You are here:

SMC Minutes Tuesday 05 April 2011

Minutes of the SMC Meeting
held on Tuesday 05 April 2011
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present:
Professor Ken Paterson (Chairman), Ms Sandra Auld, Dr Keith Brown, Professor Scott Bryson, Mrs Helen Cadden, Mr Robert Calderwood, Mr Dave Carson, Ms Sara Davies, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie, Dr Jan Jones, Dr Alan MacDonald, Dr Frances Macdonald, Mrs Margo McGurk, Dr Simon Maxwell, Dr James McLay, Dr Paul McNamee, Mrs Sandra McNaughton, Ms Aileen Muir, Mrs Anne Murray, Dr Anthony Ormerod, Dr Mercia Page, Dr Robert Peel, Mr Michael Pratt, Mr Alistair Thorburn, Ms Angela Timoney, Mrs Sheila Tunstall-James, Professor David Wray

In Attendance:
Mrs Corinne Booth, Ms Melanie Barnes, Ms Ailsa Brown, Mrs Susan Downie, Mr Stephen Ferguson, Professor Peter Helms, Mrs Anne Lee, Ms Marie McHenery, Ms Rosie Murray, Ms Alex Robertson, Mrs Catherine Tait, Ms Janice Watt

Apologies:
Mrs Laura Ace, Professor James Barbour, Mr Colin Brown, Dr Jennifer Burns, Dr Dominic Culligan, Dr David Dunlop, Dr Jacqui Howes, Professor Stephen Lawrie, Dr John McElhinney, Dr Chris Lush, Ms Veronica Moffat, Professor Dilip Nathwani, Dr Andrew Power, Dr Brian Robson, Ms Emma Riches, Mrs Maureen Stark, Dr Sarah Taylor, Dr Andrew Walker

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 Melanie Barnes, Financial Accountant, Healthcare Improvement Scotland

NDC Members/Lead Assessors presenting submissions to SMC:

• Ms Janice Watt
• Professor Peter Helms

1.3 Thank You and Goodbye

Professor Ken Paterson SMC Chair
 
Professor Paterson was attending his last meeting as Chair of SMC.  Ms Angela Timoney, newly appointed Chair of SMC, expressed her sincere thanks and appreciation to Professor Paterson for his dedication and support to both committees which has been immense.  Professor Paterson’s knowledge, skills and experience will be sorely missed, and he has been involved with both committees from the begininning.  Much has been achieved during his Chairmanship and the committee wished him well for the future.

Professor Paterson thanked Ms Timoney, Members and SMC Secretariat for their good wishes.  Ms Timoney has also been involved with SMC from the beginning and that SMC was being left in good hands.

Dr Keith Beard

Dr Beard attended his last meeting of SMC in March 2011, however, we were not aware that it was Keith’s last meeting and did not formally express our thanks in his presence.  Keith was a founder member of SMC and his dedication and commitment to SMC has been immense.

Dr Anthony Ormerod

Dr Ormerod was attending his last meeting of SMC, and SMC expressed their thanks for his commitment to the committee.

Mr Alastair Thorburn

Mr Thorburn was attending his last meeting of SMC, and SMC expressed their thanks for his commitment to the committee.  Mr Thorburn is rotating to NDC.

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 (01 March 2011)

3.1 The minutes of the SMC meeting held on 01 March 2011 were accepted as an accurate record of the meeting.

4 Matters Arising

Full Submissions

4.1 bendamustine hydrochloride 25mg, 100mg soluble powder for solution for infusion (Levact®)  Napp Pharmaceuticals Limited  SMC No. (694/11)

The SMC advice for bendamustine hydrochloride 25mg, 100mg soluble powder for solution for infusion (Levact®), for first-line treatment of chronic lymphocytic leukaemia (CLL) (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate, will be published on the SMC website on Monday, 11 April 2011.

4.2 calcium acetate 435mg, magnesium carbonate 235mg tablet (Osvaren®)  Fresenius Medical Care   SMC No. (693/11)

The SMC advice for calcium acetate 435mg, magnesium carbonate 235mg tablet (Osvaren®), for the treatment of hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis), will be published on the SMC website on Monday, 11 April 2011.

4.3 botulinum toxin type A 50 unit, 100 unit and 200 unit powder for solution for injection (Botox®)  Allergan Ltd.  SMC No. (692/11)

The SMC advice for botulinum toxin type A 50 unit, 100 unit and 200 unit powder for solution for injection (Botox®), for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine), will be published on the SMC website on Monday, 11 April 2011.

Resubmission

4.4 drospirenone / ethinylestradiol 3mg/30 micrograms, film-coated tablets (Yasmin®)  Bayer Schering Pharma   SMC No. (23/03)                                

The SMC advice for drospirenone / ethinylestradiol 3mg/30 micrograms, film-coated tablets (Yasmin®), for the treatment of oral contraception, will be published on the SMC website on Monday, 11 April 2011.

Abbreviated/Resubmission

4.5 sevelamer carbonate 800mg film-coated tablets and 2.4g of anhydrous powder for oral suspension (Renvela®)  Genzyme Therapeutics Ltd  (No: 641/10)

The SMC advice for sevelamer carbonate 800mg film-coated tablets and 2.4g of anhydrous powder for oral suspension (Renvela®), for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis, will be published on the SMC website on Monday, 11 April 2011.

Non-Submissions

4.6 bendamustine (Levact®) Napp Pharmaceuticals (No. 700/11)

The SMC advice for bendamustine (Levact®), for the front line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment, will be published on the SMC website on Monday, 11 April 2011.

4.7 bendamustine (Levact®) Napp Pharmaceuticals (No. 701/11)

The SMC advice for bendamustine (Levact®), for the front line treatment of indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen, will be published on the SMC website on Monday, 11 April 2011.

4.8 paliperidone (Invega®) Jansen Cilag (No. 702/11)

The SMC advice for paliperidone (Invega®), for the treatment of psychotic or manic symptoms of schizoaffective disorder, will be published on the SMC website on Monday, 11 April 2011.

4.9 cannabinoid (Sativex®) Bayer (No. 703/11)

The SMC advice for cannabinoid (Sativex®), as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy, will be published on the SMC website on Monday, 11 April 2011.

Deferred Advice

4.10 Nothing to report.

Amended Advice

4.11 Nothing to report.

5. Appeals Update

5.1 gefitinib 250mg film-coated tablets (Iressa®) Astra Zeneca Ltd (No. 615/10)

Astra Zeneca Ltd has indicated their intention to resubmit for gefitinib (Iressa), for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK). 

5.2 botulinum toxin type A 50 unit, 100 unit and 200 unit powder for solution for injection (Botox®)  Allergan Ltd.  SMC No. (692/11)

Allergan Ltd has indicated their intention to resubmit for botulinum toxin type A 50 unit, 100 unit and 200 unit powder for solution for injection (Botox®),  for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine). 

6. Patient and Public Involvement Group (PAPIG)

6.1 PAPIG Update

Mrs Tunstall-James advised that Mrs Helen Cadden and Mrs Anne Murray, Public Partners Designate, have now taken up full membership for SMC and PAPIG.

6.2 LTCAS Annual Conference

Mrs Tunstall-James and Ms Marie McHenery attended the LTCAS Annual Conference on 22 march 2011.  They manned a stand at this event and feedback received highlighted that there are still some people who do not know exactly what SMC do.

The Chairman thanked Mrs Tunstall-James for this feedback and agreed that, while we do try to promote what SMC does, there is more work required to be done in this area.

7. New Drugs Committee: Chairman’s Report

7.1 Dr Fox advised he had nothing to report.

8. Chairman’s Business

8.1 Healthcare Improvement Scotland

NHS Quality Improvement Scotland (QIS) is now Healthcare Improvement Scotland (HIS) and was established on the 1st April 2011. The organisation has been created by the Public Services Reform (Scotland) Act 2010 and its key purpose will be to improve the quality and safety of healthcare for the people of Scotland.  It will build on the work previously done by NHS QIS and the Care Commission. Healthcare Improvement Scotland will be a health body with NHS terms and conditions.

