A comparative analysis of coverage decisions for outpatient pharmaceuticals: Evidence from Denmark, Norway and Sweden

Grepstad, Mari; Kanavos, Panos

doi:10.1016/j.healthpol.2014.12.013

Cited by 11 publications

(8 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The analysis also showed that HTAB views among the subset of participating HTABs are not as fragmented as might have been considered, given the differing HTA appraisals and reimbursement decisions across EU Member States [11][12][13]. It also confirmed the findings of a recent study produced by the European Parliament, exploring how relative effectiveness assessments are conducted in different Member States, which discovered that the underlying principles are not fundamentally incompatible and share the same goals and concepts [14].…”

Section: Discussionsupporting

confidence: 73%

How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice

Tafuri

Pagnini²,

Moseley³

et al. 2016

Brit J Clinical Pharma

View full text Add to dashboard Cite

BackgroundIn 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development plans for medicines.AimsThe present retrospective qualitative analysis aimed to explore how the parallel scientific advice system is working and levels of commonality between the EU regulators and HTABs, and among HTABs, when applicants obtain parallel scientific advice from both a regulatory and an HTA perspective.MethodsWe analysed the minutes of discussion meetings held at the EMA between 2010, when parallel advice was launched, and 1 May 2015, when the cutoff date for data extraction was set. The analysis was based on predefined criteria and conducted at two different levels of comparison: the answers of the HTABs vs. those of the regulators, and between the answers of the participating HTA agencies.ResultsThe analysis was based on 31 procedures of parallel scientific advice. The level of full agreements was highest for questions on patient population (77%), while disagreements reached a peak for questions on the study comparator (30%). With regard to comparisons among HTABs, there was a high level of agreement for all domains.ConclusionsThere is evident commonality, in terms of evidence requirements between the EU regulators and participating HTABs, as well as among HTABs, on most aspects of clinical development. Indeed, regardless of the question content, the analysis showed that a high level of overall agreement was reached through the process of parallel scientific advice.

show abstract

Section: Discussionsupporting

confidence: 73%

How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice

Tafuri

Pagnini²,

Moseley³

et al. 2016

Brit J Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…In the literature, one can find comparative analyses, i.e. describing a number of different national models [indicatively [1][2][3][4], descriptive and comparative studies analysing reimbursement decisions [5][6][7][8][9][10][11][12][13] and empirical analyses on HTA decisions [14][15][16][17][18].…”

Section: Introductionmentioning

confidence: 99%

Disagreement on cancer drug decisions in Europe

Maynou

Cairns

2020

Int J Technol Assess Health Care

View full text Add to dashboard Cite

ObjectivesDespite the efforts of the European Union (EU) to promote voluntary cooperation among Health Technology Assessment (HTA) agencies, different reimbursement decisions for the same drug are made across European countries. The aim of this paper is to compare the agreement of cancer drug reimbursement decisions using inter-rater reliability measures.MethodsThis study is based on primary data on 161 cancer drug reimbursement decisions from nine European countries from 2002 to 2014. To achieve our goal, we use two measures to analyze agreement, in other words, congruency: (i) percentage of agreement and (ii) the κ score.ResultsOne main conclusion can be drawn from the analysis. There is a weak to medium agreement among cancer drug decisions in the European countries analyzed (based on the percentage of agreement and the κ score). England and Scotland show the highest consistency between the two measures, showing a medium agreement. These results are in line with previous literature on the congruency of HTA decisions.ConclusionsThis paper contributes to the HTA literature, by highlighting the extent of weak to medium agreement among cancer decisions in Europe.

show abstract

“…Various comparative analyses have been recently published describing a number of different national models [indicatively 2 -10]. Moreover, a number of descriptive and comparative studies have specifically analysed reimbursement decisions [1,[11][12][13][14][15][16][17][18][19][20][21][22]. However, few empirical analyses exist and they mainly focus on the UK or include few observations [23][24][25][26][27][28][29].…”

Section: Introductionmentioning

confidence: 99%

What is driving HTA decision-making? Evidence from cancer drug reimbursement decisions from 6 European countries

Maynou

Cairns

2019

Health Policy

View full text Add to dashboard Cite

This research was funded under the European 7th Framework Programme with Advance-HTA (nº 305983). The results presented reflect the author's views. The EC is not liable for any use of the information communicated. Acknowledgements This paper was developed within the research project funded by the European Commission's Research Framework Programme (FP7), Advance-HTA (nº 305983). The authors would like to thank the Advance-HTA Consortium members and the experts from the National HTA Agencies for their support on the data collection process. Moreover, the authors appreciate the good feedback received in the different conferences where the WP1 research has been presented (HESG, EvaluAES, AES, HTAi, iHEA, internal seminars at LSHTM and CRES, UPF). We would also like to thank Prof. Marc Saez. We would like to thank the comments of two anonymous reviewers of a previous version of this work who, without doubt, helped us to improve our work.

show abstract

A comparative analysis of coverage decisions for outpatient pharmaceuticals: Evidence from Denmark, Norway and Sweden

Cited by 11 publications

References 18 publications

How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice

How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice

Disagreement on cancer drug decisions in Europe

What is driving HTA decision-making? Evidence from cancer drug reimbursement decisions from 6 European countries

Contact Info

Product

Resources

About