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SMC Minutes Tuesday 01 November 2011

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

Present: Ms Angela Timoney (Chairman), Mrs Laura Ace, Ms Sandra Auld , Professor James Barbour, Dr Keith Brown, Professor Scott Bryson, Dr Jennifer Burns, Mrs Helen Cadden, Mr Robert Calderwood, Dr Dominic Culligan, Dr David Dunlop, Dr Jonathan Fox, Dr John Gemmill, Dr Jacqui Howes, Dr Jan Jones, Dr Chris Lush, Dr Frances Macdonald, Dr John McElhinney, Dr James McLay, Ms Aileen Muir, Mrs Anne Murray, Dr Mercia Page, Dr Robert Peel, Dr Brian Robson, Professor Colin Suckling, Dr Sarah Taylor, Dr Andrew Walker

In Attendance: Ms Melanie Barnes, Ms Ailsa Brown, Ms Polly Buchanan, Mrs Susan Downie, Mr Stephen Ferguson, Mr Scott Hill, Mrs Anne Lee, Mrs Kirsty MacFarlane, Mrs Linda McGlynn, Ms Rosie Murray, Mrs Sharon Pfleger, Ms Alex Robertson, Mrs Maureen Stark

Apologies: Mrs Corinne Booth, Mr Colin Brown, Mrs Alison Campbell, Mr Dave Carson, Ms Sara Davies, Dr Barclay Goudie, Professor Stephen Lawrie, Dr Alan MacDonald, Mrs Margo McGurk, Dr Paul McNamee, Mrs Sandra McNaughton, Dr Simon Maxwell, Ms Veronica Moffat, Professor Dilip Nathwani, Mr Michael Pratt, Mrs Catherine Tait

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:

Observer: Ms Polly Buchanan, Regional Manager, Galderma UK and SMC User Group member.
  
NDC Member/Lead Assessor: Mrs Sharon Pfleger, Consultant in Pharmaceutical Public Health, Grampian.

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 (04 October 2011)

3.1 The minutes of the SMC meeting held on 04 October 2011 were accepted as an accurate record of the meeting.

4. Matters Arising

Full Submissions Reviewed at October SMC

4.1 ranibizumab, 10mg/mL solution for injection (Lucentis®) Novartis Pharmaceuticals UK Ltd SMC No. (732/11)

The SMC advice for ranibizumab (Lucentis®), for the treatment of visual impairment due to macular oedema (MO) secondary to retinal vein occlusion (RVO) (branch RVO or central RVO) in adults, will be published on the SMC website on Monday, 07 November 2011.

4.2 naproxen/esomeprazole 500mg/20mg modified release tablets (Vimovo®) AstraZeneca UK   SMC No. (734/11)

The SMC advice for naproxen/esomeprazole (Vimovo®), for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS), in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated gastric and/or duodenal ulcers and where treatment with lower doses of naproxen or of other NSAIDs is not considered sufficient, will be published on the SMC website on Monday, 07 November 2011.

4.3 golimumab 50mg solution for injections prefilled pen (auto-injector) or pre-filled syringe (Simponi®)  MSD Ltd  SMC No. (733/11)

The SMC advice for golimumab (Simponi®), in combination with methotrexate, for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drug therapy including methotrexate has been inadequate, will be published on the SMC website on Monday, 07 November 2011.

4.4 cabazitaxel, 60mg concentrate and solvent for solution for infusion (Jevtana®)   Sanofi-Aventis SMC No. (735/11)

The SMC advice for cabazitaxel, (Jevtana®), in combination with prednisone or prednisolone, cabazitaxel is licensed for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen, will be published on the SMC website on Monday, 07 November 2011.

Resubmissions Reviewed at October SMC

4.5 aprepitant 80mg, 125mg hard capsules (Emend®) Merck, Sharp & Dohme Ltd  SMC No. (242/06)

The SMC advice for aprepitant (Emend®), as part of combination therapy, for prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, will be published on the SMC website on Monday, 07 November 2011.

4.6 paliperidone palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion)  Janssen-Cilag Ltd  SMC No. (713/11)

The SMC advice for paliperidone palmitate (Xeplion), for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone, will be published on the SMC website on Monday, 07 November 2011.

