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A comparative study of European rare disease and orphan drug markets / Alain Denis in Health Policy, 97(2010)2-3 ([10/01/2010])
[article] A comparative study of European rare disease and orphan drug markets [printed text] / Alain Denis, Author ; Lut Mergaert, Author ; Christel Fostier, Author ; Irina Cleemput , Author ; Simoens, Steven, Author . - 2010 . - p. 173-179.
Languages : English (eng)
in Health Policy > 97(2010)2-3 [10/01/2010] . - p. 173-179
Descriptors: Classification
W 1 Serials. Periodicals
Indexation
Cost Control ; Drug and Narcotic Control ; Drug Costs ; Europe ; Fees, Pharmaceutical ; Health Policy ; Insurance, Health, Reimbursement ; Journal Article ; legislation and jurisprudence ; Marketing ; Orphan Drug Production ; Peer ReviewAbstract: OBJECTIVES: This article aims to compare regulatory aspects of rare disease and orphan drug markets in Belgium, France, Italy, the Netherlands, Sweden and the United Kingdom. METHODS: Information was derived from the international literature, analysis of legal texts, and a survey completed by national experts. RESULTS: These countries adopted varying approaches towards regulating rare disease and orphan drug markets and, hence, the availability, pricing and reimbursement of orphan drugs vary between countries. Strategies to keep down prices include public procurement in Sweden, profit controls in the United Kingdom, and price comparisons with other countries. To gain reimbursement, the cost-effectiveness and/or budget impact of orphan drugs is considered in some countries. Other societal considerations, such as whether the drug treats a life-threatening disease, are sometimes taken into account. CONCLUSIONS: Extensive government intervention exists in rare disease and orphan drug markets in the countries studied. Our recommendations are to define priorities for research on rare diseases and orphan drugs at the European level, to set up disease and patient registries with a view to investigating the long-term effectiveness and cost-effectiveness of orphan drugs, to assess the profitability of orphan drugs, and to take into account societal considerations when evaluating orphan drugs. Link for e-copy: https://doi.org/10.1016/j.healthpol.2010.05.017 Format of e-copy: PDF [Requires Subscription] Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4095 [article]Construction d’un index médical pour les contrats privés d’assurance maladie. / Pierre Devolder / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2008)
Construction d’un index médical pour les contrats privés d’assurance maladie. [printed text] / Pierre Devolder, Author ; Michel Denuit, Author ; Xavier Maréchal, Author ; Benoît-Laurent Yerna, Author ; Jean-Pierre Closon, Author ; Christian Léonard , Author ; Arnaud Senn ; Imgard Vinck . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2008 . - viii, 58 p. : ill. ; 30 cm.. - (KCE Reports B. Health Services Research (HSR); 96B) .
ISSN : D/2008/10.273/83 : 0 €
Etude n° 2008-58
Languages : French (fre)
Descriptors: Classification
W 100 Medical, Dental, and Pharmaceutical Service Plans -- General works
Indexation
2008-58 ; Cost Control ; Economic Competition ; Insurance, Health ; Price Indexes ; Price Regulation ; R96Link for e-copy: http://doi.org/10.57598/R95B Format of e-copy: .PDF (681 KB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1403 Copies(0)
Status No copy Het opstellen van een medische index voor private ziekteverzekerings-overeenkomsten / Pierre Devolder / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2008)
Copies(0)
Status No copy How to improve the Belgian process for Managed Entry Agreements? / Sophie Gerkens / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2017)
How to improve the Belgian process for Managed Entry Agreements? : An analysis of the Belgian and international experience [printed text] / Sophie Gerkens , Author ; Mattias Neyt , Author ; Lorena San Miguel , Author ; Imgard Vinck , Author ; Nancy Thiry, Author ; Irina Cleemput , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2017 . - 69 p. : ill., ; A4. - (KCE Reports. Health Services Research (HSR); 288) .
