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SMC Minutes Tuesday 7 September 2010

Minutes of the SMC Meeting
held on Tuesday 07 September 2010
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: 
Ms Angela Timoney (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Dr Jennifer Burns, Professor Scott Bryson, Dr Dominic Culligan, Ms Jane Davidson, Dr David Dunlop, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie, Dr Jacqui Howes, Dr Jan Jones, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Dr James McLay, Mrs Sandra McNaughton, Dr Paul McNamee, Dr Simon Maxwell, Ms Aileen Muir, Dr Mercia Page, Dr Andrew Power, Mrs Sheila Tunstall-James, Mr Keith Thompson, Dr Andrew Walker, Professor David Wray

In Attendance:
Mrs Corinne Booth, Ms Ailsa Brown, Dr Sara Davies, Mrs Susan Downie, Mr Stephen Ferguson, Mrs Anne Lee, Ms Marie McHenery, Ms Veronica Moffat, Ms Rosie Murray, Mrs Catherine Tait

Apologies:
Mr Colin Brown, Mr Robert Calderwood, Mr Dave Carson, Professor Dilip Nathwani, Dr Anthony Ormerod, Professor Ken Paterson, Dr Robert Peel, Mr Andrew Powrie-Smith, Mr Michael Pratt, Dr Nick Reed, Ms Alex Robertson, Dr Brian Robson, Mrs Maureen Stark, Dr Sarah Taylor, Mr Alistair Thorburn, Professor Tony Wells

1. Welcome and Apologies for Absence

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

1.2 Welcome to New Members
A welcome was extended to the following individuals who were observing the meeting:

  • Ms Jane Davidson, Director of Finance, NHS Borders
  • Dr David Dunlop, Medical Director, The Beatson West of Scotland Cancer Centre
  • Dr Jacqui Howes, Consultant Anaesthetist, Raigmore Hospital, Inverness
  • Dr James McLay, Senior Lecturer & Consultant Physician, School of Medicine, Aberdeen
  • Marie McHenery, newly appointed Patient and Public Involvement Officer (PPIO), who will support the work of SMC and ensure that a patient view is considered for new medicines under review. 

1.3 Thank you and Goodbye:

The Chairman expressed his thanks to Dr Nick Reed (in his absence) whose term of membership on SMC has ended.

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 (03 August 2010)

3.1 The minutes of the SMC meeting held on 03 August 2010 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 trabectedin (Yondelis)  PharmaMar S.A (No. 634/10)

4.1.1 The SMC advice for trabectedin (Yondelis), in combination with pegylated liposomal doxorubicin (PLD), for the treatment of patients with relapsed platinum-sensitive ovarian cancer, will be published on the SMC website on Monday, 13 September 2010.

4.2 roflumilast (Daxas)  Nycomed (No. 635/10)

4.2.1 The SMC advice for roflumilast (Daxas), for the 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, was withheld pending product availability.  However advice will be published on the SMC website on Monday 11 October 2010.

4.3 dronedarone (Multaq)  Sanofi-aventis (No. 636/10)

4.3.1 The SMC advice for dronedarone (Multaq), for the treatment of 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, will be published on the SMC website on Monday, 13 September 2010.

4.4 febuxostat (Adenuric)  A Menarini Pharma UK SRL (No. 637/10)

4.4.1 The SMC advice for febuxostat (Adenuric), for the treatment chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence, of tophus and/or gouty arthritis), will be published on the SMC website on Monday, 13 September 2010.

4.5 bivalirudin (Angiox)  The Medicines Company (No. 638/10)

4.5.1 The SMC advice for bivalirudin (Angiox), as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI,  will be published on the SMC website on Monday, 13 September 2010.

Resubmissions

4.6 agomelatine (Valdoxan®)  Servier (No. 564/09)

4.6.1 The SMC advice for agomelatine (Valdoxan), for the treatment of major depressive episodes in adults, will be published on the SMC website on Monday, 13 September 2010.

4.7 imatinib (Glivec)  Novartis Pharmaceuticals UK Limited (No. 584/09)

4.7.1 The SMC advice for imatinib (Glivec), for adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST), will be published on the SMC website on Monday, 13 September 2010.

Abbreviated Submission

4.8 esomeprazole oral suspension (Nexium)  AstraZeneca UK Ltd (No.639/10)

4.8.1 The SMC advice for esomeprazole oral suspension (Nexium), for treatment of gastro-oesophageal reflux disease in children 1 to 11 years old, will be published on the SMC website on Monday, 13 September 2010.

4.9 Deferred Advice

4.9.1 roflumilast (Daxas)  Nycomed (No. 635/10)

4.9.2 Roflumilast (Daxas), for the 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, was reviewed by SMC in August 2010 and advice was withheld pending product availability.  However advice has now been distributed, in confidence, to NHSScotland and will be published on the SMC website on Monday 11 October 2010.

