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The legally binding text is the original French version TRANSPARENCY COMMITTEE APPENDIX Re-assessment of methylphenidate-based proprietary medicinal products in attention-deficit hyperactivity disorder in response to a request from the Directorate-General for Health OPINION 3 October 2012 Proprietary medicinal products concerned: ▪ 10 mg, tablet RITALINE RITALINE LP 10 mg, 20 mg, 30 mg, 40 mg, capsule ▪ ▪ LP 18 mg, 36 mg, 54 mg, tablet CONCERTA ▪ LP 10 mg, 20 mg, 30 mg, capsule QUASYM MethylphenidateATC Code: N06BA04 (psychostimulants and nootropics) Narcotic. Prescription restricted to 28 days. Prescription on form meeting the requirements laid down in the decree of 31 March 1999. Initial annual hospital prescription restricted to neurology, psychiatry and paediatric specialists and/or specialist services.
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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................... 2BACKGROUND AND INTRODUCTION .......................................................................................... 3I.SUBJECT OF THE REQUEST ....................................................................................... 4II.DESCRIPTION OF THE PRODUCTS CONCERNED..................................................... 4II.I.ATC classification ........................................................................................................ 4II.II.Medicines in the same therapeutic category ................................................................ 4LITERATURE SEARCHES.............................................................................................................. 6CLINICAL DATA ............................................................................................................................. 7I.NICE META-ANALYSIS, 2009........................................................................................ 7II.MTA STUDY ................................................................................................................... 8III.ADVERSE EFFECTS ..................................................................................................... 9III.I. 9Main adverse effects ....................................................................................................III.II.Re-evaluation by the European Medicines Agency (EMA) ........................................... 9III.III. 13 ..............................................................................Measures implemented by ANSMIV.ABUSE AND DEPENDENCE ....................................................................................... 14V.Conclusion .................................................................................................................... 15USAGE DATA ............................................................................................................................... 17
I.DATA FROM THE BROAD SAMPLE OF HEALTH INSURANCE BENEFICIARIES (EGB) ................................................................................................................................. 17I.I.Number of people refundable for methylphenidate in 2011 ........................................ 17I.II.ANSM analysis of patient characteristics between 2006 and 2009............................. 17II.DATA FROM THE IMS DATABASE ............................................................................. 18TRANSPARENCY COMMITTEE CONCLUSIONS ........................................................................ 19I.RE-EVALUATION OF ACTUAL BENEFIT .................................................................... 19II.Transparency Committee recommendations................................................................. 20APPENDICES................................................................................................................................ 21