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SMC Minutes - Tuesday 4th July 2006

NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow G1 2NP

Present: Dr Ken Paterson (Vice Chairman); Professor James Barbour; Dr Keith Beard; Mrs Marion Bennie;
Mrs Barbara Black; Mrs Michelle Caldwell; Dr David Crookes; Mr Jim Eadie; Dr Barclay Goudie; Dr John Haughney;  Dr Jan Jones; Dr Chris Lush;  Mrs Pat Murray;  Ms Wendy Nganasurian; Dr Andrew Power; Ms Fiona Ramsay;  Dr Nick Reed; Dr Philip Rutledge; Dr Alexander Simpson;  Mr Derek Yuille.

In Attendance: Ms A Campbell; Dr Sara Davies; Mr Stephen Ferguson; Ms Fiona Halcrow;  Mrs Hazel Illingworth; Mr Colin McAllister; Mrs Laura McIver; Ms Aileen Muir; Ms Corinne O’Dowd; Mrs Maureen Stark; Dr Andrew Walker.

Apologies: Professor David Webb (Chairman); Ms Laura Ace; Dr Jennifer Armstrong; Ms Rosaleen Beattie;  Dr Keith Brown; Mr Nick Brown; Professor John Cairns; Ms Carol Davidson; Mr Tom Divers; Dr Peter Donnan;; Mr John Glennie; Dr Harpreet Kohli; Mrs Anne Lee; Dr Grace Lindsay; Dr Graham Lowe;  Professor Angus McKay; Ms Angela Munday; Miss Rosie Murray;  Dr Andrew Riley; Dr Sarah Taylor; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Dr John Webster.

1 Welcome and Apologies for Absence

1.1  Dr Paterson, Vice Chairman, welcomed members to the meeting and apologies for absence were noted. 

The Vice Chairman welcomed:

  • Mr Stephen Ferguson, Communications Officer, NHS QIS, who will be assisting Colin McAllister with SMC Media handling and communication issues.
  • Ms Colette Kerr, Senior Prescribing Advisor, NHS Ayrshire & Arran who was observing the work of SMC.
  • Ms Fiona Halcrow who was representing Nick Brown who was unable to attend the meeting.

The Vice Chairman also thanked Ms Carol Davidson in her absence, for her support and contribution to SMC in representing Dr Andrew Riley for the last six months.

2 Declarations of Interest

2.1  The Vice 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 6 June 2006 were agreed as an accurate record.

4   Matters Arising From the Previous Minutes

 SMC Budget

The Vice Chairman was pleased to announce that the SMC Budget had been finalised and all aspects had been approved.


Full Submissions

4.1  tigecycline (Tygacil) cSSSI Wyeth (No 276/06)

4.1.1  The SMC advice for tigecycline (Tygacil), for the treatment of complicated skin and soft-tissue infections will be posted on the SMC website on Monday 10 July 2006.

4.2  tigecycline (Tygacil) cIAI Wyeth (No 277/06)

4.2.1 The SMC advice for tigecycline (Tygacil), for the treatment of complicated intra-abdominal infection, will be posted on the SMC website on Monday 10 July 2006.

4.3  trastuzumab (Herceptin) Roche (No 278/06)

4.3.1 The SMC advice for trastuzumab (Herceptin), for the treatment of patients with HER-2 positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable), was posted on the SMC website on Friday 9 June 2006.

4.4  cetuximab (Erbitux) Merck KGaA (No 279/06)

4.4.1 The SMC advice for cetuximab (Erbitux), in combination with radiation therapy, for the treatment of patients with locally advanced squamous cell cancer of the head and neck will be posted on the SMC website on Monday 10 July 2006.


Abbreviated Submissions

4.5  clobetasol propionate 0.05% foam (Clarelux) 3M Health Care Ltd  (No. 280/06)

4.5.1  The SMC advice for clobetasol propionate 0.05% foam (Clarelux) for the short course treatment of steroid-responsive dermatoses of the scalp such as psoriasis, which do not respond satisfactorily to less active steroids will be posted on the SMC website on Monday 10 July 2006.

4.6  rosiglitazone maleate/metformin hydrochloride (Avandamet) triple therapy GlaxoSmithKline (No 281/06) 

4.6.1  The SMC advice for rosiglitazone maleate/metformin hydrochloride (Avandamet), for the treatment of type 2 diabetes mellitus in triple oral therapy with sulphonylurea in patients with insufficient glycaemic control despite dual oral therapy with their maximally tolerated dose of metformin and a sulphonylurea, will be posted on the SMC website on Monday 10 July 2006.

