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SMC Minutes - Tuesday 7 June 2005

Minutes of Meeting held on Tuesday 7 June 2005
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Professor David Webb (Chairman) , Dr Keith Beard, Mrs Barbara Black, Professor Martin Brodie, Mrs Michelle Caldwell, Professor John Cairns, Mr Tom Divers, Dr Peter Donnan,
Dr John Haughney, Dr David Hood, Mrs Moira Howie, Dr Jan Jones, Dr Harpreet Kohli, Dr Chris Lush, Mrs Angela Munday, Ms Wendy Nganasurian, Mr Chris Nicolson, Dr Ken Paterson, Ms Fiona Ramsay, Dr Andrew Riley, Dr Philip Rutledge, Mr Mike Wallace, Dr John Webster, Mr Derek Yuille

In Attendance: Dr Jennifer Armstrong, Ms Jane Griffin, Ms Fiona Halcrow, Ms Anne Lee,
Ms Leanne Oliver, Mr Hector MacKenzie, Mr Patrick Maitland-Cullen, Dr John McElhinney,
Mrs Laura McIver, Miss Rosie Murray, Mrs Maureen Stark

Apologies: Professor James Barbour, Ms Chris Beech, Dr Corri Black, Ms Sandra Blevings,
Dr Ross Camidge, Mr John Glennie, Dr Barclay Goudie, Dr Marianne Nicholson, Ms Helen Tyrrell,
Mrs Fiona Scott, Dr Sandy Simpson

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 the following who were observing the work of the SMC:

  • Dr Jennifer Armstrong, Public Health Consultant, National Services Division Edinburgh 
  • Ms Jane Griffin, Head, Health Economics & Outcome Research, Boehringer Ingelheim Ltd and New Drugs Committee Member
  • Ms Fiona Halcrow, Quality Manager, seconded to SEHD
  • Ms Anne Lee, Principal Pharmacist, Horizon Scanning, SMC 
  • Dr John McElhinney, General Practitioner, Fife and New Drugs Committee Member 
  • Ms Leanne Oliver, SMC secretariat

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 (03.05.05)

3.1 The minutes of the meeting of 3 May, 2005, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Review of Membership

4.1.1 The SMC Executive team have reviewed nominations from ADTCs and are in the process of recruiting new members.  The Chairman highlighted the importance of rotating membership and thanked those who are leaving the committee for their valued contribution to SMC and for their willingness to remain until new members are in place.

4.2 Experts

4.2.1 Work has been ongoing to develop SMC's process for obtaining expert clinical advice.  It has been agreed that experts will now be known as clinical experts. As a result of the ongoing work to develop a standardised approach to expert clinical advice, it is proposed that a two-stage process be adopted for engaging experts.  On initial acceptance of a submission for assessment, a set of generic questions will be sent to 3-5 clinical experts, identified from the SMC database.  This is designed to engage the experts and confirm their experience in a particular disease area.  A reasonable timeframe will be allowed to complete this stage.  Thereafter, if required, a second set of more detailed questions can be sent to those clinical experts who have committed to providing advice.  The timeframe for this stage of the process will be somewhat shorter.  A flow diagram outlining the proposed new process was tabled for consideration and discussion.  It was agreed that the SMC User Group Forum will be involved in the development of generic questions.  The proposals were accepted and it was agreed that the new process should be piloted for submissions received from this point forward. 

FULL SUBMISSIONS

4.3 vinorelbine oral (Navelbine oral)  Pierre Fabre Ltd  (No: 179/05)

4.3.1 SMC advice for vinorelbine oral (Navelbine oral), for the treatment of non-small-cell lung cancer, will be posted on the SMC website on Monday 13 June, 2005.

4.4 modafinil (Provigil)  Cephalon UK Ltd (No. 183/05)

4.4.1 SMC advice for modafinil (Provigil), for the treatment of excessive sleepiness associated with shift work disorder, will be posted on the SMC website on Monday 13 June, 2005.

RESUBMISSION

4.5 modafinil (Provigil)  Cephalon UK Ltd  (No. 63/03)

4.5.1 SMC advice for modafinil (Provigil), for the treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea, will be posted on the SMC website on Monday 13 June, 2005.
 
ABBREVIATED SUBMISSIONS

4.6 rosiglitazone maleate (AvandiaTriple Therapy)  GlaxoSmithKline  (No: 181/05) 

4.6.1 SMC advice for rosiglitazone maleate (Avandia Triple Therapy), as triple oral therapy in combination with metformin and a sulphonylurea in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapyand where patients are unable or unwilling to take insulin, will be posted on the SMC website on Monday 13 June, 2005.

