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SMC Minutes Tuesday 2 August 2011

Minutes of the SMC Meeting
held on Tuesday 02 August 2011
Healthcare Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present:
Ms Angela Timoney (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Brown, Professor Scott Bryson, Mrs Helen Cadden, Mr Robert Calderwood, Mrs Alison Campbell, Mr Dave Carson, Dr Dominic Culligan, Ms Sara Davies, Dr David Dunlop, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Mrs Margo McGurk, Dr James McLay, Mrs Sandra McNaughton, Ms Aileen Muir, Mrs Anne Murray, Dr Mercia Page, Dr Robert Peel, Mr Michael Pratt, Dr Brian Robson, Dr Sarah Taylor, Mrs Sheila Tunstall-James, Dr Andrew Walker

In Attendance:
Ms Melanie Barnes, Mrs Corinne Booth, Ms Ailsa Brown, Mrs Susan Downie, Mr Stephen Ferguson, Mrs Linda McGlynn, Mrs Anne Lee, Ms Stacey McPhail, Ms Rosie Murray, Ms Alex Robertson, Mrs Catherine Tait

Apologies:
Ms Sandra Auld, Dr Jennifer Burns, Mr Colin Brown, Dr Jacqui Howes, Professor Stephen Lawrie, Dr Simon Maxwell, Dr John McElhinney, Dr Paul McNamee, Ms Veronica Moffat, Professor Dilip Nathwani, Mrs Maureen Stark, Professor David Wray

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:

Observers
Ms Stacey McPhail, doctoral researcher at the University of Strathclyde. Stacey’s research focuses on the multi-stakeholder engagement processes that occur within health technology appraisals. She is interested in the way different stakeholders are represented and how committee dynamics function with respect to final outcomes. Stacey observed the June meeting of NDC. 

Thank you and Goodbye:
Mrs Sheila Tunstall-James has completed her extended term of office as a member of SMC and is attending her last meeting.

Sheila joined SMC in August 2007 as a public partner and assumed the Chair of PAPIG in March 2008.  She should be applauded for developing patient and public involvement within SMC’s processes, securing the post of Public Involvement Officer, and for continuing to champion the cause for patients and their carers over the past 4 years. 

Mrs Tunstall-James expressed thanks to SMC members and SMC Secretariat for their support over the years, and wishes SMC every success for the future.

Professor David Wray who has given his apologies for what would have been his last meeting of SMC.  Professor Wray is retiring at the end of August and as such has resigned from SMC.

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 (05 July 2011)

3.1 The minutes of the SMC meeting held on 05 July 2011 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 nilotinib 150mg hard capsules (Tasigna®) SMC No. (709/11)  Novartis Pharmaceuticals UK Ltd

The SMC advice for nilotinib (Tasigna®), for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, will be published on the SMC website on Monday, 08 August 2011.

4.2 collagenase clostridium histolyticum 0.9mg powder and solvent for solution for injection (Xiapex®)  SMC No. (715/11)  Pfizer Ltd

The SMC advice for collagenase clostridium histolyticum (Xiapex®), for treatment of Dupuytren’s contracture in adult patients with a palpable cord, will be published on the SMC website on Monday, 08 August 2011.

4.3 capecitabine, 150mg, 500mg, tablets (Xeloda®) SMC No. (716/11)  Roche Products Limited

The SMC advice for capecitabine (Xeloda®), for the treatment of for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer in combination with oxaliplatin, will be published on the SMC website on Monday, 08 August 2011.

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

The SMC advice for darunavir (Prezista®), for the treatment of for the treatment of HIV-1 infection in antiretroviral therapy experienced adults with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count =100 cells/mm3, will be published on the SMC website on Monday, 08 August 2011.

Resubmissions

4.5 glucosamine sulphate 1,500mg powder for oral solution (Glusartel®) SMC No. (647/10)  Rottapharm Madaus

The SMC advice for glucosamine sulphate (Glusartel®), for symptoms in mild to moderate osteoarthritis of the knee, will be published on the SMC website on Monday, 08 August 2011.

