Health-related quality of life improved in people with multiple sclerosis who had clinically meaningful changes in walking ability with PR-Fampridine: Post hoc analysis of enhance

Hobart, Jeremy; Hupperts, Raymond; Linnebank, Michael; Acosta, C; McNeill, Manjit; Lima, Gabriel Paiva da Silva

doi:10.1016/j.jns.2017.08.3486

Cited by 2 publications

(11 citation statements)

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“…The utility data from the combined trials was used in scenario analyses that also led to a decrease of the ICER to 46,359 kr/QALY. Utility values for BSC and Fampridine responders show a numerical difference at baseline, even if patients were evenly distributed on most of the baseline clinical characteristics in ENHANCE 28 . A scenario analysis was conducted to investigate the impact of such a difference in baseline utility values and resulted in an ICER of 163,202 kr/QALY.…”

Section: Discussionmentioning

confidence: 96%

“…It has previously been demonstrated in a cross-sectional, patient record-based study in five European countries, that patients with greater walking impairment used significantly The 5-level classification system of the EQ-5D (EQ-5D-5L) was used in MOBILE 17 whereas the 3-level EQ-5D (EQ-5D-3L) was used in ENHANCE 28 . To pool these data sets, the "crosswalk" method, developed by the EuroQol Group, was used to map the EQ-5D-5L data to the EQ-5D-3L UK value set before calculating the utility index score 31 .…”

Section: Discussionmentioning

confidence: 99%

“…The 3-level version of EQ-5D (no problems, some problems, or unable to/extreme problems) might not be sensitive enough to detect the impact of walking changes on utility given that PR-fampridine is restricted to patients with baseline mobility impairment. In ENHANCE, 82% of PR-fampridine responders reported no change in mobility as measured by EQ-5D-3L from baseline to Week 24 28 . A greater improvement was observed in MOBILE, likely due to the more sensitive 5-level questionnaire (no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems) 29 .…”

Section: Utility Datamentioning

confidence: 95%

“…In the base-case analysis, health state utilities were derived from EuroQoL-5 Dimensions-3 Level (EQ-5D-3L) values from the ENHANCE study (Table 3), given that ENHANCE was the largest and longest phase III randomized trial of PR-fampridine 28 . The 3-level version of EQ-5D (no problems, some problems, or unable to/extreme problems) might not be sensitive enough to detect the impact of walking changes on utility given that PR-fampridine is restricted to patients with baseline mobility impairment.…”

Section: Utility Datamentioning

confidence: 99%

“…Furthermore, a conservative scenario analysis was conducted in which the utility gains observed in the BSC group were applied to the Responder baseline utility (Table 3), to explore the impact of the numerical difference in ENHANCE baseline utilities between treatment arms. The resulting utilities were then applied to the BSC arm 28,29 .…”

Section: Utility Datamentioning

confidence: 99%

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Modeling the cost-effectiveness of prolonged-release fampridine for the treatment of walking impairment in patients with multiple sclerosis in Sweden

Acosta

Gianinazzi

Dort

et al. 2021

Journal of Medical Economics

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Aims: To evaluate the cost-effectiveness of adding prolonged-release (PR)-fampridine to best supportive care (BSC) versus BSC alone for the improvement of walking ability in patients with MS. Methods: A cost-utility analysis based on a Markov model was developed to model responders and timed 25-foot walk (T25FW) scores, accumulated costs, and quality-adjusted life-years (QALY) in adults with MS and Expanded Disability Status Scale (EDSS) scores between 4 and 7. The analysis was conducted from a Swedish societal perspective. Results: In the base-case analysis, PR-fampridine plus BSC led to a higher QALY gain than BSC alone. The largest direct cost was professional care provision followed by hospital inpatient stays while the indirect cost was the loss of earnings due to days off work. The incremental cost-effectiveness ratio (ICER) for PR-fampridine plus BSC compared with BSC alone was 57,109 Swedish Kronor (kr)/QALY (e5,607/QALY [1 kr ¼ e0.0981762 on

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Section: Utility Datamentioning

confidence: 95%

Section: Utility Datamentioning

confidence: 99%

Section: Utility Datamentioning

confidence: 99%

See 3 more Smart Citations

Modeling the cost-effectiveness of prolonged-release fampridine for the treatment of walking impairment in patients with multiple sclerosis in Sweden

Acosta

Gianinazzi

Dort

et al. 2021

Journal of Medical Economics

View full text Add to dashboard Cite

show abstract

Efficacy of prolonged-release fampridine versus placebo on walking ability, dynamic and static balance, physical impact of multiple sclerosis, and quality of life: an integrated analysis of MOBILE and ENHANCE

Hupperts

Gasperini

Lycke

et al. 2022

Ther Adv Neurol Disord

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Background: MOBILE and ENHANCE were similarly designed randomized trials of walking-impaired adults with relapsing-remitting or progressive multiple sclerosis (MS) who received placebo or 10 mg prolonged-release (PR)-fampridine twice daily for 24 weeks. Both studies showed sustained and clinically meaningful improvement in broad measures of walking and balance over 24 weeks of PR-fampridine treatment. Objective: To evaluate the functional benefits and safety of PR-fampridine versus placebo using a post hoc integrated efficacy analysis of MOBILE and ENHANCE data. Methods: Data from the intention-to-treat (ITT) populations of MOBILE and ENHANCE studies were pooled in a post hoc analysis based on the following outcome measures: 12-item MS Walking Scale (MSWS-12), Timed Up and Go (TUG) speed, Berg Balance Scale (BBS), MS Impact Scale physical impact subscale (MSIS-29 PHYS), EQ-5D utility index score, visual analogue scale (VAS), and adverse events. The primary analysis was the proportion of people with MS (PwMS) with a mean improvement in MSWS-12 score (⩾8 points) from baseline over 24 weeks. A subgroup analysis based on baseline characteristics was performed. Findings: In the ITT population ( N = 765; PR-fampridine, n = 383; placebo, n = 382), a greater proportion of PR-fampridine–treated PwMS than placebo-treated PwMS achieved a clinically meaningful improvement in the MSWS-12 scale over 24 weeks (44.3% versus 33.0%; p < 0.001). PR-fampridine MSWS-12 responders demonstrated greater improvements from baseline in TUG speed, BBS score, MSIS-29 PHYS score, and EQ-5D utility index and VAS scores versus PR-fampridine MSWS-12 nonresponders and placebo. Subgroup analyses based on baseline characteristics showed consistency in the effects of PR-fampridine. Conclusion: The pooled analysis of MOBILE and ENHANCE confirms previous evidence that treatment with PR-fampridine results in clinically meaningful improvements in walking, mobility and balance, self-reported physical impact of MS, and quality of life and is effective across a broad range of PwMS.

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Health-related quality of life improved in people with multiple sclerosis who had clinically meaningful changes in walking ability with PR-Fampridine: Post hoc analysis of enhance

Cited by 2 publications

References 0 publications

Modeling the cost-effectiveness of prolonged-release fampridine for the treatment of walking impairment in patients with multiple sclerosis in Sweden

Modeling the cost-effectiveness of prolonged-release fampridine for the treatment of walking impairment in patients with multiple sclerosis in Sweden

Efficacy of prolonged-release fampridine versus placebo on walking ability, dynamic and static balance, physical impact of multiple sclerosis, and quality of life: an integrated analysis of MOBILE and ENHANCE

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