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SMC Minutes - Tuesday 2 May 2006

Minutes of the SMC Meeting held on Tuesday, 2 May 2006 NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Ms Laura Ace, 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, Mr Jim Eadie, Dr Barclay Goudie, Dr David Hood, Dr Grace Lindsay, Dr Graham Lowe , Dr Chris Lush, Ms Angela Munday, Ms Wendy Nganasurian, Dr Marianne Nicolson , Dr Ken Paterson, Ms Fiona Ramsay , Dr Philip Rutledge, Dr Alexander Simpson , Ms Angela Timoney, Ms Helen Tyrrell, Mr Mike Wallace, Mr Derek Yuille

In Attendance: Dr Jennifer Armstrong, Dr Sara Davies, Mrs Hazel Illingworth, Mrs Anne Lee, Mrs Sandra McNaughton, Mrs Laura McIver, Miss Rosie Murray, Ms Corinne O’Dowd, Mrs Emma Stoica, Mrs Maureen Stark, Dr Andrew Walker,

Apologies: Professor James Barbour, Ms Rosaleen Beattie, Dr Peter Donnan, Mr John Glennie, Dr Harpreet Kohli, Dr John Haughney, Dr Chris Lush, Mr Colin McAllister, Mrs Pat Murray, Dr Andrew Riley, Dr John Webster,

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 Mrs Sandra McNaughton, NDC member.

1.3 Thanks were given to Drs David Hood and Marianne Nicholson who attended their last meeting 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 4 April 2006 were agreed as an accurate record.

4  Matters Arising From the Previous Minutes

Process for Non-Submissions

A flowchart outlining the product tracking and SMC advice process in case of non-submissions was circulated with paperwork for information.  It was agreed that the document be presented to the next User Group Forum meeting for consideration.

SMC Budget

The Chairman reported that funding to appoint x 1 WTE co-ordinator and x 0.75 WTE Health Economist has been approved.    Funding for a 0.5 WTE pharmacist post is under discussion.


Full Submissions

4.1 letrozole (Femara) Novartis Pharmaceuticals UK Ltd (No: 251/06)

4.1.1 The SMC advice for letrozole (Femara), for the adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer, will be posted on the SMC website on Monday 8 May, 2006.   Following distribution to NHSScotland, the manufacturer, highlighted minor factual inaccuracies in the advice.  The Detailed Advice Document (DAD) has been amended accordingly and will be reissued to NHSScotland on 5 Friday May, 2006.

4.2 escitalopram (Cipralex) Lundbeck Ltd (No: 253/06)

4.2.1 The SMC Advice for escitalopram (Cipralex), for the treatment of generalised anxiety disorder (GAD), will be posted on the SMC website on Monday 8 May 2006.


4.3 inhaled insulin (Exubera) Pfizer Ltd (No: 254/06)

4.3.1  The SMC Advice for inhaled insulin (Exubera), for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral anti-diabetic agents and requiring insulin therapy, and for the treatment of adult patients with type 1 diabetes mellitus in addition to long or intermediate acting subcutaneous insulin for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns, will be withheld pending confirmation of launch.

Abbreviated Submissions

4.4 transdermal fentanyl (Durogesic D Trans Transdermal Patches 12mcg/hr)  Janssen-Cilag Ltd (No: 250/06)

4.4.1 The SMC Advice for transdermal fentanyl (Durogesic D Trans Transdermal Patches 12mcg/hr), for the treatment of patients with chronic intractable pain due to non-malignant conditions, will be posted on the SMC website on Monday 8 May 2006.

4.5  pioglitazone/metformin (Competact) Takeda UK Ltd (No: 252/06)

4.5.1 The SMC Advice for pioglitazone/metformin (Competact), for the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone, will be withheld pending confirmation of launch.

Non-Submissions

4.6 fondaparinux (Arixtra) GlaxoSmithKline (No:261/06)

4.6.1 The SMC advice for fondaparinux (Arixtra), for the treatment of prevention of venous thromboembolic events (VTE) in medical patients who are judged to be at high risk of VTE and who are immobilised due to acute illness, such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infections or inflammatory disease, will be posted on the SMC website on Monday 8 May 2006.

