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.

The drugs covered by the Scheme are:

• Avonex (interferon beta-1a)
• Betaferon (interferon beta-1b)
• Copaxone (glatiramer acetate)
• Rebif (interferon beta-1a)

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. This is achieved by monitoring the effectiveness of the drugs in a proportion of people on the Scheme. This research elements involves almost 5,000 people and is due to run for ten years. The first review of this research element was published in December 2009 (see news story).

Under the Scheme, the NHS is obliged to prescribe treatments for eligible people (see below). Any decision to stop treatment can only be based on clinical reasons, not on the cost of the treatments to the NHS. This principle was laid out at the start of the Scheme in a document called Health Service Circular 2002/004. In December 2011, the Department of Health issued a letter that reminded NHS organisations that their obligations under Health Service Circular 2002/004 still apply.

Prescription criteria (2001 guidelines)

The ABN published guidance for the treatment of multiple sclerosis with interferon beta and glatiramer acetate in 2001. These form the prescription guidelines for the disease modifying drugs. In order to start treatment an individual should:

• be able to walk at least 10 metres with or without assistance for interferon beta; and at least 100m without assistance for glatiramer acetate
• have experienced at least two clinically significant relapses in the last two years
• normally be aged 18 or above

In November 2009, the ABN published revised guidelines that incorporate subsequent advances in treatment. The new guidelines include treatment with natalizumab (Tysabri) licensed in the UK in 2006 but not covered by the Risk-sharing Scheme.

Two further disease modifying drugs - Extavia (interferon beta-1b) and fingolimod (Gilenya) - have been licensed since 2001 and are not included in the Risk-sharing Scheme.

There are no mandatory stopping criteria that apply in all cases, but the ABN has set guidance on when treatment with self-administered disease modifying drugs should be stopped because they are no longer effective. The decision to discontinue treatment will be made following discussion between the individual and their neurologist or MS nurse.

References

Boggild M, et al.
Multiple sclerosis risk sharing scheme: two year results of clinical cohort study with historical comparator.
BMJ 2009;339:b4677
read online

Association of British Neurologists (ABN)
Revised (2009) guidelines for prescribing in multiple sclerosis.
London; ABN: November 2009.
download (pdf 124kb)

HSC 2002/004 - Cost effective provision of disease modifying therapies for people with Multiple Sclerosis
London; Department of Health: 4 February 2002.
read online

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