Authors' objectives:

The aim of the report is to provide a rapid review of the effectiveness and costs of disease-modifying drugs in multiple sclerosis (MS).

Authors' results and conclusions: Azathioprine: Evidence on the effectiveness of azathioprine comes from a good quality systematic review of the literature, as well as from one good and one poor quality RCT. Results suggest that azathioprine may reduce rates of relapse in patients with relapsing-remitting, relapsing-progressive and progressive MS. However, side-effects are common, particularly gastrointestinal disorders, and may affect compliance. Annual drug costs per patient are estimated to be between 50 and 1200. Beta interferon: There is evidence from three large RCTs that IFB-1a (two trials) and IFB-1b (one trial) have limited benefit in relapsing-remitting and secondary progressive MS, respectively, although all the trials have methodological limitations. Benefits, in terms of reduced relapse rate and severity, are achieved at high cost with the annual cost per patient estimated to be between 10,000 and 20,000. Side-effects are common, particularly flu-like symptoms and injection site reactions. Cladribine: Evidence on the effectiveness of cladribine comes from two small RCTs, one in chronic progressive MS patients and the other in relapsingremitting MS patients. Results suggest that cladribine may be effective in delaying disease progression in chronic progressive MS but no significant treatment effect was found in disease progression or relapse rate in relapsingremitting MS. The annual drug cost per patient is estimated to be 5800-8800. Cyclophosphamide: The quality of evidence on the effectiveness of cyclophosphamide comes from five RCTs, of variable design and quality, and in which different types and severity of MS and different treatment regimes are considered. One study in progressive MS suggests that cyclophosphamide combined with adenocorticotrophic hormone may be of some benefit, while another suggests that boosters of cyclophosphamide may slow progression. A wide range of side-effects is reported in all studies. The annual drug cost per patient is estimated to be less than 100. Glatiramer: Evidence for the effectiveness of glatiramer comes from one systematic review of two RCTs and a paper in which additional outcomes are reported from one of the RCTs included in the systematic review. The results suggest that relapse rate may be reduced by glatiramer treatment but the size of the benefit is not clear. The annual drug cost per patient is estimated to be about 1hmeof 11e naooin1t Shnesa or3

Authors' recommendations: Evidence for the effectiveness of immunomodulatory drugs in MS is problematic because: - there are few good quality trials for each drug - trials often have methodological limitations or poor reporting of data - trials are often of small size and short duration - there is no consistency in treatment regimes, patient groups and outcome measures - the clinical significance of reported benefits is not clear.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.hta.ac.uk/1163

Year Published: 2000

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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