ISSN : D/2017/10.273/41 : € 0,00
Study 2015-13
Languages : English (eng)
Descriptors: Indexation
2015-13 ; Antineoplastic Agents ; Cost Control ; Data Collection ; Insurance, Health, Reimbursement ; Insurance, Pharmaceutical Services ; Public contracts ; R288
Classification
W 265 Pharmaceutical insuranceContents note: LIST OF FIGURES 3 -- LIST OF TABLES .3 -- LIST OF ABBREVIATIONS 4 -- SCIENTIFIC REPORT .6 -- 1 INTRODUCTION 6 -- 1.1 BACKGROUND 6 -- 1.2 STUDY OBJECTIVES AND RESEARCH QUESTIONS 7 -- 1.3 A DIFFICULT PROCESS DUE TO DATA CONFIDENTIALITY AND THREAT OF LEGAL PROCEEDINGS .7 -- 1.4 A RAPID LOOK AT THE EXISTING TAXONOMY 8 -- 2 A REVIEW OF THE LITERATURE ON MANAGED ENTRY AGREEMENTS: WHAT CAN BE LEARNED FROM THE CURRENT EUROPEAN EXPERIENCE? 11 -- 2.1 INTRODUCTION .11 -- 2.2 METHODS 11 -- 2.3 RESULTS 16 -- 2.3.1 Strengths of MEAs 16 -- 2.3.2 Weaknesses/Challenges of MEAs 18 -- 2.3.3 What products should be the target of MEAs 24 -- 2.3.4 Evaluation process for MEAs .24 -- 2.3.5 Checklists for evaluating the need for a MEA or the impact of an already established MEA 30 -- 2.4 LIMITATIONS 33 -- 3 DESCRIPTION OF THE LEGISLATION 34 -- 3.1 INTRODUCTION .34 -- 3.2 METHOD .34 -- 3.3 MARKET AUTHORIZATION, PRICING AND REIMBURSEMENT IN BELGIUM (FOR BOTH OUTPATIENTS AND INPATIENTS PHARMACEUTICALS) 34 -- 3.3.1 Market authorization 34 -- 3.3.2 Price setting 34 -- 3.3.3 The reimbursement procedure 35 -- 3.3.4 Specificities of orphan drugs 39 -- 3.4 EVOLUTION OF THE LEGISLATION ON MEA IN BELGIUM .40 -- 3.4.1 Situation from January 2010 until July 2014 41 -- 3.4.2 Situation from July 2014 41 -- 3.4.3 The negotiation process 42 -- 3.4.4 The convention 43 -- 3.4.5 Process at the end of the convention .43 -- 3.5 NO REGULATION OF MEAS IN A EUROPEAN CONTEXT 44 -- 4 ANALYSIS OF THE BELGIAN PROCESS FOR MEA: WHAT LESSONS CAN BE LEARNED FROM THE BELGIAN EXPERIENCE? 45 -- 4.1 INTRODUCTION .45 -- 4.2 METHOD .45 -- 4.3 RESULTS 47 -- 4.3.1 Description of the convention procedure .47 -- 4.3.2 The evaluation by the CTG-CRM .51 -- 4.3.3 Analysis of approved conventions 53 -- 4.3.4 Analysis of expired conventions 58 -- 4.3.5 Impact on the health care budget for pharmaceuticals .60 -- 5 STAKEHOLDER CONSULTATION .61 -- APPENDIX .62 -- REFERENCES .64 Link for e-copy: https://doi.org/10.57598/R288C Format of e-copy: PDF (868 Kb) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4182 How to improve the Belgian process for Managed Entry Agreements? / Sophie Gerkens / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2017)
How to improve the Belgian process for Managed Entry Agreements? : - Short report [printed text] / Sophie Gerkens , Author ; Mattias Neyt , Author ; Lorena San Miguel , Author ; Imgard Vinck , Author ; Nancy Thiry, Author ; Irina Cleemput , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2017 . - 33 p. : ill., ; A4. - (KCE Reports. Health Services Research (HSR); 288Cs) .
ISSN : D/2017/10.273/40 : € 0,00
Study 2015-13
Languages : English (eng)
Descriptors: Indexation
2015-13 ; Antineoplastic Agents ; Cost Control ; Data Collection ; Insurance, Health, Reimbursement ; Insurance, Pharmaceutical Services ; Public contracts ; R288
Classification
W 265 Pharmaceutical insuranceContents note: SHORT REPORT 1 -- 1. INTRODUCTION 2 -- 1.1. BACKGROUND 2 -- 1.2. A RAPID LOOK AT THE EXISTING TAXONOMY 3 -- 2. (SUGGESTIONS TO IMPROVE) THE DIFFERENT STAGES OF THE PROCESS 6 -- 2.1. HORIZON SCANNING 6 -- 2.2. THE CTG-CRM PROCEDURE 6 -- 2.2.1. CTG-CRM submission files .6 -- 2.2.2. The evaluation reports of the CTG-CRM 7 -- 2.3. THE CONVENTION PROCESS 11 -- 2.3.1. Composition of the working group 11 -- 2.3.2. Criteria to qualify for a convention procedure 12 -- 2.3.3. Identification of products under convention 13 -- 2.4. THE CONVENTIONS CHARACTERISTICS 14 -- 2.4.1. The type of convention 14 -- 2.4.2. A link with the uncertainty / problem identified by the CTG-CRM 16 -- 2.4.3. The convention duration and the new evaluation process 28 -- 2.4.4. Impact on the health care budget for pharmaceuticals 29 -- 3. CONCLUSION 30 -- REFERENCES 32 Link for e-copy: https://doi.org/10.57598/R288CS Format of e-copy: PDF (536 Kb) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4183 Pistes om het Belgische systeem van artikel 81 overeenkomsten te verbeteren / Sophie Gerkens / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2017)
PermalinkPistes pour améliorer le système belge de conventions article 81 / Sophie Gerkens / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2017)
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