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Drug treatments for multiple sclerosis (beta-interferons and glatiramer acetate): risk-sharing scheme (HSC 2002/004) briefing note November 2006

The Risk-Sharing Scheme commenced in May 2002. A cohort of over 5,000 patients with MS is being routinely monitored over 10 years. The purpose of this note is to remind PCTs and Hospital Trusts that there is a statutory duty under directions made under the NHS Act 1977 to fund treatment for eligible patients, including those who are not subject to routine monitoring

Health Service Circular 2002/004, announcing the risk-sharing scheme, was issued to the NHS on 4 February 2002. The scheme makes provision for MS patients to be eligible for treatment on the NHS with disease modifying drugs. A large cohort of patients is being monitored in order to assess the long-term cost effectiveness of the products. Ministers have expressed their commitment to seeing effective implementation of the scheme. In England this commitment has taken the form of directions under the NHS Act 1977 (see annex D of HSC 2002/004), which place the same statutory funding obligations on NHS bodies as apply to positive recommendations from NICE.

Progress with the Scheme

The Scheme is an observational hypothesis-testing study over 10 years. The study is being conducted as part of routine clinical practice, with data being collected for around 5,200 patients across 70 UK prescribing centres. The recruitment of such a large number of patients represents a considerable achievement. Progress of the disease for patients receiving treatment will be compared with a group of patients who did not receive treatment to gauge the extent to which patients benefit from treatment. Analyses will be conducted on a regular cycle and the first is expected to be completed in summer 2007. The treatments involved are Avonex, Betaferon, Copaxone and Rebif, and if they do not perform as anticipated their prices to the NHS might reduce.

Action for Strategic Health Authorities

Strategic Health Authorities are asked to ensure that their PCTs and Trusts continue to meet their obligations to fund the treatment of eligible patients under the scheme.