4.6 mifamurtide 4mg powder for suspension for infusion (Mepact®) SMC No. (621/10)  Takeda UK and Ireland Ltd

The SMC advice for 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.  Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis, will be published on the SMC website on Monday, 08 August 2011.

Abbreviated Submissions

4.7 alteplase 2mg powder and solvent for solution for injection for infusion (Actilyse Cathflo®) (No: 717/11) Boehringer Ingelheim

The SMC advice for alteplase (Actilyse Cathflo®) for thrombolytic treatment of occluded central venous access devices including those used for haemodialysis, will be published on the SMC website on Monday, 08 August 2011.

4.8 calcium carbonate equivalent to 500mg calcium, cholecalciferol (vitamin D3) 800 IU (20 microgram) tablets (Kalcipos-D 500mg/800 IU chewable tablets®)  (No: 718/11 )  Meda Pharmaceuticals Ltd

The SMC advice for calcium carbonate + cholecalciferol (Kalcipos-D®) for:

  • Prevention and treatment of calcium and vitamin D deficiency in the elderly;
  • Vitamin D and calcium supplement in addition to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency, will be published on the SMC website on Monday, 08 August 2011.

4.9 methotrexate 50mg/mL solution for injection  (Metoject®) prefilled syringes 12.5mg, 17.5mg, 22.5mg, 27.5mg and 30mg  (No: 724/11)  Medac GmbH

The SMC advice for methotrexate 50mg/ml solution for injection (Metoject®) for polyarthritic forms of severe active juvenile idiopathic arthritis, when the response to non-steroidal anti-inflammatory drugs has been inadequate, will be published on the SMC website on Monday, 08 August 2011.

NON Submissions

4.10 glucosamine sulphate (Dolenio®) (No. 729/11) Alissa Healthcare Research

The SMC advice for glucosamine sulphate (Dolenio®) for symptomatic treatment of mild to moderate osteoarthritis (OA) of the knee, will be published on the SMC website on Monday, 08 August 2011.

4.11 bilastine (Ilaxten®) (No. 730/11) A Menarini Pharma  UK SRL

The SMC advice for bilastine (Ilaxten®) for symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria, will be published on the SMC website on Monday, 08 August 2011.

Deferred Advice

4.12 Nothing to report.

Amended Advice

4.13 retigabine, 50mg, 100mg, 200mg, 300mg and 400mg film-coated tablets (Trobalt®) SMC No. (712/11)  GlaxoSmithKline

SMC reviewed a submission for retigabine (Trobalt®), on 07 June 2011 and was accepted for restricted use in NHS Scotland, for adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy.  SMC restriction: patients with refractory epilepsy.

Following information received from the manufacturer, a correction has been made to the budget impact forecast.  Revised advice was reissued to Boards and ADTCs on Friday 08 July 2011 and published on Monday 11 July 2011.

5. Appeals Update

5.1 ranibizumab, 10mg/mL solution for injection (Lucentis®) Novartis Pharmaceuticals UK Ltd  SMC No. (711/11)

In June 2011, SMC considered but did not recommend a submission for ranibizumab, 10mg/mL solution for injection (Lucentis®), for the treatment of visual impairment due to diabetic macular oedema in adults.  Ranibizumab significantly improved visual acuity over 12 months compared with standard laser photocoagulation treatment.  The manufacturer’s justification of the treatment’s health benefits in relation to its cost was not sufficient and in addition, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.  The licence holder has intimated their intention to make a resubmission.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to SMC meeting and advised that Mrs Anne Murray had accepted the position of Interim Chair and wished her well in this role for the future. 

There was nothing further to report.

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 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 been in discussion with SMC for some time with regards to the wording within the DAD and we have agreed to make some amendments.  There are three main amendments:

  • The data on mortality have been reinstated (and reference to 'commercial-in-confidence' data removed).  The word 'mortality' has been added to make it clearer what the data show.
  • The health economic section has been revised to reflect that clinical and cost data were provided by the manufacturer and that an independent health economic analysis was undertaken:
  • The advice box has been amended to fit in with the revised HE section and to make mention of the independent HE assessment.

