More MS news articles for Jan 2002
2002/003 Appeal Decision: Technology Appraisal on the use of beta interferon and glatiramer

http://www.nice.nhs.uk/article.asp?a=26812

Issued: 25 January 2002
NICE 2001/003
Press release

The National Institute for Clinical Excellence has today announced that the appeals against the Institute's Final Appraisal Determination on the use of beta interferon and glatiramer acetate for multiple sclerosis, heard on 26th November 2002, have not been upheld.

The Appeal Panel's decision has been published today.

Andrew Dillon, Chief Executive, NICE, said, "The decision of the Appeal Panel means that the conclusions set out in the Final Appraisal Determination will form the basis of the Institute's guidance to the NHS in England and Wales. NICE will issue its guidance on Monday 4th February 2002.

The Institute's provisional determination in August 2001, suggested that the Department of Health, the National Assembly for Wales, and manufacturers should consider how they could enable any or all of these drugs, to be secured for patients in a cost effective manner.

We are pleased that the Department of Health acted on the Institute's advice and have entered into discussions with manufacturers. Since the Institute has not been party to these discussions I am unable to comment on them further"

Notes for editors

Background

1.  The following documents relating to this appraisal are available on the NICE website at www.nice.org.uk:

Decision of Appeal heard 28 November 2001 - January 2002
Provisional Appraisal Determination - August 2001
Final Appraisal Determination - November 2001
Guidance for appellants - March 2000
Key dates and activities in this appraisal to date - January 2002
 
2. The appraisal process followed by the Institute allows for submissions from manufacturers, groups that represent patients and professional organisations. It also provides for periods of consultation, feedback, and appeal should it be required.
 
3.  The Institute's provisional and final determinations on Interferon beta and glatiramer in MS (published in August and October respectively www.nice.org.uk), encouraged the Department of Health to consider, with manufacturers, a strategy to acquire any or all of the medicines appraised in a manner that could be considered to be cost effective. The NHS has cash limited budgets and the procurement of technologies and products plays an important part in the overall application of resources in a fair and efficient way. We are pleased to see from the media reports that the Department and the manufacturers have begun these discussions. The Institute has not been involved in the discussions between the Department of Health and the manufacturers; therefore we are unable to comment, as we have not seen the detail of the scheme.
 
Requests for further information on the Department of Health's negotiations with manufacturers should be directed to the Department of Health's press office.
 
4.  The consultees in this appraisal are:
  • Association of British Neurologist
  • Aventis Pharma Ltd.
  • Biogen Ltd
  • Chartered Society of Physiotherapy
  • Department of Health
  • MS Research Trust
  • Multiple Sclerosis Society of Great Britain and Northern Ireland
  • National Assembly for Wales
  • Neurological Alliance
  • Royal College of General Practitioners
  • Royal College of Nursing
  • Royal College of Physicians
  • Schering Health Care Ltd
  • Serono Pharmaceuticals Ltd.
  • Teva Pharmaceuticals Ltd.
 
The Appeal.
 
5.  The Final Appraisal Determination was sent to the consultees on Monday 29th October 2001 and was published on the NICE website on Friday 2nd November 2001. The consultees had until 14th November 2001 to lodge an appeal against the guidance if they believed that the Institute:
  • has not acted fairly and in accordance with its procedures
  • has made a decision that is perverse in light of the evidence presented
  • has exceeded its powers
 
6.  Appeals were lodged by the following appellants:
  • Teva Pharmaceuticals and Aventis Pharma Ltd jointly
  • Biogen Ltd and Schering Health Care jointly
  • Serono Pharmaceuticals Ltd ("Serono")
  • The Neurological Alliance
  • The Royal College of Nursing ("RCN")
  • The Multiple Sclerosis Society ("MS Society")
  • The Multiple Sclerosis Trust ("MSRT")
 
All the appellants were represented at the appeal hearing with the exception of the Neurological Alliance. The MS Society communicated the views of the Neurological Alliance on its behalf.
 
7.  The Appeal Panel convened on 26th November 2001 to consider these appeals. The Appeal Panel comprised Professor Sir Michael Rawlins (chair of the Appeal Panel and chair of the Institute), Mrs Mary McClarey and Ms Mercy Jeyasingham (non-executive directors of the Institute's Board), Mrs Gill Donovan (patient representative) and Dr Peter Brock (industry representative).

 
Copyright ©2002 National Institute for Clinical Excellence