Cost-utility of fingolimod compared with dimethyl fumarate in highly active relapsing-remitting multiple sclerosis (RRMS) in England

Maruszczak, M.; Montgomery, Stephen; Griffiths, Matt; Bergvall, Niklas; Adlard, Nicholas

doi:10.3111/13696998.2015.1056794

Cited by 22 publications

(45 citation statements)

References 29 publications

(28 reference statements)

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“…These were calculated from AE rates derived from clinical trials of the treatments included in the submission. Disutilities for AEs were obtained from the study by Maruszczak et al,287 from the manufacturers' submissions to NICE for 119 and from the Summary of Product Characteristics for 44 µg of SC IFN-β-1a three times weekly (Rebif).…”

Section: Adverse Event Disutilitiesmentioning

confidence: 99%

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: Adverse Event Disutilitiesmentioning

confidence: 99%

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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“…The physical and psycho-emotional sequelae result not in endurance and resilience but rather in pain, financial burden, and other significant impacts on lifestyle ( Osterberg and Boivie, 2010 ; Arewasikporn et al., 2018 ; Ferraro et al., 2018 ; Young et al., 2017 ; Marck et al., 2017 ; Hakansson et al., 2019 ; Kratz et al., 2017 ; Amtmann et al., 2015 ; Benson and Kerr, 2014 ; Pinkston et al., 2007 ; Pinkston and Alekseeva, 2006 ; Shahrbanian et al., 2013 ; Kratz et al., 2017 , 2017 ; Harding et al., 2019 ). Typically, standard of care therapies for neurological disorders focus only on primary (physical/motor) symptoms, when it is actually the non-physical effects that have the greatest impact on quality of life ( Zivadinov et al., 2016 ; Tornatore et al., 2016 ; Kappos et al., 2015 ; Harel et al., 2018 ; Bovis et al., 2019 ; Sormani et al., 2019 ; Mattioli et al., 2014 ; Maruszczak et al., 2015 ). As such, there has recently been a concerted effort to better characterize the neuropsychological aspects of MS ( Benedict et al., 2017 ; Isernia et al., 2019 ; Migliore et al., 2019 ; Macias Islas and Ciampi, 2019 ; Di Stefano et al., 2019 ; Scherder et al., 2017 , 2018 ; Khan et al., 2018 ), including pain and cognitive, psychological, and social deficits, and to redefine them as essential aspects of MS pathology ( Arewasikporn et al., 2018 ; Ferraro et al., 2018 ; Young et al., 2017 ; Marck et al., 2017 ; Hakansson et al., 2019 ; Kratz et al., 2017 ; Kratz et al., 2017 , 2017 ; Newland et al., 2016 ; Benedict et al., 2017 ; Isernia et al., 2019 ; Chalah and Ayache, 2017 ; Lex et al., 2018 ).…”

Section: Discussionmentioning

confidence: 99%

Strain and sex differences in somatosensation and sociability during experimental autoimmune encephalomyelitis

Ondek

Nasirishargh

Dayton

et al. 2021

Brain, Behavior, & Immunity - Health

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Multiple Sclerosis (MS) is an immune-mediated disease that results in major locomotor deficits. However, recent studies have revealed that fatigue, slow processing speed, and memory impairment are the top variables impacting employment status for MS patients. These suggest that cognitive effects may have a greater impact on productivity, lifestyle, and quality of life than do disease-related motor deficits. However, these debilitating non-locomotive effects have been largely overlooked in rodent models of the disease, such as experimental autoimmune encephalomyelitis (EAE). We hypothesized that murine EAE can also be used to assess non-locomotive dysfunctions (mood, sociability, muscle strength, and balance), as well as potential biases in these dysfunctions due to sex and/or strain. We actively immunized male and female C57BL/6 (B6) and SJL mice for EAE and evaluated their performance on the Deacon's weight grip test, Kondziela's inverted screen test, Hall's rope grip test, manual von Frey test for somatic nociception, and a three-chamber social preference paradigm. We hypothesized that EAE progression is associated with changes in muscle strength, balance, pain, and sociability and that these variations are linked to sex and/or strain. Our results indicate that strain but not sex influenced differences in muscle strength and balance during EAE, and both sex and strain have an impact on mechanical nociception, regardless of EAE disease status. Furthermore, both sex and strain had complex effects on differences in sociability. In conclusion, testing these additional modalities during EAE helps to unveil other signs and symptoms that could be used to determine the efficacy of a drug or treatment in the modulation of a MS-like behavior.

