Open Access Research article

The Multiple Sclerosis Risk Sharing Scheme Monitoring Study – early results and lessons for the future

Mark Pickin1*, Cindy L Cooper1, Timothy Chater1, Anthony O'Hagan2, Keith R Abrams3, Nicola J Cooper3, Mike Boggild4, Jackie Palace5, George Ebers5, James B Chilcott6, Paul Tappenden6 and Jon Nicholl1

Author Affiliations

1 Medical Care Research Unit, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK

2 Department of Probability and Statistics, University of Sheffield, The Hicks Building, Hounsfield Road, Sheffield, S3 7RH, UK

3 Department of Health Sciences, University of Leicester, Adrian Building, University Road, Leicester, LE1 7RH, UK

4 The Walton Centre, Liverpool, L9 7LJ, UK

5 University of Oxford Department of Clinical Neurology, Level 3, West Wing, John Radcliffe Hospital, Oxford, OX3 9DU, UK

6 Health Economics and Decision Science Section, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK

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BMC Neurology 2009, 9:1  doi:10.1186/1471-2377-9-1

Published: 6 January 2009

Abstract

Background

Risk sharing schemes represent an innovative and important approach to the problems of rationing and achieving cost-effectiveness in high cost or controversial health interventions. This study aimed to assess the feasibility of risk sharing schemes, looking at long term clinical outcomes, to determine the price at which high cost treatments would be acceptable to the NHS.

Methods

This case study of the first NHS risk sharing scheme, a long term prospective cohort study of beta interferon and glatiramer acetate in multiple sclerosis (MS) patients in 71 specialist MS centres in UK NHS hospitals, recruited adults with relapsing forms of MS, meeting Association of British Neurologists (ABN) criteria for disease modifying therapy. Outcome measures were: success of recruitment and follow up over the first three years, analysis of baseline and initial follow up data and the prospect of estimating the long term cost-effectiveness of these treatments.

Results

Centres consented 5560 patients. Of the 4240 patients who had been in the study for a least one year, annual review data were available for 3730 (88.0%). Of the patients who had been in the study for at least two years and three years, subsequent annual review data were available for 2055 (78.5%) and 265 (71.8%) patients respectively. Baseline characteristics and a small but statistically significant progression of disease were similar to those reported in previous pivotal studies.

Conclusion

Successful recruitment, follow up and early data analysis suggest that risk sharing schemes should be able to deliver their objectives. However, important issues of analysis, and political and commercial conflicts of interest still need to be addressed.