You are here:

Minutes of the SMC Meeting - Tuesday 1 September 2009

Minutes of the SMC Meeting held on Tuesday 1 September 2009
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 Keith Brown, Mr Scott Bryson, Mr Robert Calderwood, Mr Dave Carson, Dr David Crookes, Dr Sara Davies, Ms Susan Goldsmith, Dr Barclay Goudie, Dr Chris Lush, Dr Frances Macdonald, Dr John McElhinney, Dr Simon Maxwell, Ms Veronica Moffat, Ms Aileen Muir, Dr Mercia Page, Dr Robert Peel, Dr Andrew Power, Mr Mike Pratt, Dr Nick Reed, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Dr Iain Wallace, Professor Tony Wells, Professor David Wray.

In Attendance: Mrs Corinne Booth, Ms Ailsa Brown, Mr Stephen Ferguson, Dr Paul McNamee, Mr Ishtiaq Mohammed, Ms Rosie Murray, Ms Emma Riches, Mrs Maureen Stark, Mrs Catherine Tait.

Apologies: Mrs Laura Ace,  Professor James Barbour, Mr Colin Brown, Dr Jennifer Burns, Professor John Cairns, Dr Jonathan Fox, Dr John Gemmill, Dr Jan Jones, Mrs Anne Lee,Dr Alan MacDonald, Professor Dilip Nathwani, Dr Anthony Ormerod, Mr Andrew Powrie-Smith, Ms Alex Robertson, Dr Sarah Taylor, Mr Keith Thompson.

1. Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting and apologies for absence were noted. 

1.2 Mrs Laura McIver, SMC’s Chief Pharmaceutical Adviser, was welcomed back following a period of maternity leave. A further welcome was extended to Mr Ishtiaq Mohammed, recently appointed Clinical Effectiveness Pharmacist for NHS Fife, Dr Paul McNamee, Senior Lecturer at the Health Economics Research Unit in Aberdeen and Ms Andrea Patten, Information Analyst for the Scottish Antimicrobial Prescribing Group (SAPG), who were observing the meeting.

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 August 2009 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 darunavir, 400mg tablets (Prezista)  Tibotec, a division of Janssen-Cilag Ltd No (566/09)

4.1.1 The SMC advice for darunavir (Prezista), for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART) naïve adults, will be published on the SMC website on Monday 7 September 2009.

4.2 prasugrel 5 and 10mg tablets (Efient) Daiichi-Sankyo/Eli Lilly and Company Limited  No (562/09)

4.2.1 The SMC advice for prasugrel (Efient), for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention, will be published on the SMC website on Monday 7 September 2009.

4.3 mecasermin, 10mg/mL solution for injection (Increlex) Ipsen Limited  No (563/09)

4.3.1 The SMC advice for mecasermin (Increlex), for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (primary IGFD), will be published on the SMC website on Monday 7 September 2009.

4.4 ranolazine, 375mg, 500mg and 750mg prolonged-release tablets (Ranexa) A Menarini Pharma UK SRL No (565/09)                                                                        

4.4.1 The SMC advice for ranolazine, prolonged-release tablets (Ranexa), as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists), will be published on the SMC website on Monday 7 September 2009.

Abbreviated Submissions

4.5 fosamprenavir 50mg/ml oral suspension and 700mg film-coated tablet (Telzir) GlaxoSmithKline UK Ltd No (431/07)

4.5.1 The SMC advice for fosamprenavir (Telzir), for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adolescents and children of six years and above in combination with other antiretroviral medicinal products, will be published on the SMC website on Monday 7 September 2009.

4.6 lamivudine/zidovudine fixed-dose combination (Combivir) GlaxoSmithKline UK Ltd  No (569/09 )

4.6.1 The SMC advice for lamivudine/zidovudine fixed-dose combination (Combivir), for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) in paediatric patients weighing 14kg to 30kg, will be published on the SMC website on Monday 7 September 2009.

4.7 etanercept (Enbrel) Wyeth Pharmaceuticals  No (570/09)

4.7.1 The SMC advice for etanercept (Enbrel), for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies, will be published on the SMC website on Monday 7 September 2009.