Abbreviated Submissions Reviewed at October SMC

4.7 fluticasone proprionate and formoterol fumarate metered dose inhaler, 50microgram/5microgram, 125microgram/5 microgram 250microgram/10 microgram (Flutiform®) Napp Pharmaceuticals Ltd  SMC No. (736/11)

The SMC advice for fluticasone proprionate and formoterol fumarate metered dose inhaler, (Flutiform®), will be withheld pending confirmation of licence and availability, in the regular treatment of asthma where the use of a combination product [an inhaled corticosteroid (ICS) and a long-acting ß2 agonist (LABA)] is appropriate:

  • for patients not adequately controlled on ICS and ‘as required’ inhaled short-acting ß2  agonist or;
  • for patients already adequately controlled on both an ICS and a LABA.

4.8 somatropin 5.83mg/ml and 8mg/ml solution for injection (Saizen®) Merck Serono Ltd  SMC No. (737/11)

The SMC advice for somatropin solution for injection (Saizen®), will be published on the SMC website on Monday, 07 November 2011  for:

Children and adolescents:

  • Growth failure in children caused by decreased or absent secretion of endogenous growth hormone.
  • Growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.
  • Growth failure in prepubertal children due to chronic renal failure (CRF).
  • Growth disturbance (current height SDS <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last year) by 4 years of age or later.

Adults:

  • Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfil the following criteria:

Childhood Onset:

  • Patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with Saizen is started.

Adult Onset:

  • Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.

4.9 adalimumab (Humira®), 40mg solution for injection in pre-filled syringe or pen, 40mg/0.8ml solution for injection vial for paediatric use Abbott Laboratories SMC No (738/11)

The SMC advice for adalimumab (Humira®), in combination with methotrexate for the treatment of active polyarticular juvenile idiopathic arthritis, in children and adolescents aged 4 to 17 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Or given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate, will be published on the SMC website on Monday, 07 November 2011.

4.10 abatacept (Orencia®), 250mg powder for concentrate for solution for injection Bristol-Myers Squibb Pharmaceuticals Ltd SMC No. (618/10)

The SMC advice for abatacept (Orencia®), in combination with methotrexate, abatacept is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (JIA) in paediatric patients 6 years of age and older who have had an insufficient response to other disease modifying antirheumatic drugs (DMARDs) including at least one tumour necrosis factor (TNF) inhibitor, will be published on the SMC website on Monday, 07 November 2011.

4.11 Deferred Advice

Nothing to report.

4.12 Amended Advice

golimumab (Simponi®)  Merck Sharp & Dohme Ltd (No.733/11)

In October 2011, SMC accepted restricted use of golimumab (Simponi), in combination with methotrexate, for the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease modifying anti-rheumatic drug therapy including methotrexate has been inadequate.  Following comparator comments minor amendments have been made to the Advice - in the Summary of comparative health economic evidence.  Advice for golimumab (Simponi), will be published on 07 November 2011.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the PAPIG Meeting Held on 04 October 2011

The minutes of the PAPIG meeting held on 04 October 2011 were noted.

6.2 PAPIG Update: Mrs A Murray, Chair of PAPIG

Significant progress is being made in terms of engaging patients and carers.  PAPIG is currently piloting a new template for patient groups who wish to make a submission to SMC for a particular medicine, and in recent months a significant increase in the number and quality of submissions from patient groups has been noted. 

However, PAPIG is now planning to focus on public involvement and will begin by reviewing how PAPIG has previously engaged with members of the public and how they may develop strategies to increase public involvement.  PAPIG   will report on their findings to SMC in late 2012. 

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 Affordability of All Healthcare Interventions

The Chair of SMC recently wrote to Mr Derek Feeley, Director General, Health and Social Care, and Chief Executive, NHS Scotland, concerning the current financial constraints within NHS Scotland and the challenges that NHS Boards face in terms of affordability and associated SMC Advice.  SMC noted Mr Feeley’s positive response to SMC’s national approach to new medicines and his understanding that affordability of new medicines is a matter for NHS Boards and the Scottish Government Health Directorate and not a consideration for the SMC.

8.2 The Public Petitions Committee

The Public Petitions Committee has asked for SMC views on the issues raised by three petitions, based on access to medicines for rare diseases.  SMC will prepare a response to the Committee but SMC members were first invited to comment in writing on the key issues. 

8.3 Worldwide withdrawal of its [drotrecogin alfa (activated)] Xigris® product for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.

