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SMC Minutes - Tuesday 6 September 2005

Minutes of Meeting held on Tuesday 6 September 2005
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 Barbara Black, Mr Tom Divers, Dr Peter Donnan, Dr John Haughney, Dr David Hood,
Mrs Moira Howie, Dr Jan Jones, Dr Grace Lindsay, Dr Graham Lowe, Dr Chris Lush, Mrs Angela Munday, Mrs Pat Murray, Ms Wendy Nganasurian, Dr Marianne Nicholson, Dr Ken Paterson, Dr Andrew Riley, Dr Philip Rutledge, Mrs Fiona Scott, Dr Sandy Simpson, Ms Helen Tyrrell, Mr Mike Wallace, Dr John Webster

In Attendance: Dr Jennifer Armstrong, Dr Ross Camidge, Ms Sara Davies, Mr Stewart Herring,
Dr John Larkin, Mrs Anne Lee, Professor Angus Mackay, Mr Hector Mackenzie, Mrs Laura McIver,
Mr Patrick Maitland-Cullen, Miss Rosie Murray, Mrs Maureen Stark

Apologies: Dr Corri Black, Professor John Cairns, Mrs Michelle Caldwell, Mr John Glennie, Dr Barclay Goudie, Dr Harpreet Kohli, Mr Chris Nicolson, Mrs Fiona Ramsay, 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 the following who were observing the work of the SMC:

  • Mr Stewart Herring, representing the Bipolar Fellowship Scotland, Patient Interest Group
  • Dr John Larkin, NDC Member ¿ presenting bemiparin sodium (Zibor)

1.3 The following were welcomed as new members of SMC:

  • Mrs Laura Ace, Director of Finance, Dumfries and Galloway NHS Board
  • Dr Grace Lindsay, Reader in Clinical Nursing Research, Glasgow Caledonian University
  • Dr Grahame Lowe, Consultant Dermatologist, Ninewells Hospital and Medical School
  • Mrs Pat Murray, Chief Pharmacist, Lothian Primary Care Organisation

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 (02.08.05)

3.1 The minutes of the meeting of 2 August, 2005, were agreed as an accurate record of the meeting.

4 Matters Arising From the Previous Minutes

4.1 Experts

4.1.1 Work is in progress to review the existing database and to identify areas of clinical specialty which are not represented and move forward with the new process.  A set of generic questions have been presented to APBI who have made some suggestions regarding wording.  These suggestions have been reported to the Expert Working Group and SMC for consideration.  It is anticipated that the new process for consulting experts will be in operation within the next few months.


FULL SUBMISSIONS

4.2 anastrazole (Arimidex) AstraZeneca UK Ltd (No. 198/05)
  
4.2.1 SMC advice for anastrazole (Arimidex), for the adjuvant treatment of postmenopausal women with hormone receptor-positive early invasive breast cancer, will be posted on the SMC website on Monday 12 September 2005.

Following comments from the company post-SMC, it was agreed that the category of advice should be changed to restricted use.  This amendment will be made to the Detailed Advice Document and reissued to NHS Boards and ADTCs on Friday 9 September, 2005.

4.3 duloxetine (Cymbalta) Eli Lilly &Co. Ltd/ Boehringer  Ingelheim (No. 195/05)
                                
4.3.1 SMC advice for duloxetine (Cymbalta) for the treatment of major depressive episodes, will be posted on the SMC website on Monday 12 September, 2005.

4.4 oxycodone hydrochloride (OxyContin) Napp Pharmaceuticals Ltd (No. 197/05)

4.4.1 SMC advice for oxycodone hydrochloride (OxyContin), for the treatment of severe non-malignant pain requiring a strong opioid will be posted on the SMC website on Monday 12 September, 2005.
   
RESUBMISSIONS

4.5 eflornithine 11.5% cream (Vaniqa) Shire Pharmaceuticals (No. 159/04)

4.5.1 SMC advice for eflornithine 11.5% cream (Vaniqa), for the treatment of facial hirsutism in woman, will be posted on the SMC website on Monday 12 September, 2005.

