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SMC Minutes: Tuesday 1 February 2011

Minutes of the SMC Meeting
held on Tuesday 01 February 2011
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present:
Professor Ken Paterson (Chairman), Ms Sandra Auld, Dr Keith Beard, Dr Keith Brown, Mrs Margo Biggs, Professor Scott Bryson, Dr Jennifer Burns, Mrs Helen Cadden, Mr Robert Calderwood, Mr Dave Carson, Dr Dominic Culligan, Ms Sara Davies, Dr David Dunlop, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie, Dr Jacqui Howes, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Mrs Margo McGurk, Dr James McLay, Dr Paul McNamee, Ms Aileen Muir, Mrs Anne Murray, Dr Anthony Ormerod, Dr Mercia Page, Dr Robert Peel, Dr Andrew Power, Mr Keith Thompson, Mr Alistair Thorburn, Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor David Wray,

In Attendance: 
Ms Mary-Jane Anderson, Mrs Corinne Booth, Ms Ailsa Brown, Mr Stephen Ferguson, Mrs Anne Lee, Ms Marie McHenery, Ms Rosie Murray,
Ms Rosemary Newham, Ms Emma Riches, Ms Alex Robertson, Ms Marina Shannon, Mrs Catherine Tait, Ms Janice Watt,

Apologies:
Mrs Laura Ace, Professor James Barbour, Mr Colin Brown, Mrs Susan Downie, Professor Stephen Lawrie, Dr Chris Lush, Mrs Sandra McNaughton, Dr Simon Maxwell, Ms Veronica Moffat, Professor Dilip Nathwani, Mr Michael Pratt, Dr Brian Robson, Mrs Maureen Stark, Dr Sarah Taylor, Ms Angela Timoney

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:

Observers:

  • Ms Mary-Jane Anderson, Information Analyst, working with the SMC Evaluation team
  • Ms Rosemary Newham, Qualitative Researcher, working with the SMC Evaluation team
  • Mrs Helen Cadden, Newly appointed Public Partner
  • Mrs Anne Murray, Newly appointed Public Partner

NDC Members/Lead Assessors presenting submissions to SMC:

  • Ms Marina Shannon
  • Ms Janice Watt

New Member:

  • Mrs Margo McGurk, Head of Finance, NHS QIS, attending her first SMC meeting.

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 (11 January 2011)

3.1 The minutes of the SMC meeting held on 11 January 2011 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions

4.1 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) (No. 671/11)

The SMC advice for filgrastim (Nivestim), 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); Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia; The mobilisation of peripheral blood progenitor cells (PBPC); In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of £ 0.5 x 109/l and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events; The treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate, will be published on the SMC website on Monday, 07 February 2011.

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

The SMC review of dabigatran etexilate (Pradaxa), for the prevention of stroke and systemic embolism in adults with atrial fibrillation, was suspended pending confirmation of the EMA positive opinion and marketing authoristation.

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

The SMC advice for capsaicin cutaneous patch (Qutenza), for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain, will be published on the SMC website on Monday, 07 February 2011.

As a result of comparator comments, amendments have been made to the Summary of Clinical effectiveness. There has also been a minor amendment within the advice box in response to feedback from the service. Revised advice will be issued to NHS Boards and ADTCs on Friday, 04 February 2011.

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

The SMC advice for golimumab (Simponi), 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, will be published on the SMC website on Monday, 07 February 2011.

As a result of comparator comments, amendments have been made to the Summary of Clinical effectiveness. Revised Advice will be issued to NHS Boards and ADTCs on Friday, 04 February 2011.

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

The SMC advice for rituximab (MabThera), for the treatment of follicular lymphoma patients responding to induction therapy, will be published on the SMC website on Monday, 07 February 2011.

Resubmissions

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

The SMC advice for trastuzumab (Herceptin), 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, will be published on the SMC website on Monday, 07 February 2011.

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

The SMC advice for miconazole MucoAdhesive Buccal Tablet (Loramyc), for the treatment of oropharyngeal candidiasis (OPC) in immunocompromised patients, will be published on the SMC website on Monday, 07 February 2011.

Abbreviated Submission

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

The SMC advice for fosaprepitant dimeglumine, (IVEmend 150 mg®), for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults.

Advice was withheld in confidence pending confirmation of product availability. The manufacturer has advised that IVEmend will be available to prescribers on 15th February 2011 and has given SMC written permission to distribute the advice to Boards on Friday 04 February 2011.  Advice will be published on the SMC website on Monday 07 March 2011.

Non-Submissions

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

The SMC advice for 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, will be published on the SMC website on Monday, 07 February 2011.

4.10 colesevelam (Cholestagel) Genzyme Therapeutics Limited (No. 690/11)

The SMC advice for colesevelam (Cholestagel), in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia, will be published on the SMC website on Monday, 07 February 2011.

