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SMC Minutes - Tuesday 1 March 2005

Minutes of Meeting held on Tuesday 1 March 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Mr Jeff Ace, Professor James Barbour, Mrs Marion Bennie, Mrs Barbara Black, Professor Martin Brodie, Professor John Cairns, Ms Michelle Caldwell,
Mr Tom Divers, Dr Peter Donnan, Dr Barclay Goudie, Dr David Hood, Dr John Haughney,
Dr Chris Lush, Ms Angela Munday, Ms Wendy Nganasurian, Dr Ken Paterson, Ms Fiona Ramsay,
Dr Sandy Simpson, Dr Philip Rutledge, Ms Helen Tyrrell, Mr Mike Wallace, Mr Derek Yuille

In Attendance: Mrs Alison Campbell, Mr Paul Gibbons, Dr Jan Jones, Mrs Laura McIver, Ms Aileen Muir, Miss Rosie Murray, Mrs Maureen Stark

Apologies: Dr Keith Beard, Ms Chris Beech, Dr Corri Black, Mr John Glennie, Mrs Moira Howie,
Dr Harpreet Kohli, Professor Angus MacKay, Mr Hector MacKenzie, Dr Marianne Nicholson,  
Mr Chris Nicolson, Dr Andrew Riley, Ms Fiona Scott, Ms Angela Timoney, Ms Pamela Warrington,
Dr John Webster

1. Welcome and Apologies for Absence

1.1 The Chairman welcomed members and apologies for absence were noted.

1.2 A welcome was extended to the following observers:

  • Mrs Alison Campbell, New Drugs Committee
  • Dr Jan Jones, New Drugs Committee
  • Ms Aileen Muir, New Drugs Committee

2. Declarations of Interest

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

3. Minutes of the Previous Meeting (01.02.04)

3.1 The minutes of the meeting of 1 February, 2004, were agreed as an accurate record of the meeting.

4. Matters Arising From the Previous Minutes

4.1 Medicines and Healthcare products Regulatory Agency (MHRA) Regulations - SMC Response

4.1.1 Dr Paterson advised that the final SMC response to the discussion paper on key committees and conflicts of interest, had been submitted to the MHRA.  A copy of the response will be provided to members for information.

4.2 Issue of SMC Advice for methylphenidate (Equasym XL) ( No. 99/04) Celltech

4.2.1 Members were asked to note that following confirmation of the product licence, advice on methylphenidate (Equasym XL) would be issued to NHS Boards and Area Drug & Therapeutic Committees (ADTCs) on 04 March 2005 and released into the public domain on 11 April 2005.

4.3 Freedom of Information (Scotland) Act 2001 (FOI)

4.3.1 Mr Gibbons tabled a draft protocol for dealing with FOI requests to SMC (and its New Drugs Committee), NHS Boards, ADTCs and members of these bodies.  Members of SMC were asked to consider the draft and forward comments to the Secretariat.   On receipt of final comments, the protocol will be finalised and distributed to NHS Boards and ADTCs for implementation.

4.3.2 Mr Gibbons provided an illustration of the type of FOI request that had been received to date and explained that in accordance with the draft protocol, interim measures had been taken to ensure correct and timely responses.  The Chairman requested that Mr Gibbons report back to SMC at a later stage on the number and type of FOI requests received and the effectiveness of the protocol for dealing with them.

4.3.3 Mr Gibbons reminded members of the Consortium that they should not retain SMC papers after a meeting had taken place.  SMC will hold the master dataset and all requests for information will be responded to with information drawn from the master dataset.

FULL SUBMISSIONS

4.4 letrozole (Femara): Novartis  (No. 152/05)

4.4.1 SMC advice for letrozole (Femara), for the treatment of invasive early breast cancer, will be posted on the SMC website on Monday 7 March 2005.

4.5 atomoxetine (Strattera): Eli Lilly & Company (No. 153/04)

4.5.1 SMC advice for atomoxetine (Strattera), for the treatment of attention deficit/hyperactivity disorder (ADHD), will be posted on the SMC website on Monday 7 March 2005.   Minor amendments to wording were noted and will be advised to ADTCs and NHS Boards on Monday 7 March 2005.
 
4.6 gemcitabine/paclitaxel (Gemzar): Eli Lilly & Company (No. 154/05)

4.6.1 SMC advice for gemcitabine/paclitaxel (Gemzar), for the treatment of metastatic breast cancer, will be posted on the SMC website on Monday 7 March 2005.  Minor amendments to wording were noted and will be advised to ADTCs and NHS Boards on Monday 7 March 2005.

4.7 cetuximab (Erbitux):  Merck Pharma (No. 155/05) 

4.7.1 SMC advice for cetuximab (Erbitux), for the treatment of metastatic colorectal cancer, will be posted on the SMC website on Monday 7 March 2005.  Minor amendments to wording were noted and will be advised to ADTCs and NHS Boards on Monday 7 March 2005.

4.8 bivalirudin (Angiox): Nycomed UK (No. 156/05)

4.8.1 SMC advice for bivalirudin (Angiox), for use as an anticoagulant in patients undergoing percutaneous coronary intervention, will be posted on the SMC website on website on Monday 7 March 2005.

It was noted that a number of price changes had been made for this product.  Whilst it was considered that prescribers in NHS Scotland were normally very aware of such changes, it was agreed that a statement should be issued to NHS Boards and posted on the SMC website indicating that SMC advice is based on the price at the time of assessment and NHS boards should be aware that subsequent prices changes are possible.

4.9 pregabalin (Lyrica): Pfizer Ltd (No. 157/05)

4.9.1 SMC advice for pregabalin (Lyrica), for the treatment of neuropathic pain, will be posted on the SMC website on Monday 7 March 2005.

5. Appeals Update

5.1 There were no appeals to report

6. Patient and Public Involvement Group (PAPIG)

6.1 Mrs Nganasurian reported that the regular PAPIG meeting had taken place immediately prior to the SMC meeting and minutes would be available for consideration at the SMC meeting on 5 April 2005.

7. New Drug Committee: Update

7.1 Review of recent New Drugs Committee (NDC) meeting

7.1.1 The Chairman of NDC advised that whilst 8 full and 6 abbreviated submissions were considered by NDC on 25 January 2005, only 7 full and 4 abbreviated submissions would be carried forward for consideration by SMC on 5 April 2005. 

8. Chairman's Business

8.1 SMC Annual Report 2004

8.1.1 The Chairman advised that the SMC Annual Report 2004, was in the final stages of preparation and publication was expected within the following few weeks.  He thanked all those who had contributed, with particular thanks to Mrs Naganasurian, PAPIG, and Mr Wallace, ABPI.

8.2 Secretariat IT Difficulties

8.2.1 The Chairman indicated that the IT difficulties reported over December 2004/January 2005 had largely been addressed.  However, SMC were developing a Service Level Agreement with NHS Quality Improvement Scotland (NHSQiS) to ensure continuity of service in the future.

8.3 Expert Advice Panel

8.3.1 It was agreed that the working group charged with the establishment of an SMC panel of clinical experts should be re-constituted to develop the Expert Advice Panel further, in line with SMC's progress and development.   Dr Philip Rutledge will chair the working group.

8.4 Press Article on zoledronic acid (Zometa)

8.4.1 The recent press article concerning SMC and zoledronic acid (Zometa) was noted. 

8.5 Acetylcholinesterase Inhibiting Drugs for Alzheimer's Disease

8.5.1 The preliminary NICE Guidance on acetylcholinesterase inhibiting drugs for Alzheimer's disease, was noted with interest.

9. NDC Assessment Reports - Full Submissions

Members were reminded that Key Points were no longer included in the submission documentation.  The focus of discussion would therefore centre around the Detailed Advice Documents for each submission.

9.1 pegvisomant (Somavert):  Pfizer  (No: 158/05)

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

9.1.2 The NDC Chairman provided a detailed overview of the assessment, the draft recommendation, and expert comments.  A lengthy and detailed discussion followed and the group agreed that pegvisomant (Somavert), for the treatment of patients with acromegaly should not be recommended for use within NHS Scotland. Amendments to wording were noted.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 March 2005.
 
9.2 eflornithine 11.5% cream (Vaniqa):  Shire Pharmaceuticals  (No: 159/05)

9.2.1 A declaration of interest was recorded in relation to this product/comparator drugs.  An observer with a personal specific interest left the room during this agenda item.
   
9.2.2 The NDC Interim Vice Chairman provided a detailed overview of the assessment, the draft recommendation, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that eflornithine 11.5% cream (Vaniqa), for facial hirsutism in women, 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 Friday 4 March 2005.

9.3 triptorelin (Gonapeptyl Depot):  Ferring Pharmaceuticals  (No: 160/05)

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

9.3.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft recommendation, expert comments, and comments received from the company. Detailed discussion followed and the group agreed that triptorelin (Gonapeptyl Depot), for precocious puberty, should be accepted 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 Friday 4 March 2005.

9.4 candesartan cilexetil (Amias):  Takeda Uk Ltd  (No: 161/05)

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

9.4.2 The NDC Chairman provided a detailed overview of the assessment, the draft recommendation, expert comments and comments received from the company. Detailed discussion followed and the group agreed that candesartan cilexetil (Amias), for the treatment of heart failure with left ventricle systolic dysfunction, should be accepted for use within NHS Scotland.  Amendments to wording were noted.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 March 2005.

9.5 valsartan (Diovan):  Novartis  (No: 162/05)

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

9.5.2 The NDC Chairman provided a detailed overview of the assessment, draft recommendation, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that valsartan (Diovan), for the treatment of patients, post MI, with left ventricular failure and/or left ventricular systolic dysfunction, should be accepted for restricted use within NHS Scotland. Amendments to wording were noted.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 March 2005.

9.6 anagrelide hydrochloride (Xagrid):  Shire Pharmaceuticals:  (No: 163/05)

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

9.6.2 The NDC Vice Chairman provided a detailed overview of the assessment, draft recommendation, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that anagrelide hydrochloride (Xagrid), for the reduction of elevated platelet counts in patients with essential thrombocythaemia, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 March 2005.

RE-SUBMISSION

9.7.1 adefovir dipivoxil (Hepsera)  Gilead Sciences:  (No: 54/03)

9.7.2 A declaration of interest was recorded in relation to this product/comparator drugs. 

9.7.3 The NDC Chairman provided a detailed overview of the assessment, draft recommendation, comments received from the company and expert comments.  Detailed discussion followed and the group agreed that adefovir dipivoxil (Hepsera) for the treatment of Hepatitis B, should be accepted for restricted use within NHS Scotland. Amendments to wording were noted.

9.7.4 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 March 2005. 

9.8 eplerenone (Inspra)  Pfizer  (No: 136/04)

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

9.8.2 The NDC Chairman provided a detailed overview of the assessment, draft recommendation, comments received from the company and expert comments. Detailed discussion followed and the group agreed that eplerenone (Inspra) for the treatment of LV dysfunction and clinical evidence of heart failure early after MI, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 4 March 2005. 

10. Forthcoming Submissions
 
10.1 A list of forthcoming submissions was noted.

11. ADTC Feedback

11.1 No matters were raised in relation to ADTCs.

12. ABPI Code of Practice

12.1 The revised SMC response to the ABPI Code of Practice, was noted with minor amendments to wording.

13. Any Other Business

13.1 Review of Membership

The Chairman advised that the annual review of membership was due.  It was expected that there would be a natural rotation of 2-3 members.  The secretariat will seek nominations for replacements from the appropriate NHS Boards.

13.2 Seminar for SMC members

It was agreed that a half-day seminar should be arranged for SMC and NDC members, just before or after the summer break, to allow time for the full discussion of topical issues.

13.3 NICE /SIGN and SMC Advice

It was noted that NHSQiS outputs refer to NICE Guidance but do not make it clear that the NICE Guidance supercedes SMC guidance.  It was also considered necessary to have further dialogue with SIGN to determine whether the same stance should be taken with SIGN Guidelines, bearing in mind that SIGN do not always consider cost effectiveness in their Health Technology Assessments (HTAs).

It was agreed that the Chairman would clarify these issues with NHSQiS and the Scottish Executive Health Department.

14. Date of Next Meeting

 The date of the next meeting was confirmed as Tuesday 5 April, 2005, 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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