The revised DAD has been published on the website and will be reissued to NHS Boards and ADTCs on Friday 5 August, 2011.

The Chairman expressed thanks for support from both ABPI in communication with the company, and to Professor Ken Paterson in his capacity as former Chair of the SMC.

8.2 Establishment of  a Secure Website for Accessing Meeting Papers

Some discussion took place at the beginning of the year concerning the feasibility of moving to electronic distribution of paperwork.  The Secretariat has been working to create a secure section on the SMC website where members can log in securely and print papers for the meeting or download to their PC or laptop.

The Secretariat intends to pilot this system for two months, commencing with NDC on 30 August, 2011 and to roll out to all SMC/NDC members thereafter. It’s hoped that from October 2011 all meeting papers will be available for printing or downloading via the secure site and the Secretariat will no longer provide printed copies of meeting papers.

Members queried on wireless internet access in Delta House, and the security on confidentiality when downloading secure documents. Ms Rosie Murray advised that a statement will be detailed on the secure site advising that meeting papers should be downloaded or printed in advance of the meeting and that there is no wireless internet access in Delta House.  If you wish to download your papers and copy to your PC or laptop for review rather than printing, please ensure all papers are deleted after the meeting.   Members will also be requested not to share the meeting papers with anyone else.

The Chairman expressed thanks to Ms Murray for all the work involved in the establishment of the new Secure Site, and a thank you to all those members who have volunteered to take part in the pilot phase.

8.3 NICE (Multiple) Technology Appraisal Guidance No 228 – Bortezomib and thalidomide for the first-line treatment of multiple myeloma

NICE recommends that thalidomide in combination with an alkylating agent and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma in people for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate.

The Scottish Medicines Consortium (SMC) has previously issued guidance to NHSScotland on the use of thalidomide in this indication (525/08).  This NICE MTA guidance supersedes the SMC advice.

In January 2009 SMC accepted thalidomide (Thalidomide Pharmion) for use within NHS Scotland in combination with melphalan and prednisone, as first line treatment of patients with untreated multiple myeloma, aged 65 years or over or ineligible for high dose chemotherapy.

No important differences were identified for this NICE appraisal and Healthcare Improvement Scotland advises that the recommendations from the NICE MTA are as valid for Scotland as for England and Wales.

Further information is noted in the Appendix to the minutes.

8.4 NICE Single Technology Appraisal Guidance No 229 – Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion

NICE guidance was published on 27th July 2011. The NICE guidance states that:

Dexamethasone intravitreal implant is recommended as an option for the treatment of macular oedema following central retinal vein occlusion and as an option for the treatment of macular oedema following branch retinal vein occlusion when treatment with laser photocoagulation has not been beneficial or treatment with laser photocoagulation is not considered suitable because of the extent of macular haemorrhage.

SMC published a Statement of Advice (652/10) on this medication for this indication in December 2010.

There is a material difference between the recommendations of the NICE STA and SMC.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland.  NHS boards should adhere to the Scottish Medicines Consortium (SMC) advice.

Further information is noted in the Appendix to the minutes.

8.5 NICE Single Technology Appraisal Guidance No 230 – Bivalirudin for the treatment of ST-segment-elevation myocardial infarction

This NICE guidance was published on 27th July 2011. The NICE guidance states that:

Bivalirudin in combination with aspirin and clopidogrel is recommended for the treatment of adults with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

SMC published a Statement of Advice (638/10) on this medication for this indication in September 2010.
There is no material difference between the recommendations of the NICE STA and SMC.  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland. NHS boards should adhere to the Scottish Medicines Consortium (SMC) advice.

Further information is noted in the Appendix to the minutes.

8.6 NICE Single Technology Appraisal Guidance No 232 –  Retigabine for the adjunctive treatment of partial onset seizures in epilepsy

This NICE guidance was published on 27th July 2011. The NICE guidance states that:

Retigabine is recommended as an option for the adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and older with epilepsy, only when previous treatment with carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate and topiramate has not provided an adequate response, or has not been tolerated.