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“…Patients may experience difficulty in identifying their disease course, 80 and PPMS patients have on average a higher age of disease onset than RRMS and SPMS patients. 81 Although a number of model-based economic evaluations included populations with similar mean ages at onset based on study samples from pivotal DMD studies, ranging from 36 to 38 years, 29 , 32 , 82 – 85 some other studies included populations with mean ages of 29 40 or 33 32 years. Sensitivity analyses show that with lower ages of mean onset, shared decision making becomes more cost-effective, reducing the ICER with 17% (€3064) per QALY in comparison with the base case analysis.…”

Section: Discussionmentioning

confidence: 99%

“…We adapted a state transition model developed by the Institute for Clinical and Economic Review, an independent and nonpartisan research institute, in the United States. 28 The model evaluated the cost-effectiveness of a range of DMDs for MS. 28 The model structure and inputs, based on various other models, [29][30][31][32][33][34][35] have previously been validated through rounds of public comments, cross-validation with other models, and sensitivity analyses. 28 We modified the model to assess the cost-effectiveness of implementing shared decision making regarding DMDs choice and estimated the potential societal costs, QALYs, and incremental cost-effectiveness using a Dutch perspective and following clinical practice and guidelines for economic evaluations in health care.…”

Section: Methodsmentioning

confidence: 99%

Exploring the Cost Effectiveness of Shared Decision Making for Choosing between Disease-Modifying Drugs for Relapsing-Remitting Multiple Sclerosis in the Netherlands: A State Transition Model

et al. 2020

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Background Up to 31% of patients with relapsing-remitting multiple sclerosis (RRMS) discontinue treatment with disease-modifying drug (DMD) within the first year, and of the patients who do continue, about 40% are nonadherent. Shared decision making may decrease nonadherence and discontinuation rates, but evidence in the context of RRMS is limited. Shared decision making may, however, come at additional costs. This study aimed to explore the potential cost-effectiveness of shared decision making for RRMS in comparison with usual care, from a (limited) societal perspective over a lifetime. Methods An exploratory economic evaluation was conducted by adapting a previously developed state transition model that evaluates the cost-effectiveness of a range of DMDs for RRMS in comparison with the best supportive care. Three potential effects of shared decision making were explored: 1) a change in the initial DMD chosen, 2) a decrease in the patient’s discontinuation in using the DMD, and 3) an increase in adherence to the DMD. One-way and probabilistic sensitivity analyses of a scenario that combined the 3 effects were conducted. Results Each effect separately and the 3 effects combined resulted in higher quality-adjusted life years (QALYs) and costs due to the increased utilization of DMD. A decrease in discontinuation of DMDs influenced the incremental cost-effectiveness ratio (ICER) most. The combined scenario resulted in an ICER of €17,875 per QALY gained. The ICER was sensitive to changes in several parameters. Conclusion This study suggests that shared decision making for DMDs could potentially be cost-effective, especially if shared decision making would help to decrease treatment discontinuation. Our results, however, may depend on the assumed effects on treatment choice, persistence, and adherence, which are actually largely unknown.

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Cost-utility of fingolimod compared with dimethyl fumarate in highly active relapsing-remitting multiple sclerosis (RRMS) in England

Cited by 22 publications

References 29 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

Strain and sex differences in somatosensation and sociability during experimental autoimmune encephalomyelitis

Exploring the Cost Effectiveness of Shared Decision Making for Choosing between Disease-Modifying Drugs for Relapsing-Remitting Multiple Sclerosis in the Netherlands: A State Transition Model

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