4.11 fenticonazole (Ginoxin) Recordati Sp.A (No. 691/11)

The SMC advice for fenticonazole (Ginoxin), for the treatment of treatment of vulvovaginal candidiasis, will be published on the SMC website on Monday, 07 February 2011.

Deferred Advice

4.12 See above fosaprepitant dimeglumine (IVEmend 150 mg®) MSD Ltd (No. 678/11)

Amended Advice

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

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

5. Appeals Update

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

Merck, Sharp and Dohme has indicated their intention to resubmit for golimumab (Simponi), 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.

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Tunstall-James advised that PAPIG had met immediately prior to the SMC and confirmed that 3 candidates had been appointed in the recent recruitment campaign for new Public Partners. Both Mrs Helen Cadden and Mrs Anne Murray observed their first PAPIG and SMC meeting today.  Professor Colin Suckling will observe the July meeting and will attend his first meeting in September.

Mrs Margo Biggs and Mr Keith Thompson will attend their last PAPIG and SMC meeting on 01 March 2011.

6.2 LTCAS Annual Conference

The LTCAS Annual Conference will take place in Perth Concert Hall on 22nd March 2011. Mrs Tunstall-James and Ms Marie McHenery will attend this event.

6.3 International Patients Summit

The International Patients Summit will take place on 23rd and 24th February 2011. Ms Marie McHenery will attend this event.

6.4 Rare Disease Day

PAPIG have been invited by Rare Disease UK to a reception at the Scottish Parliament for Rare Disease Day on 22nd February 2011. Mrs Tunstall-James and Ms Marie McHenery will attend this event.

6.5 PAPIG Training Day

The PAPIG Training Day date has now been arranged for Tuesday 24 May 2011. Members of the Executive have agreed to participate in this training day and a programme will be circulated in due course.

The Chairman thanked Mrs Tunstall-James for her update and welcomed the new public partners to SMC.

7. New Drugs Committee: Chairman’s Report

7.1 Dr Jan Jones advised that sadly she had attended her last NDC meeting as NDC Chairman. She had found her last three years intense and sometimes challenging but at the same time enjoyable and very rewarding. 

The Chairman expressed his sincere thanks and appreciation to Dr Jones for her dedication and support to both committees. Dr Jones’s knowledge, skills and experience will be sorely missed but is pleased that she will continue to contribute to SMC as a member. The Chairman welcomed Dr Jonathan Fox in his new role as NDC Chairman.

8. Chairman’s Business

8.1 Move to Electronic Distribution of paperwork

The SMC Secretariat are currently investigating the feasibility of moving to electronic distribution of paperwork. The number and volume of papers within submissions has increased substantially over the last couple of years and the resource required to copy and collate along with the associated cost of paper and postage, coupled with the requirement to streamline spending has made it necessary to think of alternative methods. 

The Chairman would like members’ views on whether they would be willing/able to bring their own laptops to the meeting or would prefer to work from hard copy papers which they will have to download and print off for the meeting. We are exploring the opportunity of the possibility of providing a number of netbooks to enable members to review papers on line. A questionnaire will be sent to members for their views in due course.

8.2 NICE Single Technology Appraisal Guidance No 213 – Aripiprazole for the treatment of schizophrenia in people aged 15-17, published on 26 January 2011

NICE recommends aripiprazole as a possible treatment for some people aged 15 to 17 years with schizophrenia.

(SMC) published a Statement of Advice (630/10) on this medication for this indication in August 2010 following an abbreviated submission.  This stated that Aripiprazole tablets, orodispersible tablets and oral solution (Abilify®) are accepted for restricted use within NHS Scotland for the treatment of schizophrenia in adolescents 15 years and older. Use is restricted to initiation and management under the supervision of a child/adolescent psychiatrist. 

There is a material difference between the recommendations of the NICE STA and the SMC. NICE recommend aripiprazole as an option for those who are intolerant of risperidone, or for whom risperidone is contraindicated, or whose schizophrenia has not been adequately controlled with risperidone. Note that in this case the SMC advice was based on an abbreviated submission from the manufacturer.

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

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 pazopanib 200mg, 400mg film-coated tablets (Votrient®) GlaxoSmithKline UK SMC No. (676/11)

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 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 pazopanib (Votrient®), should be accepted for restricted use within NHS Scotland, for first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. SMC restriction: use is restricted to the first-line treatment of advanced RCC. Pazopanib was superior to placebo for the primary endpoint, progression free survival, in the whole population and the treatment naïve and cytokine pre-treated sub-groups. An indirect comparison demonstrated that pazopanib had similar efficacy to the main comparator. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pazopanib. This SMC advice is contingent upon the continuing availability of the Patient Access Scheme 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, 04 February 2011.