4.7 ezetimibe/simvastatin (Inegy)  Merck Sharp Dohme - Schering  Plough Ltd  (No. 182/05) 

4.7.1 SMC advice for ezetimibe/simvastatin (Inegy), for the treatment of patients who have failed to achieve target cholesterol levels after titration and optimisation of statin monotherapy and where the combination of ezetimibe 10mg and simvastatin 20mg, 40mg or 80mg is appropriate, will be posted on the SMC website on Monday 13 June, 2005.

DEFERRED SUBMISSION

4.8 Insulin detemir (Levemir) (No: 138/04)

4.8.1 SMC advice for insulin determir (Levemir), for the treatment of children and adolescents with diabetes mellitus, will be posted on the SMC website on Monday 13 June, 2005.

5 Appeals Update

5.1 cinacalcet 30mg, 60mg and 90mg tablets  (Mimpara®) No. (169/05) Amgen

5.1.1 The company has advised of their intention to make a resubmission.

6 PAPIG

6.1 The minutes of the PAPIG meeting held on 3 May, 2005, were reviewed.   Two particular items were noted.

6.1.1 It was reported that NHS QiS have developed a paper entitled 'Refreshing the NHS QiS patient and public partnership  - a reform agenda'.  This is a draft for consultation and PAPIG propose to formulate a response for consideration and approval by SMC.

6.1.2 Patient Interest Group observers are currently unable to attend a meeting of SMC if a medicine of specific interest to the group is on the agenda.  It has now been decided that observers may attend but must leave the room during discussion specific to the drug. 

7 Freedom of Information

7.1 There were no new requests for information to report. It was agreed that in future this item would only be on the agenda when there is information to report.

8 New Drug Committee: Update

8.1 There were no items to report.

9 Chairman's Business

9.1 Orphan Drugs

9.1.1 The Chairman presented a paper to open discussions regarding SMC's handling of orphan drugs.  The issues outlined within the document will be discussed further at the SMC Brainstorming Event on 14 June, 2005.  

9.2 Enzyme Replacement Therapy (ERT)

9.2.1 The Chairman updated members on recent discussions with the Chief Medical Officer (CMO) regarding ERT and proposals to support the development of a procedure for managing the care of patients requiring ERT.  

It was noted that in England and Wales there are plans to organise the assessment and treatment of all patients with metabolic diseases (such as Hurler's syndrome, Gaucher's syndrome, etc.) at one of 6 regional centres.  SMC have received copies of the protocols for management of patients with mucopolysaccharidosis I, and have been asked by the CMO whether application of this approach could be seen as consistent with SMC advice. 

The Chairman requested members consider whether the protocol is based on the cost-effectiveness of treatment, whether it comprises those patients who are likely to gain benefit based on the clinical trials, and whether the 'stopping rules' are sufficiently robust. 

Detailed discussion followed and those present unanimously agreed that this is outwith the remit of SMC, but did not provide a basis for changing the SMC's decision on Laronidase. It was acknowledged that if the opportunity arose for broader UK discussion of orphan drugs the expertise of the group would be useful.

9.3 MSP Seminar - SMC and Access to Medicines - 26 May 2005

9.3.1 The Chairman provided an update regarding the recent MSP Seminar regarding SMC and Access to New Medicines and advised that it was a useful meeting. 

9.4 Unique Drug Definition

9.4.1 A proposal has made for a definition of  'unique' and this will be discussed at the SMC Brainstorming Event on 14 June, 2005.

9.5 reminyl XL  Shire Pharmaceuticals (No.  139/04)

9.5.1 Reminyl XL, for the treatment of mild-to-moderately severe dementia in Alzheimer's disease in patients for whom therapy with galantamine is appropriate, was reviewed by SMC in November 2004, but advice was withheld pending confirmation of launch.  The product has now been launched and advice will be distributed to ADTCs and NHS Boards on Friday 10 June, 2005, and posted on the SMC website on Monday 13 June, 2005.

9.6 SMC Brainstorming Event

9.6.1 The SMC Brainstorming Event will take place on Tuesday 14 June, 2005.  This event will provide an opportunity for open discussion on a variety of issues and is open to both members and observers of SMC and NDC.