On 25 October 2011 Eli Lilly and Company announced worldwide withdrawal of its [drotrecogin alfa (activated)] Xigris® product for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.

The worldwide withdrawal (including the UK) has been announced following results of a clinical study (the PROWESS-SHOCK study), which showed that Xigris did not achieve a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. The company is working in collaboration with regulatory agencies on the withdrawal, and is in the process of notifying health care professionals and clinical trial investigators.

SMC has noted the withdrawal on the SMC website with respect to SMC Advice (No,13/02).

8.4 Secure Website for Distributing SMC Meeting Papers

The Secretariat will run a dual system for one more month providing both paper copies and web-enabled access to paperwork.  Therefore, from the SMC meeting in January 2011, hard copy papers will not be issued. 

The secure site system now allows members to reset their passwords however if members forget their passwords they will need to contact the system administrator to have them reset.

8.5 NICE Single Technology Appraisal Guidance No 235 – Mifamurtide for the treatment of osteosarcoma

NICE guidance was published on 26 October 2011.  NICE recommends mifamurtide as a possible treatment for some children, adolescents and young adults with osteosarcoma.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (621/10) on this medication for this indication in August 2011. It stated that mifamurtide (Mepact) is accepted for use within NHS Scotland in combination with post-operative multi-agent chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults.  This advice is contingent upon the continuing availability of a Patient Access Scheme (PAS) in NHS Scotland.

There is no material difference between the recommendations of the NICE STA and SMC.  Please note that Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland.

8.6 NICE Single Technology Appraisal Guidance No 236 – Ticagrelor for the treatment of acute coronary syndromes

NICE guidance was published on 26 October 2011.  NICE recommends ticagrelor combined with low-dose aspirin for up to a year as a possible treatment for some people with acute coronary syndromes.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (699/11) on this medication for this indication in May 2011. It stated that ticagrelor film-coated tablets (Brilique®) are accepted for use within NHS Scotland, co-administered with aspirin, for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non ST elevation myocardial infarction [NSTEMI] or ST elevation myocardial infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).

There is no material difference between the recommendations of the NICE STA and SMC.  Please note that Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 apixaban 2.5mg film-coated tablet (Eliquis®)  SMC No. (741/11)  Bristol-Myers Squibb Pharmaceuticals Ltd/Pfizer Ltd.

9.1.1 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.

9.1.2 The NDC Co-Vice Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from Anticoagulant Europe.  Detailed discussion followed and the group agreed that apixaban (Eliquis®), should be accepted for use in NHS Scotland.

Indication under review: Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
 
In two large phase III double-blind comparative studies, in patients undergoing elective hip or knee replacement surgery, apixaban was superior to a low molecular weight heparin for the incidence of VTE and all cause death whilst incidence of major bleeding events was similar between groups.
 
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 November 2011.

9.2 telaprevir, 375mg, film-coated tablets (Incivo®) SMC No. (742/11)  Janssen

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 NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Two members of PAPIG presented patient interest group submissions from Waverly Care and Hepatitis C Trust.  Detailed discussion followed and the group agreed that telaprevir, (Incivo®), should be accepted for use in NHS Scotland.

Indication under review: In combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis) who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders.

In the pivotal phase III randomised study, the addition of telaprevir to current standard therapy in patients with genotype 1 chronic hepatitis C virus, who had failed previous therapy, significantly increased the proportion of patients who achieved a sustained virologic response.

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 November 2011.
 
9.3 telaprevir, 375mg, film-coated tablets (Incivo®) SMC No. (743/11)  Janssen

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 Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Two members of PAPIG presented patient interest group submissions from Waverly Care and Hepatitis C Trust.  Detailed discussion followed and the group agreed that telaprevir, (Incivo®), should be accepted for use in NHS Scotland. 

Indication under review: in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis), who are treatment naïve.

In the pivotal phase III randomised study, addition of telaprevir to current standard therapy in treatment-naïve patients with genotype 1 chronic hepatitis C virus, significantly increased the proportion of patients who achieved a sustained virologic response, even in patients treated for a shorter overall duration using response-guided therapy.

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 November 2011.

RESUBMISSION

9.4 dexamethasone 700 microgram intravitreal implant (Ozurdex®) SMC No. (652/10)  Allergan Ltd

9.4.1 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.

