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Tuesday 4 September 2007

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

Present: Professor David Webb (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mrs Marion Bennie, Mrs Barbara Black, Dr Keith Brown, Mr David Carson, Dr David Crookes, Mr Tom Divers Mr Jim Eadie, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Mr Billy Malcolm, Dr Alan MacDonald, Dr Ken Paterson, Dr Andrew Power, Ms Fiona Ramsay, Dr Sandy Simpson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James

In Attendance: Ms Ailsa Brown, Dr Jennifer Burn,s Dr Sara Davies, Dr Michael Eddleston, Mr Stephen Ferguson, Mrs Hazel Illingworth, Mrs Anne Lee, Dr John McElhinney, Mrs Laura McIver, Ms Karen Murray
Ms Rosie Murray, Ms Alex Robertson, Mrs Maureen Stark, Dr Andrew Walker

Apologies: Mr Colin Brown Professor, John Cairns, Mr Steven Fenocchi, Dr Harpreet Kohli, Dr Grace Lindsay, Dr Graham Lowe, Mr Colin McAllister, Ms Aileen Muir, Mrs Pat Murray, Professor Dilip Nathwani,  Mrs Wendy Nganasurian, Dr Nick Reed, Dr Andrew Riley, Dr Sarah Taylor, Mr Mike Wallace, Professor Tony Wells

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 Michael Eddleston, Specialist Registrar in clinical pharmacology and toxicology, Edinburgh
  • Ms Karen Murray, Director, East Dunbartonshire Community Health Partnership

The Chairman also welcomed the following NDC members and indicated that they would be presenting submissions to SMC:

  • Dr Jennifer Burns
  • Dr John McElhinney

Mrs Barbara Black, Public Partner Member, having completed a four year term of office, was attending her last SMC meeting.  The Chairman thanked Mrs Black for supporting the interests of patient and public involvement and for the valuable contribution she had made to the work of SMC.

1.2 Establishment of a Quorum for  SMC Meetings

SMC meetings are normally very well attended.  However, in the absence of a formal quorum it was proposed that a quorum be set at fifty percent of the membership plus one.  Members discussed and approved the proposal.

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 07 August 2007 were agreed as an accurate record, with minor amendments to wording.

4. Matters Arising From the Previous Minutes

There were no matters arising from the previous minutes.

Full Submissions

4.1 testosterone 300 microgram/24hours transdermal patch (Intrinsa TTP) Procter & Gamble Pharmaceuticals UK Ltd (No. 398/07)

4.1.1 The SMC advice for testosterone transdermal patch (Intrinsa TTP), for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant oestrogen therapy, will be posted on the SMC website on Monday, 10 September 2007.

4.2 levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra) as adjunctive therapy UCB Pharma Limited (No. 394/07) 

4.2.1 The SMC advice for levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra), as adjunctive therapy, in the treatment of partial onset seizures with or without secondary generalisation in children from 4 years of age with epilepsy, will be posted on the SMC website on Monday, 10 September 2007.

4.3 levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra) as adjunctive therapy UCB Pharma Limited (No: 395/07)

4.3.1 The SMC advice for levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra), as adjunctive therapy, in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy, will be posted on the SMC website on Monday, 10 September 2007.

4.4 levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra) as adjunctive therapy UCB Pharma Limited  (No: 396/07)  

4.4.1 The SMC advice for levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra), as adjunctive therapy, in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with generalised idiopathic epilepsy, will be posted on the SMC website on Monday, 10 September 2007.

4.5levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra) as monotherapy UCB Pharma Limited  (No. 397/07)

4.5.1 The SMC advice for levetiracetam 250, 500, 750 and 1000mg tablets and levetiracetam oral solution 100mg/1ml (Keppra) as monotherapy, in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy, will be posted on the SMC website on Monday, 10 September 2007.

4.6 pioglitazone 15mg, 30mg and 45mg tablets (Actos) Takeda UK Ltd (No. 399/07) 

4.6.1 The SMC advice for pioglitazone 15mg, 30mg and 45mg tablets (Actos), in combination with insulin, for the treatment of type 2 diabetes mellitus patients with insufficient glycaemic control on insulin for whom metformin is inappropriate because of contraindications or intolerance, will be posted on the SMC website on Monday, 10 September 2007.

4.7 abatacept 250mg powder concentrate for solution (Orencia) Bristol Myers Squibb Pharmaceuticals Ltd  (No. 400/07)

4.7.1 The SMC advice for abatacept 250mg powder concentrate for solution (Orencia), for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease modifying anti rheumatic drugs (DMARDs) including at least one tumour necrosis factor (TNF) inhibitor, will be posted on the SMC website on Monday, 10 September 2007.

4.8 capecitabine150mg and 500mg tablets (Xeloda)  Roche (No. 401/07)

4.8.1 The SMC advice for capecitabine150mg and 500mg tablets (Xeloda), for the first line treatment of patients with advanced gastric cancer in combination with a platinum based chemotherapy regimen, will be posted on the SMC website on Monday, 10 September 2007.

RESUBMISSIONS

4.9 sodium oxybate 500mg/ml oral solution (Xyrem) UCB Pharma Limited (No. 246/06)   

4.9.1 The SMC advice for sodium oxybate 500mg/ml oral solution (Xyrem), for the treatment of cataplexy in adult patients with narcolepsy, will be posted on the SMC website on Monday, 10 September 2007.

4.10 natalizumab 300mg concentrate, for solution for infusion, (Tysabri) Biogen Idec Ltd  (No.329/06)           

4.10.1 The SMC advice for natalizumab 300mg concentrate, for solution for infusion, (Tysabri), as single disease modifying therapy in highly active relapsing remitting multiple Sclerosis (RRMS) for the following patient groups; patients with high disease activity despite treatment with beta-interferon and in patients with rapidly evolving severe RRMS, will be posted on the SMC website on Monday, 10 September 2007.

ABBREVIATED SUBMISSION

4.11 tacrolimus 0.5mg, 1mg, 5mg prolonged release capsules (Advagraf) Astellas Pharma Ltd (No. 402/07) 

4.11.1 The SMC advice for tacrolimus 0.5mg, 1mg, 5mg prolonged release capsules (Advagraf), for prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients will be posted on the SMC website on Monday, 10 September 2007.

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

4.12.1 The SMC advice for risperidone 3mg, 4mg orodispersible tablets (Risperdal Quicklet), for the treatment of acute and chronic schizophrenia and similar psychosis and episodes of mania in bipolar disorder, will be posted on the SMC website on Monday, 10 September 2007.

Non submission

4.13 celecoxib  (Celebrex)  Pfizer (No. 410/07)

4.13.1 The SMC advice for celecoxib (Celebrex), for the treatment of ankylosing spondylitis, will be posted on the SMC website on Monday, 10 September 2007.

5. Appeals Update

5.1 pregabalin, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg capsules (Lyrica )  Pfizer No.  (389/07)

Pfizer Ltd has advised of their intention to make a resubmission to SMC for pregabalin (Lyrica), for the treatment of central neuropathic pain in adults.

5.2 beclometasone dipropionate 5mg tablet (Clipper)

Trinity Chiesi Pharmaceuticals has advised of their intention to make a resubmission to SMC for beclometasone dipropionate 5mg tablet (Clipper), for the treatment of mild to moderate ulcerative colitis in active phase, as add-on therapy to 5-ASA containing drugs.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the  meeting held on 07 August 2007

The minutes of the PAPIG meeting held on 07 August 2007 were noted.

7. New Drugs Committee Chairman’s Report

7.1 The NDC Chairman had nothing to report.

8.Chairman’s Business

8.1 Health Select Committee Visit - 5 July 2007

The Health Select Committee is currently reviewing the work of NICE and had requested a meeting with SMC to provide Committee members with an opportunity to explore the relationship between SMC and NICE, and the differences and similarities in their respective roles and process.  The meeting took the form of presentations from various members of the SMC Executive and Assessment Teams followed by a lively and challenging discussion.   The Chairman advised that the meeting had in his view been very successful and the Committee appeared to be generally supportive of the work of SMC.  He looked forward to receiving details of the Committee’s findings when their report on NICE is published.  The report will be circulated to SMC members for information.

8.2 Office of Fair Trading (OFT) Market Study in Pharmaceutical Price Regulation Scheme (PPRS) - Acknowledgement of SMC response

An acknowledgement has been received from the Office of Fair Trading (OFT) in relation to SMC’S response to the OFT Market Study into the Pharmaceutical Price Regulation Scheme (PPRS).  A copy of the response is available to SMC and NDC members on request.

8.3 Meeting with Representatives of the Department for Business, Enterprise and Regulatory Reform

Representatives of the Department for Business Enterprise and Regulatory Reform (BERR), who are leading the Government response to the Office of Fair Trading Report on PPRS,  recently met with  representatives of the SMC Executive Team to gain an understanding of SMC's role and remit, it's assessment process and its operating costs, in comparison with NICE.  The Government response will follow a widespread consultation and SMC await the outcomes with interest.

8.4 Freedom of Information (FoI)

On behalf of Lothian NHS Board, SMC has processed a request for information in relation to sunitinib (Sutent) for the first line treatment of metastatic renal cell carcinoma (mRCC).  A response was issued to the enquirer on 28 August, 2007.  All Health Boards have been advised accordingly, via their FoI contacts.

A further request, made directly to SMC, for information in relation to sunitinib (Sutent) for the first line treatment of metastatic renal cell carcinoma (mRCC), is currently being processed by the SMC secretariat.  The deadline for responding is 24 September, 2007.  Details of the request and the response made, will be circulated to Boards in due course.

8.5 Inclusion of Summaries of Product Characteristics (SPCs) in Meeting Papers for SMC

At present, all submissions to SMC include a hard copy of the Summary of Characteristics (SPC) for the product, in members meeting papers.  Due to the increasingly large volumes of meeting papers, members were consulted on whether they wished to continue to receive a hard copy of every SPC or whether they would be happy to work with an electronic link to the relevant document.

Discussion followed and members decided that they would wish to continue to receive hard copies for every submission as they considered SPCs to be key reference documents.

8.6 SMC Relocation

The previous Scottish Administration instigated a policy of relocating key government bodies outwith the Capital city.  NHS QIS and therefore SMC were scheduled to relocate to a new site in the East End of Glasgow, some time in 2008/09.

The recently installed Scottish Government has revoked the relocation policy and therefore SMC is likely to remain in its current base for the foreseeable future.

8.7 Scottish Management of Antimicrobial Resistance Action Plan (ScotMARAP)

Members were asked to recall a previous consultation paper, prepared by Professor David Lawson on the management of antimicrobial resistance in NHS Scotland.  The Scottish Management of Antimicrobial Resistance Action Plan (ScotMARAP) is now moving towards implementation and further details of the implementation phase is expected to be circulated in the near future.

As a result of the consultation, SMC has been asked to participate in the implementation and management of ScotMARAP and in preparation, a team of six, including 3 SMC representatives, an information analyst, a consultant microbiologist and a specialist antimicrobial pharmacist will be undertaking a fact finding visit to Denmark and Sweden to carry out a scoping exercise on the antimicrobial services operating in these countries.

A report on the outcomes of the visit will be made available to SMC in October /November 2007.


9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 Ertapenem, 1g vial of powder for concentrate for solution for intravenous infusion (Invanz)  Merck Sharp & Dohme Limited  (No. 404/07)

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

9.1.2 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 agreed that ertapenem (Invanz), for the prophylaxis of surgical site infection following elective colorectal surgery in adults, 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.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 07 September 2007.

9.2 Ziconotide, 100 micrograms/ml solution for infusion (Prialt)  Eisai Ltd (No. 405/07)

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

9.2.2 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 ziconotide (Prialt), for the treatment of severe, chronic pain in patients who require intrathecal analgesia, 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, 07 September 2007.

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

9.3.1 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.

9.3.2 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 escitalopram (Cipralex), for the treatment of obsessive compulsive disorder, 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, 07 September 2007.

9.4 Betaine, anhydrous oral powder (Cystadane) Orphan Europe (No. 407/07)

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

9.4.2 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 agreed that betaine anhydrous oral powder (Cystadane), as adjunctive treatment for homocystinuria in line with the manufacturer’s license, 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.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 07 September 2007.

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

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

9.5.2 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 Diabetes UK Scotland. Detailed discussion followed and the group agreed that 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, 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.

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 07 September 2007.

RESUBMISSIONS

9.6 Omalizumab, 150mg powder and solvent for injection (Xolair) Novartis Pharmaceuticals UK Ltd No. (259/06)  Second Resubmission

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

9.6.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments, tabled expert comments and comments received from the company.     A member of PAPIG presented a patient interest group submission from Asthma UK Scotland.  Detailed discussion followed and the group agreed that 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, 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.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 07 September 2007.

ABBREVIATED SUBMISSIONS

9.7 Budesonide, 2mg rectal foam (Budenofalk)  Dr Falk Pharma  (No. 409/07)

9.7.1 There were no declarations of interest 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 the group agreed that budesonide 2mg rectal foam (Budenofalk Foam), for the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon, 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, 07 September 2007.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was noted.

11. SMC User Group Forum (UGF)

11.1 The minutes of the meeting of the UGF held on 31 July 2007 were noted.

12. ADTC Feedback

12.1 There was nothing to report.

13. Any Other Business

13.1 Patient Interest Group Submissions

A member of PAPIG noted that the minutes of the previous meeting did not detail patient interest group submissions considered in relation to resubmissions. The Secretariat Manager apologised for the oversight and indicated that the minutes would be corrected.

13.2 Exenatide (Byetta) Eli Lilly (No. 376/07)

Following a breach of confidentiality in relation to the early release of SMC advice for exenatide (Byetta) Eli Lilly (No. 376/07) the manufacturer advised that they were unable to find any evidence that the breach had arisen because the company had failed to hold the information in confidence until the designated date for release.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 02 October 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.