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Minutes of the SMC Meeting - Tuesday 2 September 2008

Minutes of the SMC Meeting held on Tuesday 02 September 2008
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Dr Ken Paterson (Chairman), Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs,
Dr Keith Brown, Professor John Cairns, Mr David Carson, Dr David Crookes, Mr Tom Divers, Dr Jonathan Fox, Ms Susan Goldsmith, Dr Barclay Goudie, Dr Jan Jones, Dr Harpreet Kohli, Dr Chris Lush, Dr Frances Macdonald, Dr Alan MacDonald, Dr John McElhinney, Mr Billy Malcolm, Dr Simon Maxwell, Ms Aileen Muir, Dr Andrew Power, Mr Andrew Powrie-Smith, Dr Nick Reed, Dr Sandy Simpson, Dr Sarah Taylor, Ms Angela Timoney, Mrs Sheila Tunstall-James.

In Attendance: Ms Ailsa Brown, Ms Susan Downie, Mr Stephen Ferguson, Mrs Anne Lee, Ms Rosie Murray, Mrs Maureen Stark, Mrs Catherine Tait, Dr Andrew Walker.

Apologies: Mrs Laura Ace, Mr Colin Brown, Dr Sara Davies, Dr John Gemmill, Dr Grace Lindsay, Mr Colin McAllister, Mrs Laura McIver, Ms Veronica Moffat, Professor Dilip Nathwani, Dr Anthony Ormerod, Ms Alex Robertson, Mr Keith Thompson, 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. 

The Chairman welcomed Ms Janice Watt, NDC member, who was observing the meeting. 

A welcome was also extended to Mrs Catherine Tait, newly appointed SMC Co-ordinator, and Mrs Alison Campbell, NDC Member, who was presenting a submission to SMC.

The Chairman advised SMC that Mrs Laura McIver, SMC Chief Pharmaceutical Advisor was about to begin a period of maternity leave.  Mrs Anne Lee will be acting Chief Pharmaceutical Advisor in her absence. 

Dr Harpreet Kohli, who represented NHS QIS on the Consortium for almost seven years, was attending his last meeting of SMC.  Dr Kohli is to take up a new post as Director of Public Health in NHS Lanarkshire and SMC wished him well.

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 05 August 2008 were agreed as an accurate record.

4.  Matters Arising From the Previous Minutes

4.1  SMC Response to the Evaluation Programme – Key Recommendations

Ms Angela Timoney thanked members for their comments which were incorporated into the final version of the SMC Evaluation Programme, Key Recommendations paper.  It was noted that the recommendations were listed in no order of priority.  The paper will be presented at the SMC conference on 23 September, 2008.

Full Submissions

4.2  icatibant 30mg/3ml solution for subcutaneous injection in pre-filled syringes (Firazyr) No.  (476/08)

4.2.1 The SMC advice for icatibant (Firazyr), for the symptomatic treatment of acute attacks of hereditary angioedema in adults (with C1-esterase-inhibitor deficiency), will be withheld pending confirmation of licence and product availability.

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

4.3.1  The SMC advice for 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, will be posted on the SMC website on Monday, 08 September 2008.

4.4  alemtuzumab, 30mg/ml for concentrate for solution for infusion (MabCampath) (No. 494/08)  

4.4.1  The SMC advice for alemtuzumab (MabCampath for treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate, will be posted on the SMC website on Monday, 08 September 2008.

4.5  micafungin 50 and 100mg powder for solution for infusion (Mycamine) (No. 497/08)

4.5.1  The SMC advice for micafungin (Mycamine): for the treatment of invasive candidiasis in adults, elderly, and children (including neonates; for the treatment of oesophageal candidiasis in adult, elderly, and adolescent (≥16 years of age) patients for whom intravenous therapy is appropriate; for prophylaxis of Candida infection in adults, elderly, and children (including neonates) undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days, will be posted on the SMC website on Monday, 08 September 2008.

4.6  rituximab, 100mg and 500mg concentrate for solution for infusion (MabThera) (No. 493/08)

4.6.1  The SMC advice for rituximab (MabThera), for the treatment of previously untreated patients with stage III to IV follicular lymphoma in combination with chemotherapy, will be posted on the SMC website on Monday, 08 September 2008.

Resubmission

4.7  pemetrexed 500mg vial of powder for solution for intravenous infusion  (Alimta) (No. 342/07)

4.7.1  The SMC advice for pemetrexed (Alimta), for monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology, will be posted on the SMC website on Monday, 08 September 2008.

