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Report of the Expert Committee for the Selection and Inclusion Of Report of the Expert Committee / A Report of the Expert Committee for the Selection and Inclusion of Medicines in the Pan American Health Organization Strategic Fund – July 2013 Report of the Expert Committee for the Selection and Inclusion of Medicines in the Pan American Health Organization Strategic Fund – July 2013 PAHO HQ Library Cataloguing-in-Publication Data ***************************************************************************************** Pan American Health Organization. Report of the Expert Committee for the Selection and Inclusion of Medicines in the Pan American Health Organization Strategic Fund – July 2013. Washington, DC : PAHO, 2013. 1. Pharmaceutical Preparations. 2. Chronic Disease. 3. Cardiovascular Diseases. 4. Neoplasms. 5. Immunosuppressive Agents. 6. Complementary Therapies. 7. Americas. I. Title. II. PAHO Strategic Fund. ISBN 978-92-75-11814-6 (NLM Classification: QV55) The Pan American Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. Applications and inquiries should be addressed to the Department of Knowledge Management and Communications (KMC), Pan American Health plansOrganization, for new Washington,editions, and D.C.,reprints U.S.A. and ([email protected]). translations already available. The Department of Health Systems and Services (HSS) will be glad to provide the latest information on any changes made to the text, © Pan American Health Organization, 2013. All rights reserved. Publications of the Pan American Health Organization enjoy copyright protection in accordance with the provisions of Protocol 2 of the Universal Copyright Convention. All rights are reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Secretariat of the Pan American Health Organization concerning the status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. that they are endorsed or recommended by the Pan American Health Organization in preference to othersThe of amention similar natureof specific that companies are not mentioned. or of certain Errors manufacturers’ and omissions products excepted, does the not names imply of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the Pan American Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the Pan American Health Organization be liable for damages arising from its use. / iii Contents Acronyms .................................................................................................................. iv Executive Summary ............................................................................................... 1 List of Participants ................................................................................................ 2 Declaration of Interests of Members of the Expert Committee for the Selection and Inclusion of Medicines in the PAHO Strategic Fund ....... 3 Introduction to the PAHO Strategic Fund and Expert Committee ......... 3 General Items .......................................................................................................... 5 ........................................................................................... 5 ............................................................................. 5 1. Meeting Proceedings Applications ............................................................................................................. 6 2. General Recommendations ............................................................................... 6 1.1 Chlorthalidone .................................................................................................. 6 1. Cardiovascular Medicines 1.2 Clopidogrel ......................................................................................................... 9 1.3 Lisinopril .............................................................................................................. 12 1.4 Losartan ............................................................................................................... 15 .................................................................................................. 18 2.1 Trastuzumab ..................................................................................................... 18 2. Cancer Medicines ................................... 23 3.1 Mycophenolate Mofetil ...................................................................... 24 3. Transplant and Immunosuppression Medicines 3.2 Sirolimus .............................................................................................................. 25 3.3 Tacrolimus ........................................................................................................ 27 Summary of Recommendations ........................................................................ 31 ................................................................................................................... 31 ......................................................................................... 32 1. Inclusion References ................................................................................................................ 33 2. Rejected Applications Annexes - Medicine Dossiers Compiled by PAHO Chlorthalidone ............................................................................................................. 39 Clopidogrel .................................................................................................................... 59 Lisinopril ....................................................................................................................... 87 Losartan ......................................................................................................................... 112 Mycophenolate Mofetil ............................................................................................ 137 Sirolimus ........................................................................................................................ 165 Tacrolimus .................................................................................................................... 195 Trastuzumab ................................................................................................................ 231 iv / Report of the Expert Committee for the Selection and Inclusion of Medicines in the PAHO Strategic Fund – July 2013 Acronyms ACCIb-CCIb Asociación Colaboración Cochrane Iberoamericana – Centro Cochrane Iberoamericano ACEi Angiotensin Converting Enzyme inhibitor ALLHAT Antihypertensive and lipid-lowering treatment to prevent heart attack trial ARB Angiotensin Receptor Blockers ATLAS Adjuvant tamoxifen, longer against shorter AZA Azathioprine BP Blood pressure CAPRIE Clopidogrel versus aspirin in patients at risk of ischaemic events CAS Cyclosporine, azathioprine, and corticosteroid CHD Coronary heart disease CHF Congestive heart failure CI Cytomegalovirus Confidence interval CNI Calcineurin inhibitors CMV CNS Central nervous system CTD Chlorthalidone Cardiovascular disease CYP Cyclosporine CVD DFS Disease-free survival EML Essential medicines list EMLc Essential medicines list for children GRADE Grading of recommendations assessment, development and evaluation GODT Global observatory on donation and transplantation HCTZ Hydrochlorothiazide GVHD Graft versus host disease HER2+ Human epidermal growth factor receptor 2-positive HF Heart failure HR Hazard ratio HS Herpes Simplex HSS/MT Medicines and health technologies unit ICER Incremental cost-effectiveness ratio Left ventricular ejection fraction MI Myocardial infarction LVEF MMF Mycophenolate mofetil MRFIT Multiple risk factor intervention trial Acronyms / v NCD Noncommunicable disease NICE National Institute for Health and Care Excellence NMH/ND Noncommunicable Diseases and Disabilities Unit NNT Number needed to treat NYHA New York Heart Association OR Odds ratio OS Overall survival PAD Peripheral arterial disease PAHO Pan American Health Organization pCR pathologic Complete Response PFS Progression-free survival RCIDT Red/ Consejo Iberoamericano de Donación y Trasplantes QALY Quality-Adjusted Life Year RCT Randomized controlled trial RR Relative risk sRL Sirolimus TAC Tacrolimus TAS Tacrolimus, azathioprine and a corticosteroid WHO World Health Organization VKA Vitamin K Antagonist / 1 Executive Summary The inaugural meeting of the Expert Committee for the Selection and Inclusion of Medicines in the Pan American Health Organization Strategic Fund was held at the Headquarters of the Pan American Health Organization (PAHO)Experts in Washington, from the Region D.C., on of 17-18the Americas July 2013. where convened to provide recommendations to the PAHO Director for the potential inclusion of eight medicines in the Strategic Fund Medicine List. The names of the members of the Expert Committee and their corresponding declarations of interests are provided in the full report. The Expert Committee reviewed applications for eight medicines for the treatment of noncommunicable diseases, such as cardiovascular disease and cancer, and immunosuppressive
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