Enhancing the utilisation of generic clopidogrel: implications for future efficiency meetings
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Date
2012
Authors
Godman, B.
Baumgaertel, C.
Skiold, P.
Bishop, I.
Abuelkhair, M.
Burkhardt, T.
Furst, J.
Teixeira, I.
Vitry, A.
Voncina, L.
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Conference item
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9th HTAi Annual Meeting: HTA in Integrated Care for a Patient Centered System, 2012, pp.230-230
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9th HTAi Annual Meeting (23 Jun 2012 - 27 Jun 2012 : Bilbao, Spain)
Abstract
Background: Countries must learn from each other to maximise efficiency from generics. However, savings reduced if originators challenge entry and use. Clopidogrel provides a good case history as initial generics a different salt with fewer indications and high expenditure ($10bn globally in 2010 prior to patent loss).
Objectives: (a) Appraise activities of authorities to licencing, reimbursing and encouraging utilisation of generic clopidogrel; (b)Compare countries to provide future guidance
Methods: Feedback from payers across Europe, Middle East and Australia. Period from 2006 (when first generic clopidogrel preparations available) to 2011.
Results: Considerable variation: (a) Generic clopidogrel reimbursed for all indications in Croatia with reference pricing (molecule); (b)Abu Dhabi – compulsory INN prescribing including clopidogrel (similar in Lithuania); (c) Austria - authorities stated no efficacy or safety problems with different salts and indications; prescribing restrictions eased for generic clopidogrel; (d) Initial confusion in France – with some advocating prescribing originator whilst others INN; now resolved with substitution target of 75%; (e) Portugal - first generic clopidogrel approved in April 2009, reimbursed from December 2009; however some formulations challenged by originator leading to withdrawals; (f) Scotland - generic prescribing endorsed as perceived limited risks; (g) Spain - activities ongoing in regions to address prescribing of originator including scientific publications and presentations; (h) Sweden - mandatory substitution agreed prior to generics. In contrast, originator challenged generics in Norway and Slovenia, e.g. in Slovenia, generic available from June 2006-June 2008.Subsequently, removed as patent problems but reimbursed from May2010. Considerable differences already exist in reimbursed prices.
Conclusions: Considerable variation in availability, utilisation and pricing of generic clopidogrel across countries. Activities thwarted by physicians and/or originator in some countries limiting savings.Countries already learning from each other to enhance future efficiency including measures to further lower generic prices and accelerate disinvestment
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Copyright 2012 SESPAS. Published by Elsevier