2017
DOI: 10.1016/j.jval.2017.08.410
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PROS In Oncology HTA Decisions, Do They Matter?

Abstract: Objectives: NICE of England and SMC of Scotland are responsible for issuing appraisal guidance for reimbursement of new health technologies. While both agencies consider clinical and cost-effectiveness in their decisions, they have unique policies and procedures and may yield different outcomes. We conducted an analysis of past appraisal decisions by NICE and SMC for oncology treatments to compare results and identify trends. MethOds: Oncology appraisal decisions from January 2012 to May 2017 were identified o… Show more

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Cited by 4 publications
(4 citation statements)
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“…The value of PROs data is already being recognized in reimbursement decisions, as demonstrated by a study in oncology HTA submissions between 2011-2016 in Germany, France and the UK. This study found that improvements in HRQoL led to higher benefit ratings by the G-BA and HAS and supported clinical benefit assigned by SMC and NICE despite a lack of OS data in some cases [17].…”
Section: Standalone Value Of Ores Beyond Ossupporting
confidence: 76%
“…The value of PROs data is already being recognized in reimbursement decisions, as demonstrated by a study in oncology HTA submissions between 2011-2016 in Germany, France and the UK. This study found that improvements in HRQoL led to higher benefit ratings by the G-BA and HAS and supported clinical benefit assigned by SMC and NICE despite a lack of OS data in some cases [17].…”
Section: Standalone Value Of Ores Beyond Ossupporting
confidence: 76%
“…These PRO claims were granted by the EMA for the only two available drugs for MDS, thus anticipating the EMA guidelines on the evaluation of anticancer medicinal treatments which recommended the consideration of PROMs in future trials due to the impact of MDS on HRQOL. Collecting PROs is slowly becoming a standard approach in oncology clinical studies, and such data are expected and valued by European Health Technology Assessment bodies . PRO data are also highly promoted by both the EMA and the US FDA.…”
Section: Discussionmentioning
confidence: 99%
“…According to an investigation about how inclusion of PRO evidence has evolved and influenced recommendations by HTA agencies (G-BA, HAS, NICE and SMC), 72% of the drug indication combinations included PRO data in one or more submissions. It shows that, however it is not yet a standard practice, HTA agencies tend to value the submission of PRO data and it can have a positive influence on recommendations ( 20 ).…”
Section: Introductionmentioning
confidence: 99%