HOW SHOULD BIOSIMILARS BE VALUED AND SHOULD THEY UNDERGO HEALTH TECHNOLOGY ASSESSMENT?

Author(s)

Jeanette Kusel, MSci, MSc, Costello Medical Consulting Ltd, Cambridge, UK; Frank McKenna, MD, FRCP, Central Manchester University Hospitals, Manchester, UK; Emi Psachoulia, MSc, PhD, Biogen International GmbH, Zug, Switzerland; Andrew Walker, PhD, University of Glasgow, Glasgow, UK

ISSUE: The issue under debate will be whether biosimilars should undergo health technology assessment (HTA) and if they should, then what form this should take. The perspectives of a biosimilar manufacturer, prescriber and HTA body will be covered. OVERVIEW: Due to the reduced requirement for clinical evidence for regulatory approval, biosimilars can be priced lower than the originator brand and therefore have the potential to deliver significant cost savings. How payers value biosimilars is likely to differ across countries. Being cost-saving does not necessarily mean they will automatically be cost-effective, as biosimilars still have high price tags compared to many other medicines. For example in the UK, the infliximab biosimilars have been recently rejected by NICE for the treatment of moderate rheumatoid arthritis. HTA agencies already have different approaches to handling biosimilars; for example, within the UK, NICE only assesses biosimilars through multiple technology appraisals, whereas in Scotland biosimilars whose reference product is not recommended are assessed individually. Some countries, such as Poland, do not have a published process. The panelists will give their views on how biosimilars should be valued, whether they should undergo HTA and how this might differ across markets. If HTA is deemed necessary, then the panelists will expand on whether this is only in certain cases and when this should occur with respect to marketing authorisation. The experts will be challenged on whether appraising biosimilars is an effective use of public money and what data should be required by payers. Additionally the panelists will be asked how they think the patient and clinician perspective should be incorporated into decision making. The audience will get a chance to share their own views and pose their questions to the panel. There will be an audience vote on whether biosimilars should undergo HTA.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Code

IP7

Topic

Health Technology Assessment, Specialized Treatment Areas

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