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DRUGS REQUIRING PRIOR AUTHORIZATION in the MEDICAL BENEFIT Page 1
Effective Date: 08/01/2021 DRUGS REQUIRING PRIOR AUTHORIZATION IN THE MEDICAL BENEFIT Page 1 Therapeutic Category Drug Class Trade Name Generic Name HCPCS Procedure Code HCPCS Procedure Code Description Anti-infectives Antiretrovirals, HIV CABENUVA cabotegravir-rilpivirine C9077 Injection, cabotegravir and rilpivirine, 2mg/3mg Antithrombotic Agents von Willebrand Factor-Directed Antibody CABLIVI caplacizumab-yhdp C9047 Injection, caplacizumab-yhdp, 1 mg Cardiology Antilipemic EVKEEZA evinacumab-dgnb C9079 Injection, evinacumab-dgnb, 5 mg Cardiology Hemostatic Agent BERINERT c1 esterase J0597 Injection, C1 esterase inhibitor (human), Berinert, 10 units Cardiology Hemostatic Agent CINRYZE c1 esterase J0598 Injection, C1 esterase inhibitor (human), Cinryze, 10 units Cardiology Hemostatic Agent FIRAZYR icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent HAEGARDA c1 esterase J0599 Injection, C1 esterase inhibitor (human), (Haegarda), 10 units Cardiology Hemostatic Agent ICATIBANT (generic) icatibant J1744 Injection, icatibant, 1 mg Cardiology Hemostatic Agent KALBITOR ecallantide J1290 Injection, ecallantide, 1 mg Cardiology Hemostatic Agent RUCONEST c1 esterase J0596 Injection, C1 esterase inhibitor (recombinant), Ruconest, 10 units Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug administered under Cardiology Hemostatic Agent TAKHZYRO lanadelumab-flyo J0593 direct supervision of a physician, not for use when drug is self-administered) Cardiology Pulmonary Arterial Hypertension EPOPROSTENOL (generic) -
Pharma China0409-285.P65
TM C O N T E N T S ○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○○ ○○○ I s s u e Editorial Mentholatum sues XiAn Meichen over Market Dynamics Brew New Order for trademark infringements 14 Chinese Pharma 2 API/Bulk Drugs 32 News in Focus Huaxing expands capacity of Amoxicillin MOH releases results of the 4th and 6-APA 14 APRIL National Health Service Survey 4 NCPG/DSM likely to build major The Market antibiotic API facility in Changchun 14 2 0 0 9 Data Snaptshot: Chinese OTC Shandong Antibiotics granted Germany healthcare market 5 GMP certification 15 Nicholas Hall reports slower growth Hisun sees profits up sharply in 2008 15 of OTC GI market in China 5 Changzhou Yabang-QH builds new In This Issue Industry News cGMP API plant with help from J&J 15 Chinese pharma industry perfor- Shijiazhuang Pharma receives EDQM MNCs report another year of mance in 2008 and outlook in 2009 5 certification for Vitamin B12 15 sharp revenue growth in China MNCs report another year of sharp India likely to investigate China’s 6-APA 15 Many MNCs experienced growth 20% revenue growth in China 6 MOC issues list of authorized exporters or more in China last year amid global MNCs positions for the huge diabetes of ephedrine drugs 15 slowdown P6 market potential in China 6 Data Snapshot - COS certifications and Harbin Pharma reconsiders Chinese producers likely to emerge DMFs held by Chinese companies 16 overseas IPO as global players of recombinant Chinese API in 2008 – Output and Export In preparation, Harbin Pharmaceutical human insulin 6 Volumes Down 16 Group is working on major and minor M&A is likely to intensify for retail Product and R&D News acquisitions this year P8 pharmacy sector in 2009 7 AOB to initiate clinical trials of TCM drug Pfizer opens new sterile facility Guangzhou introduces online for UI in the U.S. -
New Century Health Policy Changes April 2021
Policy # Drug(s) Type of Change Brief Description of Policy Change new Pepaxto (melphalan flufenamide) n/a n/a new Fotivda (tivozanib) n/a n/a new Cosela (trilaciclib) n/a n/a Add inclusion criteria: NSCLC UM ONC_1089 Libtayo (cemiplimab‐rwlc) Negative change 2.Libtayo (cemiplimab) may be used as montherapy in members with locally advanced, recurrent/metastatic NSCLC, with PD‐L1 ≥ 50%, negative for actionable molecular markers (ALK, EGFR, or ROS‐1) Add inclusion criteria: a.As a part of primary/de�ni�ve/cura�ve‐intent concurrent chemo radia�on (Erbitux + Radia�on) as a single agent for members with a UM ONC_1133 Erbitux (Cetuximab) Positive change contraindication