What lessons can be learned from the launch of generic clopidogrel

Christoph Baumgartel, Brian Godman, Agnes Vitry, Anne M. Ringerud, Catherine Sermet, Corrine Zara, Hanna Koskinen, Harald Herholz, Marion Bennie

Research output: Contribution to journalArticle

Abstract

Resource pressures will continue to grow. Consequently, health authorities and health insurance agencies need to take full advantage of the availability of generics in order to continue funding comprehensive health care particularly in Europe. Generic clopidogrel provides such an opportunity in view of appreciable worldwide sales of the originator. However, early formulations contained different salts and only limited indications. Consequently, there is a need to assess responses by the authorities to the early availability of generic clopidogrel including potential reasons preventing them from taking full advantage of the situation. In addition, it is necessary to determine the extent of initial price reductions obtained in practice to guide future activities.
Feedback from health authorities and health insurance personnel involved with the reforms surrounding generic clopidogrel was principally used to assess authority responses as there is limited information in the public domain. Abu Dhabi has been included as a representative of the Middle East since it has introduced compulsory international non-proprietary name (INN) prescribing except for limited situations. Generic clopidogrel is not one of these – providing direction to other health authorities alongside, e.g. Lithuania. Australia has also been included in view of the high court ruling in favour of generic clopidogrel.
Authorities from across Australia, Europe and the Middle East typically adopted a pragmatic approach to the availability of generic clopidogrel to enhance its prescribing and dispensing once approved by regulatory agencies such as EMA. This included guidance to enhance its utilisation such as academic publications, co-payment incentives and compulsory INN prescribing. However, this was not always possible with challenges to the availability of generics in some countries. Again, there was appreciable variation in the initial price reductions for generic clopidogrel versus the originator.
Authorities can take full advantage of the early availability of generics despite different formulations and indications. Pharmaceutical companies need to accept this in order to help fund new premium price products as resource pressures grow.
Original languageEnglish
Pages (from-to)58-68
Number of pages11
JournalGenerics and Biosimilars Initiative journal
Volume1
Issue number2
DOIs
Publication statusPublished - 2012

Fingerprint

clopidogrel
Availability
Health insurance
Middle East
Health
Health Insurance
Names
Comprehensive Health Care
United Arab Emirates
Lithuania
Pressure
Public Sector
Financial Management
Health care
Health Personnel
Publications
Motivation
Sales

Keywords

  • clopidogrel
  • demand measures
  • pharmaceutical pricing

Cite this

Baumgartel, Christoph ; Godman, Brian ; Vitry, Agnes ; Ringerud, Anne M. ; Sermet, Catherine ; Zara, Corrine ; Koskinen, Hanna ; Herholz, Harald ; Bennie, Marion. / What lessons can be learned from the launch of generic clopidogrel. In: Generics and Biosimilars Initiative journal. 2012 ; Vol. 1, No. 2. pp. 58-68.
@article{69b16ff1710541e78dd35e48bd3359b1,
title = "What lessons can be learned from the launch of generic clopidogrel",
abstract = "Resource pressures will continue to grow. Consequently, health authorities and health insurance agencies need to take full advantage of the availability of generics in order to continue funding comprehensive health care particularly in Europe. Generic clopidogrel provides such an opportunity in view of appreciable worldwide sales of the originator. However, early formulations contained different salts and only limited indications. Consequently, there is a need to assess responses by the authorities to the early availability of generic clopidogrel including potential reasons preventing them from taking full advantage of the situation. In addition, it is necessary to determine the extent of initial price reductions obtained in practice to guide future activities.Feedback from health authorities and health insurance personnel involved with the reforms surrounding generic clopidogrel was principally used to assess authority responses as there is limited information in the public domain. Abu Dhabi has been included as a representative of the Middle East since it has introduced compulsory international non-proprietary name (INN) prescribing except for limited situations. Generic clopidogrel is not one of these – providing direction to other health authorities alongside, e.g. Lithuania. Australia has also been included in view of the high court ruling in favour of generic clopidogrel.Authorities from across Australia, Europe and the Middle East typically adopted a pragmatic approach to the availability of generic clopidogrel to enhance its prescribing and dispensing once approved by regulatory agencies such as EMA. This included guidance to enhance its utilisation such as academic publications, co-payment incentives and compulsory INN prescribing. However, this was not always possible with challenges to the availability of generics in some countries. Again, there was appreciable variation in the initial price reductions for generic clopidogrel versus the originator.Authorities can take full advantage of the early availability of generics despite different formulations and indications. Pharmaceutical companies need to accept this in order to help fund new premium price products as resource pressures grow.",
keywords = "clopidogrel, demand measures, pharmaceutical pricing",
author = "Christoph Baumgartel and Brian Godman and Agnes Vitry and Ringerud, {Anne M.} and Catherine Sermet and Corrine Zara and Hanna Koskinen and Harald Herholz and Marion Bennie",
note = "Strathprints' policy is to record up to 8 authors per publication, plus any additional authors based at the University of Strathclyde. More authors may be listed on the official publication than appear in the Strathprints' record.",
year = "2012",
doi = "10.5639/gabij.2012.0102.016",
language = "English",
volume = "1",
pages = "58--68",
journal = "Generics and Biosimilars Initiative journal",
issn = "2033-6403",
number = "2",

