Variation in Health Technology Assessment and Reimbursement Processes in Europe

Akehurst, R; Abadie, Eric; Renaudin, Noël; Sarkozy, François

doi:10.1016/j.jval.2016.08.725

Cited by 97 publications

(101 citation statements)

References 9 publications

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“…To compare and evaluate HTA practices, many studies exist that investigate HTA recommendations for groups of medicines. [2][3][4][5][6][7][8][9][10][11] They differ in the extent to which they include practice-related factors as explanatory for differences between HTA jurisdictions. Based on our results, it is recommended to take a systematic approach to investigating practice differences between HTA jurisdictions.…”

Section: Discussionmentioning

confidence: 99%

“…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%

“…Differences in the timing of recommendations have also been established among and within countries. 11 Studies including multivariable analyses have tried to specify the relative importance of these factors on HTA recommendations. The importance of factors depends, however, on the jurisdiction(s) assessed and the variables added to the model.…”

Section: Introductionmentioning

confidence: 99%

“…A study assessing the importance of criteria to decision makers in multiple countries has quantified some of these differences, showing that criteria (eg, cost-effectiveness) may be valued extremely high in some jurisdictions but deemed irrelevant in others. 11 The HTA practices resulting from these values thus diverge. For example, in England/Wales and Scotland, most overall recommendations include CEAs and price negotiations.…”

Section: Introductionmentioning

confidence: 99%

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Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations

et al. 2020

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Background: Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or procedures, which are known as HTA practices. Objective: To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs. Methods: HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; costeffectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests. Results: The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P,.01) and Scotland (from 21% to 71%, P,.01). The subsequent inclusion of price negotiations led to significant reductions in the proportion of negative recommendations in England/ Wales (from 50% to 14%, P,.01), France (from 31% to 3%, P=.012), and Germany (from 34% to 0%, P,.01). Results indicated that the inclusion of nonsubmissions and resubmissions might affect Scottish negative HTA recommendations (from 7% to 21%), but this effect was not significant. No significant effects were observed in the Netherlands, possibly owing to sample size. Conclusion: Variations in HTA practices between international jurisdictions can have a substantial and significant impact on conclusions about recommendations by HTA bodies, as exemplified in this cohort of conditionally approved products. Studies comparing international HTA recommendations should carefully consider possible practice variations between jurisdictions.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations

et al. 2020

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“…Other studies analysing the time to reimbursement of drugs have been carried out in various other jurisdictions. Some of these studies have focused on time to reimbursement of cancer drugs specifically, whereas others analysed the timelines of all submissions submitted over a certain time period [9][10][11][12][13][14]. However, the HTA framework and timelines vary greatly between countries.…”

Section: The Hta Processmentioning

confidence: 99%

Health Technology Assessment of Drugs in Ireland: An Analysis of Timelines

Connolly

O'Donnell

Lamrock

et al. 2019

PharmacoEconomics Open

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Background The National Centre for Pharmacoeconomics (NCPE) is commissioned by the Corporate Pharmaceutical Unit of the Health Service Executive (HSE-CPU) to assess the evidence for the comparative effectiveness and cost effectiveness of drugs for use by patients in Ireland. All new drugs are required to undergo rapid review (RR) appraisal by the NCPE. Following this, high-cost drugs or those predicted to have a significant budget impact then undergo a full health technology assessment (HTA) appraisal by the NCPE. Objective The objective of this paper was to quantify each stage of the timeline from marketing authorisation (MA) to completion of HTA appraisal and explore the association between submission features and the time to appraise RRs and HTAs. Methods All RRs and HTAs submitted to the NCPE (2015-2017 inclusive) were included in the dataset. Several dates and features of each submission were also listed for the purpose of analysis. Results A total of 158 RR and 49 HTA appraisals were completed by the NCPE between 2015 and 2017. The median time from MA to submission of RR was 59 days; the median time to appraise RR was 31.5 days. Only 49% of RRs appraised (2015-2017 inclusive) were recommended for HTA. The median time from RR decision to submission of HTA was 115 days, and the median time taken by the NCPE to appraise an HTA was 131 days. Conclusion This paper identifies which stages of the process make a substantial contribution to the HTA timeline. Time to submission of RR varied widely between submissions, with only a few companies choosing to submit prior to an MA being granted. The average RR appraisal time was in line with the 4-week timeframe set out in a 2016 agreement. The time to appraise an HTA was longer than the 90-day timeframe.

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Nordic treatment guidelines for rare epileptic conditions: A literature review

2022

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Introduction:The onset of severe, drug-resistant seizures in early childhood is characteristic of the rare epileptic disorders Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and CDKL5 deficiency disorder (CDD) and is frequently observed in the rare genetic conditions tuberous sclerosis complex (TSC) and Rett syndrome (RTT).High-quality treatment guidelines are needed for optimal management of these conditions. This review aimed to assess content, availability, and development of treatment guidelines for these disorders in the Nordics region (Denmark, Finland, Iceland, Norway, and Sweden).Methods: A targeted literature review (TLR) was therefore conducted in November/December 2020 by manually searching online rare disease and guideline databases in addition to relevant health technology assessment and regulatory agency websites to identify pharmacological treatment guidelines for DS, LGS, TSC, RTT, and CDD. Search terms for each disorder were translated to identify country-specific guidelines. Treatment recommendations, geographical focus, and guideline development methodology was extracted into a predetermined extraction grid.Results: Most of the 24 eligible guidelines identified (16/24; 66%) were specific to particular countries; Sweden was the most represented (7/24 [29%] guidelines), while no guidelines were identified for Iceland. Guideline development methodologies were heterogeneous, including systematic literature reviews/TLRs and expert consultation; several methodologies did not report details on the evidence sources used (7/24[29%] guidelines). Treatment recommendation availability was variable across disorders, ranging from 126 treatment recommendations (LGS) to none (RTT, CDD). Conclusion:Comprehensive, consensus-based treatment guidance developed via international collaboration within the Nordics region is necessary to optimize patient care in these five rare epileptic conditions.

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Variation in Health Technology Assessment and Reimbursement Processes in Europe

Cited by 97 publications

References 9 publications

Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations

Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations

Health Technology Assessment of Drugs in Ireland: An Analysis of Timelines

Nordic treatment guidelines for rare epileptic conditions: A literature review

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