9.2 dalteparin sodium, 5,000IU/0.2mL, 7,500IU/0.3mL, 10,000IU/0.4mL,   12,500IU/0.5mL,  15,000IU/0.6mL, 18,000IU/0.72mL solution for injection. (Fragmin®) Pfizer Ltd  SMC No. (683/11)

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

9.2.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, and summary of information for patients.  Detailed discussion followed and the group agreed that dalteparin (Fragmin®), should be accepted for restricted use within NHS Scotland, for the extended treatment of symptomatic venous thromboembolism (VTE) and prevention of its recurrence in patients with solid tumours. SMC restriction: initiation by healthcare professionals experienced in the treatment of VTE. In patients with cancer and VTE, dalteparin significantly reduced the rates of VTE recurrence over a six month period, compared to oral anticoagulation. Bleeding and mortality rates for patients receiving dalteparin were similar to those reported in patients receiving oral anticoagulant. The economic case was demonstrated for dalteparin compared to other low molecular weight heparins. Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 February 2011.

9.3 adapalene 0.1%/benzoyl peroxide 2.5% gel (Epiduo®) Galderma SMC No.(682/11)

9.3.1 A member with a personal specific interest left the meeting for this part of the agenda.

9.3.2 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 Skin Care Campaign Scotland (SCCS). Detailed discussion followed and the group agreed that adapalene 0.1%/benzoyl peroxide 2.5% gel (Epiduo®), should not be recommended for use within NHS Scotland, for cutaneous treatment of acne vulgaris when comedones, papules and pustules are present. In a 12-week study in patients with severe acne also receiving oral doxycycline, adapalene 0.1%/benzoyl peroxide 2.5% gel reduced the total lesion count compared with vehicle gel. A 24-week extension study showed a higher rate of maintenance success with adapalene 0.1%/benzoyl peroxide 2.5% gel versus vehicle gel alone. The clinical and economic case was based on patients with severe acne who refuse treatment with, or have a contraindication to, oral isotretinoin. Comparative efficacy versus alternative treatment options in this patient group is unclear. As a consequence, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 February 2011.

9.4 vernakalant 20mg/ml concentrate for solution for infusion (Brinavess®) MSD Ltd SMC No.(685/11)

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

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 concluded their advice for vernakalant (Brinavess®), for rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. For non-surgery patients with atrial fibrillation ≤7 days duration.

9.4.3 The SMC advice will be withheld pending confirmation of product availability.  

9.5 vinflunine ditartrate 25mg/ml concentrate for solution for infusion (Javlor®) Pierre Fabre Ltd SMC No.(686/11)

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

9.5.2 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 vinflunine (Javlor®) should not recommended for use within NHS Scotland, for monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract (TCCU) after failure of a prior platinum-containing regimen. Vinflunine plus best supportive care was associated with improved survival when compared to best supportive care alone in the second-line treatment of advanced or metastatic TCCU in patients with good performance status. However, the manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient and in addition, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. 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, 04 February 2011.                                                    

9.6 exenatide, 5 or 10 micrograms, solution for injection, pre-filled pen (Byetta®) Eli Lilly and Company Limited SMC No.(684/11)

9.6.1 A member with a personal specific interest left the meeting for this part of the agenda.

9.6.2 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 exenatide (Byetta®) should be accepted for restricted use within NHS Scotland, for the treatment of type 2 diabetes mellitus in combination with thiazolidinediones with or without metformin in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. SMC restriction: restricted to use in combination with metformin and a thiazolidinedione as a third-line pre-insulin treatment option. The addition of exenatide to a thiazolidinedione alone or in combination with metformin modestly improved glycaemic control compared with placebo in studies up to 26 weeks, but was associated with nausea and vomiting in some patients. Exenatide has previously been accepted by SMC for restricted use for the treatment of type 2 diabetes mellitus in combination with metformin and/or sulphonylureas in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. 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, 04 February 2011.

RESUBMISSION

9.7 botulinum toxin type A 50 unit, 100 unit and 200 unit powder for solution for injection (Botox®) Allergan Ltd SMC No. (80/03)

9.7.1 A member with a personal specific interest left the meeting for this part of the agenda.

9.7.2 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 Botulinum toxin type A (Botox®) should be accepted for use within NHS Scotland, for the treatment of focal spasticity, including the treatment of wrist and hand disability due to upper limb spasticity associated with stroke in adults. In a placebo-controlled study, botulinum toxin type A was significantly superior to placebo in terms of the disability assessment scale and efficacy was maintained across repeated injections in an open-label extension study with a duration of one year. 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, 04 February 2011 

ABBREVIATED SUBMISSIONS

9.8 adrenaline tartrate 150 and 300 microgram solution for injection in a pre-filled pen (Jext®) ALK-Abelló Ltd SMC No. (687/11)

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 draft advice. Detailed discussion followed and the group concluded their advice for Adrenaline tartrate (Jext®), for emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis.

