The question of whether beta interferon or glatiramer acetate should be available for patients suffering from Multiple Sclerosis (MS) is one which has created controversy and has occupied NICE since the Department of Health and the National Assembly for Wales asked it to appraise these drugs on 6 August 1999.

Up until now, in the UK fewer than 5% of patients with MS have received beta interferon compared to 20% in the rest of Europe and the USA and there has been controversy over ‘postcode prescribing’ which has denied the drugs to many on the NHS.

On 4 February 2002 NICE issued its guidance to the NHS in England and Wales. The major points of the guidance were:

•  Patients on the drugs should however continue on them

This last point has apparently been discussed prior to the release of the guidance from NICE. On the same day (4 Feb) the Department of Health, National Assembly for Wales, the Scottish Executive and the Northern Ireland Department of Health had reached agreement with the manufacturers for a risk-sharing scheme. The scheme means that beta interferon and glatiramer acetate will be available to all patients who meet the criteria for treatment outlined by the Association of British Neurologists (ABN) (Fig 1) although treatment should only be initiated by specialist MS centres.

Patients must fulfil the following four criteria:

  1. Able to walk independently

  2. At least two clinically significant relapses in the last two years

  3. 18 years old or older

  4. No contrai-ndications

Only for patients with relapsing secondary progressive MS. It is not effective in patients with a non relapsing secondary progressive course. Patients must fulfil the following criteria:

  1. Able to walk at least 10 metres with or without assistance

  2. At least two disabling relapses in the last two years

  3. Any increase in disability due to slow progression over the

    last two years has been minimal

  4. 18 years old or older

The ABN Treatment Criteria for Glatiramer Acetate

Patients must fulfil the following four criteria:

  1. Able to walk at least 100 metres without assistance

  2. At least two clinically significant relapses in the last two years

  3. 18 years old or older

What is interesting about the scheme is that the manufacturers have agreed that a cohort of patients, who qualify for these drugs, will be monitored over a 20-year period to assess the cost effectiveness. It is emphasised that this is not to monitor clinical efficacy as the drugs have already been licensed on the basis safety, quality and efficacy. Cost effectiveness will be assessed in terms of cost per quality-adjusted life year (QALY) and a threshold of £36,000 per QALY has been agreed.

In England and Wales, it is estimated that 7500 - 9000 patients with MS will meet the ABN guidelines for treatment. This represents approximately 15% of patients with MS. A large proportion of these patients will be followed up at regular intervals over a 20-year period and the cost per QALY will be assessed. If the cost is over £36,000 per QALY, the Health Departments will not withdraw the drug, but the manufactures will have to adjust their price to ensure the cost remains below the threshold.

It is good to see all sides agreeing an acceptable cost that will ensure that beta interferon and glatiramer acetate will be available to everyone no matter where they live in the country.