The Commission of the European Communities recently approved Betaferon® (interferon beta-1b, Schering AG) for the treatment of secondary progressive MS. This means that in the UK, patients will now have access to the first medicine licensed to treat both relapsing-remitting and the more advanced secondary progressive phase of multiple sclerosis. The EC’s approval was based on a positive review by EMEA – the European Agency for the Evaluation of Medical Products.

The approval of Betaferon® for secondary progressive MS offers a new perspective for people with MS and their treating specialists. "Patients would often start treatment in the later phases of relapsing-remitting disease. We were not sure about the benefits of treatment when the disease became secondary progressive," explained Prof. Ludwig Kappos, Professor of Neurology, Department of Neurology, University Hospitals, Basle, Switzerland, and one of the investigators in the recent trial. "Now we know that when we begin treatment early, we can reduce relapses throughout and delay disability even if the patient progresses to the secondary progressive form of the disease, thereby preserving mobility for a longer time," he added.

The European licensing agency acted after a pivotal European trial was stopped early by an independent advisory board. The results of this study published in The Lancet, November 1998⁽¹⁾, involved 718 patients who had completed at least two years of treatment, and was double-blind, randomized, placebo-controlled, and conducted in twelve countries throughout Europe.

More than 50% of all patients initially diagnosed with relapsing-remitting MS will eventually progress to the secondary progressive phase of the disease⁽²⁾. People in the earlier stages of MS can usually continue to work and participate in family life with only occasional interruptions caused by illness. Secondary progressive MS, however, increasingly deprives patients of the ability to walk or to care for themselves unaided.

A study carried out by the Economists' Advisory Group, London, with the co-operation of the UK MS Society in 1995 investigated the practical, social and psychological impact of exacerbation’s on the quality of life of people with relapsing-remitting MS and their carers⁽³⁾. Among the social consequences singled out as most important were loss of independence, difficulties in getting and keeping a job, problems with access to buildings and transport and difficulties with sexual relationships. Among the most important physical consequences cited were: chronic fatigue, difficulties in eating and drinking, inability to walk or drive, severe disturbances of vision and problems with personal hygiene and using the toilet.

People with MS may lose a major source of their income due to loss of productivity caused by illness and handicap. Often they are unable to hold down a job and have to take very early retirement. The consequences are an increased economic burden on society in providing financial support.

The direct costs of caring for people with MS are also borne usually by society. In the past the major costs have been incurred from long term nursing care in the community rather than drugs and hospital admissions.

At least 25% of individuals with MS require assistance with day-to-day activities. Traditionally, largely female relatives have provided assistance, but the different patterns of female employment may mean that help is increasingly sought from community care providers.

Costs can be divided into three categories – direct, indirect and intangible.⁽⁴⁾ Direct costs include those of diagnosis, treatment, prevention, rehabilitation and long-term nursing. Indirect costs include loss of productivity of the individual and family members involved in caring. Intangible costs represent the burden on the family arising from psycho-social aspects of the disease and stress.

The total cost of MS in the UK was put at £1.2 billion per year in 1995. Of this, NHS costs accounted for 12.8% of the total and less than 2% of medical costs went on medicines. ⁽⁵⁾

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Betaferon® is a registered trademark of Schering AG, Berlin