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SMC Minutes Tuesday 14 December 2010

Minutes of the SMC Meeting
held on Tuesday 14 December 2010
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present:
Professor Ken Paterson (Chairman), Mrs Laura Ace, Ms Sandra Auld, Dr Jennifer Burns, Dr Dominic Culligan, Ms Sara Davies, Dr Jonathan Fox, Dr Jan Jones, Ms Veronica Moffat, Dr Robert Peel, Dr Andrew Power, Dr Sarah Taylor, Mr Keith Thompson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Professor David Wray

In Attendance:
Mrs Jill Booth, Mrs Corinne Booth, Ms Ailsa Brown, Mr Stephen Ferguson, Mrs Anne Lee, Ms Marie McHenery, Ms Rosie Murray, Ms Emma Riches, Mrs Catherine Tait

Apologies:
Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Mr Colin Brown, Dr Keith Brown, Professor Scott Bryson, Mr Robert Calderwood, Mr Dave Carson, Mrs Susan Downie, Dr David Dunlop, Dr John Gemmill, Dr Barclay Goudie, Dr Jacqui Howes, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Dr Simon Maxwell, Dr John McElhinney, Dr James McLay, Dr Paul McNamee, Mrs Sandra McNaughton, Ms Aileen Muir, Professor Dilip Nathwani, Dr Anthony Ormerod, Dr Mercia Page, Mr Michael Pratt, Ms Alex Robertson, Dr Brian Robson, Mrs Maureen Stark, Dr Andrew Walker

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 Mrs Jill Booth who will be working as a temporary Pharmacist, alongside Gail Gartshore and Libby Sillito to support Anne Lee.

1.3 Thanks to Ms Jane Davidson (in her absence). Regrettably she has had to terminate her membership of SMC. Jane has moved to another post within NHS Borders and due to conflicting pressures she is unable to attend SMC.  We thank her for her enthusiasm, commitment and active contribution to SMC and wish her well in her new endeavours.

1.4 Professor Tony Wells (in his absence).  Tony is retiring as Chief Executive, NHS Tayside and we thank him for his enthusiasm, commitment and active contribution to SMC and wish him well for the future.

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 (02 November 2010)

3.1 The minutes of the SMC meeting held on 02 November 2010 were accepted as an accurate record of the meeting.

4. Adverse Weather Conditions

4.1 Due to the adverse weather conditions, difficulties with travelling, and advice received from Strathclyde Police, the SMC meeting scheduled for 7 December 2010 was cancelled and an exceptional meeting of SMC rearranged for today, Tuesday 14 December 2010.  Therefore decisions made at SMC today will be ratified at the SMC meeting on Tuesday 11 January 2011.  Advice will be published, as planned, on the SMC website on Monday 17 January, 2011.

4.2 Professor Dilip Nathwani was scheduled to attend SMC meeting to provide a verbal update on the work of SAPG.  Due to the adverse weather conditions Professor Nathwani was unable to attend and this will now be rescheduled to take place in March/April 2011.

5. Matters Arising

Full Submissions

5.1 moxifloxacin hydrochloride in sodium chloride for infusion (Avelox IV)  Bayer Schering  (No. 650/10)

The SMC advice for moxifloxacin hydrochloride in sodium chloride for infusion (Avelox IV), Bayer Schering, for the treatment of community acquired pneumonia (CAP), was published on the SMC website on Monday 13 December 2010.

5.2 denosumab (Prolia)  Amgen  (No. 651/10)

The SMC advice for denosumab (Prolia) Amgen, for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, was published on the SMC website on Monday 13 December 2010.

5.3 dexamethasone intravitreal implant (Ozurdex)  Allergan Ltd  (No. 652/10)

The SMC advice for dexamethasone intravitreal implant (Ozurdex), Allergan Ltd, for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Following comments from the manufacturer there been amendments to the Summary of comparative health economic evidence section and Cost of relevant comparators section within the Detailed Advice Document.  Revised advice was published on Monday 13 December 2010.

5.4 prucalopride (Resolor)  Movetis UK  (653/10)

The SMC advice for prucalopride (Resolor) Movetis UK, for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief, was published on the SMC website on Monday 13 December 2010.

