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Minutes of the SMC Meeting held on Tuesday 3 February 2009

Minutes of the SMC Meeting held on Tuesday 03 February 2009
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present:  Dr Ken Paterson (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Mr David Carson, Dr David Crookes, Dr Sara Davies, Mr Tom Divers, Dr Jonathan Fox, Dr Barclay Goudie, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Dr Simon Maxwell, Ms Aileen Muir, Dr Anthony Ormerod, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Dr Sandy Simpson, Mr Keith Thompson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker.

In Attendance: Mr Amjad Ali, Ms Angela Louise Bailey, Ms Katie Jane Barker, Ms Pamela Caroline Blair, Mrs Corinne Booth, Ms Ailsa Brown, Mr Stephen Ferguson, Mr Craig Alexander Fleming, Dr Gail Gilbert, Mrs Anne Lee, Ms Zoe Teresa Marshall, Ms Lindy McFarlane, Ms Rosie Murray, Ms Alex Robertson, Ms Rosalyn Diane Shearer, Mrs Maureen Stark, Mrs Catherine Tait.

Apologies:Mr Colin Brown, Professor John Cairns, Dr John Gemmill, Ms Susan Goldsmith,
Dr Grace Lindsay, Dr Chris Lush, Ms Veronica Moffat, Professor Dilip Nathwani, 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. 

A welcome was extended to the following students who were observing the meeting:

  • Mr Amjad Ali 
  • Ms Angela Louise Bailey 
  • Ms Katie Jane Barker
  • Ms Pamela Caroline Blair 
  • Mr Craig Alexander Fleming
  • Ms Zoe Teresa Marshall
  • Ms Lindy McFarlane
  • Mr Rosalyn Diane Shearer

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 06 January 2009 were accepted.

4. Matters Arising

4.1 National Institute for Clinical Excellence (NICE) - Consultation on End of Life Medicines

The Chairman advised that following the Consultation, on 02 January 2009 where the criteria for End of Life Medicines are satisfied, NICE appraisal committees will adopt a more flexible approach to the consideration of cost-effectiveness.

Full Submissions

4.2 doripenem (Doribax)  500mg powder for solution  for infusion Janssen-cilag Ltd (No. 529/09)

4.2.1 The SMC advice for doripenem (Doribax) for the treatment of complicated intra-abdominal infections in adults, will be published on the SMC website on Monday, 09 February 2009.

4.3 pemetrexed 100mg, 500mg powder for concentrate for solution for infusion (Alimta) Eli Lilly and Company Limited (No. 531/09)

4.3.1 The SMC advice 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, will be published on the SMC website on Monday, 09 February 2009.

4.4 lapatinib 250mg film coated tablets (Tyverb) GlaxoSmithKline (No. 526/09)

4.4.The SMC advice for lapatinib (Tyverb) in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2), will be published on the SMC website on Monday, 09 February 2009.

4.5 sugammadex 100mg/ml solution for injection (Bridion) Schering-Plough (No. 527/09)

4.5.1 The SMC advice for sugammadex (Bridion) for the immediate reversal of rocuronium-induced neuromuscular blockade in adults in an emergency setting will be published on the SMC website on Monday, 09 February 2009.

4.6 extended release epidural morphine, 10mg/ml (10mg, 15mg,and 20mg)  for injection (Depodur) Flynn Pharma Ltd (No. 528/09)

4.6.1 The SMC advice for extended-release epidural morphine (Depodur), for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery, will be published on the SMC website on Monday, 09 February 2009.

4.7 etravirine 100mg tablet (Intelence) Tibotec (Janssen-cilag Limited) (No. 530/09)

4.7.1 The SMC advice for etravirine (Intelence), in combination with a boosted protease inhibitor and other antiretroviral medicinal products, for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, will be published on the SMC website on Monday, 09 February 2009.
 
4.8 lacosamide 50mg, 100mg, 150mg and 200mg tablets (Vimpat) UCB Pharma Limited (No. 532/09)

4.8.1 The SMC advice for lacosamide (Vimpat) as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older, will be published on the SMC website on Monday, 09 February 2009.

Abbreviated Submissions

4.9 adalimumab 40mg solution for injection (Humira) Abbott Laboratories (No. 533/09)

4.9.1 The SMC advice for adalimumab (Humira), in combination with methotrexate, for the treatment of active polyarticular juvenile idiopathic arthritis in adolescents aged 13-17 years who have an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), will be published on the SMC website on Monday, 09 February 2009.

4.10 sublingual fentanyl  100, 200, 300, 400, 600 and 800mcg sublingual tablets (Abstral) ProStrakan (No. 534/09)

4.10.1 The SMC advice for fentanyl sublingual tablets (Abstral) for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain, will be published on the SMC website on Monday, 09 February 2009.

4.11   Non Submissions

4.11.1 Nothing to report.

4.12   Deferred Advice

4.12.1 11.7mg etonogestrel/2.7mg ethinylestradiol vaginal ring (NuvaRing)No.  (502/08) Schering-Plough

SMC reviewed etonogestrel/ ethinylestradiol vaginal ring (NuvaRing) in September 2008. Advice was withheld pending product availability. The product was made available to prescribers on 12 January 2009.  Advice was issued to NHSScotland on Friday 09 January 2009 and will be published on the SMC website on Monday 09 February, 2009. 

4.12.2 tobramycin 300mg/4ml nebuliser solution (Bramitob) (No. 314/06) Trinity Chiesi Pharmaceuticals Ltd – Abbreviated submission 

SMC reviewed tobramycin 300mg/4ml nebuliser solution (Bramitob) in September 2006. Advice was withheld pending product availability. The product was granted a marketing authorization on 6 November 2008 and was launched in January 2009.  Advice will be issued to NHSScotland on Friday 06 February 2009 and will be published on the SMC website on Monday 09 March, 2009. 

4.13 Amended Advice

4.13.1 Nothing to report.

5.  Appeals Update

5.1 etravirine 100mg tablet (Intelence) (No. 530/09) 

SMC has not recommended etravirine (Intelence) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients.  Janssen-cilag has indicated their intention to resubmit.

5.2 aripiprazole 5mg, 10mg, 15mg, 30mg tablets; 10mg, 15mg orodispersible tablets; 1mg/ml oral solution (Abilify) No.  (498/08)

SMC has not recommended aripiprazole (Abilify) for the treatment of moderate to severe manic episodes in bipolar 1 disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.  Bristol Myers Squibb Pharmaceuticals Ltd has indicated their intention to submit.

6. Patient and Public Involvement Group (PAPIG)

6.1 Mrs Tunstall-James provided a brief update on the recent meeting at PAPIG.  Mr Powrie-Smith attended a meeting with the Long Term Conditions Alliance (LTCA) to discuss the establishment of an SMC Patient and Public Involvement Officer post.  A meeting has now been arranged on 13 February with LTCA to discuss this in more detail.

Final arrangements are underway for the training day for Patient Interest Groups which is expected to take place in 3rd week in May. 

7. New Drugs Committee: Chairman’s Report

7.1  Nothing to report.

8.   Chairman’s Business

8.1  Bio Force UK Ltd – Traditional Herbal Medicines

Further to correspondence from Bioforce UK Ltd regarding traditional herbal medicines, clarity is required that drugs certified via the traditional herbal route will not be subject to SMC assessment. This will be discussed over the coming months with ADTC’s and SMC will be updated in due course.

8.2  Confidentiality Breach

It has been brought to the SMC attention that there has been a breach of confidentiality pre-publication of SMC advice. Members are reminded that advice must not be disclosed before publication on the SMC website.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1   doripenem (Doribax) (nosocomial pneumonia)  Janssen-Cilag  (No. 539/09)

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

9.1.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments and comments received from the company.  Detailed discussion followed and the group agreed that doripenem (Doribax), should be accepted for restricted use within NHS Scotland for the treatment of nosocomial pneumonia including ventilator acquired pneumonia.  Assessors in liaison with the Secretariat to make the appropriate amendments for review by the Chairman prior to distribution of the advice.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 February 2009


9.2 alitretinoin (Toctino)  Basilea Pharmaceuticals Ltd  (No. 538/09)

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

9.2.2 The NDC 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 alitretinoin (Toctino) should be accepted within NHS Scotland, in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids.  Assessors in liaison with the Secretariat to make the appropriate amendments for review by the Chairman prior to distribution of the advice.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 February 2009.

9.3 testosterone (Nebido)  Bayer plc (Bayer Schering Pharma Division)  (No. 308/06)

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

9.3.2  The NDC 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 testosterone (Nebido), should be accepted for use within NHS Scotland for testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.  Assessors in liaison with the Secretariat to make the appropriate amendments for review by the Chairman to distribution of the advice.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 February 2009. 

9.4 oxycodone prolonged release/ naloxone prolonged release (Targinact)  Napp Pharmaceuticals Ltd  (No. 541/09)

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

9.4.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from Pain Association Scotland.  Detailed discussion followed and the group agreed that oxycodone prolonged release/ naloxone prolonged release (Targinact), should not be recommended for use within NHS Scotland, for the treatment of severe pain which can be adequately managed only with opioid analgesics.  Assessors in liaison with the Secretariat to make the appropriate amendments for review by the Chairman prior to distribution of the advice.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 February 2009.

RESUBMISSION

9.5 betaine anhydrous (Cystadane)  Orphan Europe (UK) Limited  (No. 407/07)

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

9.5.2 The NDC Chair provided an overview of the assessment, draft advice and comments received from the company.  A member of PAPIG presented a patient interest group submission from Children Living with Inherited Metabolic Diseases (CLIMB).  Detailed discussion followed and the group agreed that betaine anhydrous (Cystadane), should not be recommended for use within NHS Scotland,  for the adjunctive treatment of homocystinuria, involving deficiencies or defects in cystathionine beta-synthase (CBS), 5,10-methylene-tetrahydrofolate reductase (MTHFR) or cobalamin cofactor metabolism (cbl).    Assessors in liaison with the Secretariat to make the appropriate amendments for review by the Chairman to distribution of the advice.

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 February 2009.   

ABBREVIATED SUBMISSIONS

9.6 budesonide (Pulmicort CFC-Free Inhaler)  AstraZeneca UK Limited  (No.536/09)

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

9.6.2 The NDC Chair provided an overview of the assessment and a draft summary of advice.  Detailed discussion followed and the group concluded their advice for  budesonide (Pulmicort CFC-Free Inhaler), for the treatment of asthma. 

9.6.3 The SMC advice will be withheld pending confirmation of licence and product availability.

9.7 cladribine (Litak)  Lipomed GmbH  (No.537/09)

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, draft advice and comments received from the company.  Detailed discussion followed and the group agreed that cladribine (Litak), should be accepted for use within NHS Scotland for the treatment of hairy cell leukaemia.  Assessors in liaison with the Secretariat to make the appropriate amendments for review by the Chairman prior to distribution of advice.

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 February 2009.

NON SUBMISSION

9.8 cetuximab 5mg/ml solution for infusion (Erbitux) Merck Serono (No. 547/09)

9.8.1  In the absence of a submission from the holder of the marketing authorisation, cetuximab (Erbitux), for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease, should not be recommended for use within NHS Scotland.

9.8.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 06 February 2009.

10.  Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted.

11.  SMC User Group Forum (UGF)

11.1  Dr Frances Macdonald provided a brief update on the SMC User Group.

There is currently a piece of work underway to gain a better understanding why companies do not submit to SMC. A survey tool has been used as part of this work and progress will be reported in due course.

The Bio-Similiars Short Life Working Group is now underway and will report in due course.

Both NHS and Industry are committed to increasing uptake and patient access for new clinically and cost effective medicines in the NHS, in a sustainable manner, therefore SMC will be updated on developments in Pharmaceutical Price Regulation Scheme (PPRS) and Market Access Schemes in Scotland (MASS) via the User Group Forum.

12.   Feedback from Area Drug and Therapeutic Committees (ADTCs)

12.1  Nothing to report.

13.   Any Other Business

13.1  No other business was raised.

14.   Date of the Next Meeting

14.1  The date of the next meeting was confirmed as Tuesday, 03 March 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.