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SMC Minutes - 06 September 2011

Minutes of the SMC Meeting
held on Tuesday 06 September 2011
Healthcare Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present:  Ms Angela Timoney (Chairman), Mrs Laura Ace, Ms Sandra Auld, Dr Keith Brown, Professor Scott Bryson, Dr Jennifer Burns, Mrs Helen Cadden, Mrs Alison Campbell, Mr Dave Carson, Dr Dominic Culligan, Dr David Dunlop, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie, Dr Jacqui Howes, Dr Jan Jones, Professor Stephen Lawrie, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Mrs Margo McGurk, Dr Paul McNamee, Ms Aileen Muir, Mrs Anne Murray, Dr Mercia Page, Dr Robert Peel, Professor Colin Suckling

In Attendance: Ms Melanie Barnes, Mrs Corinne Booth, Ms Ailsa Brown, Mr Martin Brown, Mrs Susan Downie, Mr Stephen Ferguson, Dr Jane Gravil, Mr Scott Hill, Mrs Anne Lee, Mrs Linda McGlynn, Ms Rosie Murray, Ms Alex Robertson, Mrs Maureen Stark, Professor Matthew Walters

Apologies: Professor James Barbour, Mr Colin Brown, Mr Robert Calderwood, Ms Sara Davies, Dr Chris Lush, Dr James McLay, Mrs Sandra McNaughton, Dr Simon Maxwell, Ms Veronica Moffat, Professor Dilip Nathwani, Mr Michael Pratt, Dr Brian Robson, Mrs Catherine Tait, Dr Sarah Taylor, 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:

New Member

Professor Colin Suckling who is a Public Partner.

Observers

Dr Jane Gravil, Chair of the Area Drug and Therapeutic Committee for NHS Greater Glasgow and Clyde.

Mr Scott Hill, Principal Pharmacist for Emergency Planning, Scottish Government Health Directorate.  Mr Hill will be joining the SMC pharmacy team on a part-time basis from October 2011.

NDC Members/Lead Assessors

Mr Martin Brown and Professor Matthew Walters.

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 August 2011)

3.1 The minutes of the SMC meeting held on 02 August 2011 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 dabigatran etexilate 110mg and 150mg hard capsules (Pradaxa®) Boehringer Ingelheim Ltd SMC No. (672/11)

The SMC advice for dabigatran etexilate (Pradaxa®), for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more of the following risk factors:

  • previous stroke, transient ischaemic attack, or systemic embolism;
  • left ventricular ejection fraction <40%;
  • symptomatic heart failure, = New York Heart Association (NYHA) Class 2;
  • age 75 years;
  • age 65 years associated with one of the following: diabetes mellitus, coronary artery  disease or hypertension;

will be published on the SMC website on Monday, 12 September 2011.

4.2 abatacept 250mg powder for concentrate for solution for infusion (Orencia®) Bristol-Myers Squibb Pharmaceuticals Ltd SMC No. (719/11)

The SMC advice for abatacept (Orencia®), in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs including methotrexate or a tumour necrosis factor (TNF)-alpha inhibitor, will be published on the SMC website on Monday, 12 September 2011.

4.3 tenofovir disoproxil (as fumarate), 245mg, film-coated tablet (Viread®) Gilead Sciences Ltd SMC No. (720/11)

The SMC advice for tenofovir disoproxil (as fumarate) (Viread®), for the treatment of chronic hepatitis B in adults with decompensated liver disease, will be published on the SMC website on Monday, 12 September 2011.

4.4 golimumab 50mg solution for injections prefilled pen (auto-injector) or pre-filled syringe (Simponi®)  MSD  SMC No. (721/11)

The SMC advice for golimumab (Simponi®), for the treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy, will be published on the SMC website on Monday, 12 September 2011.

Resubmission

4.5 azacitidine 100mg powder for suspension for injection (Vidaza®) Celgene Ltd  SMC No. (589/09)

The SMC advice for azacitidine (Vidaza®), for treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML), will be published on the SMC website on Monday, 12 September 2011.

