Ref: NICE 2000/019 Issued: 20 June 2000 23:10

The Institute is aware of the speculation about its appraisal of Interferon Beta / glatiramer for Multiple Sclerosis. It is our policy not to comment on an appraisal until the process is complete and we have issued our Guidance to the NHS and the public.

Andrew Dillon, Chief Executive of NICE said, "We have not issued any Guidance on the use of Interferon beta or glatiramer in MS. The Appraisal committee has had the first of two meetings and the Institute is currently seeking feedback on the committee's provisional determination from patient groups, professional groups and the manufacturers involved. During this consultation phase the Institute also seeks the views of the Department of Health and the National Assembly for Wales. All these groups are required to keep the information contained in the consultation documents confidential"

"The Appraisal Committee will meet again on 27 July 2000 and reach their Final Appraisal Determination. This means that the earliest NICE will produce its guidance on Interferon beta/ glatiramer in MS is August 2000. It is difficult to be exact as our appraisal process also allows for an appeal should it be required".


Ends

Anne-Toni Rodgers
Communications Director

Background for Editors
1. The National Institute for Clinical Excellence (NICE) is a part of the NHS. It has a team of experts who produce guidance for both the NHS and patients/carers on medicines, medical equipment and clinical procedures.
2. In doing this work NICE follows a widely published process that involves patients, manufacturers and health professionals. Details of the process and dates of all meetings are published on the Institute's web site (www.nice.org.uk).
3. The process allows for all stakeholders (patients groups, manufacturers and health professionals) to prepare and submit information on the technology and its use; for them to be consulted in order that they can provide their comments and feedback to inform the process and finally to submit an appeal, should it be required.
4. The Institute had originally intended to publish its provisional views (PAD) on its web site. However the organisations that represent the manufacturers of pharmaceuticals and medical devices (ABPI, ABHI) approached the Institute with the information that the PAD, (which may vary quite considerably from the final guidance) could have a significant impact on their share price and to comply with legal requirements it should be treated as confidential material. Therefore the PAD is circulated as strictly confidential material. NICE will continue to evaluate confidentiality requirements as a part of its ongoing reviews of the Appraisal process.
5. The Department of Health (DH) and the National Assembly for Wales (NAW) asked NICE to appraise Beta Interferon/ glatiramer for MS on the 6th August 1999, at the same time they entered into consultation with the manufacturers of the products.
6. NICE wrote to interested parties (manufacturers, patient groups and professional bodies) on the same day asking that any submissions they wished to make should be made on the 1st November 1999.
7. Following the consultation between the manufacturers and the DH / NAW there was an extension to the submission date to February 2000
8. During this time NICE commissioned a review of the published material in this area.
9. In February 2000 NICE received submissions from the manufacturers, patient groups and the professional bodies involved in the area. These submissions contain both published and unpublished information.
10. The submissions from the manufacturers were assessed and combined with the review of the published literature into an Assessment report.
11. The Assessment report, and the original submissions from patient organisations and the professional groups, together with the manufacturers original submissions were made available to the Appraisal Committee.
12. The first meeting of the Appraisal committee for Interferon beta / glatiramer in MS was held on the 30th May 2000. In addition to the written submissions the committee also had 'experts for the day' at its meeting. They represented a patient organisation and health professionals. These individuals were nominated by their own organisations.
13. After the committee meeting, the Appraisal committee prepared their provisional view - known as a PAD (Provisional Appraisal determination).
14. NICE is currently seeking feedback on the committee's provisional determination from patient groups, professional groups and the manufacturers involved. During this consultation phase NICE also seeks the views of the Department of Health and the National Assembly for Wales. The documentation circulated during this process is strictly confidential - see point 4 above.
15. The committee meets again on the 28 July 2000 to consider its initial decision in the light of the feedback received from the consultation. The committee makes their final determination (Final Appraisal Determination - FAD) & submits it to NICE.
16. NICE converts the FAD into guidance and circulates it to the patient groups, professional groups and the manufacturers who have 10 working days to decide if they want to appeal.
17. If there is no appeal NICE issues its guidance direct to the NHS and patient groups.
18. If there is an appeal, NICE will notify those involved and depending on the outcome will either re-visit the guidance or issue it direct to the NHS.