Interview with: Finn Boerlum
Kristensen, M.D., Ph.D., Chairman of
the Executive Committee of the
European Network for Heal...
The Pharma Network –
marcus evans Summits group
delivers peer-to-peer information
on strategic matters, professional
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Interview with: Finn Boerlum Kristensen, M.D., Ph.D.

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Interview with: Finn Boerlum Kristensen, M.D., Ph.D., Chairman of the Executive Committee of the European Network for Health Technology Assessment (EUnetHTA) and Director of its Coordinating Secretariat, Danish Health and Medicines Authority, Denmark, a speaker at the marcus evans Evolution Summit 2013, on improving HTA processes.

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Interview with: Finn Boerlum Kristensen, M.D., Ph.D.

  1. 1. Interview with: Finn Boerlum Kristensen, M.D., Ph.D., Chairman of the Executive Committee of the European Network for Health Technology Assessment (EUnetHTA) and Director of its Coordinating Secretariat, Danish Health and Medicines Authority, Denmark “Drug developers need to come to grips with the role of Health Technology Assessment (HTA) and start considering how they can provide the information required for better decision-making,” advises Finn Boerlum Kristensen, M.D., Ph.D., Chairman of the Executive Committee of the European Network for Health Technology Assessment (EUnetHTA) and Director of its Coordinating Secretariat hosted by the Danish Health and Medicines Authority, Denmark. Companies must keep their focus on value and create internal HTA systems that do not place additional burden on everyone, he adds. As a speaker at the marcus evans Evolution Summit 2013 in Monte Carlo, Monaco, 21 - 23 October, Kristensen puts the focus on HTA, clinical development and what Chief Medical Officers (CMOs) need to take into account. In your opinion, what is the role of HTA? The role of HTA is to bridge between evidence and decision-making. Its role varies between countries - some have formalized systems, particularly in relation to pricing and reimbursement, while others do not. It is increasingly used as a tool in the process from evidence to problem clarification of policy issues, followed by clarification of the decisions to be made and the input to provide. How will HTA help the industry deliver value to all stakeholders? HTA is all about value. If the HTA focuses on the wider scope of identifying value, that process is of interest to the sponsor who wants to get a drug to market, not only through marketing authorization or approval, which is given by regulators, but to actually see market take-up. HTA has opened up several domains of value. Value on the clinical level is key, but a drug may also make a contribution to how patient care is organized and handled. For example, if a medication can be provided orally instead of by drip both the health system and patients would see the value. How HTA could benefit sponsors of technologies has to be discussed more concretely. How does the process need to improve? The industry needs to start thinking about how it can provide information in certain domains that could actually be useful for decision-making. What data would HTAs like to have further down the pipeline? This must be considered during the early development phase of a drug, as it may go beyond traditional pre-clinical development programs to include concomitant studies of the organization of care for the relevant patient group or studies of patient preferences or perceptions. HTA must go beyond the clinical aspects, to organizational and economical aspects, even wider patient, legal and ethical aspects. This is a different approach from marketing. It is more about the decision structures that lie behind reimbursement decisions, when traditionally marketing has focused on the actual prescriber of the drug. The scope is broader here and the recipient is the prescriber as well as the payer or health insurer. Any final comments? Firstly, CMOs must focus on meeting regulators’ requirements. That is the goal of marketing authorization. In parallel, they should discuss with their peers and colleagues, who may be experiencing similar issues on what data collections and studies would be good to have for HTA. The regulatory goal is to produce or bring to market drugs that are of a high quality, safe and proved to have some kind of efficacy. That focus could not be lost by the CMO. At the same time, bringing in HTA should throw light on value and not stir up everything in relation to regulatory needs or burden everyone with more work. How HTA could benefit sponsors of technologies has to be discussed more concretely Making Healthcare Technology Assessment Achieve its Goal
  2. 2. The Pharma Network – marcus evans Summits group delivers peer-to-peer information on strategic matters, professional t r e n d s a n d b r e a k t h r o u g h innovations. Please note that the Summit is a closed business event and the number of participants strictly limited. About the Evolution Summit 2013 This unique forum will take place at Le Méridien Beach Plaza, Monte-Carlo, Monaco, 21 - 23 October 2013. Offering much more than any conference, seminar or trade show, this exclusive meeting will bring together esteemed industry thought leaders and solution providers to a highly focused and interactive networking event. The Summit includes presentations on progressing clinical programmes, site selection, competing in the new drug development paradigm and winning market access. www.evolution-summit.com Contact Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division Tel: + 357 22 849 313 Email: press@marcusevanscy.com For more information please send an email to info@marcusevanscy.com All rights reserved. The above content may be republished or reproduced. Kindly inform us by sending an email to press@marcusevanscy.com About marcus evans Summits marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to individually tailor their schedules of keynote presentations, case studies, roundtables and one-to-one business meetings. For more information, please visit: www.marcusevans.com Upcoming Events Discovery Summit (Europe) - www.discovery-summit.com Evolution Summit (North America) - www.evolutionsummit.com To view the web version of this interview, please click here: www.evolution-summit.com/FinnBoerlumKristensen

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