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SMC Minutes - Wednesday, 4 January 2006

Minutes of Meeting held on Wednesday, 4 January 2006
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman)m, Dr Keith Beard, Mrs Marion Bennie, Mrs Barbara Black, Dr Keith Brown, Professor John Cairns, Dr David Crookes, Mr Tom Divers, Dr Barclay Goudie, Dr John Haughney, Mrs Moira Howie, Dr Jan Jones, Ms Grace Lindsay, Mrs Angela Munday, Mrs Pat Murray, Ms Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Riley, Dr Philip Rutledge, Dr Sandy Simpson, Ms Angela Timoney, Ms Helen Tyrrell, Mr Mike Wallace,
Dr John Webster, Mr Derek Yuille

In Attendance: Mr Scott Bryson, Ms Alison Campbell, Ms Eileen Conkie, Ms Sara Davies,
Dr Jonathan Fox, Mrs Anne Lee, Mrs Laura McIver, Ms Aileen Muir, Miss Rosie Murray, Ms Corinne O¿Dowd, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Mrs Laura Ace, Dr Jennifer Armstrong, Professor James Barbour, Mrs Michelle Caldwell, Dr Peter Donnan, Mr John Glennie, Dr David Hood, Dr Harpreet Kohli, Dr Graham Lowe, Dr Chris Lush, Mr Colin McAllister, Mrs Pat Murray, Dr Marianne Nicolson, Mr Chris Nicholson, Mrs Fiona Ramsay

1 Welcome and Apologies for Absence

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

1.2 A welcome was extended to the following who were observing the work of the SMC:

  • Mr Scott Bryson, NDC Member
  • Ms Alison Campbell, NDC Member
  • Ms Eileen Conkie, Clinical Assessor, NDC
  • Dr Jonathan Fox, NDC Member
  • Ms Aileen Muir, NDC Member
  • Ms Corinne O¿Dowd, Health Economic Trainee

1.3 Ms Marion Bennie was welcomed back to the committee after a period of maternity leave.

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 - 6 December 2005

3.1 The minutes of the meeting of 6 December, 2005, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 NICE Consultation on the Single Technology Assessment (STA) Process

4.1.1 A draft response to the NICE consultation on the STA process was tabled for review.  Detailed discussion followed and views were noted. The paper will be revised in line with the discussion and submitted to NICE within the given timeframe.

Full Submissions

4.2 bevacizumab (Avastin)  Roche  (No. 221/05)
  
4.2.1 SMC advice for bevacizumab (Avastin), for first-line treatment of patients with metastatic carcinoma of the colon or rectum, will be posted on the SMC website on Monday 9 January, 2006.

4.3 tipranavir (Aptivus)  Boehringer Ingelheim  (No 226/05)
                                
4.3.1 SMC advice for tipranavir (Aptivus), for the treatment of HIV-1 infection in highly pre-treated adult patients with virus resistant to multiple protease inhibitors, will be posted on the SMC website on Monday 9 January, 2006.

4.4 estradiol  1mg/drospirenone (Angeliq) Schering Healthcare  (No. 227/05)

4.4.1 SMC advice for estradiol 1mg/drospirenone (Angeliq), for the prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or have contra-indications to, other medicinal products approved for the prevention of osteoporosis, will be posted on the SMC website on Monday 9 January, 2006.
  
4.5 estradiol  1mg/drospirenone (Angeliq)  Schering Healthcare  (No. 230/05)

4.5.1 SMC advice for estradiol 1mg/drospirenone (Angeliq), as hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women more than 1 year post-menopause, will be posted on the SMC website on Monday 9 January, 2006.

4.6 ibandronate (Bonviva)  Roche  (No. 228/05)

4.6.1 Following the awaited confirmation of the license from the EMEA, SMC advice for ibandronate (Bonviva), for the treatment of osteoporosis in postmenopausal women in order to reduce the risk of vertebral fractures, will be posted on the SMC website on Monday 9 January, 2006.

Resubmissions

4.7 olopatadine (Opatanol)  Alcon Labs (UK) Ltd  (No. 59/03) 
                                           
4.7.1 SMC advice for olopatadine (Opatanol), for the treatment of ocular signs and symptoms of seasonal allergic conjunctivitis, will be posted on the SMC website on Monday 9 January, 2006.
 
4.8 metformin HCl (Glucophage SR)  Merck Pharma Ltd  (No. 148/04)
    
4.8.1 SMC advice for metformin HCl (Glucophage SR), for the treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, will be posted on the SMC website on Monday 9 January, 2006.

Abbreviated Submissions

4.9 mesalazine (Asacol)  Procter and Gamble  (No. 222/05)

4.9.1 SMC advice for mesalazine (Asacol), for the treatment of moderate acute exacerbations of ulcerative colitis, will be withheld pending confirmation of launch.

4.10 mesalazine (Asacol)  Procter and Gamble  (No. 223/05)

4.10.1 SMC advice for mesalazine (Asacol), for the treatment of mild acute exacerbations of ulcerative colitis, will be withheld pending confirmation of launch.

4.11 mesalazine (Asacol)  Procter and Gamble  (No. 224/05)

4.11.1 SMC advice for mesalazine (Asacol), for the maintenance of remission in ulcerative colitis and Crohn's ileo-colitis, will be withheld pending confirmation of launch.

4.12 olmesartan (Olmetec Plus)  Sankyo Pharma UK Ltd  (No. 225/05)

4.12.1 SMC advice for olmesartan (Olmetec Plus), for the treatment of hypertension as an alternative in patients unable to tolerate an ACE inhibitor, will be withheld pending confirmation of launch.

4.13 lansoprazole oro-dispersible tabs (Zoton Fas Tab)  Wyeth  (No. 229/05)

4.13.1 SMC advice for lansoprazole oro-dispersible tabs (Zoton Fas Tab), for the eradication of Helicobacter pylori from the upper gastrointestinal tract in patients with ulcer-like dyspepsia in whom Helicobacter pylori infection has been demonstrated, will be posted on the SMC website on Monday 13 February, 2006.

5 Appeals Update

5.1 bevacizumab (Avastin) and erlotinib (Tarceva)  Roche

5.1.1 Roche have advised of their intention to make resubmissions to SMC for the following products:

  • bevacizumab (Avastin) for first-line treatment of patients with metastatic carcinoma of the colon or rectum
  • erlotinib (Tarceva) for the treatment of non-small cell lung cancer.

6 PAPIG

6.1 The next meeting on PAPIG will be on Tuesday 6 February, 2006.

7 New Drugs Committee:  Update

7.1 Nothing to report.

8 Chairman's Business

8.1 Nothing to report.

9 NDC Assessment Reports - Full Submissions

9.1 tramadol HCl/paracetamol (Tramacet)  Janssen-Cilag  (No. 236/06)

9.1.1 No 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 advice, expert comments and comments from the company. Detailed discussion followed and group agreed that tramadol HCl/paracetamol (Tramacet), for the symptomatic treatment of moderate to severe pain, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.  
 
9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006.

9.2 sildenafil citrate (Revatio)  Pfizer Ltd  (No. 235/06)

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

9.2.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice and expert comments.  Detailed discussion followed and group concluded their advice for sildenafil citrate (Revatio), for the treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity.

9.2.3 The SMC advice will be withheld pending confirmation of licence/launch. 

9.3 buprenorphine (BuTrans transdermal patches)  Napp Pharmaceuticals   (No. 234/06)

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

9.3.2 The NDC Lead Assessor provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. Patient Interest Group Submissions from Pain Concern and Pain Association Scotland were presented for review. Detailed discussion followed and group agreed that buprenorphine (BuTrans transdermal patches), for the treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesics, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006.

Resubmissions

9.4 nicotinic acid (Niaspan)  Merck Pharmaceuticals  (No. 93/04) 

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

9.4.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. Detailed discussion followed and group agreed that nicotinic acid (Niaspan), for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006.

9.5 emtricitabine (Emtriva)  Gilead Sciences Ltd  (No. 105/04)

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

9.5.2 The NDC Lead Assessor provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. A Patient Interest Group submission from HIV Scotland was presented for review. Detailed discussion followed and group agreed that emtricitabine (Emtriva), for the treatment of Human Immunodeficiency Virus (HIV-1) infected adults, in combination with other antiretroviral agents, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice. 

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006

Abbreviated Submissions

It was agreed that in view of the complexity of abbreviated submissions coming through SMC further guidance is required.  A short-life working group, led by the NDC Chairman, will therefore be set up to review the current process and bring to SMC a proposal on how it might be considered.

9.6 emtricitabine/tenofovir disoproxil (Truvada) Gilead Sciences Limited  No.  237/06

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

9.6.2 The NDC Lead Assessor provided an overview of the assessment and the draft summary of advice. Discussion followed and group agreed that emtricitabin/tenofovir disoproxil (Truvada), for the treatment of Human Immunodeficiency Virus (HIV-1) infected adults, in combination with other antiretroviral medicinal products, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006

9.7 clarithromycin 125 mg, 187.5 mg, 250 mg granules for oral suspension (ClaroSip) Grunenthal Ltd  (No. 217/05)

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

9.7.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and group agreed that clarithromycin 125 mg, 187.5 mg, 250 mg granules for oral suspension (ClaroSip), for the treatment of acute and chronic infections caused by clarithromycin susceptible organisms, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006

9.8 ibuprofen intravenous injection 5mg/ml (Pedea)  Orphan Europe (UK)  (No. 233/06)
                                                                                              
9.8.1 No declarations of interest were recorded in relation to this product/comparator drugs.

9.8.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that ibuprofen intravenous injection 5mg/ml (Pedea), for the treatment of haemodynamically significant patent ductus arteriosus in pre-term newborn infants of less than 34 weeks gestational age, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006

9.9 rabeprazole sodium (Pariet)  Eisai Ltd  (No. 232/06)

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

9.9.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that rabeprazole sodium (Pariet), for the treatment of Zollinger-Ellison syndrome, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.                                  

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006

9.10 lanreotide (INN BAN) (Somatuline LA)  Ipsen Ltd  (No. 231/06)

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

9.10.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and the group agreed that lanreotide (INN BAN) (Somatuline LA), for the treatment of thyrotrophic adenomas when the circulating level of thyroid stimulating hormone remains inappropriately high after surgery and/or radiotherapy, is not suitable for review as an abbreviated submission. The secretariat to request a full submission from the manufacturer.

9.11 dorzolamide hydrochloride (Trusopt)  Merck Sharp and Dohme  (No. 238/06)

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

9.11.2 The NDC Chairman provided an overview of the assessment and draft summary of advice. Discussion followed and the group agreed that further information is required before a decision can be made.  Therefore, dorzolamide hydrochloride (Trusopt), for the treatment of elevated ocular pressure in ocular hypertension, open-angle glaucoma and pseudo-exfoliative glaucoma, will be deferred for consideration at the SMC meeting on 7 February, 2006.

9.12 formoterol 12 micrograms metered dose inhaler (Atimos Modulite) Trinity Chiesi (No.239/06)

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

9.12.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that formoterol (Atimos Modulite), for the long-term symptomatic treatment of persistent, moderate to severe asthma in patients requiring regular bronchodilator therapy, in combination with long-term anti-inflammatory therapy, (inhaled and/or oral glucocorticoids), should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

9.12.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 6 January, 2006

10 Forthcoming Submissions

10.1 A revised list of forthcoming submissions was reviewed.

11 ADTC Feedback

11.1 trastuzumab (Herceptin)

11.1.1 An update was requested with regards to trastuzumab (Herceptin). The Chairman advised that a submission for this product is awaited subject to licensing.  On confirmation of licensing plans, and subsequent receipt of an application from Roche, SMC will immediately begin their assessment process.

12 SMC User Group Forum

12.1 A copy of the minutes from the SMC User Group Forum was tabled for review.  The following items were noted:

12.1.1 Off Label Comparators

There remains concern from industry regarding the use of off label comparators. The SMC User Group will continue to work with SMC to resolve any outstanding issues.

12.2 Post Clinical Trials/Patient Continuation Exit Strategies

12.2.1 It was reported that progress is slow, but a paper is being prepared for consideration by ABPI and if this fails to progress it will be brought to SMC for review and comment.

13 Any Other Business

13.1 Licence and Launch

13.1.1 There was discussion about the difference between the terms licence, launch, promotion and marketing. The ABPI representative will prepare a paper, for review at the February meeting of SMC, outlining the different terms and their definition. 

14 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday, 7 February, 2006 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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