4.6 Deferred Advice

adrenaline tartrate 150 and 300 microgram solution for injection in a pre-filled pen (Jext®)  ALK-Abelló Ltd  SMC No. (687/11)

In February 2011 SMC accepted adrenaline tartrate 150 and 300 microgram solution for injection in a pre-filled pen (Jext®), for emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis.  

Advice was withheld pending confirmation of product availability.  The product is now available and advice will be distributed to NHS Boards and ADTCs on Friday 09 September 2011 and published on the SMC website on Monday 10 October 2011.

olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide 20mg/5mg/12.5mg, 40mg/5mg/12.5mg, 40mg/10mg/12.5mg, 40mg/5mg/25mg, 40mg/10mg/25 mg film-coated tablets (Sevikar HCT®) (No: 706/11)  Daiichi Sankyo UK Ltd

In May 2011, SMC accepted olmesartan medoxomil/amlodipine besilate/hydrochlorothiazide (Sevikar HCT®), as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide taken as a dual component (olmesartan medoxomil and amlodipine or olmesartan medoxomil and hydrochlorothiazide) and a single formulation (hydrochlorothiazide or amlodipine).  Advice was withheld pending confirmation of product availability.  The product is now available and advice will be distributed to NHS Boards and ADTCs on Friday 09 September 2011 and published on the SMC website on Monday 10 October 2011.

4.7 Amended Advice

darunavir 400mg tablets (Prezista®) SMC No. (707/11)  Janssen

Darunavir 400mg tablets (Prezista®), was reviewed by SMC in July, 2011 and advice was circulated to NHSScotland on Friday 08 July 2011.  However, as a result of comparator comments, amendments have been made to the ‘Summary of clinical effectiveness issues’.  The revised Detailed Advice Document for darunavir (Prezista) was published on the SMC website on Monday 08 August 2011 and will be reissued to NHS Boards and ADTCs on Friday 09 September 2011. 

dabigatran etexilate 110mg and 150mg hard capsules (Pradaxa®) Boehringer Ingelheim Ltd SMC No. (672/11)

Dabigatran etexilate (Pradaxa®) was reviewed by SMC in August 2011. Following comments from the manufacturer minor changes have been made to the Detailed Advice Document. Revised advice will be reissued to NHSBoards and ADTCs on Friday 09 September 2011 and will be published on the SMC website on Monday 12 September, 2011.

tenofovir disoproxil (as fumarate), 245mg, film-coated tablet (Viread®) Gilead Sciences Ltd SMC No. (720/11)

Tenofovir disoproxil (Viread®) was reviewed by SMC in August 2011.  Following comments from a comparator company, amendments have been made to the Detailed Advice Document.  Revised advice will be reissued to NHSBoards and ADTCs on Friday 09 September 2011 and will be published on the SMC website on Monday 12 September, 2011.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the PAPIG Meeting Held on 02 August 2011

The minutes of the PAPIG meeting held on 02 August 2011 were noted.

6.2 PAPIG Update

PAPIG is piloting a new template for Patient Interest Groups who wish to make a submission to SMC for a particular drug.  SMC’s Initial reactions are that the template makes it easier for Public Partners to prepare and present to SMC.  However, formal feedback will be sought at the end of the pilot phase, from SMC and the patient groups who are participating in the pilot.  Linda McGlynn (Public Involvement Officer) will collate the responses and present to SMC.

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Affordability of All Healthcare Interventions

At a recent SMC meeting some senior managers highlighted the challenges that NHS Boards face in terms of affordability and associated SMC Advice.   SMC is aware of the current financial constraints within NHS Scotland and has written to Mr Derek Feeley, Acting Director General, Health and Social Care, and Chief Executive, NHS Scotland for consideration on this issue.

8.2 Copyright

The Scottish Government Health Department, in consultation with NHS Education for Scotland, decided to withdraw from the previous NHS copyright licensing arrangements, effective from 01 April 2011.

