Abstract
BackgroundRisk 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.MethodsThis 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.ResultsCentres 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.ConclusionSuccessful 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.
Highlights
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
A National Institute for Clinical Excellence (NICE) appraisal of the use of three beta-interferon products and glatiramer acetate, published in January 2002 [1], concluded that they should not be funded through the National Health Service (NHS), as the cost per quality adjusted life year (QALY), estimated by the use of a cost-effectiveness model developed in ScHARR [2], was too high
This led to the Multiple Sclerosis (MS) Risk Sharing Scheme [3], in which the drugs were funded on condition that their effect on disease progression was monitored in a cohort of patients for ten years
Summary
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. Whatever cost-effectiveness threshold we choose, we should identify the maximum price a health service is prepared to pay for any given intervention Whilst this holds in theory, there has been little experience of implementing these schemes in practice, until the Multiple Sclerosis (MS) Risk Sharing Scheme. In the face of considerable opposition from patient and professional organisations and pharmaceutical companies, NICE recommended that the Department of Health and the four pharmaceutical companies involved in manufacturing the drugs should find a way to make them available on the NHS in a cost-effective manner This led to the MS Risk Sharing Scheme [3], in which the drugs were funded on condition that their effect on disease progression was monitored in a cohort of patients for ten years. Depending on the results observed, potential adjustments to the price of the drugs would be made at intervals to achieve an agreed cost per QALY of no more than £36,000
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