4.10 Amended Advice

4.10.1 Nothing to report.

5. Appeals Update

5.1 trastuzumab (Herceptin) Roche (No. 623/10)

5.1.1 In August 2010, SMC considered but did not recommend trastuzumab (Herceptin?) 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.  Roche have advised their intention to resubmit.

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

5.2.1 In August 2010, SMC considered but did not recommend agomelatine, 25mg film-coated tablets (Valdoxan®), for the treatment of major depressive episodes in adults.  Servier have advised their intention to resubmit.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

6.1.1 Mrs Tunstall-James welcomed the appointment of Marie McHenery, Patient and Public Involvement Office, to SMC.

7. New Drugs Committee: Chairman’s Report

7.1 The NDC Chairman advised that an indirect comparison checklist has been developed and is currently being piloted.

8. Chairman’s Business

8.1 Bridgehead Consultancy

8.1.1 A healthcare strategy consultancy called Bridgehead is working with a client who is preparing a SMC submission and has approached pharmacists working in the NHS to request participation in a mock SMC review advisory board.

The Chairman advised that in general, this type of participation is not encouraged as it would result in a personal specific conflict and would prevent a NDC member taking part in SMC evaluation of the product.            

8.2 NICE (Multiple) Technology Appraisal Guidance No 195 – Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor (part review of NICE technology appraisal guidance 36, review of NICE technology appraisal guidance 126 and 141), published 25 August 2010

Summary of NICE MTA

The appraisal of adalimumab and the review of the appraisals of etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis have resulted in changes in the guidance.  Rituximab in combination with methotrexate is still recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor. Additional treatment options are now recommended for these adults if rituximab therapy is contraindicated or withdrawn because of an adverse event, specifically:

  • If rituximab is contraindicated or withdrawn, adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are now recommended as treatment options.
  • If rituximab therapy cannot be given because methotrexate is contraindicated or withdrawn because of an adverse event, adalimumab and etanercept, each as monotherapy, are now recommended as treatment options.

SMC Advice

SMC has previously issued guidance to NHSScotland on the use of abatacept (400/07), etanercept (305/06) and ritixumab (323/06) in this indication.

SMC published advice for abatacept in September 2007 (SMC No 400/07)

abatacept (Orencia) is not recommended for use within NHS Scotland, in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) including at least one tumour necrosis factor (TNF) inhibitor.  Abatacept (in combination with DMARDs) is significantly more efficacious than placebo (plus DMARDs) in rheumatoid arthritis patients who have previously failed anti-TNF therapy due to lack of efficacy.  There are no data directly comparing abatacept with comparator products used in clinical practice.  The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

SMC published advice for etanercept in September 2006 (SMC No 305/06) Abbreviated

etanercept 50mg subcutaneous injection (Enbrel) is accepted for use within NHS Scotland for the treatment of patients with rheumatoid arthritis for whom treatment with etanercept is considered appropriate.  Etanercept is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults, either alone or in combination with methotrexate when the response to diseasemodifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate or for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.  The 50mg formulation facilitates once weekly administration of etanercept at no additional cost over the existing 25mg formulation that is administered twice weekly.
SMC published advice for rituximab in November 2007 (SMC No 323/06)

rituximab (MabThera) is accepted for restricted use within NHS Scotland in combination with methotrexate for treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) including one or more tumour necrosis factor (TNF) inhibitor.  It is restricted to use by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis. Rituximab in combination with methotrexate improves signs and symptoms and quality of life and prevents joint damage compared to methotrexate, in adults with rheumatoid arthritis who have had an inadequate response to methotrexate and an inadequate response or intolerance to at least one TNF-antagonist. Treatment should only be repeated in patients who continue to achieve an American College of Rheumatology (ACR) response of at least 20. Rituximab is cost effective if the average dosing interval for those patients who respond to initial treatment does not fall below six months.

This NICE MTA guidance supersedes the SMC advice and the SMC website will be amended accordingly.  The recommendations for the use of etanercept and rituximab are consistent.  However, there is a material difference in the recommendation for abatacept.

Tocilizumab also forms part of the treatment algorithm for this indication within NHSScotland.

NICE published a Single Technology Assessment (STA) on Tocilizumab in this indication on 25th August and recommends tocilizumab, taken with a drug called methotrexate, as a possible treatment for some people with rheumatoid arthritis.

SMC published advice for tocilizumab in January 2010 (SMC No 593/09)

tocilizumab, (RoActemra) is accepted for restricted use within NHS Scotland.

Licensed indication under review: 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. In these patients, toculizumab can be given as monotherapy in case of intolerance to methotrexate or where continued treatment with methotrexate is inappropriate.  Addition of tocilizumab to disease-modifying anti-rheumatic drugs resulted in an increased response rate for reduction of disease activity.

Restriction: It is restricted for use in combination therapy within NHS Scotland. The manufacturer did not present an economic case for monotherapy. Toculizumab should be used in accordance with the British Society of Rheumatology guidelines for prescribing TNF- blockers in adults.

There is a material difference between the advice of SMC and this NICE STA guidance. NHSScotland should continue to follow SMC advice.

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

8.3 NICE (Multiple) Technology Appraisal Guidance No 199 – Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis (review of technology appraisal guidance 104 and 125), published 25 August 2010
 

Summary of NICE MTA

NOTE: This guidance replaces NICE technology appraisal guidance 104 issued in July 2006 and NICE technology appraisal guidance 125 issued in August 2007.

NICE reviews each piece of guidance it issues.  This review and re-appraisal has resulted in an extension to the guidance:

  • Etanercept, infliximab and adalimumab are all recommended for the treatment of active and progressive psoriatic arthritis, based on specific criteria.  Treatment choice should be started with the least expensive drug (taking into account drug administration costs, required dose and product price per dose).
  • The guidance recommends that treatment should be discontinued if people’s disease does not show an adequate response on the Psoriatic Arthritis Response Criteria (PsARC) at 12 weeks.  Healthcare professionals should also consider continuing treatment if people’s skin disease has a Psoriasis Area and Severity Index (PASI) 75 response at 12 weeks in the absence of an adequate PsARC response.  This assessment should be done by a dermatologist to determine whether continued treatment is appropriate on the basis of the skin response alone.

Summary of SMC Advice

SMC has previously issued guidance to NHSScotland on the use of etanercept (107/04), etanercept (304/06) and adalimumab (218/05) in this indication.

SMC published advice for etanercept (Enbrel) in July 2004 (SMC No. 107/04)

Etanercept (Enbrel) is accepted for use within NHS Scotland for the treatment of active and progressive psoriatic arthritis in adults.  It is the first drug to be licensed for this indication and not only improves symptoms of arthritis and psoriasis, but may slow the progression of joint damage (at least over a period of one year).

SMC published advice for etanercept (Enbrel) in September 2006 (SMC No. 304/06)

etanercept 50mg subcutaneous injection (Enbrel) is accepted for use within NHS Scotland for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.  Etanercept improves the symptoms of arthritis and psoriasis and may slow the progression of joint damage (at least over a period of one year).  The 50mg formulation facilitates once weekly administration of etanercept at no additional cost over the existing 25mg formulation that is administered twice weekly.

SMC published advice for adalimumab (Humira) in December 2005 (SMC No. 218/05)

Adalimumab (Humira®) is accepted for use within NHS Scotland for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.  Adalimumab improves symptoms of arthritis and psoriasis and may slow the progression of joint damage in patients with active psoriatic arthritis.

There is no material difference between the NICE MTA guidance and SMC advice and the NICE MTA supersedes the SMC advice.  The SMC website will be amended accordingly.

8.4 NICE Single Technology Appraisal Guidance No 197 – Dronedarone for the treatment of non-permanent atrial fibrillation, published 25 August 2010

Summary of NICE STA

NICE recommends dronedarone as a possible treatment for some people with non-permanent atrial fibrillation.

SMC is due to publish a Statement of Advice on this medication for this indication in September 2010.  When this is available, NHS Scotland should adhere to this advice

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

8.5 NICE Single Technology Appraisal Guidance No 196 –  Imatinib for the adjuvant treatment of gastrointestinal stromal tumours, published 25 August 2010

Summary of NICE STA

NICE does not recommend imatinib as an adjuvant treatment for people after surgical removal of a GIST.  There is not enough evidence from clinical trials to say how well imatinib works as an adjuvant treatment, or whether it works well enough to justify its cost, so NICE did not recommend it.

SMC Advice

SMC published advice for imatinib in December 2009 (SMC No 584/09)

Imatinib (Glivec) is not recommended for use within NHS Scotland for the adjuvant treatment of adult patients who are at significant risk of relapse following resection of Kit (CD117)-positive gastrointestinal stromal tumours (GIST).

There is no material difference between the recommendations of the NICE STA and the SMC.
 
SMC has reviewed a resubmission from the manufacturer of imatinib and is due to publish advice in September 2010.  When this is available, NHS Scotland should adhere to this advice.

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

8.6 Avandia (rosiglitazone)

Following safety concerns regarding the cardiovascular safety of rosiglitazone, a member suggested it may be prudent for SMC to revisit their assessment of the medicine, as monotherapy for type 2 diabetes, which was published in 2004.  The Chairman advised that this is not an issue for SMC but for the MHRA who will review the available safety data, including cardiovascular safety data to determine the risks and benefits.  However, she advised that SMC will look at the assessment to ensure SMC are satisfied that their processes were robust in regard to this medicine.

8.7 Cost Effectiveness Threshold

8.7.1 A member expressed concern regarding affordability issues in relation to new medicines which impose considerable constrains on prescribing budgets in the present financial climate.  The Chairman advised that she is aware of the budget impact implications for NHS Scotland and the challenges that have existed for both the industry and SMC in this regard.. She will ask the chairman of the SLWG which has been formed to review budget impact to ensure these issues are addressed.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 lanthanum carbonate 500mg, 750mg, 1,000mg, chewable tablets (Fosrenol) Shire Pharmaceuticals Ltd (No. 640/10)

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

9.1.2 The NDC Vice 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 lanthanum carbonate 500mg, 750mg, 1,000mg, chewable tablets (Fosrenol), should not be recommended for use within NHS Scotland, as a phosphate binding agent for use in the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphate levels =1.78mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.  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, 10 September 2010.
 
9.2 sevelamer carbonate (Renvela) 800mg film-coated tablets and 1.6 and 2.4g powder for oral suspension  Genzyme  (No. 641/10)

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

9.2.2 The NDC Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company.  A member of PAPIG presented a patient interest group submission from the National Kidney Federation. Detailed discussion followed and the group concluded their advice for sevelamer carbonate (Renvela) 800mg film-coated tablets and 1.6 and 2.4g powder for oral suspension, for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. 

9.2.3 The SMC advice will be withheld pending confirmation of licence and product availability.
 
9.3 pemetrexed (Alimta) 100mg and 500mg powder for concentrate for solution for infusion  Eli Lilly and Company Limited  (No. 642/10)

9.3.1 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.

9.3.2 The NDC Vice Chairman provided an overview of the assessment, draft advice, expert comments and comments received from the company.  A member of PAPIG presented a patient interest group submission from the Roy Castle Lung Cancer Foundation. Detailed discussion followed and the group agreed that pemetrexed (Alimta) 100mg and 500mg powder for concentrate for solution for infusion, should not be recommended for use within NHS Scotland, as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.  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, 10 September 2010.

RESUBMISSIONS

9.4 certolizumab pegol (Cimzia) 200 mg/ml solution for injection (prefilled syringe)  UCB Pharma Ltd  (No. 590/09) 

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 Chairman provided an overview of the assessment, draft advice, expert comments, and comments received from the company.  A member of PAPIG presented a patient interest group submission from the National Rheumatoid Arthritis Society.  Detailed discussion followed and the group agreed that certolizumab pegol (Cimzia) 200 mg/ml solution for injection (prefilled syringe) UCB Pharma Ltd, should be accepted for use within NHS Scotland, in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drugs, including methotrexate, has been inadequate; and monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

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

9.4.4 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 10 September 2010.

ABBREVIATED SUBMISSIONS

9.5 ethinylestradiol 30mcg and levonorgestrel 150mcg  (Rigevidon) Consilient Health Limited  (No. 646/10)

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

9.5.2 The NDC Chairman provided an overview of the assessment and draft advice,  Detailed discussion followed and the group agreed that ethinylestradiol 30mcg and levonorgestrel 150mcg (Rigevidon), should be accepted for use within NHS Scotland, for oral contraception.  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, 10 September 2010.

9.6 ethinylestradiol and gestodene  (Millinette 20/75 and 30/75) Consilient Health Limited  (No. 644/10)

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

9.6.2 The NDC Chairman provided an overview of the assessment and draft advice.  Detailed discussion followed and the group agreed that ethinylestradiol and gestodene (Millinette 20/75 and 30/75), should be accepted for use within NHS Scotland, for oral contraception.  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, 10 September 2010.

9.7 ethinylestradiol and desogestrel (Gedarel 20/150 and 30/150) Consilient Health Limited  (No. 643/10)

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

9.7.2 The NDC Chairman provided an overview of the assessment and draft advice. Detailed discussion followed and the group agreed that ethinylestradiol and desogestrel (Gedarel 20/150 and 30/150) should be accepted for use within NHS Scotland, for oral contraception.  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, 10 September 2010.

9.8 ethinylestradiol and levonorgestrel 3 (TriRegol) Consilient Health Limited  (No. 645/10)

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

9.8.2 The NDC Chairman provided an overview of the assessment and draft advice.  Detailed discussion followed and the group agreed that ethinylestradiol and levonorgestrel 3 (TriRegol), should be accepted for use within NHS Scotland, for oral contraception.  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, 10 September 2010.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. SMC User Group Forum (UGF)

11.1 Nothing to report.

12. Area Drug and Therapeutics Committees (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 05 October 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.