Is the National Institute for Health and Care Excellence (NICE) in England more ‘innovation-friendly’ than the Federal Joint Committee (G-BA) in Germany?

Schaefer, R.; Schlander, Michael

doi:10.1080/14737167.2019.1559732

Cited by 5 publications

(5 citation statements)

References 37 publications

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“…Importantly, whereas the different HTA agencies request broadly similar evidence for their REAs, 31 they differ in the extent to which they take aspects, such as CEA, BIA, and unmet medical need into account 15,32–34 . Differences in the content and the processes of these assessments between agencies may explain discrepancies in reimbursement recommendation outcomes between them that have previously been reported 8,13,33–35 . In our current study, agency‐specific distributions of overall reimbursement recommendation outcomes indicate an association between a higher level of uncertainty and negative outcomes for HAS and ZIN, but not for NICE and SMC.…”

Section: Discussionmentioning

confidence: 56%

“…15,[32][33][34] Differences in the content and the processes of these assessments between agencies may explain discrepancies in reimbursement recommendation outcomes between them that have previously been reported. 8,13,[33][34][35] In our current study, agency-specific distributions of overall reimbursement recommendation outcomes indicate an association between a higher level of uncertainty and negative outcomes for HAS and ZIN, but not for NICE and SMC. A potential…”

Section: Accepted Articlementioning

confidence: 84%

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Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies

Bloem

Vreman

Peeters

et al. 2021

Clinical Translational Sci

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We aimed to determine whether uncertainties identified by the European Medicines Agency (EMA) were associated with negative relative effectiveness assessments (REA) and negative overall reimbursement recommendations by national health technology assessment (HTA) agencies. Therefore, we identified all HTA reports from HAS (France), NICE (England), SMC (Scotland) and ZIN (the Netherlands) for a cohort of innovative medicines that EMA had approved in 2009-2010 (excluding vaccines). Uncertainty regarding pivotal trial methodology, clinical outcomes and their clinical relevance were combined to reflect a low, medium or high level of uncertainty. We assessed associations by calculating risk ratios (RR) and 95% confidence intervals (CI), and agreement between REA and overall reimbursement recommendation outcomes. We identified 36 medicines for which 121 reimbursement recommendations had been issued by the HTA agencies between September 2009 and July 2018. High vs. low uncertainty was associated with an increased risk for negative REAs and negative overall reimbursement recommendations: RRs 1.9 (95% CI 0.9-3.9) and 1.6 (95% CI 0.7-3.5), respectively, which was supported by further sensitivity analyses. We identified a lack of agreement between 33 (27%) REA and overall reimbursement recommendation outcomes, which were mostly restricted recommendations that followed on negative REAs in case of low or medium uncertainty. In conclusion, high uncertainty identified by EMA was negatively associated with REAs and overall reimbursement recommendations. To reduce uncertainty and ultimately facilitate efficient patient access, regulators, HTA agencies and other stakeholders should discuss how uncertainties should be weighed and addressed early in the drug life cycle of innovative treatments.

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Section: Discussionmentioning

confidence: 56%

Section: Accepted Articlementioning

confidence: 84%

Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies

Bloem

Vreman

Peeters

et al. 2021

Clinical Translational Sci

View full text Add to dashboard Cite

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“…'s study of appraisals completed by December 2011 – the largest and most recent retrospective analysis of all NICE decisions – estimates that technologies costing £40,000/QALY have a 50% chance of recommendation, compared with 75% at £27,000/QALY and 25% at £52,000/QALY (Dakin et al ., 2015). Other studies similarly demonstrate a clear correlation between a technology's estimated cost-effectiveness and its likelihood of recommendation, with the average ICER of recommended technologies found to be substantially lower than that of technologies that are rejected, and the ICERs of technologies in which recommendation is restricted to a subgroup of patients typically coming somewhere between the two (Dakin et al ., 2006; Cerri et al ., 2014; Griffiths et al ., 2015; Schaefer and Schlander, 2018).…”

