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SMC Minutes Tuesday 3 August 2010

Minutes of the SMC Meeting
held on Tuesday 03 August 2010
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: 
Professor Ken Paterson (Chairman), Dr Keith Beard, Mrs Margo Biggs, Dr Jennifer Burns, Professor Scott Bryson, Mr Robert Calderwood, Mr Dave Carson, Dr David Crookes, Dr Dominic Culligan, Dr Sara Davies, Dr Barclay Goudie, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Mrs Sandra McNaughton, Dr Paul McNamee, Dr Anthony Ormerod, Ms Aileen Muir, Dr Mercia Page, Mr Michael Pratt, Dr Nick Reed, Dr Brian Robson, Mrs Sheila Tunstall-James, Mr Alistair Thorburn, Mr Keith Thompson, Ms Angela Timoney, Dr Andrew Walker

In Attendance:
Mrs Corinne Booth, Ms Ailsa Brown, Mrs Alison Campbell, Ms Veronica Harper, Mrs Anne Lee, Ms Rosie Murray, Ms Emma Riches, Mrs Catherine Tait, Mrs Janice Watt, Mr Ian Welsh

Apologies:
Mrs Laura Ace, Professor James Barbour, Mr Colin Brown, Dr Keith Brown, Mrs Susan Downie, Mr Stephen Ferguson, Dr Jonathan Fox, Dr John Gemmill, Dr Chris Lush, Dr Simon Maxwell, Mrs Laura McIver, Ms Veronica Moffat, Professor Dilip Nathwani, Dr Robert Peel, Dr Andrew Power, Ms Alex Robertson, Mr Andrew Powrie-Smith, Mrs Maureen Stark, Professor Tony Wells, Professor David Wray, Dr Sarah Taylor

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 individuals who were observing the meeting:

  • Mr Ian Welsh, Chief Executive, Long term Conditions Alliance Scotland (LTCAS).
  • Ms Veronica Harper, Head of Corporate Services, Long Term Conditions Alliance Scotland (LTCAS).

1.3 NDC Presenters

  • Mrs Alison Campbell, NDC Member and Lead Assessor who was presenting a submission to SMC.
  • Mrs Janice Watt, NDC Member and Lead Assessor who was presenting a submission to SMC.
  • Dr Andrew Walker, NDC Member and Economic Assessor who was presenting a submission to SMC.
  • Ms Ailsa Brown, NDC Member and Economic Assessor who was presenting a submission to SMC.

1.4 Thank you and Goodbye

The Chairman expressed his thanks to Mrs Laura McIver, Chief Pharmaceutical Advisor, who is commencing an 18 month secondment with NHS QIS from 9 August, 2010.

1.5 Welcome

The Chairman welcomed Mrs Anne Lee who has been successful as the new SMC Chief Pharmaceutical Advisor, and will commence with this post on 09 August 2010. 

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 (06 July 2010)

3.1 The minutes of the SMC meeting held on 06 July 2010 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 betamethasone 2.5mg medicated plaster (Betesil)  Genus Pharmaceuticals (No. 622/10)

4.1.1 The SMC advice for betamethasone 2.5mg medicated plaster (Betesil), for treatment of inflammatory skin disorders which do not respond to treatment with less potent corticosteroids, such as eczema, lichenification, lichen planus, granuloma annulare, palmoplantar pustulosis and mycosis fungoides.  Due to its particular pharmaceutical form, betamethasone medicated plaster is suitable for chronic plaque psoriasis localized in difficult to treat areas (e.g. knees, elbows and anterior face of the tibia on an area not greater than 5% of the body surface), will be published on the SMC website on Monday, 09 August 2010.

4.2 trastuzumab 150 mg as powder for concentrate for solution for infusion (Herceptin) Roche (No. 623/10)

4.2.1 The SMC advice for trastuzumab 150 mg as powder for concentrate for solution for infusion (Herceptin), in combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease, will be published on the SMC website on Monday, 09 August  2010.
 
4.3 olanzapine Long Acting injection (ZypAdhera)  Eli Lilly and Company Limited (No.624/10)

4.3.1 The SMC advice for olanzapine Long Acting injection (ZypAdhera), for maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine, will be published on the SMC website on Monday, 09 August  2010.
 