4.7  desmopressin (DesmoMelt) Ferring Pharmaceuticals Ltd. (No 282/06)

4.7.1 The SMC advice for desmopressin (DesmoMelt) for the treatment of primary nocturnal enuresis in patients from the age of 5 years up to 65 years will be posted on the SMC website on Monday 10 July 2006.

4.8  dinoprostone (Propess) Ferring Pharmaceuticals (No 283/06)

4.8.1 The SMC advice for dinoprostone (Propess) for the initiation of cervical ripening in patients at term (from 38th week of gestation), will be posted on the SMC website on Monday 10 July 2006.

4.9  testosterone (Testim) 50mg Gel Ipsen Ltd No 284/06)

4.9.1 The SMC advice for testosterone (Testim) 50mg Gel replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests will be posted on the website on Monday 10 July 2006.

Submissions Deferred Pending Launch

4.10 beclometasone dispropionate (Clenil Modulite) Abbreviated (No 177/05)

SMC reviewed a submission for beclometasone dispropionate (Clenil Modulite) for the prophylactic management of mild moderate or severe asthma in adults or children in April 2005, but SMC advice was withheld pending confirmation of product launch.  SMC advice will be distributed to NHSScotland on Friday 07 July and posted on the SMC website on Monday 07 August 2006.

5 Appeals Update

Nothing to report.

6 PAPIG

Nothing to Report.

7 New Drugs Committee: Chairman’s report

7.1 Deferral of Submissions in absence of relevant information

The Vice Chairman advised that at the last meeting of NDC a product was presented for review where the company failed to provide copies of the clinical study reports which were used to produce the submission.  As this information was necessary to enable the assessment team to verify the information contained within the submission to confirm the efficacy and effectiveness of the product, the NDC were unable to progress the review.  The product has therefore been deferred pending receipt of all relevant information and if this is not received within a specified timeframe a “Not Recommended” statement will be issued.  It was noted that if a future incident should occur the review will automatically be deferred pending receipt of necessary information.

8 Chairman’s Business

8.1 Annual Report

The Vice Chairman advised that the Annual Report, 2005 has now been published and was distributed to all members with SMC paperwork.  A PDF copy is available on the SMC website and additional hard copies are available from the secretariat on request.

8.2 Health Committee Meeting – 20 June 2006

The Vice Chairman advised that Professor Webb represented SMC at a Health Committee enquiry on 20 June 2006 into new medicines. Representatives from NHS Quality Improvement Scotland (NHSQIS), Medicines and Healthcare Products Regulatory Agency (MHRA), Royal College of General Practitioners (RCGP), Association of the British Pharmaceutical Industry (ABPI) and 2 Health Boards were also present.  A link to the transcript of the enquiry has been circulated to members for information.

8.3 Glivec 800 mg (CML and GIST) Novartis

The Vice Chairman advised that following a licence variation for dose escalation to 800mg/day in Glivec 800 mg (CML and GIST) there has been a modification to the wording within the SPC to note that higher doses may be used in some patients who are not experiencing toxicity.  The cost-effectiveness at higher doses has not been assessed and is likely to be less than at lower doses, however SMC have advised Novartis that a submission is not necessary for this licence variation.  ADTCs and NHS Boards will be advised accordingly.

8.4 Proposal by the Chief Medical Officer – Preliminary Research on Patient Safety

The Vice Chairman advised that the Chief Medical Officer (CMO), in discussions with Professor Webb, had asked if SMC would consider becoming involved in a preliminary proposal regarding patient safety in relation to drug administration and prescribing. Whilst accepting that the proposal would widen SMC’s role and remit it was acknowledged that SMC, as a consortium of ADTCs, would perhaps be best placed to facilitate networking and exchanges of information/good practice between ADTCs in relation to patient safety.  The SMC Chairman will pursue the matter further with the CMO.

8.5 docetaxel concentrate and solvent for solution for infusion, single dose vials (Taxotere) No. (209/05)

SMC issued Advice for docetaxel (Taxotere) in November 2005 advising that Docetaxel (Taxotere) in combination with prednisolone is not recommended for use within NHS Scotland for the treatment of patients with metastatic hormone refractory prostate cancer (mHRPC). Overall, docetaxel offers an improvement in median survival of 2.4 months, improved pain control, greater reduction in PSA levels and improved quality of life compared with the current standard chemotherapy regimen. However, the cost effectiveness of docetaxel for mHRPC has not been demonstrated.