SMC published a Statement of Advice (712/11) on this medication for this indication in July 2011.

There is no material difference between the recommendations of the NICE STA and SMC.  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland. NHS boards should adhere to the Scottish Medicines Consortium (SMC) advice.

Further information is noted in the Appendix to the minutes.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

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

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

9.1.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that dabigatran etexilate (Pradaxa®), should be accepted for use within NHS Scotland.

Indication under review: 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 

Dabigatran etexilate was at least as effective as standard oral anticoagulation at preventing stroke or systemic embolism in one large, open-label study in patients with atrial fibrillation and at least one risk factor for stroke. This was not associated with an increased risk of major bleeding.

The economics case made supports the use of the proposed sequenced dosing regimen (whereby the dose is reduced from 150mg twice daily to 110mg twice daily in patients aged 80 years). This applies whether the alternative treatment is warfarin, aspirin or ‘no treatment’ (i.e. neither warfarin nor aspirin). 

Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Ch2 HS Boards and ADTCs on Friday, 05 August 2011.

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

9.2.1 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.

9.2.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that abatacept (Orencia®), should not be recommended for use within NHS Scotland.

Indication under review: 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.

There is no head to head study comparing abatacept with other biologic or conventional disease-modifying anti-rheumatic drugs. In combination with methotrexate, abatacept reduced the progression of joint damage and improved physical function more than placebo in patients with moderate to severe rheumatoid arthritis who responded inadequately to previous therapy with methotrexate alone.

The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition, the 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, 05 August 2011.

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

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

9.3.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments, and comments received from the company.  Detailed discussion followed and the group agreed that tenofovir disoproxil (as fumarate) (Viread®), should be accepted for use within NHS Scotland.

Indication under review: Treatment of chronic hepatitis B in adults with decompensated liver disease.

Interim results of an ongoing phase II study assessing the safety of tenofovir disoproxil in the treatment of chronic hepatitis B in patients with decompensated liver disease demonstrated that tenofovir was as well tolerated as another nucleoside/nucleotide analogue.  Comparative efficacy was not tested in this study, but has been extrapolated from a mixed treatment comparison in treatment-naïve patients with compensated liver disease and hepatitis B e-antigen positive infection.

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, 05 August 2011.

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

9.4.1 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.

9.4.2 The NDC Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that golimumab (Simponi®), should be accepted for restricted use within NHS Scotland.

Indication under review: treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

SMC restriction: golimumab is restricted to use in accordance with the British Society for Rheumatology (BSR) guidelines for anti-TNFa agents in adults with ankylosing spondylitis. Golimumab is restricted to use at a dose of 50mg only.

In a placebo controlled study golimumab 50mg and 100mg were superior to placebo given every four weeks in terms of the proportion of patients who achieved at least 20% improvement in the Assessment in AS International Working group Criteria at week 14. An indirect comparison indicates that golimumab has similar efficacy to two other anti-TNFa agents used in the treatment of ankylosing spondylitis.

The economic case was demonstrated for golimumab when used at a dose of 50mg.  The  economic case was not demonstrated for the 100mg dose of golimumab.

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, 05 August 2011.

RESUBMISSION

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

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

9.5.2 The NDC Chairman 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 MDS UK Patient Support Group: Leukaemia Care (joined submission).  Detailed discussion followed and the group agreed that azacitidine (Vidaza®), should be accepted for use within NHS Scotland.

Indication under review: 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).

Azacitidine therapy produced a significant increase in overall survival compared with conventional care regimens in previously untreated higher-risk MDS patients.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of azacitidine. This SMC advice is contingent upon the continuing availability of the PAS in NHS Scotland. 

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, 05 August 2011.

FURTHER ISSUES

9.6 Professor Barbour suggested that in the changed economic environment a robust transparent decision-making framework is required to provide context for SMC decisions.  The SMC debated the issues and expressed a willingness to play a part in development of any such framework.  Following discussion it was agreed that the Chair would write a letter to the Scottish Government in this regard.