4.8 brinzolamide/timolol eye drops, suspension (Azarga) Alcon Laboratories (UK) Ltd No (568/09)

4.8.1 The SMC advice for brinzolamide/timolol eye drops, suspension (Azarga), for the decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction, will be published on the SMC website on Monday 7 September 2009.

4.9 droperidol 2.5mg/ml solution for injection (Xomolix) ProStrakan Ltd

4.9.1 Droperidol injection was used in the management of postoperative nausea and vomiting (PONV) prior to the inception of SMC.  It was withdrawn voluntarily by the manufacturer (Janssen-Cilag) in 2001 due to safety concerns relating to QT interval prolongation and to prevent its use in psychiatric conditions where high-dose use was frequent.
 
A new preparation of droperidol 2.5mg/ml solution for injection (Xomolix) has now been re-introduced by a different manufacturer (ProStrakan), at a lower dose and indicated for the prevention and treatment of PONV in adults, and as a second-line treatment in children and adolescents.   
 
After full consideration of the circumstances and in line with previous SMC practice, SMC has concluded that droperidol (Xomolix) is outwith SMC remit.

Non Submission

4.10 etoricoxib (Arcoxia) Merck Sharpe and Dohme No (576/09)

4.10.1 The SMC advice for etoricoxib (Arcoxia), for the treatment of ankylosing spondylitis, will be published on the SMC website on Monday 7 September 2009.

5. Appeals Update

5.1 pemetrexed (Alimta) Eli Lilly and Company Limited (No. 531/09)  Resubmission  

Eli Lilly has indicated their intention to make a further resubmission to SMC for pemetrexed (Alimta), in combination with cisplatin, for the first-line treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology. 

5.2 ranolazine, 375mg, 500mg and 750mg prolonged-release tablets (Ranexa) A Menarini Pharma UK SRL (No. 565/09)

A Menarini Pharma UK SRL has indicated their intention to make a resubmission for ranolazine (Ranexa), 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). 

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the previous meeting of PAPIG (4 August 2009)

Minutes of the previous meeting were noted.

6.2 Update on current PAPIG business

Mrs Sheila Tunstall-James reported that discussions with the Long Term Conditions Alliance Scotland (LTCAS) concerning the establishment of a Public Involvement Officer are continuing.

A final draft version of PAPIG’s Role and Remit/Terms of Reference will shortly be circulated to the SMC Executive Team for approval.

Following the successful training day for patient interest groups which took place in May 2009, PAPIG intends to offer a similar event in Spring 2010.

Two of the SMC public partners met with a representative of Macmillan Cancer Support to explain how SMC works and how patients and members of the public can get involved in the process.   The meeting was very helpful on both sides and an invitation was extended to observe a meeting of SMC.

7. New Drugs Committee (NDC): Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 quetiapine, 25mg, 100mg, 200mg, 300mg tablets (Seroquel) No  (549/09) AstraZeneca

In April 2009, SMC did not recommended quetiapine (Seroquel) for use in NHS Scotland, for the treatment of major depressive episodes in the framework of bipolar disorder, but advice was withheld pending confirmation of the licence and product availability.  The product is now licensed and available and advice will be distributed to NHS Boards and ADTCs on Friday 4 September 2009 and published on the SMC website on Monday 12 October 2009.  The licence holder has indicated their intention to resubmit.

8.2 romiplostim (Nplate) Amgen (No. 553/09) 

In May 2009, SMC accepted romiplostim (Nplate), for restricted use in NHS Scotland, for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Advice was withheld pending product availability, however Amgen has confirmed that romiplostim will be commercially launched on 1 October 2009. At the manufacturer’s request, advice will be issued to NHS Scotland on Friday 4 September 2009 and will be published on the SMC website on Monday 12 October 2009. 

8.3 Product withdrawal: epoetin delta, for injection (Dynepo) Shire Pharmaceuticals Ltd  No. (418/07)

The European Commission issued a decision to withdraw the marketing authorisation for epoetin delta, for injection (Dynepo) on 17 March 2009, for commercial reasons.