10 NDC Assessment Reports ' Full Submissions

10.1 ciclesonide (Alvesco) Altanta Pharmaceuticals Ltd (No: 184/05)

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

10.1.2 The NDC Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  Detailed discussion followed and group agreed that ciclesonide (Alvesco), for the prophylactic treatment of persistent asthma in adults (18 years and older), should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.1.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 June, 2005

10.2 montelukast 10 mg tabs (Singulair) Merck Sharp & Dohme Ltd  (No: 185/05)

10.2.1 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.

10.2.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  Detailed discussion followed and group agreed that montelukast 10 mg tabs (Singulair), for the symptomatic relief of seasonal allergic rhinitis (SAR) in adult patients in whom montelukast is indicated in asthma, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 June, 2005

10.3 pegylated Interferon alfa 2a (Pegasys) Roche (No.: 186/05)

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

10.3.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company.  Detailed discussion followed and group agreed that pegylated Interferon alfa 2a 180 mcg (Pegasys), for the treatment of HBeAg-positive or HBeAg-negative chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, increased ALT and histologically verified liver inflammation and/or fibrosis, should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 June, 2005

10.4 fosamprenavir tablets and oral suspension (Telzir)  GlaxoSmithKline  (No: 188/05)

10.4.1 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.

10.4.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. A member of the PAPIG presented a Patient Interest Group Submission from HIV Scotland.  Detailed discussion followed and group agreed that fosamprenavir 700mg tablets and oral suspension 50mg/ml, for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults in combination with other antiretroviral medicinal products should be accepted for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 June, 2005  

RESUBMISSION

10.5 atomoxetine (Strattera) Eli Lilly & Company Ltd (No:  153/05)

10.5.1 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.

10.5.2 The NDC Lead Assessor provided a detailed overview of the assessment, the draft advice, expert comments and comments received from the company. Detailed discussion followed and group agreed that atomoxetine (Strattera) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children of 6 years and older or in adolescents, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 June, 2005

ABBREVIATED SUBMISSIONS

10.6 aripiprazole tablets 5mg (Abilify) 5mg Bristol Myers Squibb Ltd  (No:  187/05)

10.6.1 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.

10.6.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that aripiprazole tablets 5mg (Abilify), for the treatment of schizophrenia, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.6.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 June, 2005

10.7 transdermal fentanyl (Durogesic D Trans)  patches  Janssen-Cilag Ltd  (No:  189/05)

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

10.7.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that transdermal fentanyl (Durogesic D Trans) patches, for the treatment of chronic intractable pain due to non- malignant conditions, should be accepted for restricted use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.   

10.7.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 10 June, 2005.

11 Forthcoming Submissions
 
11.1 A revised list of forthcoming submissions was reviewed.   The secretariat are in the process of writing to companies who have not made a submission to SMC and will provide a timeframe within which to make a submission, after which a negative recommendation will be issued.

12 ADTC Feedback

12.1 Dr David Morton has retired from Argyll & Clyde and has passed Chairmanship of the ADTC to Dr Ian Matson, Consultant Psychiatrist, Dykebar Hospital.  Dr Morton has expressed his thanks to SMC for the work of the committee which has made his role with responsibility for medicines management much easier.

13 Any Other Business

13.1 SMC User Group Forum

The SMC User Group Forum met on Tuesday 31 May, 2005. Minutes of the meeting will be available for review at the next meeting of SMC.  The following points were highlighted:

13.1.1 Economic Checklist

It was noted that a request has been made from the SMC UGF to make the checklist routinely available.  The Chairman advised that work is ongoing to ensure compatibility between the checklist and the DAD. SMC will consider this request and consider providing to companies at some stage in the future.

13.1.2 Deferral of Review Post NDC/Pre SMC

An Industry member of the SMC User Group Forum presented a paper for review detailing options for deferral of review post-NDC/pre-SMC, SMC recommendation post-launch. It was suggested that a ┬┐step down┬┐ process post NDC would provide patient access to new and innovative therapies and the avoidance of the current inequity that delayed SMC recommendation, post launch may bring. The proposal suggested that following NDC, if negative advice is given and the company identify additional relevant and newly available data which they feel will have an impact on the final decision, they should at this point be given the opportunity to defer the submission going to SMC and thus avoid it going through a resubmission process.  The SMC UGF and most ABPI companies rejected this proposal.

14 Date of Next Meeting

 The date of the next meeting was confirmed as Tuesday 5 July, 2005, at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP. 

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