The Vice Chairman explained that following an MTA the National Institute for Health and Clinical Excellence (NICE) issued guidance on 28 June2006 to the NHS in England and Wales recommending the use of docetaxel as a treatment option for men with prostate cancer that has spread to other parts of their body and is no longer responding to treatment with hormonal therapies (known as hormone-refractory metastatic prostate cancer).

Therefore, NICE guidance supersedes SMC advice.

9 NDC ASSESSMENT REPORTS

 The Vice Chairman advised that the Chairman of the Independent Review Panel (IRP) was unable to attend the meeting, and had submitted his apologies.

INDEPENDENT REVIEW PANEL

9.1  pregabalin (Lyrica)  Pfizer  (No. 157/05)  

9.1.1  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.

9.1.2  A member of the IRP provided a detailed overview of the IRP deliberations and their conclusion.  Discussion followed and the group agreed that pregabalin (Lyrica) for the treatment of peripheral neuropathic pain should not be recommended for use within the 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 Chairman of the IRP conveyed his thanks to the Panel Members, Assessors and to the Secretariat for their excellent support. The Chairman of the IRP was thanked for his input and the considered review.

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

9.1.5  SMC agreed to a proposal that all testimonials supplied by a manufacturer as part of a submission, re-submission or IRP should in future, be accompanied by a declaration of interest from the provider of the testimonial, otherwise SMC will decline to consider such testimonials.

 

FULL SUBMISSIONS

9.2  duloxetine (Cymbalta) DPNP Eli Lilly and Company Ltd (No 285/06)

9.2.1  A declaration of interest was recorded in relation to this product/comparator drugs. A member with a personal specific interest left the meeting for this part of the agenda.

9.2.2  The Vice Chairman advised that since the submission and NDC assessment of duloxetine (Cymbalta) had been undertaken there had been a very significant drop in the pricing of a generic comparator product.  The reduction in price rendered the manufacturers economic case for duloxetine (Cymbalta) ‘not proven’.  It was agreed that the submission would be deferred until the August meeting of SMC in order to give the manufacturer time to review and revise their economic case.

 

Economists’ views on including treatment costs in life-years saved – A Discussion Note

The NDC Vice Chairman referred to the above tabled paper for consideration and discussion as the following submissions either contained or did not contain associated treatment/social costs in the economic model.  It was considered important that all submissions were considered on a consistent basis in respect of associated treatment costs such as dialysis.

Following discussion it was agreed that Companies would be asked to provide the economic case both with and without associated treatment/social costs to allow the process to be transparent.

The Vice Chairman advised that these are considered exceptional circumstances and in future any submissions that fall into this category would be dealt with case by case.

9.3  lanthanum carbonate (Fosrenol) Shire Pharmaceuticals Contract Ltd (No 286/06)

9.3.1 There were no declarations of interest in relation to this product/comparator drugs

9.3.2 The NDC 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 the National Kidney Federation (UK). Detailed discussion followed and the group concluded their advice for lanthanum carbonate (Fosrenol) for the treatment of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

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

9.4 fondaparinux sodium (Arixtra) VTE abdominal surgery GlaxoSmithKline (No 287/06)

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

9.4.2 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 fondaparinux sodium (Arixtra), for the prevention of venous thromboembolic events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, should not be recommended for use within 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 ADTCs and NHS Boards on Friday 7 July 2006.

9.5 paricalcitol (Zemplar) Abbott (No 288/06)

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

9.5.2 The NDC Vice Chairman 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 paricalcitol (Zemplar), for the prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure undergoing haemodialysis, should not be recommended for use within 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 ADTCs and NHS Boards on Friday 7 July 2006.

9.6  rotigotine (NEUPRO) Schwarz Pharma (No 289/06)

9.6.1 A declaration of interest was recorded in relation to this product/comparator drugs. A member with a personal specific interest left the meeting for this part of the agenda.

9.6.2 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 rotigotine (NEUPRO), for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e.without levodopa), should not be recommended for use within 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 ADTCs and NHS Boards on Friday 7 July 2006.

9.7  pegaptanib sodium (Macugen) Pfizer Ltd (No 290/06)

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

9.7.2 The NDC Lead Assessor provided an overview of the assessment and the draft advice, expert comments and comments received from the company. Detailed discussion followed and the group agreed that pegaptanib sodium (Macugen), for the treatment of neovascular (wet) age-related macular degeneration (AMD), should be accepted for restricted use within NHS Scotland.  Assessors, in liaison with the secretariat, to make the appropriate amendments for review by the Chairman prior to distribution of the advice.