4.4 eltrombopag 25mg and 50mg film-coated tablets (Revolade)  GlaxoSmithKline UK  (No.625/10)

4.4.1 The SMC advice for eltrombopag 25mg and 50mg film-coated tablets (Revolade), for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins), will be published on the SMC website on Monday, 09 August  2010.

4.5 ofatumumab solution for infusion (Arzerra) GlaxoSmithKline UK (No. 626/10)

4.5.1 The SMC advice for ofatumumab solution for infusion (Arzerra), for the treatment of chronic lymphocytic leukaemia (CLL) in patients who are refractory to fludarabine and alemtuzumab, will be published on the SMC website on Monday, 09 August 2010.

Resubmission

4.6 betaine anhydrous (Cystadane) Orphan Europe (No. 407/07)

4.6.1 The SMC advice for betaine anhydrous (Cystadane), for adjunctive treatment of homocystinuria involving deficiencies or defects in cystathionine beta-synthase (CBS), 5,10-methylene-tetrahydrofolate reductase (MTHFR) or cobalamin cofactor metabolism (cbl), will be published on the SMC website on Monday, 09 August  2010.

Abbreviated Submissions

4.7 sitagliptin 50mg /metformin 1000mg (Janumet) Merck Sharp and Dohme (No. 627/10)

4.7.1 The SMC advice for sitagliptin 50mg /metformin 1000mg (Janumet), In combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea, will be published on the SMC website on Monday, 09 August  2010.

4.8 dutasteride 0.5 mg /tamsulosin hydrochloride 0.4mg hard capsules (Combodart) GlaxoSmithKline UK (No. 628/10)

4.8.1 The SMC advice for dutasteride 0.5 mg /tamsulosin hydrochloride 0.4mg hard capsules (Combodart), for treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH); Reduction in the risk of acute urinary retention and surgery in patients with moderate to severe symptoms of BPH, will be published on the SMC website on Monday, 09 August  2010.

4.9 filgrastim (Tevagrastim)  Teva UK Ltd  (No. 629/10)

4.9.1 The SMC advice for filgrastim (Tevagrastim) for:

  • Reduction in the duration of neutropenia and the incidence of febrile neutropenia 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);
  • In patients, 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, long term administration is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events;
  • 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, will be published on the SMC website on Monday, 09 August  2010.

4.10 aripiprazole (Abilfy)  Bristol-Myers Squibb Pharmaceuticals Ltd  (No. 630/10)

4.10.1 The SMC advice for aripiprazole (Abilfy), for the treatment of schizophrenia in adolescents 15 years and older.   Aripiprazole (Abilify) is restricted to initiation and management under the supervision of a child/adolescent psychiatrist, will be published on the SMC website on Monday, 09 August  2010.

4.11 Deferred Advice

4.11.1 Nothing to report.

4.12 Amended Advice

4.12.1 Nothing to report.

5. Appeals Update

5.1 olanzapine Long Acting injection (ZypAdhera)  Eli Lilly and Company Limited  (No.624/10)

5.1.1 In July 2010, SMC considered but did not recommend olanzapine (ZypAdhera), for maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.  Eli Lilly and Company Limited have indicated their intention to resubmit.

5.2 mifamurtide, 4mg powder for suspension for infusion (Mepact) Takeda UK and Ireland Ltd (No.621/10)

5.2.1 In June 2010 SMC considered but did not recommend mifamurtide (Mepact), in combination with post-operative multi-agent chemotherapy, for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults.  Takeda UK and Ireland Ltd have indicated their intention to resubmit.

5.3 degarelix (Firmagon) Ferring Pharmaceuticals Limited (No. 560/09)

5.3.1 In July 2009 SMC considered but did not recommend degarelix (Firmagon), for the treatment of adult male patients with advanced hormone-dependent prostate cancer.  Ferring Pharmaceuticals Limited have indicated their intention to resubmit.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

6.1.1 Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC.

