As reported by the Institute last month we have received 8 (eight) appeals against the draft guidance on the use of interferon beta in MS. The appeal is an integral part of the Institute's process for developing its guidance for the NHS. All the nationally based organisations involved in the process are provided with the opportunity to make an appeal.
An independent appeal panel will consider these appeals today, 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. 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- If appeals are rejected the draft guidance becomes final guidance and it is issued to the NHS.
From previous experience it is unlikely we will have the appeal panels' decision during the week commencing 25th September, however the Institute will issue a press release as soon as the outcome is available and appellants have been informed.
Anne-Toni Rodgers
Communications Director
Notes for Editors
- The facility for consultees to make an appeal is part of the Institute's
process for developing its guidance for the NHS. Appeals are made on one or
more of the following grounds:
• The Institute has failed to act fairly and in accordance with the Appraisal Procedure set out in the Institute's Interim Guidance to Manufacturers and Sponsors;
• The Institute has prepared Guidance which is perverse in the light of the evidence submitted;
• The Institute has exceeded its powers.
- An independent appeal panel considers the appeals and in line with the Institute's published policies we inform appellants and stakeholders of the outcome of the appeal as soon as practicably possible.
- The Panel consists 3 Non executive Directors of the Institute (who have not previously been involved in the appraisal) and two members nominated by patient organisations and the healthcare industries.
- The Institute publishes the Appeal panel's decision; the details of those who appealed, and the members of the panel that heard the appeal, on its web site web site (www.nice.org.uk). These details are not made available whilst the process is ongoing.
- 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 draft guidance becomes final and is issued to the NHS.
- Depending on the outcome of the appeal the earliest the Institute could issue guidance on this technology is mid October.
- As established with stakeholders, the Institute does not make appellant's details public, until the outcome of the appeal is published on the Institute's web site.
Update on the stages of the NICE Appraisal of Interferon Beta /glatiramer for Multiple Sclerosis (MS).
What's happened so far…
- NICE follows an open, structured and widely publicised process (developed following consultation) 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),
- 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.
- 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.
- Following the consultation between the manufacturers and the DH / NAW there was an extension to the submission date to NICE until February 2000.
- During this time NICE commissioned a review of the published material in this area from the Northern and Yorkshire Drug and Therapeutic Centre.
- 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.
- The submissions from the manufacturers were assessed and combined with the review of the published literature into an Assessment Report.
- 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.
- 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.
- After the committee meeting, the Appraisal committee prepared their provisional view - known as a PAD (Provisional Appraisal Determination).
- 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.
- The committee met again on the 27 July 2000 to consider its provisional determination in the light of the feedback received from the consultation.
- 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.
- NICE converted the FAD into draft guidance and as part of the process in developing the final guidance circulated it to the patient groups, professional groups and the manufacturers who have 10 working days to decide if they want to appeal.
- We have been notified that 8 appeals were received against the final determination for interferon beta.
- 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.
- 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 draft guidance becomes final and is issued to the NHS
- This means that if the appeals are not upheld then the earliest NICE could issue guidance on Interferon beta in MS is now mid October 2000.
- If the appeals are upheld the Institute will issue details of the revised timescale.
What stage is the process at? …
What happens next? …