4.6 cilostazol (Pletal) Otsuka Pharmaceuticals  (No. 86/04)
                                           
4.6.1 Distribution of advice for cilostazol (Pletal) for the improvement of the maximal and pain-free walking-distances in patients with intermittent claudication, will be deferred pending discussions with the Scottish Intercollegiate Guidelines Network (SIGN).
 
4.7 pioglitazone (Actos) Takeda  (No. 115/04)
    
4.7.1 SMC advice for pioglitazone (Actos) as monotherapy for type 2 diabetes mellitus patients in whom consideration is otherwise being given to commencing insulin therapy will be posted on the SMC website on Monday 12 September, 2005.

ABBREVIATED SUBMISSION

4.8 brimonidine tartrate/timolol (Combigan) Allergan Ltd (No. 196/05)

4.8.1 SMC advice for, brimonidine tartrate/timolol (Combigan), for the reduction of intra-ocular pressure in patients with chronic open-angle glaucoma or ocular hypertension, will be posted on the SMC website on Monday 12 September, 2005.

5 Appeals Update

5.1 pregabalin (Lyrica), Pfizer,  (No. 157/05) for Peripheral Neuropathic Pain

5.1.1 The Chairman reported that SMC considered a re-submission for pregabalin (Lyrica) in July 2005. A negative recommendation was issued to NHS Boards and ADTCs on 8 July 2005 and was due to be released into the public domain on 8 August 2005.

During July and early August the manufacturer, Pfizer, exchanged correspondence with SMC expressing their unhappiness about two areas of process which in their view SMC had not correctly adhered to.  SMC and Pfizer opened up a dialogue and agreement was reached that Pfizer would take the matter to an Independent Review Panel.

SMC Advice on the re-submission was posted on the Medicines section of the website at close of business on Monday, 15 August 2005.  A press release will be issued via the website on 12 September 2005. 

SMC have indicated their intention to review process documentation to ensure clarity of process for all stakeholders in future.

6. PAPIG

6.1 PAPIG met prior to SMC and a full note of the Minutes will be available for review at the next meeting of SMC. The following items were noted:

6.1.1 Message Board - SMC Website

The SMC website is currently under review and will be redesigned to include a section dedicated to PAPIG.  It was suggested that to involve members of the public not aligned to any patient group, a ¿message board¿ section on the website would be helpful to allow members of the public/patients/carers to respond to particular questions SMC might pose and/or provide information about the medicines they currently use, preferences, needs etc. Members who have experience of this type of system were encouraged to feedback their comments to the PAPIG representatives on SMC.

6.1.2 Refreshing the NHS QiS Patient and Public Partnership - A Reform Agenda

The PAPIG response on behalf of SMC to 'Refreshing the NHS QiS Patient and Public Partnership - A Reform Agenda' was noted.  The Chairman agreed to commend the response from PAPIG on behalf of SMC. It was agreed that bodies outwith SMC may endorse the report if they so wish.

7. New Drugs Committee: Update from Dr Ken Paterson

7.1 SMC User Group Forum (UGF)

Dr Keith Brown, the NDC representative for the SMC UFG is imminently rotating to SMC.  Dr Andy Power has agreed to replace Dr Brown and represent NDC on the group.

7.2 etanercept (Enbrel) for psoriasis: Wyeth

SMC scheduled etanercept (enbrel) for psoriasis for review at their meeting on 1 November, 2005.  However, on further consideration and in view of the proposed timescale for review by SMC and NICE, (publication of SMC Advice due December 2005 and publication of NICE Guidance due January 2006), it was agreed that SMC should not take the submission forward for review.

It was noted that SMC should develop a process to address the NICE programme well in advance to prevent the occurrence of products being reviewed and advice due from SMC and NICE within a similar timeframe.

