The Risk-sharing Scheme was that NICE (National Institute for Health and Care Excellence) had considered the clinical and cost-effectiveness of the disease modifying therapies for MS – beta interferon and glatiramer acetate – in a technology appraisal (TA32). At that time 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.
Subsequently, the four UK health administrations reached agreement with the manufacturers of the MS drugs to make the treatments available on the NHS and the Risk-sharing Scheme was enshrined within Health Service Circular 2002/004. Prior to entering the Scheme the manufacturers reduced the prices of the drugs to ensure they were cost effective using the NICE model.
Previous data analysis
Data from the first two years of follow-up were collected, analysed and interpreted by an independent group who concluded it was premature to reach any conclusion about the cost-effectiveness of the drugs used to treat relapsing remitting multiple sclerosis from the first interim analysis.
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.
The Department of Health and the Health Departments across the UK remain committed to the Scheme. It has realised many benefits for the 120,000+ people with MS, including infrastructure development of services, consistent access for thousands of patients 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 pharmaceutical companies engaged in the Scheme (Bayer, Biogen Idec, Merck Serono and Teva). 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.