A TERRIBLE BEAUTY - idsihealth.org

1 The theory is tough, the science is hard, the economics difficult, and the statistics advanced. The unavoidable trade-offs are often agonizing, much is uncertain, reputations are at stake, and getting things wrong costs lives. Anthony J. Culyer in A Star in the East: A short history of HITAP, 2016 When [NICE] first started to flex its muscles in 1999, the drug industry would love to have exported it, preferably to somewhere like Mars. Ten years later, the influence of NICE, far from being blunted, is beginning to spread. Its methods and organisational model have become something of a beacon to governments wrestling with the issues of efficacy and fairness in healthcare delivery.

2 British Medical Journal, 31 January 2009 Captures not just the policy issues but some of the personal dynamics that lead to success or failure. A reviewer of the draftA TERRIBLE BEAUTY : A short history of NICEN icholas TimminsSir Michael RawlinsJohn ApplebyA short history of NICETHE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCEA TERRIBLEBEAUTYH ealth Intervention and Technology Assessment Program (HITAP)6th Floor, 6th Building, Department of Health, Ministry of Public Health, Tiwanon Road, Muang, Nonthaburi 11000, ThailandTel: (66) 2590-4549 or (66) 2590-4374-5E-mail.

3 TERRIBLEBEAUTYA short history OF NICETHE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCEA TERRIBLE beAuTyA short history of NiCe The NATioNAl iNSTiTuTe for heAlTh ANd CAre exCelleNCe This is not an official history of the National Institute for health and Care Excellence. It is not endorsed by NICE and it does not necessarily represent the views of NICE. Nicholas Timmins, Sir Michael Rawlins, John Appleby 2016. All three assert the moral right to be identified as the authors of this work. All reproduction and transmission rights in any form are reserved.

4 The production of this book was supported by the Prince Mahidol Award Conference 2016, World Health Organization Country Office for Thailand, the Rockefeller Foundation, and the International Decision Support Initiative (iDSI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the funders. The funders had no influence over the process or the content of this 978-616-11-2821-0 First Published January 2016 Quantity 1,000 Amarin Printing and Publishing Public Co., intervention and Technology Assessment Program (hiTAP)6th Floor, 6th Building, Department of Health, Ministry of Public Health, Tiwanon Road Muang, Nonthaburi 11000, ThailandTel: (66) 2590-4549 or (66) 2590-4374-5E-mail: FOREWORD AND ACKNOWLEDGEMENTS 402 THE FIRST SIXTEEN YEARS.

5 8 From Relenza to the Cancer Drugs Fund Nicholas Timmins Chapter 1 THIS DECISION IS LUDICROUS 8 Chapter 2 ORIGINS 16 Chapter 3 FORMATION 36 Chapter 4 BETA-INTERFERON BITES BACK 58 Chapter 5 HERCEPTIN 74 Chapter 6 THE ROAD TO THE CANCER DRUGS FUND 92 Chapter 7 BACK TO THE BEGINNING: THE IMPORTANCE OF THE GUIDELINES 114 Chapter 8 NICE IN LA LONGUE DUR E 12103 NICE, THE LAW, ITS SOCIAL VALUES AND ITS STAKEHOLDERS 136 Sir Michael Rawlins04 WHAT S IN AND WHAT S OUT?

6 154 The Thorny Issue of the Threshold John Appleby05 GLOSSARY 17006 POSTSCRIPT 17207 ENDNOTES 174 FOREWORD ANDACKNOWLEDGEMENTSThis, as the title states, is A short history of NICE . It was constructed at considerable speed. In a matter of months from the initial idea to the final origins go back a fair way. Some six years ago John Appleby and Nicholas Timmins agreed that someone should write a history of NICE . Because we both believed this was one of the more important pieces of UK public policy, let alone in health, in the last couple of talked to Sir Michael Rawlins and Sir Andrew Dillon about that and they offered their full co-operation, as at the time did the health department in providing access to at least some of the earlier files around the creation of the , neither John nor Nick found the time, and the co-conspirators in the health department moved on.

7 A new trigger was provided by the commission from the Prince Mahidol Award Foundation as part of the conference material for the foundation s 2016 conference in Bangkok. In the middle of 2015 and after some preliminary conversations, it supplied both a deadline and a sum of money that would mainly meet research and travel costs. It was to be written in parallel with an account of HITAP, Thailand s own Health Intervention and Technology Assessment programme, a task that has been undertaken by Tony Culyer. (1) The result is this short history .

8 The authors, however, had day jobs to do, so this document is essentially a labour of is therefore important to understand that this account is based on interviews and memory (the memory of both the authors and interviewees which, as all historians will tell you, plays tricks) and on publicly available documents, whether from academic, media, or government and court sources, along with NICE s 4A TERRIBLE BEAUTY : A short history of NICE The National Institute for Health and Care Excellenceown publications, none of which have been subject to what the academics would call a literature search.

9 It has dug neither into the unpublished archive of NICE, nor into that of the Department of Health, nor into the archive of the many life sciences companies that have been affected by NICE s work were those ever to be available in the public few people from the life sciences industry have been consulted. And while other parts of NICE s activities are addressed, it concentrates chiefly on health technology assessment. From the beginning the institute had a larger portfolio than that, and the range of its activities has expanded appreciably over the provide a complete account many more people, including some who played a central role in NICE s history , would have been interviewed, and many more documents would have been That would doubtless have altered some of the judgements made here.

10 But in the time available, and given other commitments, that was not this is not just A short history of NICE it is also almost certainly far from entirely right. It leaves out, in the interests of both time and length, some important events and controversies, and one day someone either these or other authors should write a longer, more accurate, more comprehensive and much more nuanced account of hope, nonetheless, that this first rough draft of history is one that others will, at the least, have to take into account. And either praise or this account would not have been possible without help from a considerable number of people who found time for interviews or conversations or critiques, often at considerably short notice.