A to Z of MS Risk-sharing Scheme
The Risk-sharing Scheme is the mechanism that makes the disease modifying drug therapies, beta interferon and glatiramer acetate, available on the NHS to people with certain types of MS.
Prior to the Scheme, provision varied widely between areas. The Scheme was set up by the Department of Health to address these inequalities and also in the light of an assessment by the National Institute of Health and Clinical Excellence (NICE), which judged the drugs not to be cost effective.
Under the Scheme, all those with relapsing/remitting MS, and those with secondary progressive MS in which relapses are the dominant feature, who meet the criteria laid down by the Association of British Neurologists (ABN) in 2001 will be eligible for the drugs.
The 'risk' element of the Scheme involves a sharing of the financial risk between the NHS and the participating pharmaceutical companies.
Prescription criteria (2001 guidelines)
People with relapsing/remitting MS should:
- be able to walk at least 100 metres without assistance
- have had at least two clinically significant relapses in the last two years
- be aged 18 or over
People with secondary progressive MS should:
- be able to walk at least 10 metres with or without assistance
- have had at least two disabling relapses in the last two years
- have had minimal increase in disability due to gradual progression over the last two years
- be aged 18 or over
People who are trying for a family, are pregnant or who are breastfeeding should not take these drugs.
There are also criteria for stopping treatment if the drugs are no longer effective.
2007 guidelines
The ABN has since revised its prescription criteria to allow for prescribing at an earlier stage following diagnosis. In November 2008, in the light of subsequent changes with new and existing medications, the ABN announced that it had withdrawn the 2007 guidelines for immediate review. The 2001 guidelines remain the basis for the prescription criteria for the disease modifying drugs.
The 2007 Guidelines had suggested the following prescription criteria:
Starting treatment
To start treatment, an individual must:
- be able to walk, without or without assistance such as a stick
- have a confirmed MS diagnosis with a relapsing onset (ie relapsing/remitting at onset)
- normally be aged 18 or over, treatment of younger people may be warranted in some cases
Eligibility
- diagnosis of MS by the McDonald criteria within one year of presentation with a clinically isolated syndrome (beta interferon only)
- relapsing/remitting MS (beta interferon or glatiramer acetate) with active disease, defined as one or more of:
- two clinically significant relapses in the last two years
- one disabling relapse in the last year
- active MRI scan containing new or gadolinium enhancing lesions that have developed in the last year (normally individual must also be experiencing relapses)
- secondary progressive MS (beta interferon only) – only recommended when relapses are the main cause of increasing disability