Abbreviated Submission

4.8  ropinirole 2 mg, 4 mg or 8 mg prolonged-release tablets (Requip XL)  (No. 491/08)

4.8.1  The SMC advice for ropinirole (Requip XL), for the treatment of idiopathic Parkinson’s disease in patients already taking ropinirole immediate release tablets and in whom adequate symptomatic control has been established, will be posted on the SMC website on Monday, 08 September 2008.

Amended Advice

4.9  micafungin 50 and 100mg powder for solution for infusion (Mycamine) (No. 497/08)

The SMC advice for micafungin (Mycamine): for the treatment of invasive candidiasis in adults, elderly, and children (including neonates; for the treatment of oesophageal candidiasis in adult, elderly, and adolescent (≥16 years of age) patients for whom intravenous therapy is appropriate; for prophylaxis of Candida infection in adults, elderly, and children (including neonates) undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days, was issued to NHS Boards on 08 August 2008 however, as a result of comparator comments, a minor amendment has been made to the section entitled “Cost of Relevant Comparators”.  The DAD will be published on the SMC website on Monday 08 September, 2008.

5.  Appeals Update

5.1  Nothing to report

6.  Patient and Public Involvement Group (PAPIG)

6.1  Minutes of the PAPIG Meeting on Tuesday 05 August, 2008

The minutes of the meeting held on Tuesday 05 August, 2008 were noted.

6.2  PAPIG Public Involvement Officer

Mrs Sheila Tunstall James regretfully advised that the SMC business case for 2008/09 would not be able to fully support a bid for a new public involvement officer to support the work of PAPIG.  PAPIG considered it a priority and are therefore looking into other sources of funding from the voluntary sector.  A meeting has been arranged with Voluntary Health Scotland to put together a business plan to achieve alternative funding.  The Chairman commended the Group’s initiative and expressed his hope that SMC will be able to contribute to the total funding costs.

7.  New Drugs Committee: Chairman’s Report

7.1  Procedure for abbreviated submissions for new medicines in children

Mrs Anne Lee, in collaboration with the User Group Forum, has been driving work forward for a new abbreviated submission process which will allow easier consideration of some paediatric medicines.  The new process will be explained in more detail at the next SMC meeting on 07 October, 2008 when the first example will come before the committee.

8.  Chairman’s Business

8.1  SMC Conference: 23 September 2008

Members were reminded that completed registration forms for the conference must be reach the SMC Secretariat by 08 September, 2008.

8.2  Roy Castle Lung Foundation

The Chairman had that morning attended an event hosted by the Roy Castle Lung Foundation in Glasgow City Chambers at which he explained the need for health technology appraisals and how SMC goes about its work.  His presentation received a positive response and provoked further discussion.

8.3  NICE – Single Technology Appraisal (STA) Guidance

NICE issued STA guidance No 153 on 27 August, 2008,  with regards to entecavir recommending it as a possible treatment for people with chronic hepatitis B

SMC published advice in October 2006 advising that entecavir (Baraclude) is accepted for use within NHS Scotland for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation and or fibrosis. Clinical studies have shown that entecavir is more effective than lamivudine in nucleosidenaïve HBeAg positive and negative patients and in lamivudine refractory patients.

There is no material difference between the NICE STA and the SMC recommendation.

NICE issued STA guidance No 154 on 27 August, 2008, with regards to telbivudine. NICE did not recommend for people with chronic hepatitis B. Healthcare professionals should not stop prescribing telbivudine for people who were already taking it when the guidance was issued.These patients should be able to carry on taking telbivudine until they and their healthcare professionals decide that it is the right time to stop treatment.

SMC published advice in February 2008 advising that telbivudine (Sebivo) is accepted for use within NHS Scotland for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation and/or fibrosis. For a number of therapeutic endpoints telbivudine proved to be equivalent or superior to a comparator nucleoside reverse transcriptase inhibitor.

There is a material difference between the NICE STA and the SMC recommendation.

Note NICE STAs have no status in Scotland.

8.4  NICE (Multiple) Technology Appraisal Guidance No 155 – Ranibizumab and Pegaptanib for Age-related Macular Degeneration

SMC noted that NICE has approved the use of Lucentis (ranibizumab) for the treatment of people with wet age-related macular degeneration (AMD) with the drug manufacturer sharing the cost of the treatment.

NICE guidance published on 27 August, 2008 indicates that the first 14 injections of the drug will be paid for by the NHS but the cost of further injections will be met by the drug manufacturer Novartis, following an agreement with the company.

Scotland do not as yet accept such market access schemes as part of a health technology appraisal, however a working group has been established to assess potential schemes.

Advice on this NICE MTA will therefore be provided to NHSScotland by NHS Quality Improvement Scotland in due course. In the meantime NHSScotland should continue to adhere to the SMC advice on ranibizumab (Lucentis) and pegaptanib (Macugen) for age-related macular degeneration.

SMC advice published in June 2007 - Ranibizumab (Lucentis) is accepted for use within NHS Scotland for the treatment of neovascular (wet) age-related macular degeneration (AMD).  Ranibizumab reduces the rate of visual acuity loss and increases visual acuity. It should be stopped if visual acuity falls persistently below 6/60 during treatment.

SMC advice published in August 2006 - Pegaptanib for intravitreal injection (Macugen) is accepted for restricted use within NHS Scotland for the treatment of neovascular (wet) age-related macular degeneration (AMD). It has been shown to reduce the rate of loss of visual acuity in patients with subfoveal neovascular AMD. Pegaptanib should be restricted to patients with visual acuity between 6/12 to 6/60 (inclusive) and should be stopped if visual acuity falls below 6/60 during treatment or where severe visual loss is experienced. The cost effectiveness of pegaptanib in patients who are also receiving photodynamic therapy has, however, not been demonstrated.

9.  NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1  capecitabine (Xeloda)  Roche Products Limited  (No.507/08)

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

9.1.2  The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that capecitabine (Xeloda), for the treatment of metastatic colorectal cancer, should be accepted for use in NHS Scotland.  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, 05 September 2008.

9.2  etonogestrel/ethinyl estradiol vaginal ring (NuvaRing)  Organon Laboratories/ Schering Plough (No. 502/08)

9.2.1  A declaration of interest was 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 updated expert comments, revised data/analyses and comments received from the company were tabled.  Detailed discussion followed and the group concluded their advice for etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), for contraception. 

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

9.3  pegylated liposomal doxorubicin, 2mg/ml concentrate for solution for infusion  (Caelyx)   Schering-Plough  (No.503/08)

9.3.1  Declarations of interests 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-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 patient interest group submissions from Leukaemia CARE  and Myeloma UK.  Detailed discussion followed and the group agreed that pegylated liposomal doxorubicin, 2mg/ml concentrate for solution for infusion (Caelyx), in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant, should not be recommended for use in NHS Scotland.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 September 2008.

9.4  sitagliptin (Januvia)  Merck Sharp and Dohme Limited   (No. 505/08)

9.4.1  Declarations of interests 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 Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that sitagliptin (Januvia), for the treatment of patients with type 2 diabetes mellitus to improve glycaemic control in combination with a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance or in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control, should be accepted for use in NHS Scotland.  Assessors in liaison with the Secretariat, 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 NHS Boards and ADTCs on Friday, 05 September 2008.

9.5  fosaprepitant  dimeglumine (Ivemend)  Merck Sharp and Dohme Limited (No. 506/08)

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

9.5.2  The NDC Chair provided an overview of the assessment, draft advice, expert comments and revised data/analyses   Detailed discussion followed and the group agreed that fosaprepitant  dimeglumine (Ivemend), for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy, should be accepted for restricted use in NHS Scotland.  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, 05 September 2008.

RESUBMISSIONS

9.6  maraviroc (Celsentri)  Pfizer Ltd   (No. 458/08)  

9.6.1  Declarations of interests were recorded in relation to this product/comparator drugs.

9.6.2  The NDC Vice-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 HIV Scotland.  Detailed discussion followed and the group agreed that maraviroc (Celsentri),  in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable, should not be recommended for use in NHS Scotland.  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, 05 September 2008.

9.7  dexrazoxane (Savene)  TopoTarget A/S  (No: 361/07)

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

9.7.2 The NDC Vice-Chair provided an overview of the assessment, draft advice, expert comments, tabled expert comments and comments received from the company A member of PAPIG presented a patient interest group submission from Myeloma UK.  Detailed discussion followed and the group agreed that dexrazoxane (Savene), for the treatment of anthracycline extravasation, should not be recommended for use in NHS Scotland. 

9.7.3  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 September 2008.

ABBREVIATED SUBMISSIONS

9.8  salbutamol sulphate (Salbulin MDPI Novoliser)  Meda Pharmaceuticals Ltd  (No.504/08) 

9.8 1  There were no declarations of interest recorded in relation to this product/comparator drugs.