and/or intolerance to cisplatin use OR B.Head and Neck Cancers ‐ For recurrent/metasta�c disease as a single agent, or in combination with chemotherapy. Add inclusion criteria: UM ONC_1133 Erbitux (Cetuximab) Negative change NOTE: Erbitux (cetuximab) + Braftovi (encorafenib) is NCH preferred L1 pathway for second‐line or subsequent therapy in the metastatic setting, for BRAFV600E positive colorectal cancer.. Add inclusion criteria: B.HER‐2 Posi�ve Breast Cancer i.Note #1: For adjuvant (post‐opera�ve) use in members who did not receive neoadjuvant therapy/received neoadjuvant therapy and did not have any residual disease in the breast and/or axillary lymph nodes, Perjeta (pertuzumab) use is restricted to node positive stage II and III disease only. ii.Note #2: Perjeta (pertuzumab) use in the neoadjuvant (pre‐opera�ve) se�ng requires radiographic (e.g., breast MRI, CT) and/or pathologic confirmation of ipsilateral (same side) axillary nodal involvement. -
China Pharmaceutical Newsletter
Volume VII 2011 CHINA PHARMACEUTICAL ڵNEWSLETTER З֡Ԛ哦֡ଢ଼рࡗЗ แྼჯ)ཀৄDžᄱᆶ၌ࠅິ SFDA Commissioner Shao Mingli SFDA Deputy Commissioner Wu Zhen of NPC Standing Committee attended the met with new Cuban Ambassador to meets the Head of Iran's Innovation and meeting. Chen Zhu, the Health Minister China On September 29, 2011, Shao Technology Cooperation Center On the & Chairman of the Forum attended the Mingli, Commissioner of SFDA met morning of September 6, 2011, Wu Zhen, forum and delivered a speech. with Mr. ALberto Jesus Blanco Silva, the SFDA Deputy Commissioner, met with the Chen Zhu said in his speech, through new Cuban Ambassador Extraordinary visiting Mr. Hamidreza Amirinia, Head of 30 years of reform and opening up, and Plenipotentiary to China, and his Innovation and Technology Cooperation China's GDP has maintained a 10% entourage in Beijing. The two sides Center of Iran. Both parties exchanged growth in 30 consecutive years, and held in-depth discussions on further views on enhancing mutual exchanges and created an economic miracle. In 2010, strengthening the bilateral cooperation in understanding, and promoting cooperation China's GDP had ranked second in the WKH¿HOGVRIELRORJLFDl products and drug LQWKH¿HOGRIWUDGLWLRQDO&KLQHVHPHGLFLQH world. In the 21st century, the Chinese safety supervision. (September 30, 2011) and biopharmaceuticals. (September 8, 2011) Government pays more attention to social SFDA Deputy Commissioner Wu development, taking the alleviation of SFDA Deputy Commissioner Bian Zhen meets the delegation of MHLW On poverty and improvement of health care, Zhenjia attends the APEC LSIF Drug the morning of August 23, 2011, Wu Zhen, education, housing, and employment, etc. -
SABCS 2020 – Focus on Breast Cancer
EPICS Conference Coverage: SABCS 2020 – Focus on Breast Cancer Chair: Adam Brufsky Faculty: Mark Pegram, Peter Kaufman, Joyce O’Shaughnessy (joining 9.30 AM), Nadia Harbeck, Miguel Martin, Hope Rugo Date: Monday, December 14, 2020 Time: 9.00 AM – 12.00 PM EST Time EST Topic Speaker/Moderator 9.00 AM Welcome and Introductions Adam Brufsky, MD, PhD (10 min) CDK4/6 Inhibitors and Other Targeted Agents for ER+ Breast Cancer • GS1-01. Primary outcome analysis of invasive disease-free survival for monarchE: abemaciclib combined with adjuvant endocrine therapy for high risk early breast cancer. O’Shaughnessy et al. • GS1-02. Phase III study of palbociclib combined with endocrine therapy (ET) in patients with hormone-receptor-positive (HR+), HER2-negative primary breast cancer and with high relapse risk after neoadjuvant chemotherapy (NACT): First results from PENELOPE-B. Loibl et al. • GS1-04. Correlative biomarker analysis of intrinsic subtypes and efficacy across the MONALEESA Phase III studies. Prat et al. 9.10 AM • PD2-01. High Ki-67 as a biomarker for identifying Miguel Martin, MD, PhD (10 min) patients with high risk early breast cancer treated in monarchE. Harbeck et al. • PD2-03. Treatment persistence and dose modifications in the PALLAS trial: PALbociclib CoLlaborative Adjuvant Study of palbociclib with adjuvant endocrine therapy for HR+/HER2- early breast cancer. Mayer et al. • GS4-02. E2112: randomized phase 3 trial of endocrine therapy plus entinostat/placebo in patients with hormone receptor-positive advanced breast cancer. A trial of the ECOG-ACRIN cancer research group. Connolly et al. • PD1-01. Open-label, randomized, phase 2 study of sapanisertib (TAK-228/MLN0128) in combination with fulvestrant in postmenopausal women with Aptitude Health - US Aptitude Health - EU Page 1 of 6 5901-C Peachtree Dunwoody Road NE Wilhelmina van Pruisenweg 104 Suite 200 2595 AN The Hague Atlanta, GA 30328, US the Netherlands aptitudehealth.com Copyright © 2020 Aptitude Health. -