6.2 Verbal Update  - Mrs Tunstall-James

Mrs Tunstall James advised that intereviews have now taken place for the post of the new Patient and Public Involvement Officer (PPIO) which will support the work of SMC and ensure that a patient view is considered for new medicines under review.  A candidate has been offered the position and has verbally accepted the post, and subject to reference should commence employment on 17 August 2010.  The Chairman is pleased that this post has now been recruited and looks forward to meeting the new PPIO. Mrs Tunstall James was delighted to have Dr Jan Jones, NDC Chairman join the PAPIG meeting earlier today and thanked Dr Jones for attending the meeting.

6.3 Following a recent submission received from a Patient Interest Group, and although explicit in our guidance, this submission was not relevant to the disease area.  It was agreed to write to the group to request that future submissions to SMC are targeted specifically within the Patient Interest Group's own area of expertise.  Following discussion at the meeting it was agreed we should revise guidance to stipulate this. The appointment of the new Public Involvement Officer will be more proactive in liaising with Patient Groups, thus providing a greater support to the process
 
6.4 The Chairman advised that a one day Patients Group Conference in Berlin is planned  to take place in October 2010.  Dr Jan Jones and a member of the PAPIG group will attend the conference. 

7. New Drugs Committee: Chairman’s Report

7.1 Dr Jan Jones, NDC Chairman thanked Mrs Aileen Muir, NDC Co-Vice Chair for chairing the NDC meeting in June 2010.

7.2 At NDC in July 2010 there were interesting presentations and discussion on discount pricing.  A presentation was given from Ms Margaret Dolan, Pharmacy Advisor, National Procurement, NHS National Services Scotland.  A joint presentation was given by Dr Frances MacDonald, Director, ABPI and SMC member, and Ms Ailsa Brown, SMC Health Economist, on the challenges of using discount prices in SMC submissions.  Ms Brown provided information on the issues associated with using NHS list prices ie undiscounted pricing in SMC assessments.  Ms Dolan explained the discount structure in NHS Scotland and why discount prices are used.  Dr Macdonald outlined they key issues for the pharmaceutical industry.  Various options were discussed and it is anticipated that a worked example will be presented to NDC, and the Chairman will keep SMC updated on progress.

8. Chairman’s Business

8.1 Freedom of Information Request

SMC has received a request under the Freedom of Information (Scotland) Act 2002 for a copy of:
Roche’s submission to SMC for tocilizumab (RoActemra), which was reviewed by SMC in December 2009 and; any email communication that relates to the selection and treatment of comparators for tocilizumab (RoActemra), in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs or tumour necrosis factor antagonists.

The request has originated from UCB Pharma Ltd.  SMC is responding to the request and will issue a response by 24 August 2010.

8.2 NICE Single Technology Appraisal (STA) Guidance No 191 – Capecitabine for the treatment of advanced gastric cancer, published 28 July, 2010

Summary of NICE STA

NICE recommends capecitabine, taken with platinum-containing drugs, for some people with stomach cancer.

Patients should be able to have capecitabine if:

  • their stomach cancer is advanced and;
  • they have not had treatment for advanced stomach cancer before and;
  • their cancer cannot be removed with an operation.

SMC Advice

SMC published advice for capecitabine in September 2007 (SMC No. 401/07)

Capecitabine (Xeloda) is accepted for use within NHS Scotland, for first line treatment of patients with advanced gastric cancer in combination with a platinum-based chemotherapy regimen.  Capecitabine was non-inferior to continuously infused intravenous 5-FU in terms of progression-free survival when each was used in combination with a platinum-based drug in patients with advanced gastric cancer. It also demonstrated non-inferiority in overall survival compared with continuously infused intravenous 5-FU in patients with advanced gastric cancer when each was used in a triple regimen containing a platinum-based drug and an anthracycline drug.  Capecitabine is more expensive than 5-FU, however, the convenience of oral administration may allow changes to service delivery that have individual patient or organisational benefits.

There is no material difference between the recommendations of the NICE STA and the SMC.   STAs have no status in NHS Scotland.

8.3 NICE Single Technology Appraisal (STA) Guidance No 192 – Gefitinib for the first-line treatment of locally advanced or metastatic non-small-cell lung cancer, published 28 July, 2010.

Summary of NICE STA

NICE recommends gefitinib as a possible first treatment for some people with locally advanced or metastatic non-small-cell lung cancer.