8. Chairman's Business

8.1 Formalising the Role of the SMC Executive Team

8.1.1 The Chairman requested approval from members for the SMC Executive Team (i.e, Chairman and Vice Chairman of SMC and NDC and Chief Pharmaceutical Advisor) the freedom to work with the secretariat to make important decisions and in a timely manner on behalf of SMC without bringing to the Consortium for review and approval.  Members agreed to this proposal.

8.2 pemetrexed disodium (Alimta)  Eli Lilly & Company  (No: 192/05)

8.2.1 Declarations of interest were recorded in relation to this product/comparator drugs. Members with a personal specific interest left the room for this part of the agenda.

8.2.2 Further to review of pemetrexed disodium (Alimta), for the treatment of chemotherapy-naïve patients with unresectable malignant pleural mesothelioma, in July, 2005, the company, Eli Lilly have requested SMC give further consideration to the merit of unique status for this drug.  Members discussed at length and it was agreed that pemetrexed disodium (Alimta) did not fall within this category. The Chairman however advised that Dr Anna Gregor, Lead Clinician for Cancer in Scotland is supportive of a National Implementation Plan for this drug to ensure it is widely available.  

If was agreed that SMC need to adopt a more formal approach for identifying unique drugs, but it is recognised that they would be considered on a case by case basis.

8.3 Antimicrobial Prescribing Policy and Practice in Scotland ' Recommendations for Good Antimicrobial Practice in Acute Hospitals

8.3.1 The report was launched by the Scottish Executive on Monday 5 September 2005.  This was produced for NHSScotland by the SMC on behalf of the Ministerial HAI Task Force.

8.4 A Scottish Prescription - Managing the Use of Medicines in Hospitals - Audit Scotland July 2005

8.4.1 The report was tabled for review.  The Chairman reported that this is a helpful report which endorses the work of SMC, recommending that SMC should continue to develop its work on estimating the anticipated budget impact of new medicines, so that NHS boards are provided with information on all anticipated costs and cost savings.  NHS boards need this information to estimate the local financial impact of new medicines.

There was also a recommendation that SIGN guidelines, NICE health technology appraisals (HTAs) reviewed by NHS QIS and NHS QIS HTAs that relate to medicines should include an assessment of the budget impact  and cost effectiveness for NHSScotland.

8.5 Round Table Meeting on NICE Technology Assessments

8.5.1 The Chairman is scheduled to attend a round-table meeting, organised by the Health Service Journal, on Thursday 8 September, 2005, regarding NICE and SMC HTAs.  It promises to be a very interesting discussion bringing together leading experts in the field.

The discussion will be a closed event, but the meeting will be recorded and an edited version published as a major article in HSJ. The article will form part of the first of two major supplements HSJ is running on Health Technology Assessments. The first will focus on process and the second on implementation. They will be published on 20 October and 24 of November in time for the NICE conference.

8.6 Representatives from NICE to attend October SMC

8.6.1 Professor David Barnett, Chairman Appraisals Committee, and Ms Carole Longson, Centre Director, NICE have asked if they could observe the October SMC meeting.  This is part of NICE¿s wish to consider re-engineering their current processes to encompass a more rapid appraisal system dealing with new and important technologies close of licensing.  The committee agreed to this request.

8.7 Meeting with the Medical Adviser for the National Specialist Commissioning Advisory Group (NSCAG)

8.7.1 The Chairman is meeting with Edmund Jessop, the Medical Adviser for the National Specialist Commissioning Advisory Group (NSCAG) of the Dept of Health, to discuss enzyme replacement therapies (ERTs). The meeting is scheduled for 3 November, 2005.   Progress will be reported at the December meeting of SMC.

