Convergence yet Continued Complexity: A Systematic Review and Critique of Health Economic Models of Relapsing-Remitting Multiple Sclerosis in the United Kingdom

Allen, Felicity; Montgomery, Stephen; Maruszczak, M.; Kusel, J.; Adlard, Nicholas

doi:10.1016/j.jval.2015.05.006

Cited by 19 publications

(38 citation statements)

References 32 publications

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“…On the basis of title and abstract, 966 records were excluded and the remaining 57 records were included for full-text screening. A further 48 articles were excluded at the full-text stage, leaving nine systematic reviews, [245][246][247][248][249][250][251][252][253] of which eight were economic evaluation studies [245][246][247][248][249][250][251][252] and one was a systematic review of studies that used a generic tool to measure HRQoL in people with multiple sclerosis. 253 …”

Section: Resultsmentioning

confidence: 99%

“…First, most studies were unclear on whether study selection and data extraction were carried out in duplicate or did not carry out study selection and data extraction in duplicate. Second, although some authors [245][246][247][248][249][250][251]253 provided a list of included studies, not all of these authors 246,[248][249][250]253 provided a list of excluded studies. Third, it was unclear or not stated whether some authors assessed and/or documented the scientific quality of the included studies.…”

Section: Discussionmentioning

confidence: 99%

“…We identified several related systematic reviews of cost-effectiveness evaluations in RRMS in the overview of systematic reviews. [245][246][247][248][249][250][251][252][253] Therefore, we performed searches for primary cost-effectiveness studies from the earliest search date found in these selected reviews (i.e. 2012) to April 2016.…”

Section: Introductionmentioning

confidence: 99%

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Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Melendez‐Torres

Auguste

Armoiry

et al. 2017

Health Technol Assess

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Background At the time of publication of the most recent National Institute for Health and Care Excellence (NICE) guidance [technology appraisal (TA) 32] in 2002 on beta-interferon (IFN-β) and glatiramer acetate (GA) for multiple sclerosis, there was insufficient evidence of their clinical effectiveness and cost-effectiveness. Objectives To undertake (1) systematic reviews of the clinical effectiveness and cost-effectiveness of IFN-β and GA in relapsing–remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) and clinically isolated syndrome (CIS) compared with best supportive care (BSC) and each other, investigating annualised relapse rate (ARR) and time to disability progression confirmed at 3 months and 6 months and (2) cost-effectiveness assessments of disease-modifying therapies (DMTs) for CIS and RRMS compared with BSC and each other. Review methods Searches were undertaken in January and February 2016 in databases including The Cochrane Library, MEDLINE and the Science Citation Index. We limited some database searches to specific start dates based on previous, relevant systematic reviews. Two reviewers screened titles and abstracts with recourse to a third when needed. The Cochrane tool and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and Philips checklists were used for appraisal. Narrative synthesis and, when possible, random-effects meta-analysis and network meta-analysis (NMA) were performed. Cost-effectiveness analysis used published literature, findings from the Department of Health’s risk-sharing scheme (RSS) and expert opinion. A de novo economic model was built for CIS. The base case used updated RSS data, a NHS and Personal Social Services perspective, a 50-year time horizon, 2014/15 prices and a discount rate of 3.5%. Outcomes are reported as incremental cost-effectiveness ratios (ICERs). We undertook probabilistic sensitivity analysis. Results In total, 6420 publications were identified, of which 63 relating to 35 randomised controlled trials (RCTs) were included. In total, 86% had a high risk of bias. There was very little difference between drugs in reducing moderate or severe relapse rates in RRMS. All were beneficial compared with BSC, giving a pooled rate ratio of 0.65 [95% confidence interval (CI) 0.56 to 0.76] for ARR and a hazard ratio of 0.70 (95% CI, 0.55 to 0.87) for time to disability progression confirmed at 3 months. NMA suggested that 20 mg of GA given subcutaneously had the highest probability of being the best at reducing ARR. Three separate cost-effectiveness searches identified > 2500 publications, with 26 included studies informing the narrative synthesis and model inputs. In the base case using a modified RSS the mean incremental cost was £31,900 for pooled DMTs compared with BSC and the mean incremental quality-adjusted life-years (QALYs) were 0.943, giving an ICER of £33,800 per QALY gained for people with RRMS. In probabilistic sensitivity analysis the ICER was £34,000 per QALY gained. In sensitivity analysis, using the assessment group inputs gave an ICER of £12,800 per QALY gained for pooled DMTs compared with BSC. Pegylated IFN-β-1 (125 µg) was the most cost-effective option of the individual DMTs compared with BSC (ICER £7000 per QALY gained); GA (20 mg) was the most cost-effective treatment for CIS (ICER £16,500 per QALY gained). Limitations Although we built a de novo model for CIS that incorporated evidence from our systematic review of clinical effectiveness, our findings relied on a population diagnosed with CIS before implementation of the revised 2010 McDonald criteria. Conclusions DMTs were clinically effective for RRMS and CIS but cost-effective only for CIS. Both RCT evidence and RSS data are at high risk of bias. Research priorities include comparative studies with longer follow-up and systematic review and meta-synthesis of qualitative studies. Study registration This study is registered as PROSPERO CRD42016043278. Funding The National Institute for Health Research Health Technology Assessment programme.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Melendez‐Torres

Auguste

Armoiry

et al. 2017

Health Technol Assess

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“…For example, the general hybrid decision tree/Markov structure developed for the assessment of glycoprotein IIb/IIIA antagonists for the treatment of non-ST elevation acute coronary syndromes (ACS) developed by Palmer et al [12] (later cited in Briggs et al [1]) was subsequently used to inform appraisals of other products within the National Institute for Health and Care Excellence (NICE) Technology Appraisal Programme, including ticagrelor for the treatment of ACS [13] and bivalirudin for the treatment of ST-segment-elevation myocardial infarction [14]. Similarly, the School of Health and Related Research (ScHARR) Multiple Sclerosis (MS) Model [15], which was originally developed to inform NICE's appraisal of beta interferon and glatiramer acetate, despite various modifications and adaptations [16], is cited as the source of the general model structure used by the manufacturers of products in all subsequently completed NICE appraisals of disease-modifying therapies for MS [17][18][19][20][21]. A further example is the York Psoriasis Model: this model was initially developed within NICE Technology Appraisal 103 [22] and was explicitly adopted by the manufacturers in subsequent appraisals of infliximab [23], adalimumab [24], and ustekinemab [25].…”

Section: Levels Of Model Replicationmentioning

confidence: 99%

Replicating Health Economic Models: Firm Foundations or a House of Cards?

2017

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Health economic evaluation is a framework for the comparative analysis of the incremental health gains and costs associated with competing decision alternatives. The process of developing health economic models is usually complex, financially expensive and time consuming. For these reasons, model development is sometimes based on previous model-based analyses: this endeavour is usually referred to as model replication. Such model replication activity may involve the comprehensive reproduction of an existing model or "borrowing" all or part of a previously developed model structure. Generally speaking, the replication of an existing model may require substantially less effort than developing a new de novo model by bypassing, or undertaking in only a perfunctory manner, certain aspects of model development such as the development of a complete conceptual model and/or comprehensive literature searching for model parameters. A further motivation for model replication may be to draw on the credibility or prestige of previous analyses which have been published and/or used to inform decisionmaking. The acceptability and appropriateness of replicating models depends on the decision-making context: there exists a trade-off between the "savings" afforded by model replication and the potential "costs" associated with reduced model credibility due to the omission of certain stages of model development. This paper provides an overview of the different levels of, and motivations for, replicating health economic models, and discusses the advantages, disadvantages and caveats associated with this type of modelling activity. Irrespective of whether replicated models should be considered appropriate or not, complete replicability is generally accepted as a desirable property of health economic models, as reflected in critical appraisal checklists and good practice guidelines. To this end, the feasibility of comprehensive model replication is explored empirically across a small number of recent case studies.Recommendations are put forward for improving reporting standards to enhance comprehensive model replicability. Key points for decision makers Model replicability is generally perceived to be an indicator of the quality of published models. Model replication is associated with both advantages and disadvantages. Replication may be quicker and less expensive than developing a de novo model, however model authors should be aware that these "savings" may impact upon the credibility of the model. Our pilot study indicates that even amongst a very small sample of studies, the majority of the models considered could not be fully replicated.

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“…However, these studies can be biased by a significant recall error, or by more severe MS patients, being prompted in participating with their experiences. Furthermore, there is a considerable range in the estimates due to the heterogeneity in the methodology used for data collection, and in the selection of resource use . Nevertheless, other investigations focused on cost‐effectiveness of treatments for MS, but reported sparse and uncertain results .…”

Section: Introductionmentioning

confidence: 99%

Predictors of the 10-year direct costs for treating multiple sclerosis

et al. 2016

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Objectives. Disease Modifying Treatments (DMTs) constitute the largest direct medical cost for Multiple Sclerosis (MS). The present study aims at investigating predictors of the 10-year economic burden for DMT administration and management. Relapsing Remitting MS (RRMS) patients, followed up for 10.1±3.3 years. Costs for DMT administration and management were calculated, and referred to each year of observation (annual costs). Possible predictors of disease evolution were categorized into early predictors (age, gender, disease duration, baseline EDSS, 1-point EDSS progression within 2 years, and annualized relapse rate -ARR-within 2 years), and long-term predictors (reaching of EDSS 4.0, conversion to secondary progressive -SP-, ARR, number of DMTs, follow-up duration). Association between predictors and study outcome was explored using mixed effect log-linear regression models.Results. A 1-point higher EDSS at diagnosis was associated with 13.21% increase in the annual costs (95%CI=4.16-23.04%). Each additional year of age at diagnosis was associated with a 0.74% decrease in the annual costs (95%CI=-1.43--0.04%). Female gender was associated with a 12.43% decrease in the annual costs (95%CI=-22.61--0.93%). Converting to SP was associated with a 14.26% decrease in the annual costs (95%CI=-14.26--2.94%).Each additional year of follow-up was associated with a 3.05% decrease in the annual costs (95%CI=-4.51--1.57%).Conclusions. An estimate of the 10-year costs associated with DMT administration and management can be calculated by analysing different factors, and might be of particular interest for planning resources needed for treating people with MS.

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Convergence yet Continued Complexity: A Systematic Review and Critique of Health Economic Models of Relapsing-Remitting Multiple Sclerosis in the United Kingdom

Cited by 19 publications

References 32 publications

Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Clinical effectiveness and cost-effectiveness of beta-interferon and glatiramer acetate for treating multiple sclerosis: systematic review and economic evaluation

Replicating Health Economic Models: Firm Foundations or a House of Cards?

Predictors of the 10-year direct costs for treating multiple sclerosis

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