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SMC Minutes - Tuesday 5 April 2005

Minutes of Meeting held on Tuesday 5 April 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Ms Angela Timoney (Chairman) , Dr Keith Beard, Ms Chris Beech, Mrs Marion Bennie,
Mrs Barbara Black, Professor John Cairns, Mr Tom Divers, Dr Barclay Goudie, Dr John Haughney,
Dr David Hood, Mrs Moira Howie, Dr Jan Jones, Dr Chris Lush, Mr Chris Nicolson, Ms Wendy Nganasurian, Dr Marianne Nicholson, Dr Ken Paterson, Ms Fiona Ramsay, Dr Andrew Riley,
Dr Philip Rutledge, Dr Sandy Simpson, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Mr Norman Best , Dr Ross Camidge, Dr Sarah Davies, Mr Hector MacKenzie,
Dr John McElhinney, Ms Aileen Muir, Miss Rosie Murray, Dr Eimear NicLochlainn, Mrs Maureen Stark

Apologies: Mr Jeff Ace, Professor James Barbour, Dr Corri Black , Ms Sandra Blevings,
Professor Martin Brodie, Mrs Michelle Caldwell, Dr Peter Donnan, Mr John Glennie, Dr Harpreet Kohli, Professor Angus Mackay, Mrs Laura McIver, Mrs Angela Munday, Mrs Fiona Scott, Ms Helen Tyrrell, Professor David Webb

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 Norman Best, Scottish Association of Prostate Cancer Support Groups 
  • Dr Ross Camidge, Clinical Lecturer in Medical Oncology and Clinical Pharmacology, Edinburgh Cancer Centre, Western General Hospital, Edinburgh
  • Dr Sarah Davies, Scottish Executive Health Department
  • Dr John McElhinney, General Practitioner and New Drugs Committee Member
  • Dr Eimear NicLochlainn, Senior Health Analyst and New Drugs Committee Member

1.3 Dr Jan Jones, Principal Pharmacist in Tayside, has now joined the SMC Executive Team and will cover Marion Bennie¿s period of absence.  Dr Jones will present an NDC Recommendation Report to the committee.

1.4 Ms Aileen Muir, Lead Pharmacist at the Southern General Hospital and New Drugs Committee Member was also welcomed.  Ms Muir will present an NDC Recommendation Report to the committee.

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 (01.03.05)

3.1 The minutes of the meeting of 1 March, 2005, were agreed as an accurate record of the meeting with a minor amendment to the attendance list noted.

4 Matters Arising From the Previous Minutes

4.1 Freedom of Information

4.1.1 Following an initial request for information on cetuximab (Erbitux) and bortezomib (Velcade), SMC has responded directly to the enquirer and also provided guidance to ADTCs and Health Boards to allow them to respond to related requests. 

SMC has also received separate requests for information regarding three HIV drugs and Glucophage SR prolonged release tablets (metformin).   SMC will respond directly to these requests, however details have been forwarded to ADTCs and Health Boards in case they subsequently receive similar requests.

FULL SUBMISSIONS

Purdah

During the period 5 April 2005 to 5 May, 2005, NHSScotland will enter a period of purdah which outlines the conduct of business during the General Election, during which no public announcements will be made. Therefore detailed advice documents for the products listed below will be published on the SMC website on Monday 9 May, 2005. 

4.2 pegvisomant (Somavert):  Pfizer  (No: 158/05)

4.2.1 SMC advice for pegvisomant (Somavert), for the treatment of acromegaly, will be posted on the SMC website on Monday 9 May, 2005.

4.3 eflornithine 11.5% cream (Vaniqa):  Shire Pharmaceuticals  (No: 159/05)

4.3.1 SMC advice for eflornithine 11.5% cream (Vaniqa) for the treatment of facial hirsutism, will be posted on the SMC website on Monday 9 May, 2005.

4.4 triptorelin (Gonapeptyl Depot):  Ferring Pharmaceuticals  (No: 160/05)

4.4.1 SMC advice for triptorelin (Gonapeptyl Depot), for the treatment of precocious puberty, will be posted on the SMC website on Monday 9 May, 2005. 
 
4.5 candesartan cilexetil (Amias):  Takeda Uk Ltd  (No: 161/05)

4.5.1 SMC advice for candesartan cilexetil (Amias) for the treatment of, heart failure with left ventricle systolic dysfunction, will be posted on the SMC Monday 9 May, 2005. 

4.5.2 Further to competitor comments, minor amendments to wording were noted and will be advised to ADTCs and NHS Boards on Friday 8 April, 2005.

4.6 valsartan (Diovan):  Novartis  (No: 162/05)

4.6.1 SMC advice for valsartan (Diovan), for the treatment of, post MI left ventricular failure and/or left ventricular systolic dysfunction, will be posted on the SMC website on Monday 9 May, 2005. 

