3.1 There are four general approaches to the treatment of MS, which may be undertaken separately or in combination:
Management of symptoms and disability with speech, physio- and occupational therapy and pharmacological or other therapeutic agents;
Management of the emotional and social consequences of relapses and disability;
Treatment of acute relapses with corticosteroids;
Disease-modifying treatment targeted at reducing the frequency and/or severity of relapses and/or slowing the course of the disease. The beta interferons and glatiramer acetate constitute the only options presently available in this category.
3.2 There are three beta interferon products: Avonex (manufactured by Biogen) and Rebif (Serono) are interferon beta-1a products licensed only for the treatment of RRMS. Betaferon (Schering) is interferon beta-1b and is licensed for the treatment of both RRMS and SPMS .
3.3 The beta interferons work by reducing the inflammatory process that characterises MS. Such inflammation usually precedes an MS relapse. However, the precise mode of action of these disease-modifying agents on immunological mechanisms remains uncertain.
3.4 The beta interferons commonly cause temporary influenza-like adverse effects (in about 50% of patients), as well as injection site reactions and leucopenia. Less commonly, the use of the beta interferons is associated with symptoms of depression. In addition, these agents, by the nature of their chemical structure, have antigenic effects and therefore may induce the development of antibodies, high titres of which have been observed in some patients. Theoretically, these antibodies may produce allergic reactions or bind to the drug molecule neutralising its effects. The significance of these antibodies on the effectiveness of the beta interferons is uncertain, as such effects have not been reported in clinical practice.
3.5 Based on a survey of health authorities in England and Wales, undertaken in January 2000, an estimated 1,750 people are currently prescribed beta interferons, which equates to 2.8% of all MS patients, or 3.3% of those with RRMS or SPMS. These percentages vary between health authorities.
3.6 The current annual cost per patient of the beta interferons in the UK is £7,259 (Betaferon), £9,061 (Avonex) or £9,088/£12,068 (lower dose/higher dose Rebif).
3.7 Glatiramer acetate (Copaxone, TEVA/Aventis) is licensed for the treatment of RRMS.
3.8 Glatiramer acetate works by reducing the inflammation around nerves. Such inflammation usually precedes an MS relapse. Glatiramer is an acetate salt of polypeptides formed from the synthesis of four amino acids. It resembles myelin, the basic protein that is found in the sheath surrounding nerves. In structure, therefore, glatiramer is quite distinct from the beta interferons. Its exact mode of action, as with the beta interferons, is unknown, but it is thought also to inhibit antigen presentation to white blood cells and to induce antigen-specific suppressor T cells.
3.9 Glatiramer acetate can cause flushing, chest tightness, palpitations, anxiety and breathlessness, and also injection site reactions, but these effects are generally easily managed. In addition, by the nature of its chemical structure, glatiramer acetate has antigenic effects and therefore may induce the development of antibodies in patients. Theoretically these antibodies may produce allergic reactions or bind to the drug molecule neutralising its effects. The significance of these antibodies on the effectiveness of glatiramer is uncertain as such effects have not been reported in clinical practice.
3.10 The cost per patient of glatiramer acetate is £6,650 per year.