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SMC Minutes - Tuesday, 6 June 2006

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;  Mrs Michelle Caldwell;  Dr David Crookes;  Ms Carol Davidson;  Mr Tom Divers;  Dr Peter Donnan;  Mr Jim Eadie;  Dr John Haughney;  Dr Jan Jones;  Dr Harpreet Kohli;  Dr Graham Lowe;  Dr Chris Lush;  Ms Angela Munday;  Mrs Pat Murray;  Dr Ken Paterson;  Dr Andrew Power;  Ms Fiona Ramsay;  Dr Nick Reed;  Dr Philip Rutledge; Dr Sarah Taylor;  Ms Angela Timoney;  Mr Mike Wallace;  Dr John Webster;  Mr Derek Yuille.

In Attendance: Dr Jennifer Armstrong;  Dr Sara Davies;  Mrs Hazel Illingworth;  Mrs Anne Lee;  Mr Colin McAllister;  Mrs Laura McIver;  Miss Rosie Murray;  Ms Corinne O’Dowd;  Ms Melanie Salton;  Mrs Maureen Stark;  Dr Andrew Walker.

Apologies: Ms Laura Ace;  Ms Rosaleen Beattie;  Mr Nick Brown;  Mr John Glennie; Dr Barclay Goudie; Dr Grace Lindsay; Ms Wendy Nganasurian; Dr Andrew Riley; Dr Alexander Simpson; Ms Helen Tyrrell.


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 who were attending their first meeting of SMC:

  • Dr Jan Jones, Principal Pharmacist, Pharmaco-economics, Tayside,
  • Dr Andrew Power, Head of Medicines Management Team, Greater Glasgow Primary Care,
  • Dr Nick Reed, Consultant in Clinical Oncology, Beatson Oncology Centre, Glasgow
  • Dr Sarah Taylor, Director of Public Health, Shetland NHS Board, Gilbert Bain Hospital, Lerwick

The Chairman also welcomed Melanie Salton, SMC Secretary to Professor Webb, who was observing 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.

The Chairman highlighted to members the types of interest that require to be declared.

3 Minutes of the Previous Meeting

3.1 The minutes of the SMC meeting held on 2 May 2006 were agreed as an accurate record.

4 Matters Arising From the Previous Minutes

SMC Budget

The Chairman announced that NHS Quality Improvement Scotland have recently appointed a health economist, on behalf of SMC, who will be undertaking SMC Reviews.

 Disclosure of Clinical Expert Comments

At the last meeting of SMC it was reported that the Greater Glasgow and Argyll ADTC had asked if clinical expert comments could be made available locally.  This request had also been subject to discussion by the SMC User Group Forum.

The Chairman advised that SMC do not propose to make the expert comments routinely available but propose to incorporate a comment regarding expert involvement into the “Summary of Clinical Effectiveness Section” in the Detailed Advice Document, where relevant, and when these have influenced the decision.

4 Matters Arising From the Previous Minutes

SMC Budget

The Chairman announced that NHS Quality Improvement Scotland have recently appointed a health economist, on behalf of SMC, who will be undertaking SMC Reviews.

Disclosure of Clinical Expert Comments

At the last meeting of SMC it was reported that the Greater Glasgow and Argyll ADTC had asked if clinical expert comments could be made available locally.  This request had also been subject to discussion by the SMC User Group Forum.

The Chairman advised that SMC do not propose to make the expert comments routinely available but propose to incorporate a comment regarding expert involvement into the “Summary of Clinical Effectiveness Section” in the Detailed Advice Document, where relevant, and when these have influenced the decision. 

Exit Strategies from Clinical Trials

The SMC Vice Chairman reported that the Scottish Executive will take responsibility for bringing this matter forward.  Dr Sara Davies will lead on this matter. 

Progress will be reported at a future meeting of SMC.

Full Submissions

4.1  posaconazole (Noxafil) Schering-Plough (No 256/06)

4.1.1   The SMC advice for posaconazole (Noxafil), for the treatment of adults with specific invasive fungal infections refractory to or intolerant of specified antifungal agents, will be posted on the SMC website on Monday 12 June 2006.

Following comparator comments, the Detailed Advice Document has been amended.  The revised DAD will be distributed to NHSScotland on Friday 9 June and posted on the SMC website on Monday 12 June 2006.

4.2  esomeprazole (Nexium®) AstraZeneca UK Ltd (No 257/06) 

4.2.1   The SMC Advice for esomeprazole (Nexium®), for the prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory (NSAID) therapy in patients at risk, will be posted on the SMC website on Monday 12 June 2006.

4.3  esomeprazole (Nexium®) AstraZeneca UK Ltd (No: 274/06)

4.3.1  The SMC Advice for esomeprazole (Nexium®), for the healing of gastric ulcers associated with non-steroidal anti-inflammatory drug (NSAID) therapy, will be posted on the SMC website on Monday 12 June 2006.