SMC issued advice for epoetin delta (Dynepo) in November 2007, accepting it for use for the treatment of anaemia in patients with chronic renal failure.

The SMC website has been amended to reflect that the product has been withdrawn for commercial reasons.

8.4 NICE Single Technology Appraisal (STA) Guidance No 176

The NICE STA for cetuximab, for the first line treatment of metastatic colorectal cancer, was published on 26 August 2009. Cetuximab in combination with 5-fluorouracil(5-FU), folinic acid and oxaliplatin(FOLFOX), within its licensed indication, is recommended for the first-line treatment of metastatic colorectal cancer only when all of the following criteria are met:

  • The primary colorectal tumour has been resected or is potentially operable.
  • The metastatic disease is confined to the liver and is unresectable.
  • The patient is fit enough to undergo surgery to resect the primary colorectal tumour and to undergo liver surgery if the metastases become resectable after treatment with cetuximab.
  • The manufacturer rebates 16% of the amount of cetuximab used on a per patient basis.

Cetuximab in combination with 5-FU, folinic acid and irinotecan (FOLFIRI), within its licensed indication, is recommended for the first-line treatment of metastatic colorectal cancer only when all of the following criteria are met:

  • The primary colorectal tumour has been resected or is potentially operable.
  • The metastatic disease is confined to the liver and is unresectable.
  • The patient is fit enough to undergo surgery to resect the primary colorectal tumour and to undergo liver surgery if the metastases become resectable after treatment with cetuximab.
  • The patient is unable to tolerate or has contraindications to oxaliplatin.

The Scottish Medicines Consortium (SMC) published Advice on this medication for this indication in April 2009, as follows: cetuximab (Erbitux) is not recommended for use within NHS Scotland for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy.

There is a material difference between the recommendations of the NICE STA and the SMC. The NICE STA advice includes the application of a Department of Health agreed Patient Access Scheme. A process has been agreed to consider Patient Access Schemes for NHSScotland. The manufacturer of cetuximab (Erbitux) has indicated their intention to provide a resubmission to SMC for further consideration. Advice on the resubmission is anticipated before the end of March 2010.

8.5 NICE Single Technology Appraisal (STA) Guidance No177

The NICE STA for alitretinoin, for the treatment of severe chronic hand eczema, was published on 26 August 2009.  Alitretinoin is recommended, within its licensed indication, as a treatment option for adults with severe chronic hand eczema that has not responded to potent topical corticosteroids if the person has:

  • severe disease, as defined by the physician’s global assessment (PGA) and
  • a dermatology life quality index (DLQI) score of 15 or more.

The Scottish Medicines Consortium (SMC) published Advice on this medication for this indication in March 2009, as follows: alitretinoin (Toctino) is accepted for use within NHS Scotland in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids.  Evidence is limited to a randomised placebo-controlled study where alitretinoin was superior to placebo in terms of the primary endpoint, Physician Global Assessment of response.  It is recommended that alitretinoin is dispensed by a hospital-based pharmacy.

There is no material difference between the recommendations of the NICE STA and the SMC.

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

8.6 NICE Multiple Technology Appraisal (MTA) Guidance No 178

The NICE MTA for bevacizumab (first line), sorafenib, (first and second line), sunitinib (second line) and temsirolimus (first line) for the treatment of advanced and/or metastatic renal cell carcinoma was published in August 2009. Bevacizumab, sorafenib and temsirolimus are not recommended as first-line treatment options for people with advanced and/or metastatic renal cell carcinoma. 

Sorafenib and sunitinib are not recommended as second line treatment options for people with advanced and/or metastatic renal cell carcinoma. 

Patients currently being treated should have the option to continue their therapy until they and their clinicians consider it appropriate to stop.

SMC has either not recommended or not reviewed these medicines for first or second line treatment of advanced and/or metastatic renal cell carcinoma.  NHS QIS has advised that the NICE MTA recommendations are valid for Scotland as for England and Wales.