CDK4/6 and MAPK—Crosstalk As Opportunity for Cancer Treatment
pharmaceuticals Review CDK4/6 and MAPK—Crosstalk as Opportunity for Cancer Treatment Lisa Scheiblecker, Karoline Kollmann and Veronika Sexl * Institute of Pharmacology and Toxicology, University of Veterinary Medicine Vienna, 1210 Vienna, Austria; [email protected] (L.S.); [email protected] (K.K.) * Correspondence: [email protected] Received: 24 October 2020; Accepted: 22 November 2020; Published: 24 November 2020 Abstract: Despite the development of targeted therapies and novel inhibitors, cancer remains an undefeated disease. Resistance mechanisms arise quickly and alternative treatment options are urgently required, which may be partially met by drug combinations. Protein kinases as signaling switchboards are frequently deregulated in cancer and signify vulnerable nodes and potential therapeutic targets. We here focus on the cell cycle kinase CDK6 and on the MAPK pathway and on their interplay. We also provide an overview on clinical studies examining the effects of combinational treatments currently explored for several cancer types. Keywords: CDK6; MAPK; p38; combinational; palbociclib; inhibitors; cancer 1. Introduction Tumorigenesis requires that cells hijack regulatory networks to obtain their full oncogenic potential. The MAPK (mitogen-activated protein kinase) pathway is a tightly regulated signaling cascade frequently mutated or deregulated in cancer. Extra- and intracellular stimuli activate the MAPK cascade that regulates a broad variety of cellular programs including proliferation, differentiation, stress responses and apoptosis [1]. The best-studied MAPK pathways are the extracellular signal-regulated kinase (ERK) and stress-activated MAPK (c-Jun N-terminal kinase JNK and p38) pathways (Figure1). While the ERK pathway is predominantly activated by growth factors to drive survival and cell growth, activation of the JNK or p38 pathway is accomplished by environmental stressors and inflammatory cytokines and is associated with apoptosis and growth inhibition [1]. -
International Nonproprietary Names for Pharmaceutical Substances (INN)
WHO Drug Information, Vol. 31, No. 2, 2017 Proposed INN: List 117 International Nonproprietary Names for Pharmaceutical Substances (INN) Notice is hereby given that, in accordance with article 3 of the Procedure for the Selection of Recommended International Nonproprietary Names for Pharmaceutical Substances, the names given in the list on the following pages are under consideration by the World Health Organization as Proposed International Nonproprietary Names. The inclusion of a name in the lists of Proposed International Nonproprietary Names does not imply any recommendation of the use of the substance in medicine or pharmacy. Lists of Proposed (1–113) and Recommended (1–74) International Nonproprietary Names can be found in Cumulative List No. 16, 2015 (available in CD-ROM only). The statements indicating action and use are based largely on information supplied by the manufacturer. This information is merely meant to provide an indication of the potential use of new substances at the time they are accorded Proposed International Nonproprietary Names. WHO is not in a position either to uphold these statements or to comment on the efficacy of the action claimed. Because of their provisional nature, these descriptors will neither be revised nor included in the Cumulative Lists of INNs. Dénominations communes internationales des Substances pharmaceutiques (DCI) Il est notifié que, conformément aux dispositions de l'article 3 de la Procédure à suivre en vue du choix de Dénominations communes internationales recommandées pour les Substances pharmaceutiques les dénominations ci-dessous sont mises à l'étude par l'Organisation mondiale de la Santé en tant que dénominations communes internationales proposées. -