4.4  interferon-alpha-2b/ ribavirin (Viraferon/Rebetol) Schering-Plough (No 258/06) 

4.4.1  The SMC advice for Interferon-alpha-2b/ ribavirin (Viraferon/Rebetol), for the treatment of children and adolescents three years of age and over, who have chronic hepatitis C, previously treated, without liver decompensation and who are positive for serum HCV RNA, will be posted on the SMC website on Monday 12 June 2006.

4.5  omalizumab (Xolair) Novartis (No 259/06) 

4.5.1   The SMC advice for omalizumab (Xolair), as add-on therapy to improve asthma control in adult and adolescent patients (12 years of age and above) with severe persistent allergic asthma, will be posted on the SMC website on Monday 12 June 2006. 

Re-Submissions

4.6  pegvisomant (Somavert) Pfizer Ltd (No 158/05)

4.6.1   The SMC advice for pegvisomant (Somavert), for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-1 concentrations or was not tolerated, will be posted on the SMC website on Monday 12 June 2006.

4.7  erlotinib (Tarceva) Roche (No 220/05)

4.7.1 The SMC advice for erlotinib (Tarceva), for the treatment of patients with locally advanced or metastatic non small cell lung cancer, after failure of at least one prior chemotherapy regimen, in patients who would otherwise be eligible for treatment with docetaxel monotherapy, will be posted on the SMC website on Monday 12 June 2006.

Following comments received from the company the Detailed Advice Document has been amended.  The revised DAD and will be distributed to NHSScotland on Friday 9 June and posted on the SMC website on Monday 12 June 2006.

4.8  bevacizumab (Avastin) Roche (No 221/05)

4.8.1  The 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 12 June 2006.

 Abbreviated Submissions

4.9  somatropin (Norditropin SimpleXx) Novo Nordisk Ltd (No 260/06) 

4.9.1  The SMC advice for somatropin (Norditropin SimpleXx), for the treatment of growth disturbance (current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 standard deviations, who failed to show catch-up growth (Height Velocity SDS < 0 during the last year) by 4 years of age or later, will be posted on the SMC Website on Monday 12 June 2006.

Submissions Deferred Pending Launch

4.10  Ropinirole (Adartrel) GlaxoSmithKline – Resubmission (No 165/05)

4.10.1 SMC reviewed a resubmission for ropinirole (Adartrel), for the treatment of moderate to severe idiopathic restless legs syndrome in February 2006, but SMC advice was withheld pending confirmation of license/launch.    The SMC advice will be distributed to NHSScotland on Friday 9 June and posted on the SMC website on Monday 10 July, 2006.

5 Appeals Update

Nothing to report.

6 PAPIG

Nothing to report.

7 New Drugs Committee: Chairman’s report

Nothing to report.

8 Chairman’s Business

8.1 HDL (2006) 29

The Scottish Executive have issued an HDL reflecting the need to follow advice from SMC rather than advice in NICE STAs, but to follow NICE MTAs approved by QIS. The Chairman thanked the Scottish Executive for producing this letter to clarify the position of SMC advice and NICE guidance within Scotland.

8.2 Cross Border Meeting – 19 May, 2006

The Chairman provided a brief report following a meeting with representatives from SMC, NHS QIS, SIGN, NICE and Health Scotland. He advised that this meeting had been very successful and that the group will meet annually with a further meeting being held in November 2006, which will include Wales and Northern Ireland.

8.3 Orphan Drugs

A commentary from the Quarterly Journal of Medicine on orphan drugs from Dr McCabe, and colleagues from around the UK, was previously circulated to SMC and NDC members and will be the subject for discussion at a later point.

8.4 Holyrood News

The Chairman congratulated Mike Wallace on his article regarding SMC which has been published in the Holyrood News, May 2006.  The secretariat will forward a copy to members for review and information.

9 NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1  sunitinib (Sutent) Pfizer (No 275/06)

9.1.1 The SMC assessment of sunitinib (Sutent), for the treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance, was deferred pending confirmation of final pricing and will be re-scheduled for a future meeting of SMC when this has been confirmed.

9.2  tigecycline (Tygacil) cSSSI Wyeth (No 276/06)

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

9.2.2  The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that tigecycline (Tygacil), for the treatment of complicated skin and soft-tissue infections, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 9 June 2006.

9.3  tigecycline (Tygacil) cIAI Wyeth (No 277/06)

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

9.3.2  The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that tigecycline (Tygacil), for the treatment of complicated intra-abdominal infection, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 9 June 2006.

9.4  trastuzumab (Herceptin) Roche (No 278/06)

9.4.1  There were no declarations of interest in relation to this product/comparator drugs.

9.4.2  The NDC Lead Assessor provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. A response from the manufacturer to economic questions, existing Guidelines & Protocols referred to in Expert Comments and a final Summary of Product Characteristics were tabled at the meeting. A member of PAPIG presented Patient Interest Group Submissions from Breast Cancer Care and a joint submission from Cancer Backup and Breakthrough Breast Cancer. Detailed discussion followed and the group agreed that trastuzumab (Herceptin), for the treatment of patients with HER-2 positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable), should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 9 June 2006.

