NICE 2001/ 035
Issued: 02 November 2001

Press release

The National Institute for Clinical Excellence has today published on its website (www.nice.org.uk) the Final Appraisal Determination (FAD) on beta interferon and glatiramer for multiple sclerosis.

This document does not constitute the Institute's formal guidance and it should not be viewed as a recommendation to practice for the NHS at this time.

The FAD is a consultative document that has been sent to the consultees involved in the appraisal for them to consider making an appeal. The closing date for receipt of appeals is14 November 2001.

Andrew Dillon, Chief Executive of NICE said, "The Appraisal Committee has considered carefully the responses it received from stakeholders following the recent consultation on its provisional determination. Following this consideration it has prepared its Final Appraisal Determination. The Institute has issued this Final Appraisal Determination to the organisations with whom it has been formally consulting; this includes the organisations that represent people with MS, healthcare professional organisations, the manufacturers and the Department of Health & the National Assembly for Wales. In line with our established process they now have the opportunity to lodge an appeal. Because the FAD is the subject of possible appeal, the Institute will not make any further statements until any appeals that may be made have been heard and the decision of the Appeal Panel has been published".

"Both the PAD and the FAD invite the Department of Health and the National Assembly for Wales 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. NICE is pleased to see from the media reports that the Department and the manufacturers have begun these discussions."

- ENDS-

Notes for editors

Background

1. The Final Appraisal Determination was sent to the consultees on Monday 29th October. The consultees were informed in advance that the FAD would be published on the NICE website by the end of the working week in which it was received or earlier if the information contained within the FAD was disclosed.
   
2. The consultees in this appraisal are
  • Association of British Neurologists
  • Biogen Ltd
  • Department of Health
  • Faculty of Pharmaceutical Medicine
  • MS Research Group of the Association of British Neurologists
  • MS Research Trust
  • National Assembly for Wales
  • Neurological Alliance
  • Royal College of General Practitioners
  • Royal College of Physicians
  • Royal Pharmaceutical Society
  • Schering Health Care Ltd
  • Serono Pharmaceuticals Ltd
  • Teva Pharmaceuticals Ltd.
  • The Chartered Society of Physiotherapy
  • The Multiple Sclerosis Society of Great Britain and Northern Ireland
  • The National Hospital for Neurology and Neurosurgery
   
3. The FAD is now with the consultees who may lodge an appeal against the guidance if they believe 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
   
4. The appeal period ends at 5:00pm on Thursday 14 November 2001. The Institute will issue a press release after this time to confirm if any appeals have been received.
   
5. If any appeals are received they will be heard at a meeting on 26 November 2001 and the Panel's decision will be published as soon as practicably possible after that. The Appeal Panel's decision will identify members of the Panel and the appellants.
   
6. For further details on the appraisal of beta interferon and glatiramer for multiple sclerosis please visit the Institute's website at www.nice.org.uk and use the search engine in the top right corner of the Institute's web site. By typing in "sclerosis" the search engine will bring up all the documents available on this appraisal.
   
7. The following are some of the documents published on our web site that you may find useful:
  Final Appraisal Determination - November 2001
  Provisional Appraisal Determination - August 2001
  Key dates and activities in this appraisal to date - August 2001
  Details of the appeal panel decision - 8 November 2000
  Minutes of the Appraisal Committee - 13 December 2000
  Press Release on new economic modelling- 22 December 2000
  Summary of the appeal process - 24 August 2000
  Press Release on consultation for new economic model - 29 January 2001
   
The FAD itself
   
8. The Final Appraisal Determination (published on nice.org.uk) states that:
 
  • On the balance of their clinical and cost effectiveness neither beta interferon nor glatiramer acetate is recommended for the treatment of Multiple Sclerosis (MS) in the NHS in England and Wales.
  • It is likely that patients currently receiving beta interferon or glatiramer acetate for MS, whether as routine therapy or part of a clinical trial, could suffer potential loss of well being if their treatment is discontinued at a time they did not anticipate. Because of this, patients and their consultants may wish to continue therapy (including at the conclusion of the clinical trial) until they consider it is appropriate to stop, having regard to the criteria established for withdrawal from treatment in the Guidelines of the Association of British Neurologists published in January 2001.
  • The Department of Health and the National Assembly for Wales are invited to consider a strategy with a view to acquiring any or all of the medicines appraised for this guidance in a manner which could be considered to be cost effective.
9. The FAD has the following sections
 
  1. Guidance - this section describes the Institutes proposed guidance to the NHS in England and Wales
  2. Clinical Need and Practice - This section provides information on MS and how it progresses, its impact on patients and their carers, and information such as scoring systems
  3. The Technologies - this section describes the approaches to treatment and provides more detail on the beta interferons and glatiramer acetate.
  4. Evidence - this section summarises the evidence considered in the appraisal it has three sub sections:
    i.

    Clinical Effectiveness (data on the clinical effects of the technology)

    ii. Cost effectiveness (economic modelling and data)
    iii.

    Consideration (summary of Committee considerations of this evidence)

  5. Further Research - topics for further research by interested parties including the NHS
  6. Implications for the NHS
  7. Implementation
  8. Related Guidance -other NICE work in this area
  9. Review of guidance - the date the guidance will be reviewed
10. The PAD and the FAD invite the DH and the NAW 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. NICE is pleased to see from the media reports that the Department and the manufacturers have begun these discussions. NICE has not been involved in any discussions between Manufacturers and the DH/NAW on this topic, although like you we have seen the recent news reporting that they have occurred. You would have to speak to the DH or the NAW regarding this topic.