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

9.9 sildenafil citrate 0.8mg/mL solution for injection (Revatio®) Pfizer UK SMC No. (688/11)

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

9.9.2 The NDC Chair provided an overview of the assessment and draft advice. Detailed discussion followed and the group agreed that sildenafil citrate 0.8mg/mL injection (Revatio®) should be accepted for restricted use within NHS Scotland, for the treatment of patients with pulmonary arterial hypertension who are currently prescribed oral sildenafil and who are temporarily unable to take oral medicine, but are otherwise clinically and haemodynamically stable. SMC restriction: restricted to use on the advice of specialists in the Scottish Pulmonary Vascular Unit and from the Scottish Adult Congenital Cardiac Service. Oral sildenafil is indicated for treatment of patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. SMC has previously accepted oral sildenafil in this orphan indication. The intravenous formulation is significantly more expensive than the oral preparation but it is intended only for short-term use (the estimated average duration of intravenous treatment is three days). 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 NHS Boards and ADTCs on Friday, 04 February 2011.

NON SUBMISSIONS

9.10 botulinum toxin type a (Bocouture) Merz Pharma (No. 695/11)

9.10.1 In the absence of a submission from the holder of the marketing authorisation, botulinum toxin type a (Azzalure), should not be recommended for use within NHSScotland, for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient.

9.10.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 February 2011.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. Area Drug & Therapeutics Committee (ADTC) Issues

11.1 Nothing to update.

12. SMC User Group Forum

12.1 Update from UGF Meeting

Dr Frances Macdonald advised that the SMC UGF met on 25 January, 2011. It was reported that ABPI have sent a note to companies who are currently in the process of preparing a submission to remind them that there is support via ABPI if they want strategic advice for their submissions. It is anticipated that interacting with companies will provide clarity where things are less clear or where there is doubt due to a lack of experience.

Work in ongoing on the review of process guidance and clarification of methods with the proposal that a joint team be constituted and a date for completion scheduled.

ABPI are in discussions with various groups regarding value based pricing with a central working group looking at the UK implications and the Scottish Access and Value Group looking at Scottish issues and feeding into the central group. 

The SMC Chairman reported that SMC will take forward with the SGHD to discuss the implications for SMC and NHSScotland.

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 March 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 01 February 2011

NICE Single Technology Appraisal Guidance No 213 – Aripiprazole for the treatment of schizophrenia in people aged 15-17, published on 26 January 2011

NICE Guidance

  1. Aripiprazole is recommended as an option for the treatment of schizophrenia in people aged 15 to 17 years who are intolerant of risperidone, or for whom risperidone is contraindicated, or whose schizophrenia has not been adequately controlled with risperidone.
  2. People aged 15 to 17 years currently receiving aripiprazole for the treatment of schizophrenia who do not meet the criteria specified in 1.1 should have the option to continue treatment until it is considered appropriate to stop. This decision should be made jointly by the clinician and the person with schizophrenia, and if appropriate, their parents or carers.

http://guidance.nice.org.uk/TA213

SMC Advice: following an abbreviated submission:

aripiprazole tablets, orodisperible tablets and oral solution (Abilify®) are accepted for restricted use within NHS Scotland.

Indication under review: The treatment of schizophrenia in adolescents 15 years and older.

SMC restriction: Restricted to initiation and management under the supervision of a child/adolescent psychiatrist.

Aripiprazole has demonstrated short and long-term efficacy in adolescents in the 15 to 17 year old subgroup which is similar to that observed in the adult patient population.

The Scottish Medicines Consortium has previously accepted this product for use in schizophrenia in adults.

Aripiprazole is one of several atypical antipsychotic medicines that improve symptoms of an acute relapse and reduce the risk of relapse comparable to a typical antipsychotic. The evidence of comparable efficacy to other atypical antipsychotics is limited. It is associated with a lower incidence of extra-pyramidal side effects than typical antipsychotics, and comparable to other atypicals. It is associated with less elevation of serum prolactin, less lipid abnormalities and less clinically significant weight gain over the short-term compared with other atypical antipsychotics. It does not adversely effect blood glucose nor have a clinically significant advantage compared to other antipsychotics with respect to this.

Access the advice of the Scottish Medicines Consortium

There is a material difference between the recommendations of the NICE STA and the SMC. NICE recommend aripiprazole as an option for those who are intolerant of risperidone, or for whom risperidone is contraindicated, or whose schizophrenia has not been adequately controlled with risperidone. Note that in this case the SMC advice was based on an abbreviated submission from the manufacturer.

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