2000/029 NICE Appraisal of glatiramer in the Treatment of Multiple Sclerosis

Ref: NICE 2000/029 Issued: 23 August 2000

The process the Institute follows for technology appraisals is widely published and takes around 12 months to complete. 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's Appraisal Committee has two meetings. Following the first meeting the Committee produces a Provisional Appraisal Determination (draft view) that is sent to manufacturers, the groups that represent patients and professional organisations, the Department of Health and the National Assembly for Wales for consultation.

The feedback from this consultation is reviewed at the second committee meeting. Following this second meeting the committee produces a Final Appraisal Determination (FAD) that is sent to the same groups providing them with an opportunity to appeal.

The technology appraisal of Interferon beta and glatiramer in the treatment of MS was conducted together until the production of the FAD (Final Appraisal Determination).

A FAD for Interferon beta was prepared and circulated for appeal. The closing date for Appeals was 22^nd August 2000.

The Final Appraisal Determination on the use of glatiramer in the treatment of MS was placed on hold until the product received its full Marketing Authorisation in the UK and the full terms of the licence were available to the Institute. The Institute intends to begin work on formulating the Final Appraisal Determination on the use of glatiramer in MS during the week commencing 11 September 2000.

The FAD and guidance document referring to the use glatiramer in MS will be circulated to relevant manufacturers, the groups that represent patients and professional organisations, the Department of Health and the National Assembly, who will have 10 working days to lodge an appeal should they wish to.

The appraisal process for glatiramer will continue as previously described and we would hope to co-incide the launch of our guidance with the marketing of glatiramer in the UK.

Anne-Toni Rodgers

Communications Director

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Notes for editors

Update on the stages of the NICE Appraisal of glatiramer 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 6^th 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 1^st 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 30^th 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.

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. The Final Appraisal Determination on the use of glatiramer in the treatment of MS was placed on hold until the product received its full Marketing Authorisation in the UK and the full terms of the licence were available to the Institute. The Institute intends to begin work on formulating the Final Appraisal Determination on the use of glatiramer in MS during the week commencing 11 September 2000.

What happens next? …

16. NICE converts the FAD into guidance and as part of the process in developing guidance 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 an appeal an independent appeal panel will consider the appeal 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 glatiramer in MS is now the end of October 2000

20. To date NICE have not issued any guidance on the use of either Interferon beta or glatiramer in MS.

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