It meant that from 01 April, until further notice, copying within NHS Scotland was strictly guided by the terms of the 1988 Copyright Act.

Following notification from Scottish Government at the end of August NHSScotland are obliged to implement, with immediate effect, a new national policy relating to use of copyright materials.

Health Care Improvement Scotland’s (HIS) internal copyright policy is currently undergoing revision to incorporate and test necessary changes.  SMC is working with HIS to ensure that the copyright policy is adhered to. The pharmaceutical industry is also working to ensure copyright materials are submitted correctly to protect SMC’s assessment process and allow SMC’s business to continue as usual.

8.3 Freedom of Information Act (FOI) (Scotland) 2002: Copyright Licensing Agency (CLA)

On the  of 17th of August 2011, SMC received an FOI request from the Copyright Licensing Agency (CLA) with questions directed at either, the Scottish Medicines Consortium, SIGN, or Healthcare Improvement Scotland.

SMC, SIGN and Healthcare Improvement Scotland are preparing their response as a group.  The deadline for response is close of business on Wednesday 14th September.

SMC understands that territorial Boards have received similar FOI requests from the CLA.

8.4 Freedom of Information Act (FOI) (Scotland) 2002: cannabinoid oromucosal spray (Sativex)

On the 29th of August 2011, SMC received an FOI request from a member of the public concerning cannabinoid oromucosal spray (Sativex).   SMC are considering the request and will respond by 23rd September, 2011.

8.5 NICE Technology Appraisal STA No.231 for: agomelatine, for the treatment of major depressive episodes. (Terminated Appraisal)

NICE is unable to recommend the use of agomelatine, for the treatment of major depressive episodes because no evidence submission was received from the manufacturers or sponsors of the technology.

Following a resubmission in September 2010, SMC did not recommend agomelatine for the treatment of major depressive episodes in adults.  The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.  The licence holder has indicated their intention to resubmit.

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

8.6 NICE Technology Appraisal STA No. 233 for: golimumab for the treatment of ankylosing spondylitis

NICE guidance was published on 24 August 2011.  Golimumab is recommended as an option for the treatment of severe, active ankylosing spondylitis in adults only if:

  • it is used as described for adalimumab and etanercept in ‘Adalimumab, etanercept and infliximab for ankylosing spondylitis’ (NICE technology appraisal guidance 143) and
  • the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose in accordance with the patient access scheme.

The Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of golimumab and is due to publish a Statement of Advice on this medication for this indication, in September 2011. When this is available, NHSScotland should adhere to this advice.

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

8.7 NICE Technology Appraisal STA No. 234 for:  abatacept for the treatment of rheumatoid arthritis

NICE guidance was published on 24 August 2011. Abatacept in combination with methotrexate is not recommended for the treatment of moderate to severe active rheumatoid arthritis in adults whose disease has responded inadequately to one or more conventional non-biological disease modifying anti-rheumatic drugs (DMARDs) including methotrexate.
 
The Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of abatacept and is due to publish a Statement of Advice on this medication for this indication in September 2011. When this is available, NHSScotland should adhere to this advice.

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

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 rosuvastatin, 5mg, 10mg, 20mg, film-coated tablets (Crestor®) SMC No. (725/1)  AstraZeneca UK

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, expert comments, and comments received from the company.    Detailed discussion followed and the group agreed that rosuvastatin, (Crestor®), should not be recommended for use in NHS Scotland.

Indication under review: Prevention of major cardiovascular events in patients who are estimated to have a high risk for a first cardiovascular event as an adjunct to correction of other risk factors.

In a randomised, placebo-controlled, double-blind, multi-centre study, treatment with rosuvastatin was associated with a significantly reduced risk of first cardiovascular event versus placebo in patient sub-groups deemed to be high-risk when assessed using the Framingham equation and the SCORE algorithm.

The submitting company did not present 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.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 September 2011.

9.2 eribulin 0.44mg/mL solution for injection (Halaven®) SMC No. (726/11) Eisai Ltd.