10. SMC User Group Forum

10.1 Update from UGF Meeting

Dr Frances Macdonald reported the following:

  • Review of SMC Guidance to manufacturers (Process Aspects) is almost finalised.
  • All other business as normal.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted. 

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Nothing to report.

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, 06 September 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 02 August 2011

NICE (Multiple) Technology Appraisal Guidance No 228 – Bortezomib and thalidomide for the first-line treatment of multiple myeloma

NICE recommends that thalidomide in combination with an alkylating agent and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma in people for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate.

Bortezomib in combination with an alkylating agent and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma if high-dose chemotherapy with stem cell transplantation is considered inappropriate and the person is unable to tolerate or has contraindications to thalidomide.

Web reference for appraisal and other related documents: http://www.nice.org.uk/guidance/TA228

The Scottish Medicines Consortium (SMC) has previously issued guidance to NHSScotland on the use of thalidomide in this indication (525/08).  This NICE MTA guidance supersedes the SMC advice.

In January 2009 SMC accepted thalidomide (Thalidomide Pharmion) for use within NHS Scotland in combination with melphalan and prednisone, as first line treatment of patients with untreated multiple myeloma, aged 65 years or over or ineligible for high dose chemotherapy.

http://www.scottishmedicines.org/SMC_Advice/Advice/525_08_thalidomide__Thalidomide_Pharmion_/thalidomide__Pharmion_

No important differences were identified for this NICE appraisal and Healthcare Improvement Scotland advises that the recommendations from the NICE MTA are as valid for Scotland as for England and Wales.

NICE Single Technology Appraisal Guidance No 229 – Dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion

NICE guidance was published on 27th July 2011.

The NICE guidance states that:

Dexamethasone intravitreal implant is recommended as an option for the treatment of macular oedema following central retinal vein occlusion and as an option for the treatment of macular oedema following branch retinal vein occlusion when treatment with laser photocoagulation has not been beneficial or treatment with laser photocoagulation is not considered suitable because of the extent of macular haemorrhage.

The web reference for the appraisal and other related documents is: www.nice.org.uk/TA229

SMC published a Statement of Advice (652/10) on this medication for this indication in December 2010. This stated that:

Dexamethasone 700 microgram intravitreal implant (Ozurdex) is not recommended for use in NHSScotland for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

The manufacturer has indicated their intention to resubmit to SMC.

Access the advice of SMC:

There is a material difference between the recommendations of the NICE STA and SMC.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland.  NHS boards should adhere to the Scottish Medicines Consortium (SMC) advice.

NICE Single Technology Appraisal Guidance No 230–  Bivalirudin for the treatment of ST-segment-elevation myocardial infarction

This NICE guidance was published on 27th July 2011. The NICE guidance states that:

Bivalirudin in combination with aspirin and clopidogrel is recommended for the treatment of adults with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

The web reference for the appraisal and other related documents is: www.nice.org.uk/TA230

SMC published a Statement of Advice (638/10) on this medication for this indication in September 2010. This stated that:

Bivalirudin (Angiox)is accepted for 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. Its use is restricted topatients 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.

Access the advice of SMC:

There is no material difference between the recommendations of the NICE STA and SMC.  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland. NHS boards should adhere to the Scottish Medicines Consortium (SMC) advice.

NICE Single Technology Appraisal Guidance No 232 –  Retigabine for the adjunctive treatment of partial onset seizures in epilepsy

This NICE guidance was published on 27th July 2011. The NICE guidance states that:

Retigabine is recommended as an option for the adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and older with epilepsy, only when previous treatment with carbamazepine, clobazam, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, sodium valproate and topiramate has not provided an adequate response, or has not been tolerated.

SMC published a Statement of Advice (712/11) on this medication for this indication in July 2011. This stated that:

Retigabine (Trobalt®) is accepted for restricted use within NHS Scotland as an adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with refractory epilepsy.

Access the advice of SMC:

There is no material difference between the recommendations of the NICE STA and SMC.  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland. NHS boards should adhere to the Scottish Medicines Consortium (SMC) advice.