4.7 anagrelide hydrochloride (Xagrid):  Shire Pharmaceuticals:  (No: 163/05)

4.7.1 SMC advice for anagrelide hydrochloride (Xagrid), for the treatment of reduction of elevated platelet counts in 'at risk' patients with essential thrombocythaemia, will be posted on the SMC website on Monday 9 May, 2005.  

4.8 adefovir dipivoxil (Hepsera)  Gilead Sciences:  (No: 54/03) Re-submission

4.8.1 SMC advice for adefovir dipivoxil (Hepsera), for the treatment of Hepatitis B, will be posted on the SMC website on Monday 9 May, 2005. 

4.9 eplerenone (Inspra)  Pfizer  (No: 136/04) Re-submission

4.9.1 SMC advice for eplerenone (Inspra), for the treatment of LV dysfunction and clinical evidence of heart failure post MI, will be posted on the SMC website on Monday 9 May, 2005. 

4.9.2 Minor amendments to wording were noted and will be advised to ADTCs and NHS Boards on Friday 8 April, 2005.

5 Appeals Update

5.1 atomoxetine (Strattera)  Eli Lilly & Company  (No: 153/05)

5.1.1 The company have made a resubmission to SMC.

5.2 gemcitabine/ paclitaxel (Gemzar)  Eli Lilly & Company Limited  (No: 154/05)

5.2.1 The company have advised of their intention to make a resubmission.

5.3 eflornithine (Vaniqa) cream Shire Pharmaceuticals (No: 159/05)

5.3.1 The company have advised of their intention to make a resubmission.

5.4 cetuximab (Erbitux)  Merck Pharma  (No: 155/04)

5.4.1 The company have advised of their intention to seek an Independent Review.  A panel is currently being assembled.

6 PAPIG

6.1 The minutes of the PAPIG meeting held on 3 March 2005 were reviewed.

7 New Drug Committee: Update

7.1 Review of recent NDC meeting

7.1.1 The Chairman of NDC advised that there were no matters arising from the NDC meeting.

8 Chairman's Business

8.1 Expert Advice

8.1.1 Further discussions have taken place regarding the best way to use experts and suggestions to improve the current process.  A paper will be developed and presented to SMC in due course. 

8.2 Half Day Seminar for SMC/NDC members

8.2.1 A half-day seminar to discuss experts, orphan drugs and unique drugs has been scheduled for the afternoon of Tuesday 14 June 2005.  An agenda will be distributed in advance of the meeting.

8.3 Media Interest

8.3.1 There was nothing to report.

8.4 Departures and Appointments

8.4.1 It was reported that it would be Mrs Marion Bennie and Ms Angela Timoney¿s last meeting for six months. Marion is commencing maternity leave and Angela will commence a period of adoptive parent leave. Dr Jan Jones and Dr John Haughney have been appointed to the SMC Exec team to cover their period of absence.

8.4.2 SMC Chief Pharmaceutical Adviser and Principal Horizon Scanning Pharmacist

Interviews have now taken place for both posts and an announcement regarding the appointees will be made imminently.

8.4.3 Secretariat staffing:

  • Ailene Botfield has been engaged as a temporary administrator in the Secretariat for a year but we now welcome her as a permanent member of staff.
  • Congratulations to Ali McAllister who is undertaking a six month secondment to the NHS QiS, Standards Development Unit on promotion to Project Officer.  She begins her secondment on 18 April 2005.
  • SMC are currently recruiting a further 3 administrators; one on a temporary basis to cover Ali's absence, a further full-time administrator to support the additional horizon scanning work which will be undertaken and a part-time member to assist with an increasing workload in the Secretariat.

8.5 SMC Annual Report 2004 

8.5.1 The SMC Annual Report 2004, is in the final stages of publication and will be circulated within the next couple of weeks.

8.6 Review of Membership 

8.6.1 The secretariat are currently seeking nominations from ADTCs for replacement members for SMC and NDC.  Current members have been asked to indicate to the secretariat if they wish to step down.

9 NDC Assessment Reports - Full Submissions

9.1 liposomal cytabarine (Depocyte)  Napp Pharmaceuticals  (No: 164/05)

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 received from the company.  Detailed discussion followed and the group agreed liposomal cytabarine (Depocyte), for the intrathecal treatment of lymphomatous meningitis should be not be recommended for use within NHS Scotland. Amendments to wording were noted.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 April 2005.

9.2 ropinirole (Adartrel)  GlaxoSmithKline  (No: 165/05)

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, expert comments, comments received from the company and a patient interest group submission from the Ekbom Support Group.  Detailed discussion followed and the group concluded their advice for ropinirole (Adartrel), for the treatment of idiopathic restless legs syndrome.  

9.2.3 SMC advice will be withheld pending confirmation of the licence and launch date for this treatment.

9.3 oral beclometasone (Clipper)  Trinity-Chiesi  (No: 166/05)

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

9.3.2 The NDC Vice-Chairman provided a detailed overview of the assessment, the draft advice, expert comments, and comments received from the company. Detailed discussion followed and the group concluded their advice for oral beclometasone (Clipper), for the treatment of ulcerative colitis.
 
9.3.3 SMC advice will be withheld pending confirmation of the licence and launch date for this treatment.

9.4 imiquimod 5% cream (Aldara)  3M Healthcare  (No: 167/05)

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

9.4.2 An NDC member provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that imiquimod 5% cream (Aldara), for small superficial basal cell carcinoma, should be accepted for restricted use within NHS Scotland.  Amendments to wording were noted.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 April 2005.

9.5 Tachosil  Nycomed UK Ltd  (No: 168/05)

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

9.5.2 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 Tachosil, for the management of haemostasis in liver surgery, should be accepted for use within NHS Scotland. Amendments to wording were noted.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 April 2005.

9.6 cinacalcet (Mimpara)  Amgen Ltd  (No: 169/05)

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

9.6.2 The NDC Vice-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 cinacalcet (Mimpara), for the treatment of secondary hyperparathyroidism in end stage renal disease, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

It was noted that the company submitted a new economic model post-NDC, but in accordance with SMC process this could not be assessed at this stage.

9.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 April 2005.

9.7 ibritumomab tiuxetan (Zevalin)  Schering HealthCare  (No: 171/05)

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

9.7.2 The NDC Chairman provided an overview of the assessment, draft advice and comments received from the company.  Discussion followed and the group agreed that, as no economic case had been submitted, ibritumomab tiuxetan (Zevalin), for the treatment of rituximab relapsed or refractory CD20+ follicular B-cell non-hodgkin¿s lymphoma, should not be recommended for use within NHS Scotland. Amendments to wording were noted.

9.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 April 2005.

ABBREVIATED SUBMISSION

9.8.1 paracetamol IV infusion (Perfalgan)  Bristol Myers Squibb  (No:  172/05)

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

9.8.3 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Detailed discussion followed and the group agreed that paracetamol IV infusion (Perfalgan) for the treatment of moderate pain and fever, should be accepted for use within NHS Scotland.

9.8.4 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 April 2005.

9.9.1 abacavir (Ziagen)  GlaxoSmithKline  (No: 174.05) 

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

9.9.3 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Detailed discussion followed and the group agreed that abacavir (Ziagen) once-daily dosage for the treatment of HIV type 1, should be accepted for use within NHS Scotland. It was agreed that simple changes of posology should not normally be assessed by SMC.

9.9.4 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 April 2005.

9.10.1 abacavir lamivudine combination (Kivexa)  GlaxoSmithKline  (No: 175/05)

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

9.10.3 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Detailed discussion followed and the group agreed that abacavir lamivudine combination (Kivexa) for the treatment of HIV type 1, should be accepted for use within NHS Scotland for patients in whom this combination was deemed appropriate.

9.10.4 The SMC advice will be issued to ADTCs and NHS Boards on Friday 8 April 2005.

9.11.1 beclometasone dispropionate ( Clenil Modulite)  Trinity-Chiesi Pharmaceuticals Ltd
(No: 177/05)

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

9.11.3 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Detailed discussion followed and the group concluded their advice for beclometasine dispropionate (Clenil Modulite) for the treatment of asthma.

9.11.4 SMC advice will be withheld pending confirmation of the licence and launch date for this treatment.

10 Forthcoming Submissions
 
10.1 A revised list of forthcoming submissions was reviewed.  

11 ADTC Feedback

11.1 No matters were raised in relation to ADTCs.

12 SMC User Group Forum

12.1 The minutes of the SMC User Group Forum were reviewed for information.

12.2 Wendy Nganasurian noted that, following discussion at the SMC UGF, PAPIG members were considering how to make a more detailed reference to patient interest group submissions within the DAD.  The Chairman requested further discussion with the SMC Executive team.

12.3 The Chairman stated that issues highlighted at the UGF were helpful and thanked Mike Wallace for the work he had done.

13 Any Other Business

13.1 Non Submissions

Companies who have not made a submission to SMC will be requested to do so.

13.2 Tolcapone (Tasmar)

In February, 2005, following a re-introduction of its licence following suspension, Valeant made a submission for assessment to SMC for tasmar (Tolcapone) which is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson's Disease (PD) and motor fluctuations, who fail to respond to, or are intolerant of, other catechol-O-methyltransferase (COMT) inhibitors.  SMC have advised Valeant that as the original licence predates the inception of SMC and the re-introduced licence is based on a narrowing, rather than a broadening, of the licence, this is outwith the remit of SMC and is therefore a local formulary decision.  Valeant are currently actively marketing this product.

14 Date of Next Meeting

The date of the next meeting was confirmed as Tuesday 3 May, 2005, 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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