Section: Resultsmentioning

confidence: 99%

“…Given the implications of such decisions for those who contribute to and benefit from national health systems, centralised processes are often put in place to ensure that they are seen to be made fairly (Kenny and Joffres, 2008). In the UK, these fall under the remit of the National Institute for Health and Care Excellence (NICE), a public body which has come to be seen as a world-leader in health care priority-setting (Smith, 2004; Timmons et al ., 2016; Schaefer and Schlander, 2018; Littlejohns et al ., 2019; Catchpole and Barrett, 2020).…”

Section: Introductionmentioning

confidence: 99%

The normative grounds for NICE decision-making: a narrative cross-disciplinary review of empirical studies

Charlton

2022

HEPL

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The National Institute for Health and Care Excellence (NICE) is the UK's primary health care priority-setter, responsible for advising the National Health Service on its adoption of health technologies. The normative basis for NICE's advice has long been the subject of public and academic interest, but the existing literature does not include any comprehensive summary of the factors observed to have substantively shaped NICE's recommendations. The current review addresses this gap by bringing together 29 studies that have explored NICE decision-making from different disciplinary perspectives, using a range of quantitative and qualitative methods. It finds that although cost-effectiveness has historically played a central role in NICE decision-making, 10 other factors (uncertainty, budget impact, clinical need, innovation, rarity, age, cause of disease, wider societal impacts, stakeholder influence and process factors) are also demonstrably influential and interact with one another in ways that are not well understood. The review also highlights an over-representation in the literature of appraisals conducted prior to 2009, according to methods that have since been superseded. It suggests that this may present a misleading view of the importance of allocative efficiency to NICE's current approach and illustrates the need for further up-to-date research into the normative grounds for NICE's decisions.

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“…This evidence suggests that cancer patients may still face healthcare expenditures and, most notably, large income losses after their diagnosis, despite nearly full health insurance coverage of anti‐cancer treatments and medications as well as extensive social security programs in Germany 35 . By making use of one of the largest and most comprehensive household surveys in Germany, the present study seeks to provide evidence on the magnitude of the income loss side of financial hardship and to overcome shortcomings in previous research.…”

Section: Introductionmentioning

confidence: 99%

Income loss after a cancer diagnosis in Germany: An analysis based on the socio‐economic panel survey

Hernández

Schlander

2021

Cancer Medicine

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Background and Aims Cancer treatments often require intensive use of healthcare services and limit patients’ ability to work, potentially causing them to become financially vulnerable. The present study is the first attempt to measure, on the German national level, the magnitude of absolute income loss after a cancer diagnosis. Methods This study analyzes data from the Socio‐Economic Panel (SOEP) survey, one of the largest and most comprehensive household surveys in Germany, consisting of approximately 20,000 individuals, who are traced annually. The empirical strategy consists of ordinary least squares (OLS) and multinomial logistic estimators to measure changes in job income, work status, working hours, and pension as a result of reporting a cancer diagnosis for the period between 2009 and 2015. Sample consistency checks were conducted to limit measurement error biases. Results Our results show that job incomes dropped between 26% and 28% within the year a cancer diagnosis was reported. The effect persisted for two years after the diagnosis and was no longer observable after four years. The finding was linked to an increased likelihood of unemployment and a reduction of working hours by 24%. Pension levels, on the other hand, were not affected by a cancer diagnosis. Conclusions These findings suggest that many cancer patients are exposed to financial hardship in Germany, particularly when the cancer diagnosis occurs during their working age and before requirements to obtain a pension are met. Further research seems warranted to identify particularly vulnerable patient groups.

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Is the National Institute for Health and Care Excellence (NICE) in England more ‘innovation-friendly’ than the Federal Joint Committee (G-BA) in Germany?

Cited by 5 publications

References 37 publications

Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies

Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies

The normative grounds for NICE decision-making: a narrative cross-disciplinary review of empirical studies

Income loss after a cancer diagnosis in Germany: An analysis based on the socio‐economic panel survey

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