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

9.2.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, updated expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented patient interest group submissions from Breast Cancer Care and Breakthrough Breast Cancer.  Detailed discussion followed and the group agreed that eribulin (Halaven®), should not be recommended for use in NHS Scotland.

Indication under review: eribulin monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease.  Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.
 
In a randomised, phase III, open-label study eribulin-treated patients had 2.5 months additional survival compared to the comparator, treatment of physicians choice, which included a range of single agent chemotherapy treatments.

The submitting company 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.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 09 September 2011.

9.3 vardenafil, 10mg orodispersible tablet (Levitra®)  SMC No. (727/11)  Bayer Healthcare

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, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that vardenafil, (Levitra®), should be accepted for restricted use in NHS Scotland.

Indication under review: Treatment of erectile dysfunction (ED) in adult men. ED is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for vardenafil to be effective, sexual stimulation is required.

SMC restriction: use is restricted to patients in whom an orodispersible tablet is an appropriate formulation. Vardenafil is subject to the same NHS prescribing restrictions as other drug treatments for erectile dysfunction in terms of National Health Service (General Medical Services) (Scotland) regulations.

Two placebo controlled, studies have shown that vardenafil orodispersible is significantly better than placebo in the treatment of erectile dysfunction in men.  No comparative evidence against other medicines for erectile dysfunction was presented.

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 September 2011.

9.4 fluorouracil 0.5% / salicylic acid 10% cutaneous solution (Actikerall®) SMC No. (728/11)  Almirall S.A.

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

9.4.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, updated expert comments, and comments received from the company.  A member of PAPIG presented patient interest group submissions from Skin Care Campaign Scotland and Melanoma Action and Support Scotland. Detailed discussion followed and the group agreed that fluorouracil (Actikerall®), should be accepted for use in NHS Scotland.

Indication under review: the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in immunocompetent adult patients.

Fluorouracil 0.5% / salicylic acid 10% cutaneous solution was superior to another topical treatment for the histological clearance of a specified target actinic keratosis lesion.

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 September 2011.

9.5 boceprevir 200mg capsule (Victrelis®) Treatment experienced patients SMC No. (722/11)  Merck, Sharpe and Dohme Ltd

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

9.5.2 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 patient interest group submissions from Waverley Care and the Hepatitis C Trust.  Detailed discussion followed and the group agreed that boceprevir (Victrelis®), should be accepted for use in NHS Scotland.

Indication under review: Treatment of chronic hepatitis C (HCV) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who have failed previous therapy.

In the pivotal phase III randomised study, addition of boceprevir to current standard therapy in patients with HCV, who had failed previous therapy, increased the proportion of patients who achieved a sustained virologic response.

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 September 2011.

9.6 boceprevir 200mg capsule (Victrelis®)  Treatment naïve patients SMC No. (723/11) Merck Sharpe and Dohme Ltd

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

9.6.2 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 patient interest group submissions from Waverley Care and the Hepatitis C Trust.  Detailed discussion followed and the group agreed that boceprevir (Victrelis®), should be accepted for use in NHS Scotland.

Indication under review: Treatment of chronic hepatitis C (HCV) genotype 1 infection, in combination with peginterferon and ribavirin, in adult patients with compensated liver disease who are previously untreated.

In the pivotal, phase III randomised study, addition of boceprevir to current standard therapy in patients with HCV who were previously untreated increased the proportion of patients with HCV who achieved a sustained virologic response.

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 September 2011.

ABBREVIATED SUBMISSION

9.7  botulinum toxin type A, 50 and 100 LD50 units powder for solution for injection (Xeomin®) SMC No. (731/11)  Merz Pharma UK Ltd

9.7.1 There were no declarations of interest 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 agreed that botulinum toxin type A, (Xeomin®), should be accepted for use in NHS Scotland. 

Indication under review: post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults.

In patients for whom botulinum toxin, type A is an appropriate choice of therapy, this offers an alternative formulation to the comparator product containing conventional botulinum toxin, type A complex.