4.7 fondaparinux (Arixtra) GlaxoSmithKline  (No 262/06)

4.7.1 The SMC advice for fondaparinux (Arixtra), for the treatment of acute deep vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients, or patients who require thrombolysis or pulmonary embolectomy, will be posted on the SMC website on Monday 8 May 2006.

4.8 choriogonadotropin alfa (Ovitrelle) Serono (No 263/06)

4.8.1 The SMC advice for choriogonadotropin alfa (Ovitrelle), for the treatment of women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF), will be posted on the SMC website on Monday 8 May 2006.

4.9 choriogonadotropin alfa (Ovitrelle) Serono (No 264/06)

4.9.1 The SMC advice for choriogonadotropin alfa (Ovitrelle), for the treatment of anovulatory or oligo-ovulatory women, will be posted on the SMC website on Monday 8 May 2006.

4.10 oxycodone (OxyNorm) Napp Pharmaceutical Ltd  (No: 266/06)

4.10.1 The SMC advice for oxycodone (OxyNorm), for the treatment of post-operative pain, will be posted on the SMC website on Monday 8 May 2006.

4.11 epinastine (Relestal) Allergen Ltd (No: 267/06)

4.11.1 The SMC advice for epinastine (Relestal), for the treatment of the symptoms of seasonal allergic conjunctivitis, will be posted on the SMC website on Monday 8 May 2006.

4.12 pemetrexed (Alimta) Eli Lilly (No: 268/06)

4.12.1 The SMC advice for pemetrexed (Alimta) as monotherapy, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy, will be posted on the SMC website on Monday 8 May 2006.

4.13 gonapeptyl depot Ferring Pharmaceuticals (No: 269/06)

4.13.1 The SMC advice for gonapeptyl depot, for the treatment of advanced, hormone-dependent prostate carcinoma, will be posted on the SMC website on Monday 8 May 2006.

4.14 gonapeptyl depot Ferring Pharmaceuticals  No: 270/06)

4.14.1 The SMC advice for gonapeptyl depot, for the treatment of for symptomatic endometriosis confirmed by laparoscopy when suppression of the ovarian hormonogenesis is indicated to the extent that surgical therapy is not primarily indicated, will be posted on the SMC website on Monday 8 May 2006.

4.15 cinacalcet (Mimpara) Amgen (No: 271/06)

4.15.1 The SMC advice for cinacalcet (Mimpara), for the reduction of hypercalcaemia in patients with parathyroid carcinoma, will be posted on the SMC website on Monday 8 May 2006.

4.16 palifermin (Kepivance) Amgen (No: 272/06)

4.16.1 The SMC advice for palifermin (Kepivance), for the treatment of oral mucositis in bone marrow transplantation, will be posted on the SMC website on Monday 8 May 2006.

4.17 darbepoetin alfa (Aranesp) Amgen (No: 273/06)

4.17.1 The SMC advice for darbepoetin alfa (Aranesp), for the treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy, will be posted on the SMC website on Monday 8 May 2006.

4.18 darbepoetin alfa (Aranesp) SureClick Amgen (265/06)

4.18.1 The SMC advice for darbepoetin alfa (Aranesp) SureClick, for the treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy, will be posted on the SMC website on Monday 8 May 2006.


5 Appeals Update

5.1 tipravavir (Aptivus)  Boehringer-Ingelheim

5.1.1 Boehringer-Ingelheim have advised of their intention to make a resubmission for tipravavir (Aptivus) for the treatment of HIV. 

5.2 pregabalin (Lyrica)   Pfizer

5.2.1 The Independent Review Panel for pregabalin (Lyrica), for the treatment of peripheral neuropathic pain, is scheduled for Friday 9 June 2006.  The findings of the IRP will be presented to the SMC at their meeting on Tuesday 4 July 2006 for review and final decision.  The final advice will be published on the SMC website on Monday 7 August 2006.