8.8 ABPI Meeting - From Clinical Trials to NHS Adoption - 15 September 2005

8.8.1 Representatives of SMC are attending the above meeting.  Progress will be reported at the next meeting of SMC. 

8.9 Evaluation

8.9.1 A programme for the evaluation of SMC work has been agreed and the work commences in October 2005.  The development of the evaluation programme will principally be progressed through partnership working across the NHS including SEHD, NHS Boards and their ADTCs and NHS QIS.  Externally there will be collaborative working with the pharmaceutical industry and academia.  The evaluation will look at the impact of SMC advice on the use of medicines across the healthcare system and compare SMC budget impact forecasts with the actual use of NHS resources. The work will also support the linking of clinical information with that on medicines use to help monitor the effectiveness of medicines in day to day patient care. A report is expected at the close of 2007.

8.10 Horizon Scanning

8.10.1 The horizon scanning process is now underway and a phased approach will be adopted with work continuing on the first report to be issued to the service by October 2005.  This will be distributed in confidence to all NHS Boards (Directors of Finance and Directors of Pharmaceutical Public Health). Initially this report will focus on forthcoming pressures in cancer therapy (both pipeline products and significant new indications), new medicines with the potential for high impact/high cost in other clinical areas and orphan drugs.  It is planned to consolidate, refine and expand data and process on an ongoing 6-monthly cycle and then to evaluate predictions from initial reports, seek feedback from Health Boards and refine processes accordingly.

Progress will be reported at future meetings.

9 NDC RECOMMENDATION REPORTS
FULL SUBMISSIONS

9.1 diclofenac epolamine (Voltarol Gel Patches 1%)  Novartis  (No 199/05)

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

9.1.2 The SMC Vice Chairman provided a detailed overview of the assessment and the draft advice.  Detailed discussion followed and group concluded their advice regarding diclofenac epolamine (Voltarol Gel Patches 1%), for the local symptomatic treatment of pain in epicondylitis and ankle sprain. Amendments to wording were noted.

9.1.3 SMC advice will be withheld pending confirmation of the launch date for this product

9.2 glyceryl trinitrate 0.4% (Rectogesic Rectal Ointment) ProStrakan Group PLC          
(No: 200/05)

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

9.2.2 The SMC Vice Chairman provided a detailed overview of the assessment, the draft advice and company comments.  Detailed discussion followed and group agreed that glyceryl trinitrate 0.4% (Rectogesic Rectal Ointment), for the relief of pain associated with chronic anal fissure, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.  

9.2.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 September, 2005.

9.3 docetaxel (Taxotere)  Breast Cancer  Sanofi-aventis (No:201/05)     
                                      
9.3.1 Declarations of interest were recorded in relation to this product/comparator drugs.

9.3.2 The NDC Vice Chairman provided a detailed overview of the assessment, the draft advice and company comments.  Detailed discussion followed and group agreed that docetaxel (Taxotere), in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of operable, node-positive breast cancer, 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.  

9.3.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 September, 2005.

9.4 bemiparin sodium  (Zibor)  Amdipharm (Nos 203/204/205/206)

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

9.4.2 bemiparin sodium (Zibor) was reviewed for the following four indications:

  • Prevention of thromboembolic disease in patients undergoing general surgery (No. 203/05)
  • Prevention of thromboembolic disease in patients undergoing orthopaedic surgery (No. 204/05)
  • Prevention of clotting in extracorporeal circuit during haemodialysis (No. 205/05)
  • Treatment of established deep vein thrombosis, with or without pulmonary embolism, during acute phase (No. 206/05)

The NDC Lead Assessor provided a detailed overview of the assessment, the draft advice and company comments.  Detailed discussion followed and group agreed that bemiparin sodium  (Zibor), for all indications listed, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.  

9.4.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 September, 2005.

RESUBMISSIONS

9.5 infliximab (Remicade)  Schering Plough (No: 101/04)

9.5.1 Declarations of interest were recorded in relation to this product/comparator drugs.
                                           
9.5.2 The NDC Vice Chair provided a detailed overview of the assessment, the draft advice and company comments.  A member of PAPIG presented a Patient Interest Group Submission from the National Ankylosing Spondylitis Society which was considered with the initial submission. Detailed discussion followed and group agreed that infliximab (Remicade) for treatment of ankylosing spondylitis, 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.

