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The United Kingdom multiple sclerosis risk-sharing scheme: final 10 year results
Author(s): ,
M. Duddy
Affiliations:
Department of Neurology, Newcastle upon Tyne Hospitals Trust, Newcastle upon Tyne
,
J. Palace
Affiliations:
Oxford University Hospitals Trust, Oxford
,
R. Lilford
Affiliations:
University of Warwick, Coventry, United Kingdom
,
T. Bregenzer
Affiliations:
PAREXEL International, Berlin, Germany
,
M. Lawton
Affiliations:
University of Bristol, Bristol, United Kingdom
,
F. Zhu
Affiliations:
University of British Columbia, Vancouver, BC, Canada
,
B. Piske
Affiliations:
PAREXEL International, Berlin, Germany
,
J. Oger
Affiliations:
University of British Columbia, Vancouver, BC, Canada
,
M. Boggild
Affiliations:
The Townsville Hospital, Townsville, QLD, Australia
,
N. Robertson
Affiliations:
Cardiff University, Cardiff
,
K. Tilling
Affiliations:
University of Bristol, Bristol, United Kingdom
,
H. Tremlett
Affiliations:
University of British Columbia, Vancouver, BC, Canada
,
Y. Ben-Shlomo
Affiliations:
University of Bristol, Bristol, United Kingdom
C. Dobson
Affiliations:
Department of Health of England, Leeds, United Kingdom
ECTRIMS Online Library. Duddy M. Sep 16, 2016; 147053
Martin Duddy
Martin Duddy
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Abstract: 211

Type: Oral

Background: In 2002, the UK´s National Institute of Clinical Excellence concluded that the multiple sclerosis (MS) disease modifying therapies (DMTs), β-interferon and glatiramer acetate, would only be cost-effective if the short term benefits seen in clinical trials were maintained over an extended period. The Risk-sharing Scheme (RSS) was established to assure cost-effective provision of these drugs in the UK. A cohort was recruited to track changes in disability and utility for 10 years following commencement of therapy. Drug prices were to be adjusted should the measured utility of the cohort deviate from a target course modelled from natural history data. Analysis at year 6 showed the drugs in aggregate to be meeting expectations for cost-effectiveness.

Methods: 5602 patients from 72 sites starting a DMT were enrolled with Expanded Disability Status Scale scores (EDSS) recorded annually. 4862 patients, with a mean EDSS of 3.4 (4217 with relapsing-remitting MS (RRMS) at baseline, mean EDSS 3.1), were eligible for the year 10 analysis.

Independent modelling of the anticipated untreated trajectory of the cohort was undertaken using both a continuous Markov and a multi-level model (MLM), employing natural history data from a subgroup of the British Columbia MS database. A 39% aggregate reduction in the loss of utility was found to be necessary to reach the pre-set long term cost-effectiveness target of £36k/QALY.

Results: There was good patient follow-up, with data for 9 years or more in 81.5% of those alive and resident in the UK. Data was analysed to compare the trajectory of the observed cohort against models of their course if untreated and their predicted course on treatment, assuming sustained efficacy of the DMTs over time. Results were derived for the full cohort (RRMS and secondary progressive at baseline) and for the subgroup with RRMS alone by both modelling methods.

A range of supplementary analyses were performed to establish the robustness of the results to assumptions made in the modelling process. Subgroup analyses explored the effect of disease duration, EDSS and gender.

Conclusions: This is the largest study to date measuring the effectiveness and cost-effectiveness of the MS DMTs. As an observational study, rather than a randomized controlled trial, the results must be treated with some caution, however, they do offer a measure of the extent to which DMTs may alter the natural history of MS in real life clinical practice.

Disclosure: MD has received speaker honoraria, consulting fees, and travel grants from, Bayer, Biogen Idec, Novartis UK Ltd, Merck Serono Ltd, Roche and Teva UK Ltd over the past 5 years. His NHS trust has received funding for his RSS clinical lead role

JP serves on the scientific advisory board for the Charcot Foundation, and has performed advisory work for Biogen Idec, Merck Serono Ltd, Bayer, Novartis UK Ltd, Teva UK Ltd, Ono Pharmaceutical Co Ltd, Primary i-research, Chugai Pharma Europe, and CI Consulting. She receives research support from the MS Society, QIDIS, Merck Serono Ltd, Novartis and Bayer, plus conference expenses from Novartis and Merck Serono Ltd. Her NHS trust has received funding for her RSS clinical lead role.

RL: nothing to disclose

TB is an employee of PAREXEL International (Department of Biostatistics) and in this role has worked for numerous pharmaceutical companies, including those participating in the UK MS Risk Sharing Scheme.

ML received funds from the Health Technology Assessment Programme to develop the

multilevel model with additional analysis time funded by RSS funders.

FZ: nothing to disclose

BP is an employee of PAREXEL International (Department of Biostatistics) and in this role has worked for numerous pharmaceutical companies, including those participating in the UK MS Risk Sharing Scheme.

JO has received, in the past 5 years, speaker honoraria, consulting fees, travel grants, research grants, or educational grants of less than CAD$5000 each from, Aspreva, Aventis, Bayer, Biogen Idec, BioMS, Berlex, Bristol-Myers Squibb, Genentech, GlaxoSmithKline, Novartis, Merck Serono, Schering, Talecris, and Teva Neurosciences, and has received fees for services from Bayer, Novartis, and Biogen Idec to serve on advisory committees.

MB sits on advisory boards for Bio CSL, Genzyme, and Biogen Idec. He has received sponsorship to attend international meetings from Novartis and BioCSL. His department has received funding to develop services from Biogen Idec, Genzyme, and Novartis. The Walton Centre, Liverpool, previously received funding for his RSS clinical lead role.

NPR has received support for attendance at scientifi c meetings and honoraria for advisory work from Biogen Idec, Merck Serono, Novartis, Sanofi , and Bayer, and has received unrestricted research grants from Genzyme.

KT has received funds from the Health TechnologyAssessment Programme to develop the multilevel model with additional analysis time funded by the RSS funders.

HT is funded by the Multiple Sclerosis Society of Canada (Don Paty Career Development Award), and is a Michael Smith Foundation for Health Research Scholar and the Canada Research Chair for Neuroepidemiology and Multiple Sclerosis. She has received research support from the National Multiple Sclerosis Society, the Canadian Institutes of Health Research, and the UK MS Trust; speaker honoraria or travel expenses to attend conferences from the Consortium of MS Centres (2013), the National MS Society (2012-14), Bayer Pharmaceuticals (2010), Teva Pharmaceuticals (2011), ECTRIMS (2011-13), UK MS Trust (2011), the Chesapeake Health Education Program, US Veterans Aff airs (2012), Novartis Canada (2012), Biogen Idec (2014), and the American Academy of Neurology (2013-14). All speaker honoraria were donated as an unrestricted grant for use by her research group.

YB-S"s department received funds from the Health Technology Assessment Programme to develop the multilevel model with additional analysis time funded by the RSS

funders. He has a relative who is on a disease-modifying therapy for multiple sclerosis.

CD is an employee of the Department of Health of England, which is one of the parties to the Risk Sharing Scheme. He declares no financial interests.



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