Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Herzogenrath
Shaker
2012
|
| Ausgabe: | 1., Aufl. |
| Schriftenreihe: | Augsburger Schriften zum Arzneimittel- und Medizinprodukterecht
16 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Erscheint: 29. Juni 2012 |
| Beschreibung: | 111 S. 1 farb. Ill. 210 mm x 148 mm, 167 g |
| ISBN: | 9783844011036 |
Internformat
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Datensatz im Suchindex
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|---|---|
| adam_text | IMAGE 1
C O N T E N T III
C O N T E N T
CONTENT I L L
LIST OF FIGURES VI
LIST O F TABLES VI
LIST OF ABBREVIATIONS VII
PART I. INTRODUCTION 1
1 EUROPEAN REGULATION OF MEDICAL DEVICES 3
2 NATIONAL PROVISIONS IN GERMANY 5
2.1 GERMAN SOCIAL SECURITY CODE (SGB) 5
2.1.1 RELEVANT RULES 6
2.1.2 N O REGULATION OF COST EFFECTIVENESS OF MEDICAL DEVICES 7
2.2 G E R M A N MEDICAL DEVICES LAW (MPG) 7
2.3 IQWIG GUIDANCE 8
3 NATIONAL PROVISIONS IN ENGLAND / WALES 9
3.1 PRECEDENT IN ENGLISH L A W 9
3.2 STATUTORY L A W (ACTS OF PARLIAMENT) 9
3.3 SECONDARY LEGISLATION 11
3.3.1 IMPLICATIONS FOR CLINICAL PRACTICE 13
3.3.2 FUNDING TECHNOLOGY APPRAISAL GUIDANCE 14
3.4 QUASI-LAW 15
3.5 S U M M A R Y 16
4 TERMINOLOGY 19
4.1 DEFINITION OF MEDICAL DEVICES 19
4.2 MEDICINAL PRODUCTS A N D MEDICAL DEVICES 19
5 STRUCTURE OF BOTH HEALTH CARE SYSTEMS 21
5.1 NATIONAL HEALTH SYSTEM IN ENGLAND 21
5.1.1 STRUCTURE 21
5.1.2 PRIMARY CARE 21
HTTP://D-NB.INFO/102301341X
IMAGE 2
IV
C O N T E N T
5.1.3 SECONDARY CARE 22
5.2 NATIONAL HEALTH SYSTEM IN GERMANY 23
5.3 MAJOR PLAYERS 23
5.3.1 N H S AUTHORITIES A N D TRUSTS 24
5.3.2 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE) 27
5.3.3 FEDERAL JOINT COMMITTE (G-BA) 31
5.3.4 INSTITUT FIIR QUALITATSSICHERUNG U N D WIRTSCHAFTLICHKEIT IM
GESUNDHEITSWESEN (IQWIG) 32
6 N E W DEVELOPMENTS: WHITE PAPER 2010 35
PART II. ECONOMIC VALUATION OF MEDICAL DEVICES 37
7 WHAT MAKES MEDICAL DEVICES SPECIAL 39
8 NICE S TECHNOLOGY APPRAISAL 41
8.1 APPRAISAL PROCESS 42
8.2 ECONOMICAL METHOD: COST UTILITY ANALYSIS 43
8.2.1 QALY 43
8.2.2 NICE S COST EFFECTIVENESS THRESHOLD 45
8.3 APPEALS 48
9 EVALUATION PATHWAY PROGRAMME FOR MEDICAL DEVICES 49
9.1 SELECTING MEDICAL TECHNOLOGIES 49
9.2 ROUTING OF SELECTED TECHNOLOGIES FOR EVALUATION 50
9.3 DEVELOPING MEDICAL TECHNOLOGIES GUIDANCE 51
9.3.1 SCOPE 52
9.3.2 THE MANUFACTURER S SUBMISSION 55
9.3.3 CONTRIBUTIONS FROM EXPERT ADVISERS 56
9.3.4 PATIENT ADVISERS 57
9.4 ASSESSMENT 57
9.4.1 EVIDENCE SYNTHESIS 57
9.4.2 INDIRECT A N D INTERMEDIATE CLINICAL A N D SYSTEM OUTCOMES 58
9.4.3 MODELLING OF COST CONSEQUENCES 58
9.5 EVALUATION OF THE EVIDENCE A N D DECISION-MAKING 60
9.6 CASE S T U D Y 61
9.6.1 W H Y DEVELOPING GUIDANCE O N SEQUENT PLEASE 61
9.6.2 DESCRIPTION OF THE TECHNOLOGY A N D REGULATORY STATUS 62
IMAGE 3
C O N T E N T V
9.6.3 ASSESSMENT REPORT 63
9.7 RESULT 69
10 IQWIG S EFFICIENCY FRONTIER 71
10.1 CONCEPT 71
10.2 DESIGNING THE EFFICIENCY FRONTIER 73
10.3 RATIONALE A N D RECOMMENDATIONS 74
10.4 USING EFFICIENCY FRONTIER CONCEPT FOR MEDICAL DEVICES 75
10.4.1 T W O STEPS APPROACH 76
10.4.2 N O EXPERIENCE W I T H THE EFFICIENCY FRONTIER 76
10.4.3 THRESHOLD 77
10.4.4 EXCLUSION OF QUALYS 77
10.4.5 PERSPECTIVE OF COSTS 78
10.4.6 TIMEFRAME OF COST ESTIMATION 79
PART III. LEGAL ANALYSIS 81
11 THE FAIRNESS PROBLEM: REFUSAL O F TREATMENT 83
11.1 NATIONAL PROVISIONS 83
11.2 INTERNATIONAL/EUROPEAN PROVISIONS 86
12 TECHNOLOGY APPRAISAL: THE EISAI CASE 89
12.1 FACTS 89
12.2 PROCEDURAL FAIRNESS 90
12.3 LEVEL OF DISCLOSURE 91
12.4 CONFIDENTIALITY 92