9.8.2  The NDC Chair provided an overview of the assessment and a draft summary of advice.  Discussion followed and the group agreed that salbutamol sulphate (Salbulin MDPI Novoliser),  for the treatment in patients with reversible airways obstruction such as asthma for relief and prevention of asthma symptoms,  should be accepted for use in NHS Scotland.  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, 05 September 2008.

9.9  insulin lispro (Humalog Kwik Pen)  Lilly UK  (No.508/08)    

9.9.1  A declaration of interest was recorded in relation to this product/comparator drugs. A member with a personal specific interest did not contribute to the meeting.

9.9.2  The NDC Chair provided an overview of the assessment and a draft summary of advice.  Discussion followed and the group concluded their advice for insulin lispro (Humalog Kwik Pen), for the treatment of adults and children with diabetes mellitus who require insulin for maintenance of normal glucose homeostatsis, and for the initial stabilisation of diabetes mellitus.

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

9.10  insulin lispro (Humalog Mix 25, Mix 50 Kwik Pen)  Lilly UK  (No.509/08)

9.10.1  A declaration of interest was recorded in relation to this product/comparator drugs.   A member with a personal specific interest did not contribute to the meeting.

9.10.2  The NDC Chair provided an overview of the assessment and a draft summary of advice. Discussion followed and the group concluded their advice for insulin lispro (Humalog Mix 25, Mix 50 Kwik Pen), for the treatment of patients with diabetes mellitus who require insulin for maintenance of normal glucose homeostasis.

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

NON SUBMISSIONS

9.11  cinacalcet (Mimpara)  Amgen Ltd (No. 513/08)

9.11.1  In the absence of a submission from the holder of the marketing authorisation, cinacalcet (Mimpara), for the reduction of hypercalcaemia in patients with primary hyperparathyroidism (HPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels (as defined by relevant treatment guidelines), but in whom parathyroidectomy is not clinically appropriate or is contraindicated, should not be recommended for use within NHS Scotland.

9.11.2  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 September  2008.

9.12  duloxetine (Cymbalta) Eli Lilly and Company Limited (No. 514/08)

9.12.1  In the absence of a submission from the holder of the marketing authorisation, duloxetine (Cymbalta), for the treatment of generalised anxiety disorder, should not be recommended for use within NHS Scotland.

9.12.2  The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 September  2008.

10.  Forthcoming Submissions

10.1  A list of forthcoming submissions was tabled and noted.

11.  SMC User Group Forum (UGF)

11.1  Minutes of the SMC User Group Forum on Tuesday 29 July , 2008

The minutes of the meeting held on Tuesday 29 July, 2008 were noted.

11.2  Forward Look Report No 4

It was noted that pharmaceutical companies have been working with SMC to produce Forward Look Report No 4, which will be issued in October, 2008.

11.3  Lookback Exercise

A lookback exercise to compare the predicted uptake of new medicines featured in the Forward Look with the actual uptake once the product has been accepted by SMC, will be undertaken and will link in with the next phase of the SMC Evaluation Programme.

11.4  ABPI/ Office of Health Economics (OHE) Review of SMC Recommendation Rates

Further to the minutes of the previous SMC meeting Dr Frances MacDonald advised that a full ABPI report on SMC’s recommendation rates over time will be presented to the User Group Forum in October.

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

12.1  Melatonin  (Circadin) – Lundbeck

Dr David Crookes referred to recent MHRA advice to clinicians, pharmacists and procurement staff on the prescribing of melatonin.  The licensed modified release melatonin product, Circadin ® became available in the UK in June 2008.  Before June 2008, melatonin was only available in the UK in unlicensed medicinal products, many of which were imported and of a non-pharmaceutical grade.

The Chairman explained that as the manufacturer of melatonin tablets (Lundbeck) has not made a submission to SMC, we are unable to advise NHS Scotland on its clinical and cost-effectiveness. We have therefore advised that its use within the licensed indication is not recommended.  Dr Crookes highlighted that NHS Lothian has an existing protocol for off-label use of melatonin for children.  The MHRA advice means that when clinicians are prescribing off label they are almost duty bound to use the licensed product which SMC has not recommended. 

The MHRA have issued specific advice in relation to melatonin which restates that the licensed product should be used where possible and makes clear that off-label use of the new melatonin is preferred to use of the unlicensed product. SMC endorses the MHRA position on this.

13.  Any Other Business

No other business was noted.

14.  Date of the Next Meeting

14.1  The date of the next meeting was confirmed as Tuesday, 07 October 2008 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP