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02 October 2007

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

Present: Professor David Webb (Chairman), Mrs Laura Ace, Dr Keith Brown, Professor John Cairns, Dr David Crookes, Mr Tom Divers, Mr Jim Eadie, Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli, Mr Billy Malcolm, Ms Aileen Muir, Dr Alan MacDonald, Mrs Wendy Nganasurian, Dr Ken Paterson, Dr Andrew Power, Ms Fiona Ramsay, Dr Nick Reed, Dr Sandy Simpson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Mr Mike Wallace, Professor Tony Wells

In Attendance: Mr Bryan Archibald, Mr Scott Bryson, Dr Sara Davies, Ms Lorna Dunipace, Dr Michael Eddleston, Mr Steven Fenocchi, Mr Stephen Ferguson, Mrs Hazel Illingworth, Mrs Anne Lee, Ms Rosie Murray, Ms Corinne O’Dowd, Dr Rupert Payne, Ms Marina Shannon, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Professor James Barbour, Dr Keith Beard, Ms Marion Bennie, Ms Ailsa Brown, Mr Colin Brown, Mr David Carson, Dr Jonathan Fox, Dr Grace Lindsay, Dr Graham Lowe, Dr Chris Lush
Mrs Pat Murray Mr Colin McAllister, Mrs Laura McIver, Professor Dilip Nathwani,  Dr Andrew Riley, Ms Alex Robertson, Dr Sarah Taylor
 
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 observers to the meeting:

• Dr Rupert Payne, Clinical Lecturer, Clinical Pharmacology Unit, University of Edinburgh.
• Dr Michael Eddleston, Specialist Registrar in clinical pharmacology and toxicology, Edinburgh.
• Ms Lorna Dunipace Head of Health and Community Care, East Glasgow Community Health Partnership.
• Ms Marina Shannon, NDC Member.
• Mr Bryan Archibald, Scottish Government Policy Officer.

The Chairman also welcomed Mr Scott Bryson, NDC member, and indicated that he would be presenting a submission to 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 4 September 2007 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

There were no matters arising from the previous minutes.

Full Submissions

4.1 ertapenem 1g vial of powder for concentrate for solution for intravenous infusion (Invanz) Merck Sharp & Dohme Ltd (No. 404/07)

4.1.1 The SMC advice for ertapenem (Invanz), for the prophylaxis of surgical site infection following elective colorectal surgery in adults, will be posted on the SMC website on Monday, 08 October 2007.

4.2 ziconotide 100 micrograms/ml solution for infusion (Prialt) Eisai Ltd (No. 405/07)

4.2.1 The SMC advice for ziconotide (Prialt), for the treatment of severe, chronic pain in patients who require intrathecal analgesia, will be posted on the SMC website on Monday, 08 October 2007.

4.3 escitalopram 5mg, 10mg, 15mg and 20mg tablets and 10mg/ml oral drops (Cipralex) Lundbeck Ltd (No. 406/07)

4.3.1 The SMC advice for escitalopram (Cipralex), for the treatment of obsessive compulsive disorder, will be posted on the SMC website on Monday, 08 October 2007.

4.4 betaine anhydrous oral powder (Cystadane) Orphan Europe (No. 407/07)

4.4.1 The SMC advice for betaine anhydrous oral powder (Cystadane), as adjunctive treatment of homocystinuria in line with the manufacturer’s licence, will be posted on the SMC website on Monday, 08 October 2007.

4.5 sitagliptin 100mg tablets (Januvia) Merck Sharp & Dohme Ltd (No. 408/07)

4.5.1 The SMC advice for sitagliptin (Januvia), for the treatment of patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin when diet and exercise, plus metformin, do not provide adequate glycaemic control, will be posted on the SMC website on Monday, 08 October 2007.

RESUBMISSIONS

4.6 omalizumab 150mg powder and solvent for injection (Xolair) Novartis resubmission No. (259/06)

4.6.1 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, 08 October 2007.

ABBREVIATED SUBMISSION

4.7 budesonide 2mg rectal foam (Budenofalk) Dr Falk Pharma (No. 409/07)

4.7.1 The SMC advice for budesonide (Budenofalk Foam), for the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon, will be posted on the SMC website on Monday, 08 October 2007.

Deferred Advice

4.8 formoterol 12 micrograms metered dose inhaler (Atimos Modulite) Trinity Chiesi Ltd No. (349/07)

4.8.1 For the relief of bronch-obstructive symptoms in patients with chronic obstructive pulmonary disease (COPD).

4.8.2 This product was considered by SMC in February 2007; however, the advice was withheld pending confirmation of the product licence and availability.  The product is now available and the advice will be issued to NHSScotland on Friday, 5 October 2007 and published on the SMC website on Monday, 8 October 2007.

Amended Advice

4.9 risperidone 3mg, 4mg orodispersible tablets (Risperdal Quicklet) Janssen Cilag Ltd No. (403/07)

4.9.1 Advice for risperidone was published on the SMC website on Monday 10 September, 2007.  However, it had been brought to the attention of SMC that the indication was incorrect and included the treatment of behavioural symptoms of dementia which risperidone is not licensed for.  This has now been amended to the correct indication; accepted for restricted use for the treatment of acute and chronic schizophrenia and similar psychosis and treatment of mania in bipolar disorder.  The advice has been amended on the SMC website and will be reissued to NHSScotland on Friday, 5 October 2007.

5. Appeals Update

5.1 levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/ml (Keppra) UCB Pharma Limited 

UCB Pharma has advised of their intention to make a resubmission to SMC for levetiracetam (Keppra), for the treatment of epilepsy.

