2016
DOI: 10.1007/s10198-016-0823-0
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Why do health technology assessment coverage recommendations for the same drugs differ across settings? Applying a mixed methods framework to systematically compare orphan drug decisions in four European countries

Abstract: PurposeHealth technology assessment (HTA) coverage recommendations differ across countries for the same drugs. Unlike previous studies, this study adopts a mixed methods research design to investigate, in a systematic manner, these differences.MethodsHTA recommendations for ten orphan drugs appraised in England (NICE), Scotland (SMC), Sweden (TLV) and France (HAS) (N = 35) were compared using a validated methodological framework that breaks down these complex decision processes into stages facilitating their u… Show more

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Cited by 63 publications
(104 citation statements)
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“…Consequently, differences in HTA recommendations have been the subject of extensive research. [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] Studies qualitatively assessing recommendations for groups of drugs in several HTA jurisdictions report that a series of sources contribute to observed differences. These sources can be roughly divided into two categories.…”
Section: Introductionmentioning
confidence: 99%
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“…Consequently, differences in HTA recommendations have been the subject of extensive research. [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] Studies qualitatively assessing recommendations for groups of drugs in several HTA jurisdictions report that a series of sources contribute to observed differences. These sources can be roughly divided into two categories.…”
Section: Introductionmentioning
confidence: 99%
“…First, there are inconsistencies in practices, involving the ability to implement patient access schemes, the ability to file resubmissions/reassessments and nonsubmissions, and the HTA approach applied (eg, inclusion or omission of cost-effectiveness). 7,9 These inconsistencies can be classified as practice differences because they relate to the different procedures, processes, laws, tactics, and other factors applicable in different jurisdictions. Second, even when jurisdictions apply the same practice (eg, a cost-effectiveness assessment [CEA]), there may still be differences in HTA outcomes, stemming from differences in the inclusion and evaluation of evidence, the impact of evidence on the final recommendation, and the integral leveraging of different types of evidence.…”
Section: Introductionmentioning
confidence: 99%
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“…Auch englische, schottische, schwedische und französische HTA berücksichtigen neben dem klinischen Nutzen den Schweregrad und den unbefriedigten medizinischen Bedarf [25]. Beides ist bei OD definitionsgemäß gegeben und erhöht deren Nutzwert.…”
Section: Gesellschaftlicher Nutzenunclassified
“…Die Praxis der Kostenübernahmen in Europa widerspricht dem [25], und die spezialisierten englischen und schottischen HTA-Systeme für UOD suchen derzeit nach Kompromissen auch unter Einbeziehung der Patienten und Angehörigen [26].…”
Section: Gesellschaftlicher Nutzenunclassified