28 September 2000
The Institute's Appraisal of the use of glatiramer acetate in the treatment of MS was placed on hold until the product received its full Marketing Authorisation in the UK and the full terms of the licence were available to the Institute.
The manufacturer has now received this marketing authorisation and the Institute's Appraisal Committee will continue the appraisal of glatiramer acetate for MS, at its meeting on 26 October 2000.
The Institute anticipates circulating the Final Appraisal Determination (FAD) and draft guidance referring to the use glatiramer in MS to manufacturers, the groups that represent patients and professional organisations, the Department of Health and the National Assembly, within 10 working days of this meeting. These groups will then have 10 working days to lodge an appeal should they wish to.
If an appeal is required we anticipate that it would be heard late October / early November.
The appraisal process for glatiramer will continue as previously described
and we would hope to co-incide the launch of our final guidance with the
marketing of glatiramer in the UK.