Epidemiology of Metastatic Breast Cancer
ESMO 2019 Update 29 September 2019 NASDAQ: GTHX 1 Agenda 6:45 – 6:50 p.m. Welcome & G1 Overview Mark Velleca, M.D., Ph.D., Chief Executive Officer 6:50 – 7:05 p.m. Breast Cancer State of the State c. 2019 Lisa Carey, M.D., FASCO, Chief of Hematology/Oncology and Physician-in-Chief, N.C. Cancer Hospital Associate Director of Clinical Sciences, Lineberger Comprehensive Cancer Center 7:05 – 7:15 p.m. ESMO Data Review: Trilaciclib and G1T48 Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D 7:15 – 7:30 p.m. Q&A with Dr. Carey, Dr. Malik and Dr. Velleca 7:30 – 7:40 p.m. Pipeline Development Strategy and Regulatory Milestones Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D 7:40 – 7:50 p.m. Commercial Opportunity and Strategy John Demaree, Chief Commercial Officer 7:50 – 8:05 p.m. Q&A with Dr. Malik, Mr. Demaree and Dr. Velleca 8:05 – 8:10 p.m. Upcoming Catalysts and Closing Remarks Mark Velleca, M.D., Ph.D., Chief Executive Officer 2 Forward-looking statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this presentation include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48, the expected timing of data availability from ongoing clinical trials, the expected timing of initiation of future clinical trials, and the timing for the commencement and completion of marketing applications in the U.S. -
Chemotherapy and CDK4/6 Inhibitors: Unexpected Bedfellows
Author Manuscript Published OnlineFirst on June 16, 2020; DOI: 10.1158/1535-7163.MCT-18-1161 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 1 Chemotherapy and CDK4/6 inhibitors: Unexpected bedfellows Patrick J. Roberts1, Vishnu Kumarasamy2, Agnieszka K. Witkiewicz2,3, Erik S. Knudsen*2,4 1G1 Therapeutics, Research Triangle Park, NC 2Center for Personalized Medicine, Roswell Park Cancer Institute, Buffalo NY 3Department of Pathology, Roswell Park Cancer Institute, Buffalo NY 4Department of Molecular and Cellular Biology, Roswell Park Cancer Institute, Buffalo NY CONFLICT OF INTEREST STATEMENT: At the time of the initiation of this manuscript PJR was an employee of G1 Therapeutics which is involved in the clinical development of CDK4/6 inhibitors. The other authors have no potential conflicts of interest to report. Corresponding Author *Erik S. Knudsen Department of Molecular and Cellular Biology Roswell Park Cancer Center [email protected] Downloaded from mct.aacrjournals.org on September 30, 2021. © 2020 American Association for Cancer Research. Author Manuscript Published OnlineFirst on June 16, 2020; DOI: 10.1158/1535-7163.MCT-18-1161 Author manuscripts have been peer reviewed and accepted for publication but have not yet been edited. 2 Abstract: Cyclin-dependent kinases 4 and 6 (CDK4/6) have emerged as important therapeutic targets. Pharmacological inhibitors of these kinases function to inhibit cell cycle progression and exert other important effects on the tumor and host environment. Due to their impact on the cell cycle, CDK4/6 inhibitors (CDK4/6i) have been hypothesized to antagonize the anti-tumor effects of cytotoxic chemotherapy in tumors that are CDK4/6 dependent. -
Download Table of Contents [PDF 1
Advances in Biopharmaceutical Technology in China, Second Edition October 2018 Editors: Vicky (Qing) Xia, Leo (Yang) Cai BioPlan Associates, Inc. Rockville, MD Society for Industrial Microbiology and Biotechnology Fairfax, VA BioPlan Associates, Inc. 2275 Research Blvd., Ste. 500 Rockville MD 20850 USA 301-921-9074 www.bioplanassociates.com and Society for Industrial Microbiology and Biotechnology 3929 Old Lee Highway Suite 92A Fairfax, VA 22030-2421 703-691-3357 www.simbhq.org Copyright © 2018 BioPlan Associates, Inc. All rights reserved, including the right of reproduction in whole or in part in any form. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the written permission of the publisher. For information on special discounts or permissions contact BioPlan Associates, Inc. at 301- 921-5979, or [email protected] Editors: Vicky (Qing) Xia, Leo (Yang) Cai Project Director: Donnie E. Gillespie U.S. Editor: Terrell R. Otis Cover Design: LI Huijun Text Design: Esperance Shatarah, ES Design ISBN 978-1-934106-34-1 Front Cover Photo Courtesy of WuXi, by permission ii Acknowledgment This project would not have been possible without the exceptional efforts of the many people involved. In particular, we would like to thank our reviewers, whose expertise ensured this volume addressed today’s most important issues: ■ Tiffany M. Bauguess (Beeson), Consultant, MScGlobal Trials HK ■ Randy Berholz, Executive Vice President, Corporate Development and General Counsel, Innovus Pharmaceuticals, Inc. ■ David Deere, Chief Commercial Officer, PaizaBio ■ Changming Fang, Director of Biology and Drug Discovery, FronThera US Pharmaceuticals ■ Steve Ferguson, Chair, Department of Technology Transfer, Foundation for Advanced Education in the Sciences (FAES) Graduate School ■ Sean Hu, Founder, mAbKey Therapeutics ■ Charles (Changhui) Li, MS MBA, Chief Business Officer, Zhejiang Hopstem Biotech- nology Co., Ltd. -
Pharmaceutical Innovation in the APAC Region
Special report Pharmaceutical innovation in the APAC region A quantitative company ranking and future outlook Country/ Major Pharma Early-stage Drug Rank Company Maturity Total Score Region HQ (Top 50 by global revenue) Partnering Development 가장 혁신적인 1 Daiichi Sankyo Co Ltd Japan 410 320 135 865 대형 제약사 2 Takeda Pharmaceutical Co Ltd Japan 395 320 135 850 Rank 1-18 3 Eisai Co Ltd Japan 350 320 135 805 4 Astellas Pharma Inc Japan 345 320 135 800 5 Otsuka Holdings Co Ltd Japan 325 315 135 775 6 Shionogi & Co Ltd Japan 320 315 125 760 6 CSL Ltd Australia 345 310 105 760 8 Ono Pharmaceutical Co Ltd Japan 320 310 125 755 9 Mitsubishi Chemical Holdings Corp Japan (Mitsubishi Tanabe) 300 315 125 740 9 Kirin Holdings Co Ltd Japan (Kyowa Hakko Kirin) 315 300 125 740 11 Hanmi Pharmaceutical Co Ltd South Korea 325 295 115 735 12 Daewoong Pharmaceutical Co Ltd South Korea 305 300 95 700 13 Sumitomo Chemical Co Ltd Japan 265 305 125 695 14 FUJIFILM Holdings Corp Japan 265 300 125 690 15 Kyorin Holdings Inc Japan 280 280 105 665 16 Teijin Ltd Japan 250 275 115 640 17 Japan Tobacco Ltd Japan 230 260 115 605 18 Lupin Ltd India 185 280 125 590 18 Maruho Co Ltd Japan 200 265 125 590 Shanghai Fosun Pharmaceutical 18 Mainland China 175 305 110 590 (Group) Co Ltd Note: Scores do not reflect recent changes in company ownership, e.g., divestiture of CJ Healthcare to Korea Kolmar Holdings in 2018. -
5.01.540 Miscellaneous Oncology Drugs
PHARMACY / MEDICAL POLICY – 5.01.540 Miscellaneous Oncology Drugs Effective Date: Aug. 1, 2021* RELATED MEDICAL POLICIES: Last Revised: July 13, 2021 5.01.543 General Medical Necessity Criteria for Companion Diagnostics Related to Replaces: N/A Drug Approval *This policy has been updated. View changes. Select a hyperlink below to be directed to that section. POLICY CRITERIA | DOCUMENTATION REQUIREMENTS | CODING RELATED INFORMATION | EVIDENCE REVIEW | REFERENCES | HISTORY ∞ Clicking this icon returns you to the hyperlinks menu above. Introduction Chemotherapy, often called chemo, is cancer treatment that uses drugs. Radiation and surgery treat one area of cancer. But chemo usually travels through the bloodstream to treat the whole body. Treating the whole body is called a systemic treatment. The goal of chemo is to either treat cancer or ease its symptoms. Treating cancer can be to cure it, decrease the chance it will return, or stop or slow its growth. Easing cancer symptoms without trying to cure the cancer is called palliative therapy. Chemotherapy drugs can be used in many different ways. Chemo can make a tumor smaller before surgery or radiation, destroy cancer cells that surgery or radiation didn’t treat, help other treatments work better, or kill cancer cells that have come back or spread. Chemotherapy is given in different ways. This includes by mouth (oral), through a vein (intravenous), by a shot (injection), or with a cream rubbed onto the skin (topical). In some cases, chemo is injected between the layers of tissue covering the brain and spinal cord (intrathecal), is given into the belly area (intraperitoneal), or is injected into an artery (intra-arterial).