9.4.2 The NDC Chair provided an 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 RNIB.  Detailed discussion followed and the group agreed that dexamethasone (Ozurdex®), should not be recommended for use in NHS Scotland. 

Indication under review: treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

In two phase III studies dexamethasone 700 microgram intravitreal implant was superior to sham administration at day 90 for the proportion of patients with a best corrected visual acuity improvement of =15 letters.  Longer-term effectiveness of treatment is uncertain.

The submitting company did not provide a sufficiently robust clinical and 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.

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

NON-SUBMISSION

9.5 denosumab (Xgeva®)  Amgen Ltd  SMC No.(752/11)

9.5.1 In the absence of a submission from the holder of the marketing authorisation, denosumab (Xgeva®) is not recommended for use within NHS Scotland for prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.

NICE (National Institute for Health and Clinical Excellence) is currently undertaking a multiple technology appraisal (MTA) that includes the use of denosumab in this indication.  However due to the significant time interval between product availability and the expected date of NICE guidance, not recommended advice has been issued.

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

10. SMC User Group Forum (UGF)

10.1 Update from UGF Meeting 25 October 2011
 
Dr Macdonald reported that work continues on the review of SMC Guidance to Manufacturers with the aim of publishing this document on the SMC website in the near future.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted. 

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Programme of meetings with ADTCs

The SMC Chair and Co-Vice Chairs have embarked on a rolling programme of meetings with each of the Area Drug and Therapeutics in Scotland.

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, 06 December 2011 at 12.30 pm (lunch from 12 noon), in Healthcare Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

NICE Publications

Minutes of the SMC Meeting 06 September 2011

NICE Technology Appraisal STA No.231 for: agomelatine, for the treatment of major depressive episodes. (Terminated Appraisal)

NICE is unable to recommend the use of agomelatine, for the treatment of major depressive episodes because no evidence submission was received from the manufacturers or sponsors of the technology.

Following a resubmission in September 2010, SMC did not recommend agomelatine for the treatment of major depressive episodes in adults.

When used in a flexible dosing schedule, agomelatine significantly reduced the symptoms of depression and increased the number of patients who responded to treatment compared with placebo. There are no comparative data from clinical studies with existing second line antidepressants using depression as the primary outcome.

The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.

The licence holder has indicated their intention to resubmit.

http://www.scottishmedicines.org.uk/files/advice/agomelatine_Valdoxan_RESUBMISSION_FINAL.pdf

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland.

8.5 NICE Technology Appraisal STA No. 233 for: golimumab for the treatment of ankylosing spondylitis

NICE guidance was published on 24 August 2011.  Golimumab is recommended as an option for the treatment of severe, active ankylosing spondylitis in adults only if:

it is used as described for adalimumab and etanercept in ‘Adalimumab, etanercept and infliximab for ankylosing spondylitis’ (NICE technology appraisal guidance 143) and

the manufacturer provides the 100 mg dose of golimumab at the same cost as the 50 mg dose in accordance with the patient access scheme.

People currently receiving golimumab for the treatment of severe, active ankylosing spondylitis who do not fulfil the criteria for treatment with adalimumab and etanercept described in NICE technology appraisal guidance 143 should have the option to continue golimumab until they and their clinician consider it appropriate to stop.

http://www.nice.org.uk/TA233

http://guidance.nice.org.uk/TA143/Guidance/pdf/English

The Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of golimumab and is due to publish a Statement of Advice on this medication for this indication, in September 2011. When this is available, NHSScotland should adhere to this advice.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland.

8.6 NICE Technology Appraisal STA No. 234 for:  abatacept for the treatment of rheumatoid arthritis

NICE guidance was published on 24 August 2011. Abatacept in combination with methotrexate is not recommended for the treatment of moderate to severe active rheumatoid arthritis in adults whose disease has responded inadequately to one or more conventional non-biological disease modifying anti-rheumatic drugs (DMARDs) including methotrexate.
 
People currently receiving abatacept in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis, whose disease has responded inadequately to one or more conventional non-biological DMARDs including methotrexate, should have the option to continue treatment until they, and their clinicians, consider it appropriate to stop. 

http://www.nice.org.uk/TA234

Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of abatacept and is due to publish a Statement of Advice on this medication for this indication in September 2011. When this is available, NHSScotland should adhere to this advice. 

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHSScotland.