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SMC Minutes Tuesday 11 January 2011

Minutes of the SMC Meeting
held on Tuesday 11 January 2011
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present:
Professor Ken Paterson (Chairman), Mrs Laura Ace, Mrs Sandra Auld, Professor James Barbour, Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Dr Jennifer Burns, Professor Scott Bryson, Mr Robert Calderwood, Mr Dave Carson, Dr Dominic Culligan, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie Dr Jacqui Howes, Dr Jan Jones, Professor Stephen Lawrie, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Dr James McLay, Dr Paul McNamee, Mrs Sandra McNaughton, Dr Simon Maxwell, Mrs Veronica Moffat, Ms Aileen Muir, Dr Anthony Ormerod, Dr Mercia Page, Dr Robert Peel, Dr Andrew Power, Mr Michael Pratt, Mr Keith Thompson, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor David Wray

In Attendance:
Mrs Corinne Booth, Mrs Jill Booth, Ms Ailsa Brown, Mrs Alison Campbell, Mrs Susan Downie, Mr Stephen Ferguson, Mrs Anne Lee, Ms Marie McHenery, Ms Rosie Murray, Ms Jane Pearson, Ms Alex Robertson, Mrs Maureen Stark

Apologies:
Mr Colin Brown, Dr Sara Davies, Dr David Dunlop, Professor Dilip Nathwani, Dr Brian Robson, Mrs Catherine Tait, Dr Sarah Taylor

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 Professor Stephen Lawrie, Professor of Psychiatry and Neuroimaging, University of Edinburgh, who was attending his first meeting as a member, and to the following NDC members/Lead Assessors,  who were presenting submissions to SMC:

• Mrs Alison Campbell
• Ms Jane Pearson

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 (14 December 2010)

3.1 The minutes of the SMC meeting held on 14 December 2010 were accepted as an accurate record of the meeting.

4. Matters Arising

Due to severe weather conditions and difficulties with travel, the SMC’s scheduled meeting on 07 December was cancelled and an Extraordinary meeting arranged for Tuesday 14 December 2010.  Whilst a smaller number of members than usual attended the Extraordinary meeting, all key sectors of the SMC membership were represented and standard review processes were followed.  However, it was agreed that the decisions made at the Extraordinary meeting should be ratified by the full Consortium on 11 January 2011 to confirm that the decisions made at the Extraordinary meeting were robust.

Full Submissions for ratification, following the Extraordinary Meeting of SMC on 14 December 2010.

4.1 valganciclovir, 450mg tablets, 50mg/ml powder for oral solution (Valcyte®) Roche Products Ltd  SMC No. (662/10)

4.1.1 The advice for valganciclovir, (Valcyte®), for prevention of cytomegalovirus (CMV) disease in CMV negative patients who have received a solid organ transplant from a CMV positive donor, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.2 fentanyl 100microgram/dose and 400microgram/dose nasal spray solution (PecFent®)Archimedes Pharma     SMC No. (663/10)

4.2.1 The advice for fentanyl (PecFent®), for management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.3 erlotinib, 25, 100 and 150mg film-coated tablets (Tarceva®)  Roche SMC No. (664/10)

4.3.1 The advice for erlotinib (Tarceva®), as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with stable disease after 4 cycles of standard platinum-based first-line chemotherapy, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.4 histamine dihydrochloride, 500 microgram/0.5ml, vial (Ceplene®)  Meda Pharmaceuticals Ltd  SMC No. (666/10)

4.4.1 The advice for histamine dihydrochloride (Ceplene®), for maintenance therapy for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.5 prilocaine hydrochloride 2% hyperbaric solution for injection (Prilotekal®)  Goldshield Group  SMC No. (665/10)

4.5.1 The advice for prilocaine hydrochloride (Prilotekal®), for spinal anaesthesia, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

Resubmissions for ratification, following the Extraordinary Meeting of SMC on 14 December 2010

4.6 sorafenib 200mg film-coated tablets (Nexavar®) Bayer Schering Pharma  SMC No. (482/08)

4.6.1 The advice for sorafenib (Nexavar®), for the treatment of hepatocellular carcinoma, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.7 ferric carboxymaltose 50mg iron/mL solution for injection/infusion (Ferinject®)   Vifor Pharmaceuticals SMC No. (463/08)

4.7.1 The advice for ferric carboxymaltose (Ferinject), for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.8 degarelix 120mg and 80mg powder and solvent for solution for injection (Firmagon®) Ferring Pharmaceuticals Ltd SMC No. (560/09)

4.8.1 The advice for degarelix (Firmagon®), for the treatment of adult male patients with advanced hormone-dependent prostate cancer, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

Abbreviated Submissions, following the Extraordinary Meeting of SMC on 14 December 2010

4.9 valsartan 40, 80, 160, 320mg tablets (Diovan®) Novartis Pharmaceuticals UK Ltd (No: 649/10)

4.9.1 The advice for valsartan (Diovan®), for the treatment of hypertension in children and adolescents 6 to 18 years of age, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.10 levetiracetam 100mg/ml oral solution (Keppra®) UCB Pharma Ltd  (No: 661/10)

4.10.1 The advice for levetiracetam (Keppra®), for adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in children and infants from 1 month of age to 4 years with epilepsy, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

Non-Submissions for ratification following the Extraordinary Meeting of SMC on 14 December 2010

4.11 botulinum toxin type A (Azzalure ®) Galderma   (No: 679/11)

4.11.1 The advice for botulinum toxin type A (Azzalure ®), for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical “frown” lines between the eyebrows) in adult patients under 65 years and younger, when the severity of these lines has an important psychological impact on the patient, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.12 botulinum toxin Type A (Vistabel ®) Allergan  (No: 680/11)

4.12.1 The advice for botulinum toxin Type A (Vistabel ®), for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical “frown” lines between the eyebrows) in adult patients under 65 years and younger, when the severity of these lines has an important psychological impact on the patient, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

4.13 velaglucerase (Vpriv ®) Shire Pharmaceuticals (No: 681/11)

4.13.1 The advice for velaglucerase (Vpriv ®), for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease, was ratified by SMC and will be published on the SMC website on Monday, 17 January 2011.

Deferred Advice

4.9 Nothing to report.

Amended Advice

4.10 SMC advice for dronedarone (Multaq) SMC No. 636/10

SMC published advice for dronedarone (Multaq), in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate, in September 2010.

The original wording within the advice box was noted to be ambiguous and has caused some confusion therefore the wording of the restriction has been modified to provide greater clarity and reflect in more detail the original decision made by SMC, however the SMC advice remains unchanged. The SMC website will be updated to reflect the change to the Detailed Advice Document.

4.11 How can the NHS in Scotland get the best value from medicines?

Professor Barbour suggested that in the current economic climate a robust, transparent, decision process is urgently needed to ensure that the NHS gets the best value from opportunistic discounts and follow-on PAS. He proposed to provide a discussion paper on how SMC, PASAG and National Services Scotland (NSS) could work collaboratively to ensure that value is maximised across the NHS in Scotland.

5. Appeals Update

5.1 trabectedin, 0.25 and 1mg powder for concentrate for solution for infusion (Yondelis®)  SMC No. (452/08) Pharma Mar S.A. Sociedad Unipersonal

SMC did not recommend trabectedin, (Yondelis) in October 2010, for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Pharma Mar S.A Sociedad Unipersonal have advised their intention to resubmit. 

5.2 icatibant (Firazyr) Shire Pharmaceuticals (No. 476/08)

SMC did not recommend icatibant (Firazyr) in October 2008, for the symptomatic treatment of acute attacks of hereditary angioedema in adults with C1-esterase inhibitor deficiency. Shire Pharmaceuticals has advised their intention to resubmit.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the  PAPIG Meeting (14 December 2010)

The minutes of the PAPIG Meeting held on 14 December 2010 were tabled and noted.

6.2 Recruitment  for Public Partners

Interviews for new Public Partners will take place on 13th January 2011.

Interviews for new Public Partners will take place on 13th January 2011.
 
7. New Drugs Committee (NDC): Chairman’s Report

7.1 Chairman designate of the New Drugs Committee

Dr Jonathan Fox, Chairman designate of the New Drugs Committee, is currently shadowing Dr Jan Jones in preparation for taking the Chair from February 2011.

8. Chairman’s Business

8.1 SMC Chairman

Following standard process, the SMC Executive has considered all nominations for the SMC Chairman designate and with the support of SMC would like to propose Angela Timoney as Chairman Designate.  Endorsement will be sought from the Chief Medical Officer (CMO)/NHS Chief Executive Officers (CEO) Group and a formal appointment made by the CMO.  It is expected that Professor Paterson will chair his last meeting of SMC in April 2011.

8.2 Oral Mesalazine Products

SMC is aware that new branded versions of oral mesalazine are being launched in the UK, with variable presentations, strengths and costs.  In addition, for existing mesalazine products, a number of minor changes to the SPC are pending in respect of dosing, formulation etc. Having reviewed the potential submission requirements, SMC questioned the efficiency of assessing a number of individual submissions in the context of the value to the service.

After consultation with Formulary Pharmacists in NHS Scotland and the approval of the SMC committee, it has therefore been agreed that SMC will not carry out assessments on these mesalazine products and label changes. NHS Boards should review the available product range and make decisions locally to meet Formulary requirements. Health Boards are asked to contact the SMC secretariat if they identify a situation where SMC advice is considered necessary.

This statement will be shared with pharmaceutical companies who intend to make submissions to SMC for mesalazine products.

8.3 NICE Single Technology Appraisal Guidance No 211 - Prucalopride for the treatment of chronic constipation in women, published on 15 December, 2010
 

NICE recommends prucalopride as a possible treatment for women with chronic constipation.

SMC published a Statement of Advice (653/10) on this medication for this indication in December 2010. It stated that: Prucalopride (Resolor) is not recommended for use within NHS Scotland. The license holder has indicated their intention to resubmit to SMC.

There is a material difference between the recommendations of the NICE STA and the SMC.  NICE have recommended prucalopride as an option for the treatment of chronic constipation only in women for whom treatment with at least two laxatives from different classes at the highest tolerated recommended doses for at least 6 months has failed to provide adequate relief and invasive treatment for constipation is being considered.

Note:  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

Further information is noted in the appendix to the minutes.

8.4 NICE Single Technology Appraisal Guidance No 212 Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine for the treatment of metastatic colorectal cancer, published 15 December, 2010

NICE does not recommend bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine for people with metastatic colorectal cancer.

SMC published a Statement of Advice (469/08) on this medication for this indication in June 2008. It stated that: bevacizumab (Avastin) is not recommended for use within NHS Scotland in combination with fluoropyrimidine-based chemotherapy for treatment of patients with metastatic carcinoma of the colon or rectum.

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

Note:  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland

Further information is noted in the appendix to the minutes.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 filgrastim 12 million units (120microgram) / 0.2mL, 30 million units (300microgram) / 0.5mL, 48 million units (480microgram) / 0.5mL solution for injection/infusion in pre-filled syringe (Nivestim) SMC No. (671/11)

9.1.1 A declaration of interest was recorded in relation to this product/comparator drugs. A member with a personal specific interest did not participate in this part of the agenda.

9.1.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, and comments received from the company.  Detailed discussion followed and the group agreed that filgrastim (Nivestim), should be accepted for use in NHS Scotland, for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).  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, 14 January 2011.

9.2  dabigatran etexilate 110mg and 150mg hard capsules (Pradaxa) Boehringer Ingelheim Ltd (No. 672/11)

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

9.2.2 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 to suspend the review for dabigatran etexilate (Pradaxa), for the prevention of stroke and systemic embolism in adults with atrial fibrillation, pending confirmation of the marketing authorisation. 

9.3  capsaicin 179mg cutaneous patch (Qutenza) Astellas Pharma UK Ltd (No. 673/11)

9.3.1 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.

9.3.2 The NDC Co-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 Pain Concern and HIV Scotland.  Detailed discussion followed and the group agreed that capsaicin (Qutenza), should be accepted for restricted use in NHS Scotland, for the treatment of peripheral neuropathic pain in adults without diabetes either alone or in combination with other medicinal products for pain. 

Use of this product is restricted to the treatment of adults with post-herpetic neuralgia (PHN) who have not achieved adequate pain relief from, or who have not tolerated, conventional first and second-line treatments. Treatment should be under the supervision of a specialist in pain management

9.3.3 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, 14 January 2011.

9.4 golimumab 50mg, solution for injection in pre-filled pen (auto-injector) or pre-filled syringe (Simponi) Merck, Sharp & Dohme (No. 674/11)

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

9.4.2 The NDC Co-Vice 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 golimumab (Simponi), should not be recommended for use in NHS Scotland, alone or in combination with methotrexate, for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.  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, 14 January 2011.

9.5 rituximab 100mg in 10mL, 500mg in 50mL concentrate for solution for infusion (MabThera) Roche (No. 675/11) 

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

9.5.2 The SMC Co-Vice 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 rituximab (MabThera), should be accepted for restricted use in NHS Scotland, where rituximab for maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.

9.5.3 Its use is restricted to maintenance treatment in follicular lymphoma patients who have responded to induction with rituximab plus chemotherapy.

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, 14 January 2011.

RESUBMISSIONS

9.6 trastuzumab 150mg powder for concentrate for solution for infusion (Herceptin) Roche Products Ltd (No. 623/10)

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

9.6.2 The NDC Lead Assessor 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 the Rarer Cancers Group. Detailed discussion followed and the group agreed that trastuzumab (Herceptin), should not be recommended for use in NHS Scotland, in combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.  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, 14 January 2011.

9.7 miconazole 50mg mucoadhesive buccal tablet (Loramyc) Therabel Pharma UK Ltd (No. 517/08)

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

9.7.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, and comments received from the company.  Detailed discussion followed and the group agreed that miconazole (Loramyc), should not be recommended for use in NHS Scotland, for the treatment of oropharyngeal candidiasis (OPC) in immunocompromised patients.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.7.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 14 January 2011.

ABBREVIATED SUBMISSION

9.8 fosaprepitant dimeglumine (IVEmend 150 mg®) MSD Ltd (No. 678/11)

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

9.8.2 The NDC Co-Vice Chair provided an overview of the assessment and draft advice.  Detailed discussion followed and the group concluded their advice for fosaprepitant dimeglumine (IVEmend ®), for prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and/or prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. 

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

NON SUBMISSIONS

9.9 ivabradine (Procoralan)  Servier Laboratories Ltd (No. 689/11)

9.9.1 In the absence of a submission from the holder of the marketing authorisation, ivabradine (Procoralan) for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60 bpm, should not be recommended for use within NHS Scotland.

9.9.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 14 January 2011.

9.10 colesevelam 625mg film-coated tablets (Cholestagel) Genzyme Therapeutics Limited (No. 690/11)

9.10.1 In the absence of a submission from the holder of the marketing authorisation, colesevelam (Cholestagel), in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia, should not be recommended for use within NHS Scotland.

9.10.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 14 January 2011.

9.11 fenticonazole (Ginoxin)  Recordati Sp. A (No. 690/11)

9.11.1 In the absence of a submission from the holder of the marketing authorisation, fenticonazole (Ginoxin) for the treatment of vulvovaginal candidiasis, 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, 14 January 2011.

10.  Forthcoming Submissions

10.1  A list of forthcoming submissions was tabled and noted. 

11. Area Drug & Therapeutics Committee (ADTC) Issues

11.1 Introduction of  New Anti-coagulant drugs

Whilst, responsibility for managing the implementation of new drugs lies with NHS Boards, SMC recently convened a multidisciplinary working group to facilitate NHS boards in the introduction of new anti-coagulant drugs. These drugs, if accepted by SMC, may have a significant impact on prescribing practice and budgets. 

Dr Chris Lush, chaired the working group and summarised the key outputs from the working group.  Discussion followed and it was agreed that a conference should be established for key stakeholders to ensure that:

• major clinical governance issues are addressed by Boards;
• appropriate educational information is provided for  staff and  patients;
• risk stratification  for patients is discussed;
• Boards consider how they may address and manage an anticipated substantial budget impact;
• disinvestment is explored and structured;
• appropriate agreed national protocols are in place before prescribing commences

12. SMC User Group Forum (UGF)

12.1 Nothing further to report.

13. Any Other Business

13.1 No other business was noted.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday 01 February 2011 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

 

NICE Publications

Minutes of the SMC Meeting 11 January 2011

8.3 NICE Single Technology Appraisal Guidance No 211 - Prucalopride for the treatment of chronic constipation in women, published on 15 December, 2010

NICE Guidance

1. Prucalopride is recommended as an option for the treatment of chronic constipation only in women for whom treatment with at least two laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and invasive treatment for constipation is being considered.

2. If treatment with prucalopride is not effective after 4 weeks, the woman should be re-examined and the benefit of continuing treatment reconsidered.

3. Prucalopride should only be prescribed by a clinician with experience of treating chronic constipation, who has carefully reviewed the woman’s previous courses of laxative treatments specified in 1.

http://guidance.nice.org.uk/TA211

SMC Advice: Following a full submission:

prucalopride 1mg and 2mg tablet (Resolor) is not recommended for use in NHSScotland.

Indication under review: symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.

There were weaknesses in the clinical data as in the pivotal studies the majority of patients did not achieve the primary or secondary outcome measures and the exclusion criteria applied limit the ability to assess the likely clinical effectiveness of prucalopride in the target treatment population. In addition, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Access the advice of the Scottish Medicines Consortium:

There is a material difference between the recommendations of the NICE STA and the SMC. NICE have recommended prucalopride as an option for the treatment of chronic constipation only in women for whom treatment with at least two laxatives from different classes at the highest tolerated recommended doses for at least 6 months has failed to provide adequate relief and invasive treatment for constipation is being considered. The licence holder has indicated their intention to resubmit to SMC.

Note:  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

8.4 NICE Single Technology Appraisal Guidance No 212 Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine for the treatment of metastatic colorectal cancer, published 15 December, 2010

NICE Guidance

1. Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine is not recommended for the treatment of metastatic colorectal cancer.

2. People currently receiving bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine for the treatment of metastatic colorectal cancer should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

http://guidance.nice.org.uk/TA212

SMC Advice: Following a full submission

bevacizumab (Avastin) is not recommended for use within NHS Scotland in combination with fluoropyrimidine-based chemotherapy for treatment of patients with metastatic carcinoma of the colon or rectum. In a randomised trial standard chemotherapy plus bevacizumab showed a small benefit over standard chemotherapy alone in terms of progression-free survival.

However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Access the advice of the Scottish Medicines Consortium:

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

Note:  Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland