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The Department of Health Risk-sharing Scheme

The Multiple Sclerosis Risk-sharing Scheme (RSS) was set up in 2002 to ensure that people with MS could access the original four first line disease modifying drugs on the NHS (Avonex, Betaferon, Copaxone and Rebif). The Scheme covered both the legal framework for routine NHS prescribing and the collection of data from a clinical cohort to assess cost efficacy over a 10 year period within routine clinical usage.

The Scheme collected data from 5,610 people to measure the cost effectiveness of the treatments in routine clinical practice. The cohort was fully recruited by April 2005

72 centres across the UK participated in the Scheme

Background to the Risk-sharing Scheme (RSS)

NICE (National Institute for Health and Care Excellence) considered the clinical and cost-effectiveness of the disease modifying therapies for MS - beta interferon and glatiramer acetate - in a technology appraisal (TA32) published in January 2002. NICE concluded that it was not appropriate to recommend use of the treatments on the NHS because there was insufficient evidence to show their cost effectiveness over a twenty year time horizon. However, NICE invited the UK Health Departments to enter into a discussion with the license holders of the four products to see whether there was a possible basis on which they could be cost-effectively used in the NHS.

In February 2002, the four UK health administrations reached agreement with the manufacturers of the MS drugs to make the treatments available on the NHS. The 'risk' element of the Scheme involved a sharing of the financial risk between the NHS and the participating pharmaceutical companies. Prior to entering the Scheme the manufacturers reduced the prices of the drugs to ensure they were cost effective using the NICE model.

Comprehensive details of the MS Risk-sharing Scheme, including how people access treatments, are outlined in the Health Service Circular 2002/004.

Scheme Steering Group

The Scheme operated under the oversight of a Steering Group representing all the parties to the Scheme (the four UK health departments, the four companies whose products are made available through the Scheme - Bayer, Biogen Idec, Merck Serono and Teva, the Association of British Neurologists, the UK MS Specialist Nurses Association, the Royal College of Nurses, and the MS Trust). The Steering Group was advised on scientific issues by a Scientific Advisory Group.

The DH Risk-sharing Scheme for MS: moving closer to the answer (pdf 625kb)

The MS Trust had an administrative role within the Risk-sharing Scheme. In this role we managed the research provider to ensure effective interaction with the clinical centres and collection of the data. In addition the MS Trust administered the Scientific Advisory Group, and the finances for the Scheme.

Previous data analysis

Year 2

Boggild M, et al.
Multiple sclerosis Risk-sharing Scheme: two year results of clinical cohort study with historical comparator.
BMJ 2009; 339:b4677.
Full article

The two year data showed a number of issues with the methodology being used. Firstly, the natural history database used to compare disease progression on treatment with expected disease progression off treatment as part of the NICE review did not allow improvement and yet circa 40% of patients treated with drug therapy in the RSS cohort showed improvements. Secondly, the statistical assumptions underlying the model were uncertain.

Year 6

Palace J, et al.
Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator.
Lancet Neurology 2015;14(5):497-505
Summary

The six year data showed that all four drugs were clinically effective in reducing the progression of disability in line with estimates extrapolated from two year clinical trials. The drugs were meeting the cost-effectiveness target of £36 000 per quality-adjusted life-year (QALY) projected over 20 years.

To overcome problems highlighted at the year 2 analysis, a new natural history database - the British Columbia MS (BCMS) database - was utilised for the year 6 analysis. A Continuous Markov and a parallel Repeated Modelling approach was also put in place. This research methodology was published in the BMJ in December 2013.

Benefits of the Scheme

The Scheme has realised many benefits for all 100,000 people with MS, including infrastructure development of services, consistent access for thousands of people to drug treatments, and the development of the specialist centres across the UK. The support has been provided under the auspices of the Scheme by the four pharmaceutical companies engaged in the Scheme. In addition the longer-term findings of the Risk-sharing Scheme have the potential to genuinely inform and change the way in which MS is treated.

Last reviewed: 8 December 2016
This page will be reviewed within three years

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