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, 09 September 2011.

10. SMC User Group Forum (UGF)

10.1 Minutes of the  Meeting Held on 26 July 2011

The minutes of the UGF meeting held on 26 July 2011 were noted.

10.2 Update from UGF Meeting

The UGF are currently working on:

  • copyright issues in relation to SMC’s assessment process;
  • methods, as planned;
  • Budget Impact Forecast -  clarification of the use of the workbook / template;
  • improved industry guidance.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted. 

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Advice for eculizumab, 300mg concentrate for solution for infusion (Soliris®) Alexion Pharma UK Ltd SMC No. (436/07)

SMC reviewed eculizumab (Soliris) for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) in October 2010 and did not recommend for use.

The manufacturer has since been in discussion with SMC concerning the wording within the Detailed Advice Document (DAD) and a slightly amended DAD has been issued.  The health economic section was revised to reflect that clinical and cost data were provided by the manufacturer and an independent health economic analysis was undertaken.  As much of the economic data are considered academic-in-confidence no details of the economic case have been published. 

Where SMC has issued “not recommended” advice in relation to a medicine, it is expected that NHS Boards will not make it routinely available. However, medicines “not recommended” by SMC, can be made available under certain circumstances through individual patient treatment requests (IPTRs).  In the case of eculizumab, SMC will provide Boards with a summary of the health economic case, in strict confidence, to inform an IPTR.

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, 04 October 2011 at 12.30 pm (lunch from 12 noon), in Healthcare Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

NICE Publications

Minutes of the SMC Meeting 06 September 2011

NICE Technology Appraisal STA No.231 for: agomelatine, for the treatment of major depressive episodes. (Terminated Appraisal)

NICE is unable to recommend the use of agomelatine, for the treatment of major depressive episodes because no evidence submission was received from the manufacturers or sponsors of the technology.

Following a resubmission in September 2010, SMC did not recommend agomelatine 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.

The licence holder has indicated their intention to resubmit.

http://www.scottishmedicines.org.uk/files/advice/agomelatine_Valdoxan_RESUBMISSION_FINAL.pdf

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

8.5 NICE Technology Appraisal STA No. 233 for: golimumab for the treatment of ankylosing spondylitis

NICE guidance was published on 24 August 2011.  Golimumab is recommended as an option for the treatment of severe, active ankylosing spondylitis in adults only if:

  • it is used as described for adalimumab and etanercept in ‘Adalimumab, etanercept and infliximab for ankylosing spondylitis’ (NICE technology appraisal guidance 143) and
  • the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose in accordance with the patient access scheme.

People currently receiving golimumab for the treatment of severe, active ankylosing spondylitis who do not fulfil the criteria for treatment with adalimumab and etanercept described in NICE technology appraisal guidance 143 should have the option to continue golimumab until they and their clinician consider it appropriate to stop.

http://www.nice.org.uk/TA233

http://guidance.nice.org.uk/TA143/Guidance/pdf/English

The Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of golimumab and is due to publish a Statement of Advice on this medication for this indication, in September 2011. When this is available, NHSScotland should adhere to this advice.

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

8.6 NICE Technology Appraisal STA No. 234 for:  abatacept for the treatment of rheumatoid arthritis

NICE guidance was published on 24 August 2011. Abatacept in combination with methotrexate is not recommended for the treatment of moderate to severe active rheumatoid arthritis in adults whose disease has responded inadequately to one or more conventional non-biological disease modifying anti-rheumatic drugs (DMARDs) including methotrexate.
 
People currently receiving abatacept in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis, whose disease has responded inadequately to one or more conventional non-biological DMARDs including methotrexate, should have the option to continue treatment until they, and their clinicians, consider it appropriate to stop. 

http://www.nice.org.uk/TA234
 
Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of abatacept and is due to publish a Statement of Advice on this medication for this indication in September 2011. When this is available, NHSScotland should adhere to this advice. 

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