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Minutes of the SMC Meeting - Tuesday 6 October 2009

Minutes of the SMC Meeting held on Tuesday 06 October 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: Professor Ken Paterson (Chairman), Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Dr Jennifer Burns, Mr Dave Carson, Dr Sara Davies, Dr Jonathan Fox, Dr John Gemmill, Dr Jan Jones, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Ms Aileen Muir, Dr Mercia Page, Dr Robert Peel, Dr Andrew Power, Dr Nick Reed, Mr Keith Thompson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor David Wray

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Mrs Anne Lee, Ms Rosie Murray, Dr Euan Sandilands, Mr Jonathan Sim, Mrs Maureen Stark, Mrs Catherine Tait

Apologies: Mrs Laura Ace, Mr Colin Brown, Mr Scott Bryson, Mr Robert Calderwood, Dr David Crookes, Mr Stephen Ferguson, Ms Susan Goldsmith, Dr Barclay Goudie, Dr Simon Maxwell, Mrs Laura McIver, Dr Anthony Ormerod, Mr Andrew Powrie-Smith, Mr Mike Pratt, Ms Veronica Moffat, Professor Dilip Nathwani, Ms Emma Riches, Ms Alex Robertson, Dr Sarah Taylor, Dr Iain 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. 

1.2 A further welcome was extended to the following observers:

  • Dr Euan Sandilands, trainee in clinical pharmacology and therapeutics, NHS Lothian
  • Mr Jonathan Sim, recently appointed, who replaces Michelle Pasnik.

Thank you and good bye

To Dr John Cairns who has completed his term of membership on SMC.  Unfortunately due to other commitments John is unable to attend SMC until his replacement Dr Paul McNamee, Senior Research Fellow, Health Economics Research Unit, University of Aberdeen, commences in December.

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 01 September 2009 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submission

4.1 vildagliptin (Galvus®) Novartis (No. 571/09)

4.1.1 The SMC advice for vildagliptin (Galvus®), for the treatment of type 2 diabetes mellitus as dual oral therapy in combination with a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea or for whom metformin is inappropriate due to contraindications or intolerance, will be published on the SMC website on Monday 12 October 2009.

Resubmissions

4.2 etonogestrel/ethyl estradiol vaginal  ring (NuvaRing®) Schering-Plough Ltd (No. 502/08)

4.2.1 The SMC advice for etonogestrel/ethyl estradiol vaginal ring (NuvaRing®), for contraception, will be published on the SMC website on the SMC website on Monday 12 October 2009.

4.3 metformin prolonged release tablets (Glucophage SR®) Merck Serono (No. 148/04) 

4.3.1 The SMC advice for metformin prolonged release tablets (Glucophage SR®), for the treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control, will be published on the SMC  website on Monday 12 October 2009.

Abbreviated Submissions

4.4 methotrexate 50mg/ml (Metoject 50mg/ml) medac UK (No. 573/09)

4.4.1 The SMC advice for methotrexate 50mg/ml (Metoject 50mg/ml),  for the treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients, will be published on the SMC website on Monday 12 October 2009.

4.5 olmesartan medoximil/amlodipine besilate (Sevikar) Daiichi Sankyo UK Ltd (No. 574/09)

4.5.1 The SMC advice for olmesartan medoximil/amlodipine besilate (Sevikar),  for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine, will be published on the SMC website on Monday 12 October 2009.

4.6 diclofenac 4% gel spray (Mobigel Spray 4%) Goldshield Pharmaceuticals Limited (No. 575/09)

4.6.1 SMC deferred their advice for diclofenac (Mobigel Spray 4%), for the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures, pending further consideration. SMC concluded that clinical equivalence of Mobigel to the comparator gel formulation had not been demonstrated and requested further information in order to consider the abbreviated submission further. 

Non Submission

4.7 hydroxycarbamide (Siklos®)  Nordic Pharma UK  (No. 582/09)

4.7.1 The SMC advice for hydroxycarbamide (Siklos®), for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic Sickle Cell Syndrome, will be published on the SMC website on Monday 12 October 2009.

4.8 estradiol/dienogest (Qlaira®)  Bayer Schering Pharma  (No. 583/09)

4.8.1 The SMC advice for estradiol/dienogest (Qlaira®), for the treatment of oral contraception, will be published on the SMC website on Monday 12 October 2009.

Deferred Advice

4.9 Nothing to report.

Amended Advice

4.10 quetiapine, 25mg, 100mg, 200mg, 300mg tablets (Seroquel®) AstraZeneca No.  (549/09)
 
4.10.1 Quetiapine, (Seroquel®) was reviewed by SMC in April 2009, for the treatment of major depressive episodes associated with bipolar disorder, advice was withheld pending confirmation of product availability.  The product is now available and advice was distributed to NHS Boards and ADTCs on Friday 04 September 2009 and will be published on the SMC website on Monday 12 October, 2009. 

However, following a request from the manufacturer, the indication and dosing information has been amended to reflect the most recent SPC.  Advice will be reissued to Boards on Friday 09 October 2009.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC meeting and minutes would be available at November SMC. 

  • Mrs Tunstall-James advised that the final version of PAPIG’s Role and Remit/Terms of Reference is now finalised and will be brought to the SMC Executive for final approval.
  • There have been no further developments in the last month with the Long Term Conditions Alliance Scotland (LTCAS) concerning the establishment of a Public Involvement Officer.
  • It is proposed another Training Day for Patient Interest Groups will be arranged for Spring 2010.  The support of the SMC Executive was a welcome and valuable contribution and PAPIG would like to circulate dates to SMC Executive and invite members to participate in this event.
  • Mrs Tunstall-James made a presentation on public involvement to the 35th UKMi Practice Development Seminar, held in Edinburgh and was well received. 

The Chairman thanked Mrs Tunstall-James for the update and agreed that the Training Event was worthwhile and that members of the SMC Executive would be pleased to support the next Training Day Event and look forward to receiving more information on this event.

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 January Meeting of SMC

As the January meeting of SMC falls on 5 January 2010 (directly after the public holiday) the Chairman asked for views on holding the meeting on Wednesday 6 January or Tuesday 12 January.  Following discussion SMC agreed the January meeting will take place on Tuesday 12 January 2010, the date will be circulated to all SMC members. 

8.2 Affordability of Current Cost per QALY Criteria

The SMC NHS Policy group met recently and Dr Andrew Walker presented a paper on the affordability of the current cost per QALY criteria and requested views regarding whether the way SMC uses cost per QALY information produces guidance the NHS finds broadly affordable over times.  The following four options were suggested for consideration:

Option 1 – no change to current process
Option 2 – lower the £20k and £30k figures
Option 3 – raise the £20k and £30k figures
Option 4 – retain the existing figures but change the way these are interpreted in practice

It was a useful discussion and there was no desire from the group to adopt a higher level, however, the debate may be reopened should the situation change.

8.3 NICE (Multiple) Technology Appraisal Guidance No 155 Ranibizumab and Pegaptanib for the treatment of Age-related Macular Degeneration (Published 28 September 2009)

The following NICE appraisal was published in August 2008 and was considered by NHS Quality Improvement Scotland through its revised procedure of processing of NICE appraisals.  Due to additional work required, NHS QIS did not provide advice on this MTA to NHS Scotland at this time. Instead, NHS Scotland was advised to continue to adhere to the SMC advice on ranibizumab (Lucentis®) and pegaptanib (Macugen®) for age-related macular degeneration. NHS QIS is now in a position to provide advice to NHS Scotland.

The NICE MTA No 155 summarises that ranibizumab is recommended as a possible treatment for people with wet AMD if all the following apply to their eye:

  • The best possible visual acuity after correction with glasses or contact lenses is between 6/12 and 6/96. 
  • There is no permanent damage to the fovea (the part of the eye that helps people to see things in sharp detail). 
  • The area affected by AMD is no larger than 12 times the size of the area inside the eye where the optic nerve connects to the retina. 
  • There are signs that the condition has been getting worse.

Treatment should be stopped if a person's vision gets worse and there are changes inside the eye which show that treatment is not working. The NHS should cover the drug cost of ranibizumab for the first 14 injections in each eye being treated. If people need more than 14 injections per eye, the manufacturer of ranibizumab has agreed to take over the drug cost from the NHS.  Pegaptanib is not recommended for people with wet AMD. Healthcare professionals should not immediately stop prescribing pegaptanib for people who were already taking it when the guidance was issued. These people should be able to carry on taking pegaptanib until they and their healthcare professionals decide that it is the right time to stop treatment. In June 2007, SMC published the following advice: ranibizumab (Lucentis) is accepted for use within NHS Scotland for the treatment of neovascular (wet) age-related macular degeneration (AMD). Ranibizumab reduces the rate of visual acuity loss and increases visual acuity. It should be stopped if visual acuity falls persistently below 6/60 during treatment.

In August 2006, SMC published the following advice: Pegaptanib for intravitreal injection (Macugen) is accepted for restricted use within NHS Scotland for the treatment of neovascular (wet) age-related macular degeneration (AMD). It has been shown to reduce the rate of loss of visual acuity in patients with subfoveal neovascular AMD. Pegaptanib should be restricted to patients with visual acuity between 6/12 to 6/60 (inclusive) and should be stopped if visual acuity falls below 6/60 during treatment or where severe visual loss is experienced. The cost effectiveness of pegaptanib in patients who are also receiving photodynamic therapy has, however, not been demonstrated.

NICE Multiple Technology Appraisal (MTA) guidance supersedes SMC advice

8.4 NICE Single Technology Appraisal Guidance No 179 –  Sunitinib for the treatment of gastrointestinal stromal tumours (Published 23 September 2009)

The NICE STA No 179 summarises that sunitinib is recommended as a possible treatment for people with unresectable or metastatic malignant gastrointestinal stromal tumours if they have already tried imatinib treatment but it has not worked or was not suitable. The manufacturer of sunitinib has agreed to cover the cost of the drug for the first treatment cycle.  Treatment should be supervised by a specialist who is experienced in treating people with gastrointestinal stromal tumours.

In October 2006, SMC published the following advice: Sunitinib (Sutent) is not recommended for use within NHS Scotland for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance. Sunitinib compared to placebo delayed tumour progression by approximately five months. The economic case has not been demonstrated.

The NICE STA advice is based upon the application of both a Department of Health agreed Patient Access Scheme and consideration of the medicine as a life-extending, end of life treatment. The SMC will review a resubmission for sunitinib today. 

8.5 NICE Single Technology Appraisal Guidance No 181 – Pemetrexed for the first-line treatment of non-small-cell lung cancer (Published 23 September 2009)

The NICE STA No 181 summarises that pemetrexed is recommended as a possible treatment for locally advanced or metastatic non-small-cell lung cancer (NSCLC) if: the cancer is a particular type (adenocarcinoma or large-cell carcinoma) and the person has not had any treatment for NSCLC before. Healthcare professionals should not stop prescribing pemetrexed for people who do not have adenocarcinoma or large-cell carcinoma who were already taking it when the guidance was issued. These people should be able to carry on taking pemetrexed until they and their specialist decide that it is the right time to stop treatment.

In June 2006, SMC published the following advice: pemetrexed (Alimta), in combination with cisplatin, is not recommended for use within NHS Scotland for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer other than predominantly squamous cell histology. In a planned subgroup analysis of a study comparing pemetrexed plus cisplatin with another platinum-based combination regimen, treatment with pemetrexed plus cisplatin resulted in a small improvement in median survival in patients with a non-squamous histology. The manufacturer did not present a sufficiently robust economics case to gain acceptance by SMC.

There is a material difference between the recommendations of the NICE STA and the SMC. The SMC is expecting a resubmission from the manufacturer of pemetrexed (Alimta) imminently. 

NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

8.6 Patient Access Schemes

The Cabinet Secretary for Health and Wellbeing announced the establishment of a national framework for assessing proposed Patient Access Schemes (PAS) in a statement to Parliament on New Medicines (Access) and Additional Private Care (Guidance) on 25 March 2009. 

A national PAS Assessment Group (PASAG) has being established that will conduct an objective and independent assessment of schemes submitted by pharmaceutical companies for new medicines, on behalf of NHS Scotland. The group will advise on the feasibility of these schemes for implementation by NHS Boards and produce, where appropriate, an implementation package for use across Scotland. 

With regards to the paperwork for these submissions, minimal information regarding the PAS is contained with the DAD.  The “Summary of Comparative Health Economic Evidence” includes a sentence to indicate that a PAS was submitted and notes the cost of the ICER with the PAS.    PASAG have developed guidance notes to outline how the PAS operates and they will be distributed, by SMC, in confidence, to NHSScotland, in tandem with the SMC advice.  The guidance notes will remain confidential and will not form part of the DAD
 
Where a PAS has not been approved by the PASAG and is therefore not part of the SMC consideration of the cost effectiveness or where the PAS is approved by PASAG but SMC consider that the cost effectiveness is not demonstrated with the PAS, there will be no reference to the PAS within the DAD.

8.7 Non Submission

nepafenac (Nevanac)  Alcon Laboratories  (No. 588/09)

nepafenac (Nevanac) for the prevention and treatment of post operative pain and inflammation associated with cataract surgery.  The manufacturer has advised that it is anticipated that this product will only be used in hospitals, and even then mainly in the private sector. They do not consider that this would increase the cost burden to the Scottish Health Trusts, however, unfortunately at this time they do not have any Health Economic data to support this claim and are not in any position at present to submit to SMC the full dossier that SMC require to support the use of the product.

8.8 Update on Biosimilars

SMC are reviewing the first biosimilar drug today with filgrastim, (Ratiograstim®). 

Ms Angela Timoney provided an update on biosimilars.  A biosimilar medicinal product is a new biological product that has demonstrated similar efficacy and safety to an existing biological product (termed the ‘reference’ product).

In January 2009 a Short Life Working Group was set up to consider SMC policy options for biosimilar medicines. Membership included representation from NHS Scotland and Industry. The SLWG was asked to consider which SMC policy options would be most appropriate for assessing biosimilars, that is: full submission, abbreviated submission or outwith remit.

By definition, similar biological medicinal products are not generic medicinal products, since it could be expected that there may be subtle differences between similar biological medicines from different manufacturers or whencompared with the reference product. These differences might not be fully apparent until the product is marketedand there is experience of use in clinical practice. Clinical safety of biosimilars must therefore be monitored closely on an ongoing basis during the post-approval phase, including continued risk-benefit assessment. Thus in order to support pharmacovigilance monitoring, the BNF advises that it is good practice to prescribe biological medicinal products by brand name. If the specified biosimilar medicinal product is unavailable during dispensing,automatic substitution for the reference product is inappropriate. Substitution should only be considered if the prescribing physician gives prior consent.

SMC is asked to support the recommendation of the Short Life Working Group that all biosimilar products will require a full submission over the next 12 months.  After this time the policy position will be reviewed with a view to determining the most appropriate submission route for biosimilar medicines.

Ms Angela Timoney advised that 5-10 biosimilar products are expected to receive marketing authorisation within the next 12 months that will require SMC assessment.  As a number of biosimilar drugs are now coming through to SMC it is proposed that NES will arrange to delivery an educational session to support the understanding of these drugs.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 esomeprazole, 40mg vial of powder for solution for intravenous injection or infusion (Nexium I.V.®)
AstraZeneca No. (578/09)

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

9.1.2 The NDC Co-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 esomeprazole (Nexium I.V.®), should be accepted for use within NHS Scotland, for prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers.  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 09 October 2009.


9.2 filgrastim, (Ratiograstim®)  Ratiopharm UK Ltd No.  (577/09)

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

9.2.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments and revised data/analyses.  Detailed discussion followed and the group agreed that filgrastim (Ratiograstim®), should be accepted for use within NHS Scotland, for Reduction in the duration of neutropenia and the incidence of febrile neutropenia (FN) in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes); Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia; Mobilisation of peripheral blood progenitor cells (PBPC); As long term administration, to increase neutrophil counts and to reduce the incidence and duration of infection-related events in children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/L, and a history of severe or recurrent infections; For the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

Filgrastim (Ratiograstim®) is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference granulocyte colony stimulating factor (filgrastim (Neupogen®)).  The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name. 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 09 October 2009.                          

9.3 Fentanyl (Instanyl®) 0.5mg/ml, 1mg/ml and 2mg/ml  Nycomed UK Ltd  No.  (579/09)     

9.3.1 A member with a personal specific interest left the meeting for this part of the agenda.
    
9.3.2 The NDC Co-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 fentanyl nasal spray (Instanyl®), should be accepted for restricted use within NHS Scotland, for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.  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 09 October 2009.                      

9.4 agomelatine, 25mg film-coated tablets (Valdoxan®) Servier Laboratories UK Ltd (No.564/09)

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

9.4.2 The NDC Co-Vice Chair provided an overview of the assessment and draft advice.  A member of PAPIG presented two patient interest group submissions from Depression Alliance Scotland  and (One Group did not wish name to be disclosed). Expert comments, revised data/analyses and comments received from the company were considered.  Detailed discussion followed and the group agreed that agomelatine (Valdoxan®), should not be recommended for use within NHS Scotland, for the treatment of major depressive episodes in adults.  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 09 October 2009.

RESUBMISSIONS

9.5 sunitinib, 12.5mg, 25mg, 50mg hard capsules (Sutent®) Pfizer Ltd No. (275/06)        

9.5.1 Declarations of interest were recroded in relation to this product/comparator drugs.

9.5.2 The NDC Co-Vice Chair provided an overview of the assessment and draft advice.  A member of PAPIG presented a patient interest group submission from Sarcoma UK and Gist Support UK.  Expert comments, revised data/analyses and comments received from the company were considered.  Detailed discussion followed and the group agreed that Sunitinib (Sutent®), should be recommended for use within NHS Scotland, for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance.  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 09 October 2009.      
                   
9.6 bortezomib, 3.5mg vial of powder for solution for intravenous injection (Velcade®) Ortho Biotech No. (302/06)

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

9.6.2 The NDC Chair provided an overview of the assessment and draft advice.  A member of PAPIG presented a patient interest group submission from Myeloma UK.  Expert comments, revised data/analyses and comments received from the company were considered.  Detailed discussion followed and the group agreed that bortezomib (Velcade®), should be accepted for use within NHS Scotland, as mono-therapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation. 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 09 October 2009.

ABBREVIATED SUBMISSION

9.7 Pramipexole (Mirapexin®)  Boehringer-Ingelheim (No. 580/09)

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

9.7.2 The NDC Chair provided an overview of the assessment and draft advice.  Detailed discussion followed and the group concluded their advice for pramipexole dihydrochloride monohydrate  prolonged release tablets 0.375mg,0.75mg, 1.5mg, 3.0mg, 4.5mg (equivalent to 0.26mg, 0.52mg, 1.05mg, 2.1mg, 3.15mg pramipexole) (Mirapexin®), for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).

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

NON SUBMISSION

9.8 nepafenac (Nevanac®) Alcon Laboratories (No. 588/09)

9.8.1 In the absence of a submission from the holder of the Marketing Authorisation, nepafenac (Nevanac®), for prevention and treatment of postoperative pain and inflammation associated with cataract surgery, should not be recommended for use within NHS Scotland.

9.8.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 09 October 2009.

10.Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 Nothing to report.

12. Area Drug and Therapeutic Committees (ADTCs): Issues

12.1 Dr John McElhinney enquired about the availability of generic copies of clopidogrel which are formulated as different salts (besylate and hydrochloride) and the issue that whilst Plavix (clopidogrel hydrogen sulphate) is licensed for use in combination with aspirin for the treatment of acute coronary syndrome, the generic salts do not have this indication included within their marketing authorisation because of Plavix patent protection, and advised that his ADTC does not hold this information.

At present there is no price reduction for generic clopidogrel so no reason to change practice, this will of course change in the future.  It was agreed to look at this over the coming months.

13. Any Other Business

13.1 No other business was raised.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 03 November 2009 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.