Ref: NICE 2000/028 Issued: 23 August 2000

NICE is aware that there is often speculation regarding the possible outcome of its Technology Appraisals. In fairness to all parties it is our policy not to comment until the process is complete and we have issued our guidance to the NHS.

The process we follow for our technology appraisals is widely published and takes around 12 months to complete. The timetable for the ongoing appraisals is published on our web site. (www.nice.org.uk)

The appraisal process 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.

The Institute has received 8 appeals against its guidance on the use of interferon beta in MS. An independent appeal panel will consider the appeals on the 22nd September 2000 and in line with the Institute's published policies we will inform appellants and stakeholders of the outcome of the appeal as soon as practicably possible.

Depending on the outcome of the appeal the earliest the Institute could issue guidance on this technology is mid October.

Anne-Toni Rodgers

Communications Director

 

Notes for editors

 

Update on the stages of the NICE Appraisal of Interferon Beta in Multiple Sclerosis (MS).

What's happened so far
  1. NICE follows an open, structured and widely publicised process for all its technology appraisals and is the process we are following for the Interferon beta/glatiramer review. The details of the process and the dates for all appraisals are published on the NICE web site (www.nice.org.uk),
  2. The Institute had originally intended to publish its provisional views (PAD - Provisional Appraisal Determinations) 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 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.
  3. 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 the DH and NAW entered into consultation with the manufacturers of the products.
  4. 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 by the 1st November 1999.
  5. Following the consultation between the manufacturers and the DH / NAW there was an extension to the submission date to NICE until February 2000.
  6. During this time NICE commissioned a review of the published material in this area from the Northern and Yorkshire Drug and Therapeutic Centre.
  7. 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.
  8. The submissions from the manufacturers were assessed and combined with the review of the published literature into an Assessment report.
  9. 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.
  10. 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.
  11. After the committee meeting, the Appraisal committee prepared their provisional view - known as a PAD (Provisional Appraisal determination). At this point the appraisal for glatiramer in the treatment of MS was put on hold until the manufacturer received its UK marketing Authorisation.
  12. NICE sought feedback on the committee's provisional determination from patient groups, professional groups and the manufacturers involved. During this consultation phase NICE also sought the views of the Department of Health and the National Assembly for Wales. Following information from the organisations that represent pharmaceutical and medical device manufacturers 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, the PAD is circulated as strictly confidential material.

    13. What stage is the process at?

  13. The committee met again on the 27 July 2000 to consider its provisional determination in the light of the feedback received from the consultation.
  14. The committee made their final determination (Final Appraisal Determination - FAD) and has submitted it to NICE. At this point the appraisal for glatiramer in the treatment of MS was put on hold until the manufacturer received its UK Marketing Authorisation.
  15. NICE converted the FAD into guidance and as part of the process in developing guidance circulated it to the patient groups, professional groups and the manufacturers who have 10 working days to decide if they want to appeal.
  16. We have been notified that 8 appeals were received against the final determination

    17. What happens next?

  17. An independent appeal panel will consider the appeal on the 22nd September 2000 and in line with the Institute's published policies we will inform appellants and stakeholders of the outcome of the appeal as soon as practicably possible.
  18. Appeals can either be upheld or rejected. If appeals are upheld, the Appraisal Committee are asked to revisit the evidence and reconsider their Appraisal Determination in light of the appeal panel's findings. If appeals are rejected the guidance is issued to the NHS
  19. This means that the earliest NICE could issue guidance on Interferon beta/ in MS is now mid October 2000
  20. NICE have not issued any guidance on the use of either Interferon beta or glatiramer in MS.

ends