5.5 tapentadol (Palexia)  Grunenthal  Ltd (654/10)

The SMC advice for tapentadol (Palexia), Grunenthal Ltd, for the management of severe chronic pain which can be adequately managed only with opioid analgesics, was withheld pending confirmation of product availability.

Resubmissions

5.6 ranolazine (Ranexa)  A Menarini Pharma UK SRL  (No. 565/09)

The SMC advice for ranolazine (Ranexa), A Menarini Pharma UK SRL, as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta blockers and/or calcium antagonists), was published on the SMC website on Monday 13 December 2010.

5.7 gefitinib (Iressa)  Astra Zeneca Ltd  (No. 615/10)

The SMC advice for gefitinib (Iressa), Astra Zeneca Ltd, for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK), was published on the SMC website on Monday 13 December 2010.

Abbreviated Submissions

5.8 etonogestrel  68mg implant (Nexlanon)  Merck Sharp & Dohme  (No. 655/10)

The SMC advice for etonogestrel 68mg implant (Nexlanon), Merck Sharp & Dohme, for contraception, was published on the SMC website on Monday 13 December 2010.

Following feedback amendments have been made within the Detailed Advice Box.  Revised advice was published on Monday 13 December 2010.

5.9 atazanavir (Reyataz)  Bristol Myers Squibb Pharmaceuticals Ltd  (No. 656/10)

The SMC advice for atazanavir (Reyataz), Bristol Myers Squibb Pharmaceuticals Ltd, for the treatment of HIV in paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products, was published on the SMC website on Monday 13 December 2010.

5.10 tacrolimus granules for suspension (Modigraf)  Astellas Pharma Ltd  (No. 657/10)

The SMC advice for tacrolimus granules for suspension (Modigraf), Astellas Pharma Ltd, for the prophylaxis of transplant rejection in kidney, liver or heart allograft recipients and for the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients, was published on the SMC website on Monday 13 December 2010.

Non-Submissions

5.11 diclofenac 4% spray gel (Mobigel Spray ®)  Goldshield Group Plc  (No: 667/10)

The SMC advice for diclofenac 4% spray gel (Mobigel Spray ®), Goldshield Group Plc, for the relief of pain following acute blunt trauma, was published on the SMC website on Monday 13 December 2010.

5.12 fondaparinux sodium (Arixtra ®)  GlaxoSmithKline  (No: 668/10)

The SMC advice for fondaparinux sodium (Arixtra ®) GlaxoSmithKline for treatment of acute symptomatic spontaneous superficial vein thrombosis of the lower limbs without concomitant deep vein thrombosis, was published on the SMC website on Monday 13 December 2010.

5.13 denosumab 60mg solution for injection in pre-filled syringe (Prolia)  Amgen (No: 670/10)

The SMC advice for denosumab 60mg solution for injection in pre-filled syringe (Prolia), Amgen, for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, was published on the SMC website on Monday 13 December 2010.

Deferred Advice

5.14 Nothing to report.

Amended Advice

5.15 See above dexamethasone intravitreal implant (Ozurdex)  Allergan Ltd  (No. 652/10).

5.16 See above etonogestrel  68mg implant (Nexlanon)  Merck Sharp & Dohme  (No. 655/10).

6. Appeals Update

6.1 dexamethasone 700 microgram intravitreal implant (Ozurdex) Allergan Ltd (No. 652/10)  

In  November 2010,  SMC considered but did not recommend dexamethasone 700 microgram intravitreal implant (Ozurdex), for the for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).  Allergan Ltd has advised it is their intention to resubmit.

7. Patient and Public Involvement Group (PAPIG)

7.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC.  Following the recent recruitment exercise to replace two of our Public Partners, interviews have now been arranged in January 2011.

7.2 European Platform  for Patient Organisations, Science and Industry (EPPOSI)

Mrs Tunstall-James participated at a recent meeting of EPPOSI, in Brussels, to discuss patient engagement in health technology appraisals (HTAs).  This was a worthwhile event with positive feedback about patient involvement in the SMC process.

8. New Drugs Committee: Chairman’s Report

8.1 Dr Jan Jones thanked Aileen Muir Co-Vice Chair, (in her absence) for chairing the NDC meeting in November.  Dr Andrew Power Co-Vice Chair advised there was nothing further to report.

9. Chairman’s Business

9.1 SMC Chairman

Thanks to members for their nominations for the post of SMC Chairman.  In line with process the SMC Executive have considered all nominations and with the support of SMC would like to nominate Angela Timoney as chairman.    Pending support, endorsement will be sought from the CMO/NHS CEO Group and a formal appointment made by the CMO.

9.2 Colour Photocopying of SMC Papers

In order to assist with efficiency savings, where colour copy is contained within papers, this will no longer be duplicated in colour for the wider committee.   Colour copies of papers, where applicable, will still be provided for the SMC Executive and if members require access to colour papers, these will be sent electronically on request. 

9.3 SMC advice for dronedarone (Multaq) SMC No. 636/10

SMC published advice for dronedarone (Multaq) in September 2010, and accepted for restricted use in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrent of AF or to lower ventricular rate. 

A SMC member indicated that the SMC advice is providing confusing for cardiologists as the restriction appears to conflict with standard treatment guidelines and therefore we reviewed the advice and have amended in line with this.  Revised advice will be reissued to NHS Boards and ADTCs in early 2011.

9.4 Calcium Supplements and Cardiovascular Risks

Physicians have alerted SMC to an issue relating to calcium supplements and cardiovascular risk associated with additional vitamin D.  Boards already have established treatment guidelines, based on at least 2 systematic reviews.   However, a recent abstract from a BMJ meta-analysis provides conflicting evidence which is provoking some debate amongst clinicians.   

Boards are considering issuing individual statements relating to the new analysis but believe that a statement from NHS Scotland may be more appropriate and have therefore asked whether SMC could provide national guidance.  SMC will issue a statement to NHS Boards on Friday 17 December, 2010.

9.5 NICE Single Technology Appraisal (STA) No.208 – trastuzumab for the treatment of HER2-positive metastatic gastric cancer

NICE recommends trastuzumab as a possible treatment for some people with a type of HER2-positive metastatic gastric adenocarcinoma.

SMC published a Statement of Advice (623/10) on this medication for this indication in August 2010. This stated that trastuzumab (Herceptin) is not recommended for use within NHS Scotland. Access the advice of the Scottish Medicines Consortium:

There is a material difference between the recommendations of the NICE STA and the SMC. NICE has recommended the medicine for restricted use in specific types of patient with gastric cancer. SMC has received a resubmission from the manufacturer of Trastuzumab and is due to publish a Statement of Advice on this medication for this indication in February 2011. When this is available, NHS Scotland should adhere to this advice.

Note: Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

10. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

10.1 valganciclovir, 450mg tablets, 50mg/ml powder for oral solution (Valcyte®) Roche Products Ltd  SMC No. (662/10)

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

10.1.2 The SMC Vice Chair, on behalf of NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.    Detailed discussion followed and the group agreed that valganciclovir (Valcyte®), should be accepted for restricted use within NHS Scotland, for prevention of cytomegalovirus (CMV) disease in CMV negative patients who have received a solid organ transplant from a CMV positive donor. The marketing authorisation has been amended to allow the duration of CMV prophylaxis in kidney transplant patients to be increased from 100 days to 200 days post-transplantation. SMC restriction: valganciclovir should be initiated by physicians experienced in the care of post-transplant patients.  In a randomised controlled study there was a significant reduction in the incidence of CMV disease at 12 months following 200-day versus 100-day prophylaxis.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.2 fentanyl 100microgram/dose and 400microgram/dose nasal spray solution (PecFent®)  Archimedes Pharma  SMC No. (663/10) 

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

10.2.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.    Detailed discussion followed and the group agreed that fentanyl 100microgram/dose and 400microgram/dose nasal spray solution (PecFent®),  should be accepted for restricted use within NHS Scotland,  for management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain.  SMC restriction: restricted to use in patients unsuitable for short-acting oral opioids, as an alternative to other fentanyl preparations.  Fentanyl pectin nasal spray offers an advantage in the time to onset of pain relief and reduction in pain intensity of breakthrough pain compared with placebo and immediate release morphine sulphate. Indirect comparison indicates broadly comparable efficacy to an oral transmucosal fentanyl formulation and an existing fentanyl nasal spray.  Prescribers should be aware of the differing absorption and elimination characteristics of the available nasal fentanyl preparations; doses are not interchangeable.   Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.3 erlotinib, 25, 100 and 150mg film-coated tablets (Tarceva®)  Roche  SMC No. (664/10)

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

10.3.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from The Roy Castle Lung Cancer Foundation.  Detailed discussion followed and the group agreed that erlotinib (Tarceva®), should not be recommended for use within NHS Scotland, as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum-based first-line chemotherapy.  Erlotinib maintenance treatment provided a statistically significant increase in progression free survival and overall survival in patients treated with standard first-line platinum-based chemotherapy, both in the whole study population and in a post hoc analysis in patients with stable disease.  In the whole study population the changes in these outcomes were considered to be of modest size.  The manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.4 histamine dihydrochloride, 500 microgram/0.5ml, vial (Ceplene®)  Meda Pharmaceuticals Ltd  SMC No. (666/10)

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

10.4.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that histamine dihydrochloride (Ceplene®), should not be recommended for use within NHS Scotland, for maintenance therapy for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2. The efficacy of histamine dihydrochloride has not been fully demonstrated in patients older than age 60 years.  In a randomised open-label study, histamine plus interleukin-2 was superior to no treatment for the endpoint of leukaemia free survival (LFS) in a sub-group of patients in first complete remission.  In post hoc analysis of patients in first complete remission and aged less than 60 years, LFS rates at 36 months were 50% versus 30%. Overall the manufacturer did not present a sufficiently robust clinical or economic case to gain acceptance by SMC. Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.5 prilocaine hydrochloride hypebaric solution 2% (Prilotekal®)  Goldshield Group  (No. 665/10)

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

10.5.2 The NDC Economic Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.    Detailed discussion followed and the group agreed that prilocaine hydrochloride hyperbaric solution 2% (Prilotekal®), should be accepted for restricted use within NHS Scotland, for spinal anaesthesia.  SMC restriction:  for use in spinal anaesthesia in ambulatory surgery settings such as day surgery units.  Prilocaine 2% hyperbaric solution for injection was associated with faster discharge times than a hyperbaric formulation of another local anaesthetic in one small single-centre, double-blind, randomised study.  Use of this preparation may allow service improvement through benefits to individual patients or service delivery.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

RESUBMISSIONS

10.6 sorafenib 200mg film-coated tablets (Nexavar®) Bayer Schering Pharma SMC No. (482/08)

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

10.6.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses, summary of information for patients and comments received from the company.   A member of PAPIG presented patient interest group submissions for British Liver Trust; Hepatitis B Foundation UK and The Rarer Cancers Foundation.  Detailed discussion followed and the group agreed that sorafenib (Nexavar®), should not be recommended for use within NHS Scotland, for the treatment of hepatocellular carcinoma.  In one study in patients with advanced hepatocellular carcinoma, sorafenib was superior to placebo in terms of overall survival, but not for the time to symptomatic progression.   The manufacturer did not present a sufficiently robust economic analysis and in addition, the manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.7 ferric carboxymaltose 50mg iron/mL solution for injection/infusion (Ferinject®)  Vifor Pharmaceuticals  SMC No. (463/08)       

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

10.7.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company. Detailed discussion followed and the group agreed that ferric carboxymaltose (Ferinject®), should not be recommended for use within NHS Scotland, for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used.  The diagnosis must be based on laboratory tests.  Ferric carboxymaltose was superior to oral ferrous sulphate in raising haemoglobin levels in non-dialysis-dependent patients with chronic kidney disease and iron deficiency anaemia.  It has also shown similar efficacy to standard intravenous iron therapy in haemodialysed patients.  However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.8 degarelix 120mg and 80mg powder and solvent for solution for injection (Firmagon®)  Ferring Pharmaceuticals Ltd  SMC No. (560/09)

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

10.8.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from PROSTaid.    Detailed discussion followed and the group agreed that degarelix (Firmagon®),  should be accepted for use within NHS Scotland, for the treatment of adult male patients with advanced hormone-dependent prostate cancer.  In one study that included patients with all stages of prostate cancer, degarelix was shown to be non-inferior to a luteinising hormone releasing hormone (LHRH) agonist in suppressing testosterone levels over a one year treatment period without an initial testosterone flare. This SMC advice takes account of the benefits of a patient access scheme (PAS) that improves the cost-effectiveness of degarelix. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.8.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

ABBREVIATED SUBMISSIONS

10.9 valsartan (Diovan®) 40, 80, 160, 320mg tablets Novartis Pharmaceuticals UK Ltd SMC No. (649/10)

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

10.9.2 The NDC Chair provided an overview of the assessment and draft advice. Detailed discussion followed and the group agreed that valsartan (Diovan), should be accepted for restricted use within NHS Scotland, for the treatment of hypertension in children and adolescents 6 to 18 years of age. SMC restriction: use should be on the recommendation of a paediatric specialist consultant. The licence for the adult indication pre-dates SMC. Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.9.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.10 levetiracetam 100mg/ml oral solution (Keppra®)  UCB Pharma Ltd  SMC No. (661/10)

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

10.10.2 The NDC Chair provided an overview of the assessment and draft advice. Detailed discussion followed and the group agreed that levetiracetam (Keppra), should be accepted for restricted use within NHS Scotland, for adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in children and infants from 1 month of age to 4 years with epilepsy.  SMC restriction: to initiation and management under the supervision of a paediatric neurologist.  The Scottish Medicines Consortium has previously accepted this product for use within NHS Scotland as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in children from 4 years of age with epilepsy.  Addition of levetiracetam to existing anticonvulsant therapy has shown a greater reduction in partial seizure frequency than addition of placebo.  Levetiracetam is listed in the British National Formulary for Children 2010-2011 for adjunctive treatment for partial seizures with or without secondary generalisation from 1 month old.  Smaller syringe sizes of 1 and 3 ml have been made available to accommodate the smaller volumes for younger children.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

10.10.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

NON SUBMISSIONS

10.11 botulinum toxin type A (Azzalure ®)  Galderma  SMC No. (679/11)

10.11.1 In the absence of a submission from the holder of the marketing authorisation, botulinum toxin type a (Azzalure), should not be recommended for use within NHSScotland,  for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical “frown” lines between the eyebrows) in adult patients under 65 years and younger, when the severity of these lines has an important psychological impact on the patient. 

10.11.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.12 botulinum toxin Type A (Vistabel ®)  Allergan  SMC No. (680/11)

10.12.1 In the absence of a submission from the holder of the marketing authorisation, botulinum toxin (Vistabel), should not be recommended for use within NHSScotland,  for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical “frown” lines between the eyebrows) in adult patients under 65 years and younger, when the severity of these lines has an important psychological impact on the patient. 

10.12.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

10.13 velaglucerase (Vpriv ®) Shire Pharmaceuticals SMC No. (681/11)

10.13.1 In the absence of a submission from the holder of the marketing authorisation, velaglucerase (Vpriv), should not be recommended for use within NHSScotland,  for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease. 

10.13.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 17 December 2010.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted. 

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Dr Jonathan Fox advised he will be resigning as Chair of Greater Glasgow and Clyde ADTC in January 2011 to allow him to take up the role of Chairman of SMC’s New Drugs Committee.

13. SMC User Group Forum

13.1 Nothing to report.

14. Any Other Business

14.1 No other business was noted.

15. Date of the Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday, 11 January 2011 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

APPENDIX

NICE Publications

Minutes of the SMC Meeting 14 December 2010

NICE Single Technology Appraisal (STA) No.208 –  Trastuzumab for the treatment of HER2-positive metastatic gastric cancer

NICE recommends trastuzumab as a possible treatment for some people with a type of HER2-positive metastatic gastric adenocarcinoma.

SMC published a Statement of Advice (623/10) on this medication for this indication in August 2010. This stated that trastuzumab (Herceptin) is not recommended for use within NHS Scotland. Access the advice of the Scottish Medicines Consortium:

There is a material difference between the recommendations of the NICE STA and the SMC. NICE has recommended the medicine for restricted use in specific types of patient with gastric cancer. SMC has received a resubmission from the manufacturer of Trastuzumab and is due to publish a Statement of Advice on this medication for this indication in February 2011. When this is available, NHS Scotland should adhere to this advice.

Note:  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.