5.2 imiquimod 5% cream ( Aldara) Meda Pharmaceuticals Ltd No. (385/07)

Meda Pharmaceuticals has advised of their intention to make a resubmission to SMC for imiquimod 5% cream (Aldara), for the topical treatment of clinically typical, nonhypertrophic actinic keratoses on the face or scalp.

6. Patient and Public Involvement Group (PAPIG)

6.1 The Chairman of PAPIG advised that the advert for 2 new public partners had been circulated; the closing date for applications is 26 October 2007.  She asked the members to encourage anyone who was interested in these positions to look at the Patient and Public Involvement section of the SMC website.

7. New Drugs Committee Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 NDC Chairman

The Chairman was delighted to announce that Dr Jan Jones will succeed Dr Ken Paterson as NDC Chairman.  Dr Jones’ appointment will commence in January 2008.  Dr Andy Power and Ms Aileen Muir will continue their roles as NDC Vice Chairs.

8.2 SIGN/SMC Advice

The Chairman advised that Sir Graham Teasdale had acknowledged that SMC and SIGN were working hard to integrate their decisions and was delighted that the work policy plan was now with the CMO.

8.3 Freedom of Information

SMC have processed a request in relation to zoledronic Acid (Zometa), for the prevention of skeletal related events in patients with advanced malignancies involving bone.  The request is currently being processed by the SMC secretariat and the deadline for response is 18 October, 2007.

8.4 Scottish Management of Antimicrobial Resistance Action Plan (ScotMARAP)

The NDC Chairman advised that he and two representatives from SMC had travelled to Denmark and Sweden to carry out a scoping exercise on the antimicrobial monitoring activities operating in these countries.  In Denmark the antibiotic resistance patterns are recorded and analysed in human, animal and food isolates.  All this information is recorded in an annual report but there is no clinical input and no policy setting.

In Sweden the network of microbiology labs cover only human isolates in the 23 counties in Sweden.  They also gather details on antibiotic prescribing, bringing together antimicrobial use and resistance patterns.  Policies are developed and they produce recommendations for the service.

He advised that these had been very useful visits and that the way forward for Scotland will be discussed further at a meeting with SEHD at the end of the month.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 erdosteine (Erdotin) Edmond Pharma Sr.l/Galen Ltd (No: 415/07)

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

9.1.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that erdosteine (Erdotin), as an expectorant for the symptomatic treatment of acute exacerbations of chronic bronchitis in adults, should not be recommended 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.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 5 October 2007.

9.2 rufinamide, 100mg, 200mg and 400mg tablets (Inovelon) Eisai Ltd (No: 416/07)

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

9.2.2 The NDC Co Vice-Chair 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 Epilepsy Scotland. Detailed discussion followed and the group agreed that rufinamide (Inovelon), for adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome in patients four years and older, should not be recommended 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.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 5 October 2007.

9.3 adalimumab (Humira) Abbott Laboratories Ltd (No: 417/07)

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

9.3.2 The NDC Co Vice-Chair 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 the National Association for Colitis and Crohn’s Disease. Detailed discussion followed and updated clinical expert responses were tabled for review. The group agreed that adalimumab (Humira), for the 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, should not be recommended 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, 5 October 2007.

9.4 epoetin delta (Dynepo) Shire Pharmaceuticals Ltd (No: 418/07)

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

9.4.2 The NDC Co Vice-Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that epoetin delta (Dynepo), for the treatment of anaemia in dialysis and pre-dialysis patients with chronic renal failure, 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.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 5 October 2007.

ABBREVIATED SUBMISSIONS

9.5 tiotropium (Spiriva-Respimat) Boehringer Ingelheim Ltd (No: 411/07) 

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

9.5.2 The NDC Co Vice-Chair provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that tiotropium (Spiriva-Respimat), as maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease, is not acceptable for review as an abbreviated submission as this is a new formulation at a significantly increased cost. The secretariat will contact the company to request a full submission.

9.6 ciclesonide 80mcg, 160mcg inhaler (Alvesco) Altana pharma Ltd (No: 412/07) 

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

9.6.2 The NDC Co Vice-Chair provided an overview of the assessment and draft summary of advice. Discussion followed and the group agreed that ciclesonide (Alvesco), at high doses (up to 640mcg daily for up to 12 weeks) to control persistent asthma in adolescents and adults (12 years and older), 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, 5 October 2007.

9.7 conjugated estrogen 0.3mg tablet (Premarin) Wyeth Pharmaceuticals (No: 413/07)

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

9.7.2 The NDC Co Vice-Chair provided an overview of the assessment and draft summary of advice. Discussion followed and the group agreed that conjugated estrogen (Premarin), as hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women, 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, 5 October 2007.

9.8 rivastigmine 4.6mg/24h and 9.5mg/24h transdermal patch (Exelon) Novartis Pharmaceuticals UK Limited (No: 414/07)

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

9.8.2 The NDC Co Vice-Chair provided an overview of the assessment and draft summary of advice. Discussion followed and the group concluded their advice for rivastigmine transdermal patch (Exelon), for symptomatic treatment of moderately severe Alzheimer’s dementia.

9.8.3 The SMC advice will be withheld pending confirmation of licence and availability.

Non-Submission

9.9 dexrazoxane (Cardioxane) Novartis Pharmaceuticals Ltd  (No: 419/07)

9.9.1 In the absence of a submission from the holder of the marketing authorisation, dexrazoxan (Cardioxane), for the prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic cancer patients after previous anthracycline containing treatment, should not be recommended for use within NHS Scotland.

9.9.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 5 October 2007.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

12. ADTC Feedback

Nothing to report.

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, 06 November 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.