribing information for RINVOQ. CONTRAINDICATIONS • None (4) RINVOQ™ (upadacitinib) extended-release tablets, for oral use Initial U.S. Approval: 2019 WARNINGS AND PRECAUTIONS • Serious Infections: Avoid use of RINVOQ in patients with active, serious WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND infection, including localized infections. (5.1) THROMBOSIS • Malignancy: Consider the risks and benefits of RINVOQ treatment prior to initiating therapy in patients with a known malignancy. (5.2) See full prescribing information for complete boxed warning. • Thrombosis: Consider the risks and benefits prior to treating patients who • Serious infections leading to hospitalization or death, including may be at increased risk of thrombosis. Promptly evaluate patients with tuberculosis and bacterial, invasive fungal, viral, and other symptoms of thrombosis and treat appropriately. (5.3) opportunistic infections, have occurred in patients receiving RINVOQ. • Gastrointestinal Perforations: Use with caution in patients who may be at (5.1) increased risk. (5.4) • If a serious infection develops, interrupt RINVOQ until the infection is • Laboratory Monitoring: Recommended due to potential changes in controlled. (5.1) lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids. (5.5) • Prior to starting RINVOQ, perform a test for latent tuberculosis; if it is • Embryo-Fetal Toxicity: RINVOQ may cause fetal harm based on animal positive, start treatment for tuberculosis prior to starting RINVOQ. studies. Advise females of reproductive potential of the potential risk to a (5.1) fetus and to use effective contraception. -
Upadacitinib for Psoriatic Arthritis Refractory to Biologics: SELECT-Psa 2
Ann Rheum Dis: first published as 10.1136/annrheumdis-2020-218870 on 3 December 2020. Downloaded from Psoriatic arthritis CLINICAL SCIENCE Upadacitinib for psoriatic arthritis refractory to biologics: SELECT- PsA 2 Philip J Mease ,1,2 Apinya Lertratanakul,3 Jaclyn K Anderson ,3 Kim Papp,4 Filip Van den Bosch,5 Shigeyoshi Tsuji,6 Eva Dokoupilova,7,8 Mauro Keiserman,9 Xin Wang,3 Sheng Zhong,3 Reva M McCaskill,3 Patrick Zueger,3 Aileen L Pangan,3 William Tillett10,11 Handling editor Josef S ABSTRACT Key messages Smolen Background Upadacitinib is a Janus kinase inhibitor under evaluation for the treatment of psoriatic arthritis ► Additional material is What is already known about this subject? published online only. To view (PsA). We evaluated upadacitinib in patients with PsA ► Despite the availability of biologic disease- please visit the journal online and prior inadequate response or intolerance to at least modifying antirheumatic drugs (DMARDs) in (http:// dx. doi. org/ 10. 1136/ one biologic disease- modifying antirheumatic drug psoriatic arthritis, only a small proportion of annrheumdis- 2020- 218870). (DMARD). patients achieve the recommended target of Methods In this 24-week randomised, placebo- For numbered affiliations see minimal disease activity; therefore, additional controlled, double-blind, phase 3 trial, 642 patients were end of article. treatment options are needed. randomised (2:2:1:1) to once per day upadacitinib 15 Correspondence to mg or 30 mg, placebo followed by upadacitinib 15 mg What does this study add? Dr Philip J Mease, or placebo followed by upadacitinib 30 mg at week 24. In this phase 3 trial of patients with psoriatic Rheumatology, Swedish Medical The primary endpoint was the proportion of patients ► Center, Seattle WA 98122, USA; arthritis refractory or intolerant to biologic achieving American College of Rheumatology (ACR) 20 pmease@ philipmease. -
Journal of Managed Care & Specialty Pharmacy®
J MC P ■ Journal of Mana of Journal JOURNAL OF g ANAGED ed Care & Specialty Pharmac M CARE & SPECIALTY PHARMACY® y ■ October 2020 Supplement ■ Volume 26 ■ Number 10-a ■ October 2020 ■ Supplemen t ■ Vol. 26, No. 10-a Making the Way for Innovation 2020 VIRTUAL • WEEK OF OCT. 19 Poster Abstracts Journal of Managed Care & Specialty Pharmacy® Previously published as JMCP, the Journal of Managed Care Pharmacy® A Peer-Reviewed Journal of the AMCP ■ www.jmcp.org ■ www.amcp.org AMCP Abstracts Program The AMCP NEXUS 2020 VIRTUAL will be held online the week of October 19, 2020. The AMCP abstracts program provides a forum through which authors can share their insights and outcomes of advanced managed care practice. For NEXUS 2020 VIRTUAL, abstract posters are scheduled to be presented Wednesday, October 21, from 1:00 pm EDT to 2:30 pm EDT. At that time, poster presenters will be available for live chats and will also share additional information about their research at https://plan.core-apps.com/ ■ Publisher amcp2020. Professional abstracts that have been reviewed are published in the Journal of Managed Susan A. Cantrell, RPh, CAE Care & Specialty Pharmacy’s (JMCP) Poster Abstracts supplement. Chief Executive Officer Academy of Managed Care Pharmacy Abstract Review Process ■ Editor-in-Chief Sixty-seven reviewers and 4 JMCP editorial reviewers were involved in the abstract review process Laura E. Happe, PharmD, MPH for AMCP NEXUS 2020 VIRTUAL. Each abstract (with author name and affiliation blinded) was 727.488.2700 reviewed and scored using a 1-5 scale with the following 5 criteria (15 rating scores per abstract), [email protected] which are used by JMCP to evaluate manuscripts for publication: ■ Assistant Editors • Relevance • Originality • Quality • Bias • Clarity Donald G. -
Janus Kinases in Leukemia
cancers Review Janus Kinases in Leukemia Juuli Raivola 1, Teemu Haikarainen 1, Bobin George Abraham 1 and Olli Silvennoinen 1,2,3,* 1 Faculty of Medicine and Health Technology, Tampere University, 33014 Tampere, Finland; juuli.raivola@tuni.fi (J.R.); teemu.haikarainen@tuni.fi (T.H.); bobin.george.abraham@tuni.fi (B.G.A.) 2 Institute of Biotechnology, Helsinki Institute of Life Science HiLIFE, University of Helsinki, 00014 Helsinki, Finland 3 Fimlab Laboratories, Fimlab, 33520 Tampere, Finland * Correspondence: olli.silvennoinen@tuni.fi Simple Summary: Janus kinase/signal transducers and activators of transcription (JAK/STAT) path- way is a crucial cell signaling pathway that drives the development, differentiation, and function of immune cells and has an important role in blood cell formation. Mutations targeting this path- way can lead to overproduction of these cell types, giving rise to various hematological diseases. This review summarizes pathogenic JAK/STAT activation mechanisms and links known mutations and translocations to different leukemia. In addition, the review discusses the current therapeutic approaches used to inhibit constitutive, cytokine-independent activation of the pathway and the prospects of developing more specific potent JAK inhibitors. Abstract: Janus kinases (JAKs) transduce signals from dozens of extracellular cytokines and function as critical regulators of cell growth, differentiation, gene expression, and immune responses. Deregu- lation of JAK/STAT signaling is a central component in several human diseases including various types of leukemia and other malignancies and autoimmune diseases. Different types of leukemia harbor genomic aberrations in all four JAKs (JAK1, JAK2, JAK3, and TYK2), most of which are Citation: Raivola, J.; Haikarainen, T.; activating somatic mutations and less frequently translocations resulting in constitutively active JAK Abraham, B.G.; Silvennoinen, O. -
Stembook 2018.Pdf
The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.