9.5.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 September, 2005.
  
9.6 anagrelide hydrochloride (Xagrid)  Shire Pharmaceuticals  (No: 163//05) 

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

The NDC Chairman provided a detailed overview of the assessment, the draft advice and company comments. Detailed discussion followed and group agreed that anagrelide hydrochloride (Xagrid), for the reduction of elevated platelet counts in `at risk¿ patients with essential thrombocythaemia who are intolerant of their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy, 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.

The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 September, 2005.

INDEPENDENT REVIEW PANEL (IRP)

9.7 cetuximab (Erbitux)  Merck Pharmaceuticals (No: 155/05)
  
9.7.1 Declarations of interest were recorded in relation to this product/comparator drugs.

The appointed Chairman of the IRP provided a detailed overview of the IRP deliberations and their conclusion. Detailed discussion followed and group agreed that cetuximab (Erbitux), for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy, should not be recommended for use within NHS Scotland. Assessors, in liaison with secretariat, to make appropriate amendments for review by Chairman prior to distribution of advice.

The Chairman of the IRP was thanked for his input and the considered review.
   
ABBREVIATED SUBMISSIONS

9.8 atorvastatin (Liptor)  Pfizer Ltd (No: 202/05)   
                                                          
9.8.1 Declarations of interest were recorded in relation to this product/comparator drugs.

9.8.2 The NDC Chairman provided an overview of the assessment and draft summary of advice.  Discussion followed and the group agreed that atorvastatin (Liptor), as an adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in children aged 10 years and older with primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidaemia when response to diet and other non-pharmacological measures is inadequate, 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.   

9.8.3 The SMC advice will be issued to ADTCs and NHS Boards on Friday 9 September, 2005.

9.9 triptorelin (Decapeptyl SR11.25mg)   Ipsen Ltd (No: 207/05)

9.9.1 No declarations of interest were recorded in relation to this product/comparator drugs.
                                   
9.9.2 The NDC Chairman provided an overview of the assessment, draft summary of advice and company comments.  Discussion followed and the group agreed that triptorelin (Decapeptyl SR11.25mg), for the treatment of endometriosis in patients for whom the use of triptorelin is appropriate and who would benefit from reduced frequency of administration compared with triptorelin 3mg injection every 4 weeks, 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 Forthcoming Submissions

10.1 A revised list of forthcoming submissions was reviewed.

10.2 Non-Submissions

A significant piece of work has been carried out with regards to tracking non- submissions and phased submissions within a defined timeframe have been agreed with some companies.  It is anticipated SMC may be required to issue a small number of negative recommendations to non-submitting companies.  It is expected that when horizon scanning systems are in place there will be a more robust system for managing non-submissions.

11 ADTC Feedback

11.1 Nothing to report.

12 Any Other Business

12.1 SMC User Group Forum

A full note of the meeting will be available for review at the next meeting.  Points of note were as follows:

12.1.1 Economic Check List

Further to a request to make the economic checklist routinely available, although SMC currently have no plans to make this available as part of the routine documentation shared with companies, the request is under review.

12.1.2 Pricing Information

Information detailing how generic drug prices are assessed and validated as part of the SMC review process was discussed.  It was confirmed that the eVADIS data is not in the public domain this issue will be addressed further.

12.2 Relocation Review - NHS QIS

12.2.1 Discussions are ongoing and the needs of SMC will be taken into consideration and relayed to NHS QIS.

12.3 Values

12.3.1 It was suggested that in the spirit of openness and accountability a statement of values on which decisions are made should be drawn up.  The committee agreed to consider this approach.

13 Date of Next Meeting

13.1 The date of the next meeting was confirmed as Tuesday 4 October, 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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