}

Baumgartel, C, Godman, B, Vitry, A, Ringerud, AM, Sermet, C, Zara, C, Koskinen, H, Herholz, H & Bennie, M 2012, 'What lessons can be learned from the launch of generic clopidogrel', Generics and Biosimilars Initiative journal, vol. 1, no. 2, pp. 58-68. https://doi.org/10.5639/gabij.2012.0102.016

What lessons can be learned from the launch of generic clopidogrel. / Baumgartel, Christoph; Godman, Brian; Vitry, Agnes ; Ringerud, Anne M.; Sermet, Catherine; Zara, Corrine; Koskinen, Hanna; Herholz, Harald; Bennie, Marion.

In: Generics and Biosimilars Initiative journal, Vol. 1, No. 2, 2012, p. 58-68.

Research output: Contribution to journalArticle

TY - JOUR

T1 - What lessons can be learned from the launch of generic clopidogrel

AU - Baumgartel, Christoph

AU - Godman, Brian

AU - Vitry, Agnes

AU - Ringerud, Anne M.

AU - Sermet, Catherine

AU - Zara, Corrine

AU - Koskinen, Hanna

AU - Herholz, Harald

AU - Bennie, Marion

N1 - Strathprints' policy is to record up to 8 authors per publication, plus any additional authors based at the University of Strathclyde. More authors may be listed on the official publication than appear in the Strathprints' record.

PY - 2012

Y1 - 2012

N2 - Resource pressures will continue to grow. Consequently, health authorities and health insurance agencies need to take full advantage of the availability of generics in order to continue funding comprehensive health care particularly in Europe. Generic clopidogrel provides such an opportunity in view of appreciable worldwide sales of the originator. However, early formulations contained different salts and only limited indications. Consequently, there is a need to assess responses by the authorities to the early availability of generic clopidogrel including potential reasons preventing them from taking full advantage of the situation. In addition, it is necessary to determine the extent of initial price reductions obtained in practice to guide future activities.Feedback from health authorities and health insurance personnel involved with the reforms surrounding generic clopidogrel was principally used to assess authority responses as there is limited information in the public domain. Abu Dhabi has been included as a representative of the Middle East since it has introduced compulsory international non-proprietary name (INN) prescribing except for limited situations. Generic clopidogrel is not one of these – providing direction to other health authorities alongside, e.g. Lithuania. Australia has also been included in view of the high court ruling in favour of generic clopidogrel.Authorities from across Australia, Europe and the Middle East typically adopted a pragmatic approach to the availability of generic clopidogrel to enhance its prescribing and dispensing once approved by regulatory agencies such as EMA. This included guidance to enhance its utilisation such as academic publications, co-payment incentives and compulsory INN prescribing. However, this was not always possible with challenges to the availability of generics in some countries. Again, there was appreciable variation in the initial price reductions for generic clopidogrel versus the originator.Authorities can take full advantage of the early availability of generics despite different formulations and indications. Pharmaceutical companies need to accept this in order to help fund new premium price products as resource pressures grow.

AB - Resource pressures will continue to grow. Consequently, health authorities and health insurance agencies need to take full advantage of the availability of generics in order to continue funding comprehensive health care particularly in Europe. Generic clopidogrel provides such an opportunity in view of appreciable worldwide sales of the originator. However, early formulations contained different salts and only limited indications. Consequently, there is a need to assess responses by the authorities to the early availability of generic clopidogrel including potential reasons preventing them from taking full advantage of the situation. In addition, it is necessary to determine the extent of initial price reductions obtained in practice to guide future activities.Feedback from health authorities and health insurance personnel involved with the reforms surrounding generic clopidogrel was principally used to assess authority responses as there is limited information in the public domain. Abu Dhabi has been included as a representative of the Middle East since it has introduced compulsory international non-proprietary name (INN) prescribing except for limited situations. Generic clopidogrel is not one of these – providing direction to other health authorities alongside, e.g. Lithuania. Australia has also been included in view of the high court ruling in favour of generic clopidogrel.Authorities from across Australia, Europe and the Middle East typically adopted a pragmatic approach to the availability of generic clopidogrel to enhance its prescribing and dispensing once approved by regulatory agencies such as EMA. This included guidance to enhance its utilisation such as academic publications, co-payment incentives and compulsory INN prescribing. However, this was not always possible with challenges to the availability of generics in some countries. Again, there was appreciable variation in the initial price reductions for generic clopidogrel versus the originator.Authorities can take full advantage of the early availability of generics despite different formulations and indications. Pharmaceutical companies need to accept this in order to help fund new premium price products as resource pressures grow.

KW - clopidogrel

KW - demand measures

KW - pharmaceutical pricing

U2 - 10.5639/gabij.2012.0102.016

DO - 10.5639/gabij.2012.0102.016

M3 - Article

VL - 1

SP - 58

EP - 68

JO - Generics and Biosimilars Initiative journal

JF - Generics and Biosimilars Initiative journal

SN - 2033-6403

IS - 2

ER -