Patients should be able to have gefitinib if:

  • they have a type of locally advanced or metastatic non-small-cell lung cancer that responds to gefitinib treatment and
  • they have not had drug treatment for non-small-cell lung cancer before.

SMC Advice

SMC published advice for gefitinib in May 2010 (SMC No. 615/10)

Gefitinib (Iressa) is not recommended for use within NHS Scotland, 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).  In a comparative study in previously untreated patients, gefitinib was superior to a platinum-based doublet chemotherapy regimen in terms of progression-free survival; subgroup analysis supported this finding in patients with activating mutations of EGFR-TK. However, the manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC

There is a material difference between the recommendations of the NICE STA and the SMC. The NICE STA advice is based upon the application of a Department of Health agreed Patient Access Scheme. STAs have no status in NHS Scotland.

8.4 NICE Single Technology Appraisal (STA) Guidance No 193 –  Rituximab for the treatment of relapsed or refractory chronic lymphocytic leukaemia, published 28 July, 2010.

Summary of NICE STA

NICE recommends taking rituximab, fludarabine and cyclophosphamide together as a possible treatment for some people with relapsed or refractory chronic lymphocytic leukaemia.
Patients should be able to have rituximab, fludarabine and cyclophosphamide together unless:

  • they have had rituximab before or;
  • they have had fludarabine before and their condition did not respond to it or worsened within 6 months of treatment.

SMC Advice

SMC published advice for rituximab in January 2010 (SMC No. 591/09)

Rituximab (MabThera) is accepted for restricted use within NHS Scotland, for the treatment of patients with previously untreated and relapsed/refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.  Rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression-free survival than fludarabine and cyclophosphamide alone. The patient population in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status of 0 or 1 and was a younger population than that generally seen in clinical practice. Evidence in patients over 70 years of age is limited.  Restriction: Rituximab is restricted to use by specialists in haematology and haematooncology.

There is no material difference between the recommendations of the NICE STA and the SMC. STAs have no status in NHS Scotland.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 bivalirudin 250mg powder for concentrate for solution for injection or infusion (Angiox)   The Medicines Company SMC No. (638/10)       

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

9.1.2 The NDC Lead 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 bivalirudin (Angiox), should be accepted for restricted use within NHS Scotland, as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.  Bivalirudin should be administered with aspirin and clopidogrel. Restriction: patients who would have been considered for treatment with heparin in combination with a glycoprotein IIb/IIIa inhibitor.  It should not be used as an alternative to heparin alone. In patients with STEMI undergoing PCI, bivalirudin, compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with significantly lower rates of major bleeding, cardiac death and thrombocytopenia.   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, 06 August 2010.
 
9.2 trabectedin, 250 microgram, 1mg powder for concentrate for solution for infusion (Yondelis)  PharmaMar S.A. Ltd SMC No.  (634/10)   

9.2.1 A member with a personal specific interest left the meeting for this part of the agenda.

9.2.2 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 trabectedin (Yondelis), should not be recommended for use within NHS Scotland, in combination with pegylated liposomal doxorubicin (PLD) is indicated for the treatment of patients with relapsed platinum-sensitive ovarian cancer.  In an open-label randomised controlled study trabectedin in combination with PLD was significantly superior to PLD monotherapy in terms of progression free survival. There was a significant difference in an exploratory interim analysis of overall survival in the sub-group of patients with partially platinum-sensitive disease.  The manufacturer’s justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust 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.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 August 2010.

9.3 roflumilast 500 microgram tablets (Daxas®) Nycomed Ltd  SMC No. (635/10)       

9.3.1 Declarations of interest were recorded in relation to this product/comparator drugs.  Members 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 concluded their advice for roflumilast (Daxas®), for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second [FEV1] post-bronchodilator <50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.  
                                                                                   
9.3.3 The SMC advice will be withheld pending confirmation of licence and product availability.

9.4 febuxostat 80mg and 120mg tablets (Adenuric®)  A. Menarini Pharma UK SRL  SMC No. (637/10)

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

9.4.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that febuxostat (Adenuric®), should be accepted for restricted use within NHS Scotland,  for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence, of tophus and/or gouty arthritis).  SMC restriction: when treatment with allopurinol is inadequate, not tolerated or contra-indicated.  Febuxostat is superior to allopurinol 300mg daily in reducing serum uric acid to <6mg/dL, (360micromol/L) in patients with hyperuricaemia and gout. (NB The maximum licensed daily dose of allopurinol is 900mg.)  The economic case was demonstrated for second line use of febuxostat in patients who had an inadequate response to allopurinol, or when allopurinol is contraindicated or not tolerated.   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, 06 August 2010.

