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Tuesday 1 May 2007

Minutes of the SMC Meeting held on Tuesday 1 May 2007.

NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Professor James Barbour, Dr Keith Beard, Mrs Marion Bennie, Mrs Barbara Black, Dr Keith Brown, Professor John Cairns, Mr David Carson, Dr David Crookes, Mr Tom Divers, Mr Jim Eadie, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli , Dr Chris Lush, Dr Alan G MacDonald, Mr Billy Malcolm, Mrs Pat Murray, Professor Dilip Nathwani, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Dr Nick Reed, Dr Andrew Riley, Dr Sandy Simpson, Mr Alistair Thorburn, Ms Angela Timoney

In Attendance: Ms Ailsa Brown, Mr Scott Bryson, Ms Susan Christie, Mr Steven Fenocchi, Mr Stephen Ferguson, Ms Gail Gilbert, Mrs Hazel Illingworth, Mrs Anne Lee, Mrs Laura McIver, Ms Rosie Murray, Ms Alex Robertson, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Mrs Laura Ace, Mr Colin Brown, Dr Sara Davies, Mr John Glennie, Dr Grace Lindsay, Dr Graham Lowe, Mr Colin McAllister, Ms Aileen Muir, Ms Angela Munday, Ms Fiona Ramsay, Dr Sarah Taylor, Mr Mike Wallace


1. Welcome and Apologies for Absence

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

The Chairman welcomed the following new members of SMC who were attending their first meeting:

  • Dr Jonathan Fox, Consultant Nephrologist, Stobhill Hospital, Glasgow, and Chairman of the Greater Glasgow and Clyde ADTC, who has rotated from NDC.
  • Mr Alistair Thorburn, Primary Care Division Prescribing Advisor, Lanarkshire
  • Professor Dilip Nathwani, Consultant Physician with expertise in infectious diseases, Ninewells Hospital and Medical School, Dundee.

The Chairman welcomed Ms Susan Christie, Patient Involvement Co-ordinator, from the Roy Castle Lung Foundation and Ms Gail Gilbert, SMC Pharmacy Assessor, who were observing the meeting.

The Chairman also welcomed Mr Scott Bryson NDC member.

The Chairman offered his thanks for the invaluable contributions of Dr Philip Rutledge, Dr John Haughney and Dr John Webster, whose membership had expired in April 2007, to the work of SMC.

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

3.1 The minutes of the SMC meeting held on 03 April 2007 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

4.1 There were no matters arising from the previous minutes.

Full Submissions

4.1 infliximab (Remicade) Schering- Plough UK Ltd (Severe active Crohn’s disease) (No: 363/07)

4.1.1 The SMC advice for infliximab (Remicade), for maintenance treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies, will be posted on the SMC website on Monday, 07 May 2007.

4.2 infliximab (Remicade) Schering- Plough UK Ltd (Fistulating active Crohn’s disease (364/07)

4.2.1 The SMC advice for infliximab (Remicade), for maintenance treatment of fistulising, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy), will be posted on the SMC website on Monday, 07 May 2007.

4.3 dibotermin alfa (InductOs) Medtronic (No: 365/07)

4.3.1 The SMC advice for dibotermin alfa (InductOs ), for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary nail fixation in patients in whom there is a substantial risk of non-union, will be posted on the SMC website on Monday, 07 May 2007.

4.3.2 A minor amendment has been made to the advice box.  The amended advice will be reissued to NHS Scotland on Friday, 04 May 2007 and posted on the SMC website on Monday 07 May 2007.

4.4 topotecan hydrochloride (Hycamtin) GlaxoSmithKline (No: 366/07)

4.4.1 The SMC advice for topotecan (Hycamtin), for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate, will be posted on the SMC website on Monday, 07 May 2007.

4.5 standardised allergen extract of grass pollen from Timothy (Phleum pratense) 75,000 SQ-T per oral lyophilisate (Grazax) ALK-Abello Ltd (No: 367/07)

4.5.1 The SMC advice for lyophilisate (Grazax), for the treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen, will be posted on the SMC website on Monday, 07 May 2007.

4.6 esomeprazole (Nexium) AstraZeneca UK Ltd (No: 368/07)

4.6.1 The SMC advice for esomeprazole (Nexium), for patients in the age group 12-17 years inclusive, for the treatment of erosive reflux oesophagitis, the long-term management of patients with healed oesophagitis to prevent relapse, and the symptomatic treatment of gastro-oesophageal reflux disease, will be held in confidence until confirmation of licence and launch.

4.7 docetaxel (Taxotere) (Head and Neck Cancer) sanofi-aventis (No: 369/07)

4.7.1 The SMC advice for docetaxel (Taxotere), for the induction treatment of patients with unresectable locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin and 5-fluorouracil, will be posted on the SMC website on Monday, 07 May 2007.

4.8 dasatinib (Sprycel) Bristol-Myers Squibb Pharmaceuticals Ltd (Chronic Myeloid Leukaemia (CML) (No: 370/07)

4.8.1 The SMC advice for dasatinib, 20mg, tablets (Sprycel), for the treatment of adults with chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate, will be posted on the SMC website on Monday, 07 May 2007.

4.8.2 Following comparator comments amendments have been made to the DAD.  The amended advice will be reissued to NHS Scotland on Friday, 04 May 2007 and posted on the SMC website on Monday 07 May 2007.

4.9. dasatinib (Sprycel) Bristol-Myers Squibb Pharmaceuticals Ltd (Acute Lymphoblastic Leukaemia (ALL) (No: 371/07)

4.9.1 The SMC advice for dasatinib 20mg (Sprycel), for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia with resistance or intolerance to prior therapy, will be posted on the SMC website on Monday, 07 May 2007.

Abbreviated Submissions

4.10. testosterone gel 2% (Tostran) ProStrakan (No: 372/07)

4.10.1 The SMC advice for testosterone 2% gel (Tostran), for replacement therapy with testosterone for male hypogonadism when testosterone deficiency has been confirmed by clinical symptoms and laboratory analyses, will be held in confidence until confirmation of product availability.

4.10.2 The company has advised that the product will launch on 23 May 2007.  The advice will be distributed to NHS Scotland on Friday, 04 May 2007 and posted on the SMC website on Monday, 11 June 2007.

4.11. beclometasone dipropionate and formoterol (Fostex Modulite) Trinity-Chiesi Pharmaceuticals Ltd (No: 373/07)

4.11.2 The SMC advice for beclometasone 100mcg, formoterol 6mcg metered dose inhaler (Fostex Modulite), for the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate: patients not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short acting beta2-agonist; or patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists, will be held in confidence until confirmation of product availability.

Deferred Advice

4.12 budesonide/formoterol 100/6, 200/12 turbohaler (Symbicort SMART) AstraZeneca UK Limited (No. 362/07)

4.12.1 This product was reviewed by SMC in March 2007 for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate. The product was withheld in confidence pending product availability, however, the company has now advised that the product will launch on 7 June and advice will therefore be distributed to NHS Scotland on Friday, 04 May and published on the SMC website on Monday, 11 June, 2007.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG advised that the short listing for new members of PAPIG had taken place and interviews would take place shortly.

She was pleased that the meeting between NHSQIS Communications Department and the website developers had been a positive one and that further progress would be made.

She also advised that it was very difficult to access an up-to-date database of all the Patient Interest Groups.  The Chairman of SMC suggested that Voluntary Health Scotland or the Scottish Executive would be the best organisations to try, but asked that PAPIG do what they could to establish an accurate data base.

The minutes of the meeting held on 3 April 2007 were noted and the Chairman asked for any comments or questions to be sent to her.

7. New Drugs Committee: Chairman’s report

7.1 Chairing of NDC Meetings

The Chairman of NDC advised that the Co-Vice Chairs of NDC would be Chairing the NDC meetings in May and August 2007.

8. Chairman’s Business

8.1 HDL (2007) 26:  SMC Advice and STAs from NICE

The Chairman advised that the Scottish Executive released an HDL on 12 April 2007, regarding the status of SMC Advice and NICE STAs confirming that SMC remains the main source of advice in Scotland for the use of newly licensed medicines.

8.2 Napp Pharmaceuticals – buprenprphine transdermal patches (Butrans)

The Chairman noted that it had been brought to the attention of the SMC Executive Team that there had been a breach of confidentiality with regards to the SMC advice for the resubmission for buprenorphine transdermal patches (Butrans) which will be published on the SMC website on Monday, 07 May 2007. The Chairman reminded members that SMC has made a commitment to treat SMC advice in strict confidence pre-publication and advised that he has written to all ADTCs to reiterate this.

8.3 bevacizumab (Avastin) for the management of wet macular degeneration

The Chairman advised that he has written to ADTCs drawing their attention to a recent communication from Professor Norman Waugh, Department of Public Health, University of Aberdeen which has been circulated to Directors of Public Health highlighting a proposal to enlist commitment and support from Primary Care Trusts and NHS Boards in Scotland to use bevacizumab (Avastin) for the management of wet macular degeneration as part of a randomised controlled trial between bevacizumab (Avastin) and ranibizumab (Lucentis). The National Coordinating Centre for Health Technology Assessment (NCCHTA) has supported the trial but service costs would be borne by the NHS Boards.  Bevacizumab (Avastin) is not licensed for this indication and as SMC do not consider unlicensed medicines we would not promote the use of bevacizumab (Avastin), however, the ongoing trial will help to determine the manufacturer’s decision to progress and request a licence for this product and individual Health Boards may wish to consider their options.

8.4 Declarations of Interest

The Chairman advised that minor amendments have been made to the declarations of Interest document to take into account discussions at SMC in April.  The revised document will be sent to all members for information and posted on the SMC website. 

8.5 BMJ Article – Should you tell patients about beneficial treatments that they cannot have?

The paper was noted and discussed.

8.6 Lancet Article – Value Based Pricing of Drugs in the UK

The Chairman advised that he and Andrew Walker had written a response to the Office of Fair Trading (OFT) Report and it had been published in the Lancet.  A copy of the paper was tabled for information.

He also advised that the NDC Chairman was working on the response from SMC to the OFT report and asked that any members willing to contribute to the report contact Dr Paterson as soon as possible.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 exenatide (Byetta) Eli Lilly and Company Limited (No. 376/07)

9.1.1 A declaration of interest was recorded in relation to this product/comparator drugs. A member with a personal specific interest left the meeting for this part of the agenda.

9.1.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company.  A manufacturer’s response to economic questions dated 30 April 2007 was tabled for review. Detailed discussion followed and the group agreed to consider the advice further. It was therefore decided to defer exenatide (Byetta), for the treatment of type 2 diabetes mellitus in combination with metformin and/or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies, for review at the June meeting of SMC.

9.2 darifenacin (Emselex) Ardana Bioscience (No. 377/07)

9.2.1 A declaration of interest was recorded in relation to this product/comparator drugs. A member with a personal specific interest left the meeting for this part of the agenda.

9.2.2 The NDC Co Vice Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that darifenacin (Emselex), for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 May 2007

9.3 darunivir (Prezista) Tibotec (No. 378/07)

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

9.3.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company.  A member of PAPIG presented a Patient Interest Group Submission from HIV Scotland.  Detailed discussion followed and the group agreed that darunivir (Prezista), co-administered with ritonavir in combination with other antiretroviral medicinal products, for the treatment of human immunodeficiency virus (HIV-1) infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI), should be accepted for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 May 2007

9.4 posaconazole (Noxafil) prophylaxis Schering-Plough (No. 379/07)

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

9.4.2 The NDC Co Vice Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed the group agreed that posaconazole (Noxafil), for prophylaxis of invasive fungal infections in immunocompromised patients It is restricted to patients in whom there is a specific risk of Aspergillus infection or where fluconazole or itraconazole are not tolerated, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs  on Friday, 04 May 2007

9.5 enoxaparin (Clexane) Sanofi-Aventis (No. 380/07)

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

9.5.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group concluded their advice for enoxaparin (Clexane), for the treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary Intervention (PCI).

9.5.3 The SMC advice will be held in confidence until confirmation of product availability.

9.6 ranibizumab (Lucentis) Novartis Pharmaceuticals UK Ltd (No. 381/07)

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

9.6.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company. A member of PAPIG presented a joint Patient Interest Group Submission from the Royal National Institute of the Blind Scotland and the Macular Disease Society. Detailed discussion followed and the group agreed that ranibizumab (Lucentis), for the treatment of neovascular (wet) age-related macular degeneration (AMD), should be accepted for use within NHS Scotland. Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 May 2007

ABBREVIATED SUBMISSIONS

9.7.formoterol Easyhaler 12mcg per actuation inhalation powder Ranbaxy (UK) Ltd (No. 375/07)

9.7.1 A Declaration of interest was recorded in relation to this product comparator drugs.

9.7.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that formoterol Easyhaler 12mcg per actuation inhalation powder, for the treatment of asthma in patients treated with inhaled corticosteroids and who also require a long-acting beta2-agonist in accordance with current treatment guidelines; and for relief of reversible airways obstruction in patients with chronic obstructive pulmonary disease (COPD) and requiring long-term bronchodilator therapy, should be accepted for use within NHS Scotland.  Assessors, in liaison with the Secretariat to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 May 2007.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. ADTC Feedback

11.1 NHS Tayside Audit of New Medicine Exceptional Case Requests

The paper was discussed and noted.

12. SMC User Group Forum

12.1 The acting Chairman of the User Group Forum advised that the meeting held on Tuesday, 24 April 2007 had been a positive meeting. The issues around commercial in confidence data was raised and noted at the meeting.

The notes of the meeting will be available at the next meeting of SMC.

13. Any Other Business

No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 05 June 2007 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.