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

 

ABBREVIATED SUBMISSIONS

9.8 ertapenem sodium (Invanz) paediatric Merck Sharp & Dohme (No.291/06)

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

9.8.2 The NDC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that ertapenem sodium (Invanz) paediatric for the treatment of intra-abdominal infections, should be accepted for restricted use within 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 ADTCs and NHS Boards on Friday 7 July 2006.

9.9 salmeterol (Serevent Evohaler) GlaxoSmithKline (No.292/06)

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

9.9.2 The NDC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that salmeterol (Serevent Evohaler) for the regular symptomatic treatment of reversible airways obstruction in patients with asthma, including those with nocturnal asthma or chronic obstructive pulmonary disease (COPD), and the prevention of exercise-induced asthma, should be accepted for use within NHS Scotland. Assessors, in liaison with the secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

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

9.10 dorzolamide hydrochloride timolol maleate (COSOPT) Merck Sharp & Dohme (No.293/06)

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

9.10.2 The NDC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group concluded their advice for dorzolamide hydrochloride timolol maleate (COSOPT) for the treatment of elevated intra-ocular pressure (IOP) in patients with open-angle glaucoma or pseudo-exfoliative glaucoma when topical beta-blocker monotherapy is not sufficient.

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

9.11 travoprost/timolol (DUOTRAV) Alcon Laboratories (UK) Ltd (No.294/06)

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

9.11.2 The NDC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that travoprost/timolol (DUOTRAV) for decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers or prostaglandin analogues, should be accepted for use within NHS Scotland. Assessors, in liaison with the secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

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

9.12 100mg/losartan potassium/12.5mg hydrochlorothiazide (Cozaar-Comp 100/12.5) Merck, Sharp & Dohme Ltd  (No: 295/06) 

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

9.12.2 The NDC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group concluded their advice for 100mg/losartan potassium/12.5mg hydrochlorothiazide (Cozaar-Comp 100/12.5) for the treatment of hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy.

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

9.13 100mg/losartan potassium/25mg hydrochlorothiazide (Cozaar-Comp 100/25)  Merck, Sharp & Dohme Ltd  (No: 296/06) 

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

9.13.2 The NDC Vice Chairman provided an overview of the assessment and the draft summary of advice. Discussion followed and the group agreed that 100mg/losartan potassium/25mg hydrochlorothiazide (Cozaar-Comp 100/25) for the treatment of essential hypertension in patients, whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy, should be accepted for use within NHS Scotland.  Assessors, in liaison with the secretariat, to make appropriate amendments for review by the Chairman prior to presentation to the SMC meeting.

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

NON-SUBMISSIONS

9.14 testosterone (Nebido) 1000mg/4ml, solution for injection Schering Health Care Ltd (No 308/06)

9.14.1 In the absence of a submission from the holder of the marketing authorisation, testosterone (Nedido) is not recommended for use within NHS Scotland for the treatment of male hypogonadism when testosterone deficiency had been confirmed by clinical features and biochemical tests.

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

 

9.15 carbetocin (Pabal) Ferring Pharmaceuticals Ltd (No 309/06)

9.15.1 In the absence of a submission from the holder of the marketing authorisation, carbetocin (Pabal) is not recommended for use within NHS Scotland for the prevention of uterine atony and excessive bleeding following delivery of the infant by Caesarean section under epidural or spinal anaesthesia.

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

9.16 rivastigmine (Exelon) Novartis (No 310/06)

9.16.1 In the absence of a submission from the holder of the marketing authorisation, rivastigmine (Exelon) is not recommended for use within NHS Scotland for the treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease.

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

10. SMC Evaluation

Nothing to report.

11. SMC User Group Forum

A copy of the minutes of the meeting held on 30 May 2006 was noted.

12. Forthcoming Submissions

12.1 A list of forthcoming submissions was noted.

13 ADTC Feedback

Nothing to report.

14 Any Other Business

14.1 A member referred to the amount of paper generated by SMC each month and asked if the use of a secure website where documents could be accessed was something that could be considered, various views were expressed and it was agreed that this would be investigated further and suggestions would be brought to a future meeting of SMC.

15 Date of the Next Meeting

15.1 The date of the next meeting was confirmed as Tuesday, 1 August 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.