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SMC Minutes - Tuesday 4 May 2004

Minutes of Meeting
Held on Tuesday 4 May, 2004
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Lawson (Chairman), Mr Jeff Ace, Professor James Barbour, Dr Keith Beard, Ms Chris Beech, Professor Martin Brodie, Professor John Cairns, Mrs Michelle Caldwell, Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr David Hood, Mrs Moira Howie, Dr Chris Lush, Ms Laura McIver, Ms Angela Munday, Ms Wendy Nganasurian, Dr Marianne Nicholson, Dr Ken Paterson, Ms Fiona Ramsay, Dr Andrew Riley, Dr Philip Rutledge, Ms Fiona Scott, Ms Angela Timoney, Mr Mike Wallace, Professor David Webb, Dr John Webster

In Attendance: Mr Steven Fennochi, Ms Joy Hosie, Ms Ali McAllister, Miss Rosie Murray

Apologies: Mrs Marion Bennie, Mrs Barbara Black, Dr Corri Black, Mr John Glennie, Dr John Haughney, Dr Harpreet Kohli, Professor Angus Mackay, Mr Hector Mackenzie, Mr Chris Nicolson, Dr Sandy Simpson, Mrs Helen Tyrrell, Mr Derek Yuille

   

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted.   Ms Chris Beech, Nurse Consultant, Highland Primary Care, Dr Peter Donnan, Senior Lecturer in Medical Statistics, Tayside Centre for General Practice and Dr Andrew Riley, Director of Public Health, Borders NHS Board, were welcomed as new members. 

2 Declarations of Interest

2.1 The Chairman requested members declare interests in the products to be discussed and the comparator drugs as noted on the assessment reports.

3 Minutes of the Previous Meeting (06.04.04)

3.1 The minutes of the meeting of 6 April, 2004, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Membership

The Chairman proposed that Dr Ken Paterson, successor to Professor Webb as NDC Chair, become an additional Vice Chair of SMC, and that Professor Webb assume the position of Deputy Chair of SMC until his succession to the post of Chair later in the year.  Members approved this arrangement.

4.2 Relationship with SMC and NHS Quality Improvement Scotland

Discussions are moving forward regarding the budgetary allocation to SMC. Progress will be reported at the next SMC meeting.

4.3 Experts

Discussions are ongoing regarding the use of clinical experts and how to improve feedback and define expertise.  Proposals will be taken forward over the next couple of months and the outcome reported at a future meeting.

FULL SUBMISSIONS

4.4 aripiprazole (Abilify TM):   Bristol-Myers Squibb Pharmaceuticals/Otsuka Pharmaceuticals  (No.95/04)

4.4.1 As an official launch date for aripiprazole (Abilify), for the treatment of schizophrenia, is yet to be confirmed, in accordance with SMC process, the distribution of this recommendation will be withheld until launch. 

4.5 temoporfin (Foscan®): Biolitec Pharma Ltd  (No.96/04)

4.5.1 The recommendation for temporfin (Foscan), for the palliative treatment of patients with head and neck cancer failing prior therapies and unsuitable for radiotherapy, surgery or systemic chemotherapy, will be posted on the SMC website on Monday 10 May, 2004.

4.6 olanzapine (Zyprexa): Eli Lilly & Company Ltd  (No.  98/04)
 
4.6.1 The recommendation for olanzapine (Zyprexa), for the prevention of recurrence in patients with bipolar disorder, whose manic episode has responded to olanzapine treatment, will be posted on the SMC website on Monday 10 May, 2004.

4.6.2 The company identified some factual errors in the recommendation which were accepted by SMC.  In view of this an amended recommendation document will be reissued to NHS Boards and ADTCs on Friday 7 May, 2004.

4.7 Budesonide/eformoterol dry powder inhaler (Symbicort® Turbohaler®):  AstraZeneca UK Ltd  (No.  97/04)

4.7.1 The recommendation for budesonide/eformoterol dry powder inhaler (Symbicort Turbohaler) for the symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators, will be posted on the SMC website on Monday 10 May, 2004.

RESUBMISSION

4.8 botulinum toxin type A (Botox®):  Allergan Ltd  (No. 80/03)

4.8.1 The recommendation for botulinum toxin type A (Botox®), for the management of adults with post stroke spasticity of the hand and wrist, will be posted on the SMC website on Monday 10 May, 2004.

5 Appeals Update

5.1 pimecrolimus cream (Elidel)  Novartis (No. 35/03)

The Independent Review Panel meeting to review pimecrolimus cream (Elidel) took place on 23 April, 2004. The results of the meeting will be presented to SMC in June for final decision.

6 Correspondence

6.1 Link to Centre for Adverse Reactions to Drugs (CARDS/CSM - Scotland)

6.1.1 Further to discussions with CSM-Scotland, a website link has been established with SMC.  It is anticipated this will raise awareness about the two different, but related, activities.

7 Patient and Public Involvement Group (PAPIG)

7.1 The minutes of the last meeting held in April were reviewed for information and the following proposals put forward to SMC for consideration.

  • An informal approach be made to SIGN to discuss common issues and to move forward on potential joint activities to identify involvement opportunities in both organisations.
  • Increase the quantity and quality of patient interest group submissions by targeting a selection of Patient Interest Groups encouraging them to subscribe to the email alert and consider making a submission, and offer further advice and support if requested.
  • Provide Patient Interest Groups with a copy of the 5-6 page recommendation document to provide a greater understanding of the rationale of SMC decision making and acknowledge more publicly their contribution to SMC.

The first two proposals were accepted by SMC.  The Chairman advised that work is ongoing regarding putting the 5-6 page recommendation in the public domain and until this time it would not be possible to widen circulation, but agreed that ackowledgement of t a Patient Group Submission would be made by the addition of a reference in the Recommendation under the 'additional documents reviewed' section.
 
8 New Drugs Committee Update

8.1 Structure of Recommendations

8.1.1 The recommendation template is currently under review and a more structured approach is being introduced.  Members were encouraged to feedback comments regarding the new look recommendation. 

8.2 Role of Lead Assessor

8.2.1 It was agreed it would be valuable for Lead Assessors to attend SMC to present submissions from time to time and this will be encouraged. 

8.3 Economic Seminar

8.3.1 A joint seminar between the SMC economic reviewers and industry economists, organised by the Office of Health Economics, is being held on 29 June, 2004.  Members were encouraged to attend.  Details will be circulated to members when available.

8.4 Comparison between SMC and other Groups

8.4.1 A comparison between advice from SMC and other groups involved in the review of medicines was presented for review and revealed that outcomes are very similar.

8.5 Professor David Webb

8.5.1 The Chairman thanked Professor Webb for his considerable contribution to NDC, without which SMC could not have functioned effectively.

9 NDC Assessment Reports - Full Submissions

9.1 Methylphenidate (Equasym XL):  Celltech (No. 99/04)

9.1.1 Declarations of interest were recorded in relation to this product/comparator drugs.

9.1.2 The SMC Vice Chair provided a detailed overview of the assessment, the key issues identified, draft recommendation and comments received from the company.  Detailed discussion followed and the group made a recommendation. 

9.1.3 As an official launch date for methylphenidate (Equasym XL), for the treatment of attention deficit/hyperactivity disorder (ADHD) is yet to be confirmed, in accordance with SMC process the distribution of this recommendation will be withheld until launch.  If however there are any changes in the pricing of this product between now and the actual launch date the recommendation will be revisited.

9.2 laronidase (Aldurazyme):  Genzyme Therapeutics (No: 100/04) 

9.2.1 No declarations of interest were recorded in relation to this product or comparator drugs. 

9.2.2 The SMC Deputy Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, comments received from the company and patient interest group submission.  Detailed discussion followed and the group agreed that laronidase (Aldurazyme), for the treatment of long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the non-neurological manifestations of the disease, should not be recommended for use within NHS Scotland.  Amendments to wording were noted.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 May, 2004.

9.3.3 infliximab (Remicade):  Schering Plough  (No. 101/04) 
 
9.3.1 Declarations of interest were recorded in relation to this product/comparator drugs. 

9.3.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation, summary of comments received from the company and patient interest group submission. Detailed discussion followed and the group agreed that infliximab (Remicade), for the treatment of severe ankylosing spondylitis, should not be recommended for use within NHS Scotland. Amendments to wording were noted.  

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 May, 2004.

9.4 latanoprost (Xalatan):  Pfizer  (No. 102/04)

9.4.1 Declarations of interest were recorded in relation to this product/ comparator drugs. 

9.4.2 The SMC Deputy Chairman provided a detailed overview of the assessment, the key issues identified, the draft recommendation and summary of comments received from the company.  Detailed discussion followed and the group agreed that latanoprost (Xalatan), for the reduction of elevated intraocular pressure in patients with (primary) open angle glaucoma, should be accepted for restricted use within NHS Scotland. Amendments to wording were noted.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 May, 2004.

9.5 quetiapine (Seroquel):  AstraZeneca  (No. 104/04)

9.5.1 A member with a personal specific interest in relation to this product/comparator drugs left the room for this part of the agenda.

9.5.2 The SMC Vice Chair provided a detailed overview of the assessment, the key issues identified, the draft recommendation, summary of comments received from the company and patient interest group submission.  Detailed discussion followed and the group agreed that quetiapine (Seroquel), for the treatment of manic episodes associated with bipolar disorder, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 May, 2004.

Abbreviated Submission

9.6 movicol paediatric plain:  Norgine Ltd  (No. 103/04)

9.6.1 No declarations of interest were recorded in relation to this product/comparator drugs. 

9.6.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and the group agreed that movicol paediatric plain, for the treatment of for the treatment of paediatric faecal impaction, should be accepted or use within NHS Scotland. Amendments to wording were noted.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on 7 May, 2004.

10 Forthcoming Submissions

10.1 List of Forthcoming Submissions

10.1.1 A revised list of forthcoming submissions was reviewed.   The Chairman encouraged members to inform the secretariat of any products they are aware of that are not on the forthcoming submission list to enable interaction with companies and follow up as appropriate.

11 ADTC Feedback

11.1 Unique Drugs

11.1.1 Clarification regarding unique drugs was sought.  The Chairman stated that discussions are still taking place and unique drugs will be identified upon review.

12 Any Other Business

12.1 Antibiotic Prescribing Sub Group

12.1.1 The group are scheduled to meet again in May and June and progress will be reported to SMC in July.

12.2 Consultant Document ¿ Abolition of NHS Prescription Charges in Scotland

12.2.1 The Chairman highlighted a consultation document regarding NHS prescription charges and stated that although SMC would not be in a position to comment members could comment personally if they wished to do so.

12.3 Meeting with MSPs

12.3.1 The Chairman reported on a useful meeting hosted by ABPI for MSPs.  He stated that when in the public domain, SMC summary recommendations will be circulated, through ABPI, to MSPs for information.

12.4 Devices incorporating blood products

12.4.1 The Chairman requested members consider the position of SMC with regards to the assessment of devices incorporating blood products and feedback comments for discussion at the next meeting.

13 Date of Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday 1 June, 2004, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

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