PAPIG

6.1 Minutes of the previous meeting

Minutes of the meeting held on 4 April 2006 were circulated with paperwork for information.  Any comments should be forwarded to the Chair of PAPIG.

6.2 PAPIG response to NICE Social Value Judgements

The response from PAPIG to the NICE guidance on Social Value Judgements – Principles for the development of NICE guidance, was circulated with paperwork for information, as well as an article published in the BMJ referring to the same guidance.  A verbal update was provided at the meeting.

The Chairman thanked PAPIG and suggested that this be revisited as a major item for discussion at an “Away Day” meeting.

6.3 PAPIG response to Patient Focus and Public Involvement Framework 2006 – 2009 Consultation Exercise

The response from PAPIG to the Patient Focus and Public Involvement Framework 2006 – 2009 was circulated with paperwork for information and a verbal update was provided at the meeting.

New Drugs Committee: Chairman’s report

7.1 Nothing to report.

Chairman’s Business

8.1 Plenary Lecture at the meeting of the European Society of Clinical Pharmacology 17 May 2006

8.1.1 The Chairman reported that he has been invited to give a plenary lecture at the meeting of the European Society of Clinical Pharmacology (ESCP) on 17th May 2007 in Edinburgh to discuss "Scotland's approach to the managed entry of new drugs within a state health care system".
 

8.2 Faculty of Public Health Annual Scientific Meeting, Glasgow,  6 – 8 June

8.2.1 The Chairman reported that a representative of SMC has been invited to attend a plenary session on 8 June 2006 regarding “wonder drugs” and the role of public health in selecting effective interventions.

8.3 HTAi Annual Conference in Adelaide, Australia,  2 – 5 July

8.3.1 The SMC Vice Chairman has been invited to present an abstract for SMC at the HTAi Annual Conference in Adelaide, Australia, entitled The Scottish Medicines Consortium – Are Oncology Medicines Different.

8.4 Antimicrobial Prescribing Policy and Practice in Scotland

8.4.1 The Chairman reported that Professor Dilip Nathwani has published a paper in the Journal of Antimicrobial Chemotherapy regarding Antimicrobial Prescribing Policy and Practice in Scotland.  The Paper has been distributed to all SMC and NDC members for information.

8.5 calcipotriol/betamethasone dipropionate ointment (Dovobet)

8.5.1 SMC reviewed a resubmission for calcipotriol/betamethasone dipropionate ointment (Dovobet) in November 2005 and accepted for restricted use within NHS Scotland for the initial topical treatment of stable plaque psoriasis.   A revised SmPC has now been approved and clarifies the use of Dovobet beyond 4 weeks.                        

NDC ASSESSMENT REPORTS

Full Submissions

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

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

9.1.2 The NDC Lead Assessor provided a detailed overview of the assessment, draft advice, expert comments and comments from the company.  Updated clinical expert comments were tabled for review.  Detailed discussion followed and the group agreed that posaconazole (Noxafil), for the treatment of adults with specific invasive fungal infections refractory to specified antifungal agents or who are intolerant of those agents, 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.

9.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 May 2006.

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

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

9.2.2 The NDC Vice-Chairman provided a detailed overview of the assessments, draft advice, expert comments and comments received from the company. A revised Draft advice document was tabled for review.  Detailed discussion followed and the group agreed that esomeprazole (Nexium), for the prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory (NSAID) therapy in patients at risk, should not be recommended 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.

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 May, 2006.

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

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

9.3.2 The NDC Vice-Chairman provided a detailed overview of the assessments, draft advice, expert comments and comments received from the company. A revised Draft advice document was tabled for review.  Detailed discussion followed and the group agreed that esomeprazole (Nexium), for the healing of gastric ulcers associated with non-steroidal anti-inflammatory drug (NSAID) therapy, should not be recommended 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.

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 May, 2006.

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

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

9.4.2 The SMC 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 interferon-alpha-2b (Viraferon) in combination with ribavirin (Rebetol), capsules or solution, for the treatment of children and adolescents three years of age and over, who have chronic hepatitis C, have not previously been treated, have compensated liver disease and who are positive for serum HCV RNA, 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.