PART IV. SUMMARY 95
BIBLIOGRAPHY 97
|
| any_adam_object | 1 |
| author | Grinblat, Roman |
| author_facet | Grinblat, Roman |
| author_role | aut |
| author_sort | Grinblat, Roman |
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| building | Verbundindex |
| bvnumber | BV040451802 |
| ctrlnum | (DE-599)DNB102301341X |
| dewey-full | 344.4304233 344.4104233 |
| dewey-hundreds | 300 - Social sciences |
| dewey-ones | 344 - Labor, social, education & cultural law |
| dewey-raw | 344.4304233 344.4104233 |
| dewey-search | 344.4304233 344.4104233 |
| dewey-sort | 3344.4304233 |
| dewey-tens | 340 - Law |
| discipline | Rechtswissenschaft |
| edition | 1., Aufl. |
| format | Book |
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| id | DE-604.BV040451802 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T00:24:13Z |
| institution | BVB |
| isbn | 9783844011036 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-025299438 |
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| physical | 111 S. 1 farb. Ill. 210 mm x 148 mm, 167 g |
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| series2 | Augsburger Schriften zum Arzneimittel- und Medizinprodukterecht |
| spelling | Grinblat, Roman Verfasser aut Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics Roman Grinblat 1., Aufl. Herzogenrath Shaker 2012 111 S. 1 farb. Ill. 210 mm x 148 mm, 167 g txt rdacontent n rdamedia nc rdacarrier Augsburger Schriften zum Arzneimittel- und Medizinprodukterecht 16 Erscheint: 29. Juni 2012 Kosten-Nutzen-Analyse (DE-588)4032589-1 gnd rswk-swf Rechtsvergleich (DE-588)4115712-6 gnd rswk-swf Medizinprodukt (DE-588)4024018-6 gnd rswk-swf Deutschland (DE-588)4011882-4 gnd rswk-swf Großbritannien (DE-588)4022153-2 gnd rswk-swf Deutschland (DE-588)4011882-4 g Großbritannien (DE-588)4022153-2 g Medizinprodukt (DE-588)4024018-6 s Kosten-Nutzen-Analyse (DE-588)4032589-1 s Rechtsvergleich (DE-588)4115712-6 s DE-604 DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=025299438&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Grinblat, Roman Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics Kosten-Nutzen-Analyse (DE-588)4032589-1 gnd Rechtsvergleich (DE-588)4115712-6 gnd Medizinprodukt (DE-588)4024018-6 gnd |
| subject_GND | (DE-588)4032589-1 (DE-588)4115712-6 (DE-588)4024018-6 (DE-588)4011882-4 (DE-588)4022153-2 |
| title | Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics |
| title_auth | Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics |
| title_exact_search | Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics |
| title_full | Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics Roman Grinblat |
| title_fullStr | Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics Roman Grinblat |
| title_full_unstemmed | Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics Roman Grinblat |
| title_short | Economic evaluation of medical devices. A comparative analysis between the German and British system considering law and economics |
| title_sort | economic evaluation of medical devices a comparative analysis between the german and british system considering law and economics |
| topic | Kosten-Nutzen-Analyse (DE-588)4032589-1 gnd Rechtsvergleich (DE-588)4115712-6 gnd Medizinprodukt (DE-588)4024018-6 gnd |
| topic_facet | Kosten-Nutzen-Analyse Rechtsvergleich Medizinprodukt Deutschland Großbritannien |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=025299438&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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