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SMC Minutes - Tuesday, 4 April 2006

Minutes of the SMC Meeting held on Tuesday, 4 April 2006 NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman), Mrs Laura Ace, Professor James Barbour, Dr Keith Beard, Mrs Marion Bennie, Mrs Barbara Black, Professor John Cairns, Dr David Crookes, Dr Carol Davidson, Mr Tom Divers, Mr Jim Eadie, Dr David Hood, Dr Harpreet Kohli, Mrs Pat Murray, Ms Wendy Nganasurian, Dr Ken Paterson, Dr Philip Rutledge, Dr Sandy Simpson, Ms Angela Timoney, Mr Mike Wallace, Dr John Webster

In Attendance: Steven Fennochi, Mrs Hazel Illingworth, Dr Jan Jones, Mr Colin McAllister, Miss Rosie Murray, Mr Richard Norris, Mrs Maureen Stark

Apologies: Dr Jennifer Armstrong, Dr Rosaleen Beattie, Dr Keith Brown, Mr Nick Brown, Mrs Michelle Caldwell, Ms Sara Davies, Dr Peter Donnan, Mr John Glennie, Dr Barclay Goudie, Dr John Haughney, Mrs Anne Lee, Dr Grace Lindsay, Dr Graham Lowe, Dr Chris Lush, Mrs Laura McIver, Mrs Angela Munday, Mr Chris Nicholson, Dr Marianne Nicolson, Miss Corinne O’Dowd, Mrs Fiona Ramsay, Dr Andrew Riley, Mrs Helen Tyrrell, Dr Andrew Walker, Mr Derek Yuille

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 Mr Jim Eadie, Director, ABPI Scotland. who has replaced Moira Howie as ABPI representative on SMC.

1.3 A welcome was extended to Mr Richard Norris, Director, Scottish Health Council, who was observing the work of the SMC at the invitation of PAPIG

1.4 Thanks were given to Chris Nicolson, who unfortunately was unable to attend his last meeting of SMC. Chris will be replaced by Dr Sarah Taylor, Director of Public Health, Shetland. 

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 meeting held on 7 March 2006 were agreed as an accurate record.

4. Matters Arising From the Previous Minutes

Full Submissions

4.1 sodium oxybate (Xyrem) UCB Pharma Ltd (No. 246/06)

4.1.1 SMC advice for sodium oxybate (Xyrem), for the treatment of cataplexy in adult patients with narcolepsy, will be posted on the SMC website on Monday 10 April 2006.

4.2 pramipexole (Mirapexin) Boehringer Ingelheim (No. 247/06)

4.2.1 SMC Advice for pramipexole (Mirapexin), for the treatment of moderate to severe restless legs syndrome, will be withheld pending confirmation of launch.

4.3 daptomycin (Cubicin) Chiron Corporation Ltd (No. 248/06)

4.3.1 SMC Advice for daptomycin (Cubicin), for the treatment of complicated skin and soft tissue infections in adults, will be posted on the SMC website on Monday 10 April 2006.

4.4 ciclesonide (Alvesco) Paediatric Altana Pharma Ltd (No. 249/06)

4.4.1 The SMC Advice for ciclesonide (Alvesco) Paediatric, for prophylactic treatment of persistent asthma in children and adolescents (aged 6–17 years), will be withheld pending confirmation of launch.

Resubmissions

4.6 cinacalcet (Mimpara) Amgen Ltd (No. 169/05)

4.6.1 The SMC Advice for cinacalcet (Mimpara), for the treatment of secondary hyperparathyroidism (SHPT) in patients with end stage renal disease ESRD (stage 5 chronic kidney disease) on haemodialysis and peritoneal dialysis, will be posted on the SMC website on Monday 10 April 2006.

4.7 glyceryl trinitrate 0.4% (Rectogesic Rectal Ointment)  ProStrakan Group (No. 200/05)

4.7.1 The SMC Advice for glyceryl trinitrate 0.4% ointment (Rectogesic), for the relief of pain due to anal fissure, will be posted on the SMC website on Monday 10 April 2006.

5 Appeals Update

5.1 Several Companies have requested meetings to discuss the way forward following negative advice from SMC. The outcome will be reported at future meetings of SMC.

6 PAPIG

6.1 PAPIG met prior to SMC and the following items were noted:

  • Letters have been sent to patient interest groups to encourage more submissions to SMC. 
  • Letters have been sent to Directors of Public Involvement within Health Boards to develop relationships with non-voluntary health sectors.
  • PAPIG have commissioned a research proposal with the Scottish Centre for Social Research to evaluate the effectiveness of public involvement with SMC. An update will be given at a future meeting of SMC.
  • The system for recruitment of lay members has been agreed and a new member will be recruited. An advert will be placed on the PAPIG page of the SMC website and within the QIS Public Involvement Unit. 
  • A comment on the NICE Social Value Judgement paper in relation to the development of NICE guidance has been drafted and will be available at the SMC meeting in May.

Any comments, questions or suggestions from the members of SMC regarding the work of PAPIG would be gratefully received.

7. New Drugs Committee: Chairman’s report

7.1 Membership

The Chairman of NDC advised that as part of the New Drugs Committee rotation of membership, Dr Jan Jones and Dr Andrew Power will rotate to SMC.

7.2 ABPI Sponsored Meeting

The Chairman of NDC had attended an ABPI sponsored meeting regarding exit strategies. A paper is being developed for the CEO and CMO of NHSScotland but will be presented to SMC for comment and discussion in the first instance.

8. Chairman’s Business

8.1 lumiracoxib 100mg tablets (Prexige), Novartis Pharmaceuticals. 

Further to comments from a competitor company, minor changes had been made to the budget impact section of the Detailed Advice Document (DAD), for lumiracoxib (Prexige), for the symptomatic relief in the treatment of osteoarthritis only for patients in whom a COX-2 inhibitor is deemed appropriate.  The DAD will be re-issued to NHS Boards and ADTCs on Friday 7 April, 2006.

9. NDC Assessment Reports

Full Submissions

9.1 letrozole (Femara) Novartis Pharmaceuticals UK Ltd (No: 251/06)

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

9.1.2 The NDC Chairman provided a detailed overview of the assessment, draft advice, expert comments and comments from the company. Detailed discussion followed and the group agreed that letrozole (Femara), for the adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer, should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 7 April, 2006.

9.2 escitalopram (Cipralex) Lundbeck Ltd (No: 253/06)

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

9.2.2 The NDC Lead Assessor provided a detailed overview of the assessment, draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that escitalopram (Cipralex), for the treatment of generalised anxiety disorder (GAD), should be accepted for use within NHS Scotland.  Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 7 April, 2006.

9.3 inhaled insulin (Exubera) Pfizer Ltd (No: 254/06)

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

9.3.2 The SMC Vice Chairman provided a detailed 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 Diabetes UK Scotland. Detailed discussion followed and the group concluded their advice for inhaled insulin (Exubera), for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral anti-diabetic agents and requiring insulin therapy, and for the treatment of adult patients with type 1 diabetes mellitus in addition to long or intermediate acting subcutaneous insulin for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.

9.3.3 The SMC advice to ADTCs and NHS Boards will be withheld pending confirmation of launch

Abbreviated Submissions

9.4 transdermal fentanyl (Durogesic D Trans Transdermal Patches 12mcg/hr)  Janssen-Cilag Ltd (No: 250/06)

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

9.4.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that transdermal fentanyl (Durogesic D Trans Transdermal Patches 12mcg/hr), for the treatment of patients with chronic intractable pain due to non-malignant conditions, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with the secretariat, are 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 ADTCs and NHS Boards on Friday 7 April, 2006.

9.5 pioglitazone/metformin (Competact) Takeda UK Ltd (No: 252/06)

9.5.1 Declarations of interest were recorded in relation to this product/comparator drugs. A Member with personal specific interests left the room for this part of the meeting.

9.5.2 The NDC Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group concluded their advice for pioglitazone/metformin (Competact), for the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.

9.5.3 The SMC advice to ADTCs and NHS Boards will be withheld pending confirmation of launch.

10. Non Submssions

Over the last few months the secretariat have been following up non-submissions and a number of products had been identified where submissions had not been made within a specified timeframe.  The secretariat have been in contact with the companies and advised that negative advice would be issued.  A formal process has now been established to prompt companies to make submissions and to follow-up non-submissions and issue "not recommended" statements if necessary. Companies will be advised that a submission should be made to SMC by the time the product has been made available within NHS Scotland.  Failure to do so will result in a negative recommendation being issued.

Listed below are those products where the holder of the marketing authorisation did not make a submission and therefore not recommended statements will be issued to NHSScotland.

10.1 fondaparinux (Arixtra) GlaxoSmithKline (No:261/06)

10.1.1 In the absence of a submission from the holder of the marketing authorisation, fondaparinux (Arixtra), is not recommended for use within NHSScotland for the treatment of prevention of venous thromboembolic events (VTE) in medical patients who are judged to be at high risk of VTE and who are immobilised due to acute illness, such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infections or inflammatory disease.

10.1.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April, 2006.

10.2 fondaparinux (Arixtra) GlaxoSmithKline  (No 262/06)

10.2.1 In the absence of a submission from the holder of the marketing authorisation, fondaparinux (Arixtra) is not recommended for use within NHSScotland for the treatment of acute deep vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE).

10.2.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April, 2006.

10.3 choriogonadotropin alfa (Ovitrelle) Serono (No 263/06)

10.3.1 In the absence of a submission from the holder of the marketing authorisation, choriogonadotropin alfa (Ovitrelle), is not recommended for use within NHSScotland for the treatment of women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF).

10.3.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April, 2006.

10.4 choriogonadotropin alfa (Ovitrelle) Serono (No 264/06)

10.4.1 In the absence of a submission from the holder of the marketing authorisation, Choriogonadotropin alfa (Ovitrelle) is not recommended for use within NHSScotland for the treatment of anovulatory or oligo-ovulatory women.

10.4.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April, 2006.

10.5 oxycodone (OxyNorm) Napp Pharmaceutical Ltd  (No: 266/06)

10.5.1 In the absence of a submission from the holder of the marketing authorisation, oxycodone (OxyNorm), is not recommended for use within NHSScotland for the treatment of post-operative pain.

10.5.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006.

10.6 epinastine (Relestal) Allergen Ltd (No: 267/06)

10.6.1 In the absence of a submission from the holder of the marketing authorisation, epinastine (Relestal) is not recommended for use within NHSScotland for the treatment of the symptoms of seasonal allergic conjunctivitis.

10.6.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006

10.7 pemetrexed (Alimta) Eli Lilly (No: 268/06)

10.7.1 A member with personal specific interests left the room for this part of the meeting

10.7.2 In the absence of a submission from the holder of the marketing authorisation, pemetrexed (Alimta) is not recommended for use within NHSScotland, as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.

10.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006.

10.8 gonapeptyl depot Ferring Pharmaceuticals (No: 269/06)

10.8.1 In the absence of a submission from the holder of the marketing authorisation, gonapeptyl depot is not recommended for use within NHSScotland0 for the treatment of advanced, hormone-dependent prostate carcinoma.

10.8.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006.

10.9 gonapeptyl depot Ferring Pharmaceuticals  (No: 270/06)

10.9.1 In the absence of a submission from the holder of the marketing authorisation, gonapeptyl depot is not recommended for use within NHSScotland for the treatment of symptomatic endometriosis confirmed by laparoscopy when suppression of the ovarian hormonogenesis is indicated to the extent that surgical therapy is not primarily indicated.

10.9.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006.

10.10 cinacalcet (Mimpara) Amgen (No: 271/06)

10.10.1 In the absence of a submission from the holder of the marketing authorisation, cinacalcet (Mimpara) is not recommended for use within NHSScotland for the reduction of hypercalcaemia in patients with parathyroid carcinoma.

10.10.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006.

10.11 palifermin (Kepivance) Amgen (No: 272/06)

10.11.1 In the absence of a submission from the holder of the marketing authorisation, palifermin (Kepivance) is not recommended for use within NHSScotland for the treatment of oral mucositis in bone marrow transplantation.

10.11.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006

10.12 darbepoetin alfa (Aranesp) Amgen (No: 273/06)

10.12.1 In the absence of a submission from the holder of the marketing authorisation, darbepoetin alfa (Aranesp) is not recommended for use within NHSScotland for the treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

10.12.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006

10.13 darbepoetin alfa (Aranesp) SureClick Amgen (265/06)

10.13.1 In the absence of a submission from the holder of the marketing authorisation, darbepoetin alfa (Aranesp) SureClick is not recommended for use within NHSScotland for the treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

10.13.2 The SMC advice will be issued to ADTCs and NHS Boards on Friday 7 April 2006

11 Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled for review.

12 ADTC Feedback

12.1 There was nothing to report

13 SMC User Group Forum

13.1 The minutes of the meeting of the SMC UGF held on Tuesday 28 February 2006, were tabled for information. The Chairman of the group advised that he would be happy to answer any specific queries.

14 Any Other Business

14.1 Resources

In a response to a question, the Chairman advised that the SMC budget for 2006/07 was being finalised and an update would be provided at the next meeting.

15 Date of the Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday, 2 May, 2006 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.