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 May, 2006.

9.5 omalizumab (Xolair) Novartis (No: 259/06)

9.5.1 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.

9.5.2 The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company.  A member of PAPIG presented two Patient Interest Group Submissions, from Asthma UK and from the British Lung Foundation 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 who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids (ICS), plus a long-acting inhaled beta2-agonist (LABA) should not be recommended 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 5 May, 2006.

Re Submissions

9.6 pegvisomant (Somavert) Pfizer Ltd (No: 158/04)

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

9.6.2 The SMC 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 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, should not be recommended 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 5 May, 2006.

9.7 erlotinib (Tarceva) Roche (No: 220/05)

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

9.7.2 The NDC Vice-Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. A member of PAPIG presented a patient group submission from the Roy Castle Lung Cancer Foundation. Detailed discussion followed and the group agreed that 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, 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 5 May, 2006.

9.8 bevacizumab (Avastin) Roche (No: 221/05)

9.8.1 Declarations of interest were recorded in relation to this product/comparator drugs. The Chairman declared an interest and one of the SMC Vice-Chairmen chaired  this part of the meeting.

9.8.2 The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments from the company.  A member of PAPIG presented a patient group submission from Bowel Cancer UK. Detailed discussion followed and the group agreed that bevacizumab (Avastin), for first-line treatment of patients with metastatic carcinoma of the colon or rectum, in both combinations noted above, should not be recommended 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 There was discussion regarding a proposed registry programme and it was agreed that SMC are not in a position to consider a registry programme approach at this stage and that the remit for this may lie elsewhere.

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 May 2006.

Abbreviated Submissions

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

9.9.1 A declaration of interest was recorded 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 somatropin (Norditropin SimpleXx), for the treatment of growth disturbance (current height SDS < -2.5 and parental adjusted height SDS at least < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later, 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. 

9.9.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 5 May, 2006.

10 Horizon Scanning

10.1 Freedom of Information (FoI)

Minutes of the meeting held in March 2006, regarding the application of the Freedom of Information (Scotland) Act 2002 (FOI) in relation to the SMC horizon scanning processes, were included with paperwork for information. The SMC Principal Pharmacist for Horizon Scanning provided an update from the meeting and reported that the group needed to have a protocol in place for responding to requests for information under FOI.

Discussions followed and the minutes were ratified by SMC, in order to form a base for response to companies’ requests for disclosure of information, with appropriate guidance from the Central Legal Office. 

The minutes from the FoI meeting will also be made available to the industry through the User Group Forum.

11 SMC Evaluation

11.1 The Chief Pharmaceutical Adviser to SMC provided an update on the evaluation programme which has now been established and advised that an interim report will be available by the end of the summer for consideration by SMC.

12    Forthcoming Submissions

12.1 A list of forthcoming submissions was tabled for review.

13 ADTC Feedback

13.1 It was reported that at a meeting of the Greater Glasgow and Argyle ADTC it was discussed whether the clinical expert comments should be made available locally in order to reduce duplication.  The NDC Chairman advised that the clinical expert involvement is an established SMC process and although this information is recoverable under Freedom of Information, the experts may feel unprotected if their responses are disclosed.  The SMC Chairman advised that this request will be considered and discussed further at a future meeting of SMC.

14 Any Other Business

14.1 Exit Strategies from Clinical Trials

A draft report, outlining the SMC clinical trials exit strategy was circulated for review.  The SMC Vice-Chairman gave an update on the progress following two meetings hosted by the ABPI, in September 2005 and April 2006, regarding the exit strategies from clinical trials. 

It was reported that the group concluded that the exit strategies should be part of the Research Ethics Committees review, and that approval for trials should only be given if an exit strategy is in place and can be demonstrated.

It was pointed out that work was explanatory at this point and it was agreed that further discussion take place before a draft is forwarded for consultation to industry, NHS Health Boards and other relevant bodies.  The Chairman requested comments be forwarded to the SMC Executive team to take forward to the SEHD and other bodies as appropriate.

15 Date of the Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday, 6 June 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.