ORCID Profile
0000-0001-9988-2709
Current Organisation
University of York
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Publisher: Wiley
Date: 23-05-2018
Publisher: Springer Science and Business Media LLC
Date: 17-05-2023
DOI: 10.1007/S41669-023-00408-Z
Abstract: As part of the Single Technology Appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited Apellis Pharmaceuticals/Sobi to submit evidence for the clinical and cost effectiveness of pegcetacoplan versus eculizumab and pegcetacoplan versus ravulizumab for treating paroxysmal nocturnal haemoglobinuria (PNH) in adults whose anaemia is uncontrolled after treatment with a C5 inhibitor. The Liverpool Reviews and Implementation Group at the University of Liverpool was commissioned as the Evidence Review Group (ERG). The company pursued a low incremental cost-effectiveness ratio (ICER) Fast Track Appraisal (FTA). This was a form of STA processed in a shorter time frame and designed for technologies with company base-case ICER £10,000 per quality-adjusted life-year (QALY) gained and most plausible ICER £20,000 per QALY gained. This article summarises the ERG’s review of the company's evidence submission, and the NICE Appraisal Committee’s (AC’s) final decision. The company presented clinical evidence from the PEGASUS trial that assessed the efficacy of pegcetacoplan versus eculizumab. At Week 16, patients in the pegcetacoplan arm had statistically significantly greater change from baseline in haemoglobin levels and a higher rate of transfusion avoidance than patients in the eculizumab arm. Using the PEGASUS trial and Study 302 data (a non-inferiority trial that assessed ravulizumab versus eculizumab), the company conducted an anchored matching-adjusted indirect comparison (MAIC) to indirectly estimate the efficacy of pegcetacoplan versus ravulizumab. The company identified key differences between trial designs and populations that could not be adjusted for using anchored MAIC methods. The company and ERG agreed that the anchored MAIC results were not robust and should not inform decision making. In the absence of robust indirect estimates, the company assumed that ravulizumab had equivalent efficacy to eculizumab in the PEGASUS trial population. Results from the company base-case cost-effectiveness analysis showed that treatment with pegcetacoplan dominated eculizumab and ravulizumab. The ERG considered that the long-term effectiveness of pegcetacoplan was uncertain and ran a scenario assuming that after 1 year the efficacy of pegcetacoplan would be the same as eculizumab treatment with pegcetacoplan continued to dominate eculizumab and ravulizumab. The AC noted that treatment with pegcetacoplan had lower total costs than treatment with eculizumab or ravulizumab because it is self-administered and reduces the need for blood transfusions. If the assumption that ravulizumab has equivalent efficacy to eculizumab does not hold, then this will affect the estimate of the cost effectiveness of pegcetacoplan versus ravulizumab however, the AC was satisfied that the assumption was reasonable. The AC recommended pegcetacoplan as an option for the treatment of PNH in adults who have uncontrolled anaemia despite treatment with a stable dose of a C5 inhibitor for ≥ 3 months. Pegcetacoplan was the first technology recommended by NICE via the low ICER FTA process.
Publisher: Springer Science and Business Media LLC
Date: 25-06-2019
Publisher: Elsevier BV
Date: 02-2016
Abstract: Several studies have assessed the effects of food and nonalcoholic beverage (hereafter collectively referred to as food) advertising on food consumption, but the results of these studies have been mixed. This lack of clarity may be impeding policy action. We examined the evidence for a relation between acute exposure to experimental unhealthy food advertising and food consumption. The study was a systematic review and meta-analysis of published studies in which advertising exposure (television or Internet) was experimentally manipulated, and food intake was measured. Five electronic databases were searched for relevant publications (SCOPUS, PsycINFO, MEDLINE, Emerald Insight, and JSTOR). An inverse variance meta-analysis was used whereby the standardized mean difference (SMD) in food intake was calculated between unhealthy food advertising and control conditions. Twenty-two articles were eligible for inclusion. Data were available for 18 articles to be included in the meta-analysis (which provided 20 comparisons). With all available data included, the analysis indicated a small-to-moderate effect size for advertising on food consumption with participants eating more after exposure to food advertising than after control conditions (SMD: 0.37 95% CI: 0.09 0.65 I(2) = 98%). Subgroup analyses showed that the experiments with adult participants provided no evidence of an effect of advertising on intake (SMD: 0.00 P = 1.00 95% CI: -0.08, 0.08 I(2) = 8%), but a significant effect of moderate size was shown for children, whereby food advertising exposure was associated with greater food intake (SMD: 0.56 P = 0.003 95% CI: 0.18, 0.94 I(2) = 98%). Evidence to date shows that acute exposure to food advertising increases food intake in children but not in adults. These data support public health policy action that seeks to reduce children's exposure to unhealthy food advertising.
Publisher: Elsevier BV
Date: 07-2014
Abstract: Reductions in eating rate are recommended to prevent and treat obesity yet, the relation between eating rate and energy intake has not been systematically reviewed, with studies producing mixed results. Our main objective was to examine how experimentally manipulated differences in eating rate influence concurrent energy intake and subjective hunger ratings. We systematically reviewed studies that experimentally manipulated eating rate and measured concurrent food intake, self-reported hunger, or both. We combined effect estimates from studies by using inverse variance meta-analysis, calculating the standardized mean difference (SMD) in food intake between fast and slow eating rate conditions. Twenty-two studies were eligible for inclusion. Evidence indicated that a slower eating rate was associated with lower energy intake in comparison to a faster eating rate (random-effects SMD: 0.45 95% CI: 0.25, 0.65 P < 0.0001). Subgroup analysis indicated that the effect was consistent regardless of the type of manipulation used to alter eating rate, although there was a large amount of heterogeneity between studies. There was no significant relation between eating rate and hunger at the end of the meal or up to 3.5 h later. Evidence to date supports the notion that eating rate affects energy intake. Research is needed to identify effective interventions to reduce eating rate that can be adopted in everyday life to help limit excess consumption.
Publisher: Wiley
Date: 09-10-2015
Publisher: Wiley
Date: 09-02-2018
Publisher: Elsevier BV
Date: 03-2016
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Sarah Nevitt (Nolan).