9.5 dronedarone, 400mg, film-coated tablets (Multaq®)  Sanofi-aventis Ltd  SMC No. (636/10)      

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

9.5.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented patient interest group submissions from The Stroke Association and Atrial Fibrillation Association.  Detailed discussion followed and the group agreed that dronedarone (Multaq®), should be accepted for restricted use within NHS Scotland, in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.  SMC restriction: for the prevention of recurrence of AF in patients in whom conventional first-line anti-arrhythmic medicines are ineffective, contra-indicated or not tolerated. Treatment should be initiated on specialist advice only.  Dronedarone appears less effective than amiodarone in reducing atrial fibrillation recurrence but has the potential for improved tolerability compared to comparator medicines.  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, 06 August 2010.

RESUBMISSIONS

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

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

9.6.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from Depression Alliance.  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.  When used in a flexible dosing schedule, agomelatine significantly reduced the symptoms of  depression and increased the number of patients who responded to treatment compared with placebo. There are no comparative data from clinical studies with existing second line antidepressants using depression as the primary outcome.  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.

9.6.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 August 2010.

9.7 imatinib, 100mg and 400mg film-coated tablets (Glivec®) Novartis Pharmaceuticals UK Ltd SMC No. (584/09)

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

9.7.2 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 imatinib (Glivec®), should be accepted for restricted use within NHS Scotland, for adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST). Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.  SMC restriction: Imatinib is restricted to use in patients at high risk of recurrence following complete resection (according to the Armed Forces Institute of Pathology (AFIP) risk criteria).   Imatinib, given for a period of one year, significantly improved the estimated one year recurrence-free survival compared with placebo and was associated with an increase of 16.4 months in median time to recurrence in patients at high risk of relapse following resection. The economic case was demonstrated for a one-year adjuvant treatment duration only.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 August 2010.

ABBREVIATED SUBMISSION

9.8 esomeprazole 10mg gastro-resistant granules for oral solution, sachet (Nexium®) AstraZeneca UK Ltd No. (639/10)

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

9.8.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, and expert comments.  Detailed discussion followed and the group agreed that esomeprazole 10mg gastro-resistant granules for oral solution, sachet (Nexium®), should be accepted for restricted use within NHS Scotland, for treatment of gastro-oesophageal reflux disease in children 1 to 11 years old, gastro-oesophageal reflux disease (GORD)
Treatment of endoscopically proven erosive reflux oesophagitis
Symptomatic treatment of gastro-oesophageal reflux disease
Oral suspension may also be used by patients having difficulty swallowing dispersed esomeprazole gastro-resistant tablets.  SMC Restriction: the use of esomeprazole for this indication and age group should be restricted to patients in whom licensed doses of a generic proton pump inhibitor have been ineffective.  The gastro-resistant granules for oral solution have demonstrated bioequivalence to the tablet and capsule formulations. Doses of 10mg esomeprazole in children aged 1 to 11 resulted in the same exposure to drug as seen with the 20mg dose in adolescents and adults. There is no evidence of comparative efficacy in this population.  The Scottish Medicines Consortium has previously accepted this product for use in patients in the 12-17 years age group, for the treatment of erosive reflux oesophagitis, the long-term management of patients with healed oesophagitis to prevent relapse, and the symptomatic treatment of gastro-oesophageal reflux disease.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.8.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 August 2010.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 Short-life Working Group on Review of Budget Impact Assessment

Dr Frances Macdonald advised that the work of SLWG on Budget Impact and testing is almost complete.  It is anticipated that the group will make a proposal to the SMC Executive regarding incorporating the template into the Guidance to Manufacturers document and implementation. 

12. Area Drug and Therapeutics Committees (ADTC) Issues

12.1 Nothing to update.

13. Any Other Business

13.1 No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 07 September 2010 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.