9.5  cetuximab (Erbitux) Merck KGaA (No 279/06)

9.5.1  There were no declarations of interest in relation to this product/comparator drugs.

9.5.2  The SMC Vice-Chair provided a detailed 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 Mouth Cancer Foundation.  Detailed discussion followed and the group agreed that cetuximab (Erbitux), in combination with radiation therapy, for the treatment of patients with locally advanced squamous cell cancer of the head and neck should be accepted for restricted for use within NHS Scotland.  Assessors, in liaison with the secretariat, are to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 June 2006.

ABBREVIATED SUBMISSIONS

9.6  clobetasol propionate 0.05% foam (Clarelux) 3M Health Care Ltd  (No. 280/06)

9.6.1  There were no declarations of interest in relation to this product/comparator drugs.

9.6.2  The NDC Chairman provided an overview of the assessment and the draft summary of advice. Detailed discussion followed and the group agreed that clobetasol propionate 0.05% foam (Clarelux) for the short course treatment of steroid-responsive dermatoses of the scalp such as psoriasis, which do not respond satisfactorily to less active steroids, should be accepted for use within NHS Scotland. Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 9 June 2006.

9.7  rosiglitazone maleate/metformin hydrochloride (Avandamet) triple therapy GlaxoSmithKline (No 281/06)  

9.7.1  There were no declarations of interest 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 rosiglitazone maleate/metformin hydrochloride (Avandamet), for the treatment of type 2 diabetes mellitus in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 9 June, 2006.

9.8  desmopressin (DesmoMelt) Ferring Pharmaceuticals Ltd. (No 282/06)

9.8.1  There were no declarations of interest in relation to this product/comparator drugs.

9.8.2  The NDC Chairman provided an overview of the assessment and the draft summary of advice.  Discussion followed and the group agreed that desmopressin (DesmoMelt), for the treatment of primary nocturnal enuresis in patients from the age of 5 years up to 65 years, should be accepted for use within NHS Scotland.  Assessors, in liaison with the secretariat, are to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.8.3  The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 June 2006.

9.9  dinoprostone (Propess) Ferring Pharmaceuticals (No 283/06)   

9.9.1  There were no declarations of interest in relation to this product/comparator drugs.

9.9.2  The NDC Chairman provided an overview of the assessment and the draft summary of advice.  Discussion followed and the group agreed that dinoprostone (Propess), for the initiation of cervical ripening in patients at term (from 38th week of gestation), should be accepted for use within NHS Scotland.  Assessors, in liaison with the secretariat, are to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 June 2006.

9.10  testosterone (Testim) 50mg Gel Ipsen Ltd No 284/06)

9.10.1  Declarations of interest were recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the room for this part of the meeting.

9.10.2  The NDC Chairman provided an overview of the assessment and the draft summary of advice.  Discussion followed and the group agreed that testosterone (Testim) 50mg Gel replacement therapy, for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, are to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.10.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 June 2006.

10 SMC Evaluation

Nothing to report.

11 SMC User Group Forum

The Chairman of the User Group Forum advised that the minutes of the meeting held 30 May 2006 would be available at the next SMC meeting. The following three items were noted:

  • Health Economics Checklist

In response to a request from industry that the health economic checklist is made routinely available, the SMC Executive team strongly support the principle of publication, but recognise that this will require additional administrative and health economic resource, particularly in terms of formal quality assurance.  SMC propose to review the existing process and the feasibility of building the publication of the checklist into the process, and implications of this on the existing workload.  It is likely to be 6 months before this is operational.  Mr Wallace stated that he is comfortable with this approach and the commitment from SMC to publish the checklist providing this can be delivered by 1 January 2007.   

  • Comparator Medications

Following concerns raised by industry regarding SMC not recommending new products where an unlicensed product is in use, the UGF have suggested two sets of wording that could be incorporated into advice for positive and negative advice.  The SMC Chairman stated he was grateful that the UGF have taken this forward and the suggestions will now be considered by the SMC Executive.  Concern regarding the prescriber role in terms of off-label use was raised, it was reported that this has been highlighted in the Audit Scotland report and will be addressed nationally.

  • Revised Abbreviated Submission Process

A joint monitoring programme involving SMC and industry will be established to review the new abbreviated submission process   The outcome will be reported at a future meeting of SMC.

12  Forthcoming Submissions

12.1 A list of forthcoming submissions was tabled for review.

13 ADTC Feedback

Nothing to report.

14  Any Other Business

14.1 No other business was reported.

15  Date of the Next Meeting

15.1  The date of the next meeting was confirmed as Tuesday, 4 July 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.