8.7 Marketing literature for liraglutide (Victoza) (NovoNordisk)

The New Drugs Committee (NDC) is currently assessing liraglutide (Victoza), for diabetes.  It has been drawn to the SMC’s attention that the manufacturer has distributed marketing literature that prominently features the statement ‘SMC Pending’. The statement could be considered misleading, albeit unintentionally.  The SMC User Group Forum will be asked to consider and provide guidance to manufacturers on the appropriate content of their marketing initiatives during the period when an SMC decision is awaited.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSION

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

9.1.1 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.

9.1.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group agreed that vildagliptin (Galvus®), should be accepted for use within NHS Scotland, 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.  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 4 September 2009.

RESUBMISSIONS

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

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

9.2.2 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 the Family Planning Association.  Expert comments, revised data/analyses and comments received from the company were considered.  Detailed discussion followed and the group agreed that etonogestrel / ethyl estradiol vaginal ring (NuvaRing®), should be accepted for use within NHS Scotland, for contraception.  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 4 September 2009.

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

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

9.3.2 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 Diabetes UK (Scotland). Expert comments, revised data/analyses and comments received from the company were considered. Detailed discussion followed and the group agreed that metformin prolonged release tablets (Glucophage SR®), should be accepted for restricted use within NHS Scotland, 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.  It is restricted to use in patients who are intolerant of immediate release metformin and in whom the prolonged release tablet allows the use of a dose of metformin not previously tolerated or in patients for whom a once-daily preparation offers a clinically significant benefit.  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 4 September 2009.

ABBREVIATED SUBMISSIONS

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

9.4.1 There were no declarations of interest 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.  Detailed discussion followed and the group agreed that methotrexate (Metoject 50mg/ml), should be accepted for use within NHS Scotland, 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.  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 4 September 2009.

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

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

9.5.2 The NDC Co-Vice Chair provided an overview of the assessment and draft advice.  Detailed discussion followed and the group agreed that olmesartan medoximil / amlodipine besilate (Sevikar), should be accepted for use within NHS Scotland, for treatment of essential hypertension in patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine. 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 4 September 2009.

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

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 and draft advice.  Detailed discussion followed and the group 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. 

NON SUBMISSIONS

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

9.7.1 In the absence of a submission from the holder of the marketing authorisation, 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, should not be recommended for use within NHS Scotland.

9.7.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday 4 September 2009.

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

9.8.1 In the absence of a submission from the holder of the marketing authorisation, estradiol / dienogest (Qlaira), for the treatment of oral contraception, should not be recommended for use within NHS Scotland.

9.8.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday 4 September 2009.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 Minutes of the previous meeting of the SMC UGF (28 July 2009)

Minutes of the previous meeting were noted.

11.2 Update on current UGF business

Dr Frances Macdonald reported that the UGF are currently considering how best to provide guidance to manufacturers on mapping quality of life values to utilities, particularly for diseases associated with chronic  morbidity.

In addition, a small industry group has been set up to discuss options and provide guidance on the use of phase IV and other uncontrolled data in submissions.

Dr Macdonald asked whether the Chairman was able to update Members on progress with the establishment of the Patient Access Scheme Assessment Group (PASAG).  Ms Susan Goldsmith, Co-Chair of PASAG, advised that the group was making steady progress in terms of establishing key principles but it will take some time to fully develop the fine details of the process. Professor Paterson supported that view and reminded Members that whilst SMC and PASAG may work in parallel, their processes work independently of each other.

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

12.1 In order to maintain strong lines of communication between SMC and ADTCs, the Chairman reminded members that part of the role of an SMC member is to provide regular feedback to their respective Area Drug and Therapeutic Committee (ADTC), regardless of whether they are members of the ADTC.

13. Any Other Business

13.1 Pilot process for presenting Patient Interest Group Submissions

In order to maximise the impact of the patient perspective on SMC assessments, the SMC Executive have implemented some changes in the way that Patient Interest Groups submissions are presented to SMC.  Initial reactions are encouraging and it was agreed that the pilot should be continued until the end of 2009 and then evaluated.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 6 October 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.