8.2 Appointment of SMC Co-Vice Chair

The SMC Chair was pleased to advise that Dr Jennifer Burns has agreed to take the role of SMC Co-Vice Chairman, effective from 01 April 2011.

8.3 Appointment of NDC Co-Vice Chair

The SMC Chair was pleased to advise that Mrs Alison Campbell has been appointed to the role of NDC Co-Vice Chairman, effective from 01 April 2011.

8.4 NICE (Multiple Technology Appraisal Guidance No.217 - Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease (review of NICE  technology  appraisal guidance 111)

The review and re-appraisal of donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease has resulted in a change in the NICE guidance. Specifically:

• donepezil, galantamine and rivastigmine are now recommended as options for managing mild as well as moderate Alzheimer’s disease, and
• memantine is now recommended as an option for managing moderate Alzheimer’s disease for people who cannot take AChE inhibitors, and as an option for managing severe Alzheimer’s disease.

SMC has previously issued advice for the following drugs and indications however, the NICE appraisal, published on 23rd March 2011, has been considered by NHS Quality Improvement Scotland through its revised procedure of processing of NICE appraisals.  No important differences were identified for this NICE appraisal and NHS Quality Improvement Scotland advises that the recommendations are as valid for Scotland as for England and Wales therefore the NICE MTA supersedes previous SMC advice.

NHSScotland should take account of the NICE appraisal and ensure that recommended drugs or treatments are made available to meet clinical need.

8.5 NICE Single Technology Appraisal Guidance No 218 – Azacitadine for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukemia and acute myeloid leukaemia

This NICE Guidance was published 23rd March 2011, as follows:

Azacitidine is recommended as a treatmentoption for adults who are not eligible for haematopoietic stem cell transplantation and have:
 
• intermediate-2 and high-risk myelodysplastic syndromes according to the International Prognostic Scoring System (IPSS) or
• chronic myelomonocytic leukaemia with 10–29% marrow blasts without myeloproliferative disorder or
• acute myeloid leukaemia with 20–30% blasts and multilineage dysplasia, according to the World Health Organization classification and
• if the manufacturer provides azacitidine with the discount agreed as part of the patient access scheme.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (589/09) on this medication for this indication in April 2010. This stated that:

Azacitidine (Vidaza®) is not recommended for use within NHS Scotland for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML).

There is a material difference between the recommendations of the NICE STA and the SMC. The NICE STA advice is based upon the application of a Department of Health agreed Patient Access Scheme and consideration of the medicine as a life-extending, end of life treatment.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 tocofersolan, 50mg/mL, oral solution (Vedrop®) Orphan Europe UK SMC No. (696/11)

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

9.1.2 The NDC Chair, provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  Detailed discussion followed and the group agreed that tocofersolan oral solution (Vedrop®), should not be recommended for use within NHS Scotland, for vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.  In an open-label, single-arm study, 96% of patients had an improved or stable neurological score after 2.5 years of treatment with tocofersolan.  The manufacturer did not supply any economic analysis therefore the cost-effectiveness could not be assessed.  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, 08 April 2011.

9.2 iron isomaltoside 1000, 100mg/mL solution for injection/infusion (Monofer®) Pharmacosmos UK SMC No. (697/11)

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, revised data/analyses and comments received from the company. Detailed discussion followed and the group agreed that iron isomaltoside 1000 (Monofer®), should be accepted for restricted use within NHS Scotland, for treatment of iron deficiency anaemia in the following conditions:

• When oral iron preparations are ineffective or cannot be used
• Where there is a clinical need to deliver iron rapidly

SMC restriction: use is restricted to administration by high dose infusion within the licensed indication but excluding use in patients receiving haemodialysis. The manufacturer’s economic case did not consider the cost-effectiveness of iv bolus administration or use in haemodialysis patients. Efficacy data are limited to two small open-label non-comparative studies in patients with chronic kidney disease and chronic heart failure.  Haemoglobin levels significantly increased from baseline in one study only.  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, 08 April 2011.

9.3 sunitinib 12.5mg, 25mg, 37.5mg, 50mg hard capsules (Sutent®) Pfizer Limited SMC No. (698/11)

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

9.3.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses, comments received from the company and a summary of information for patients.  Detailed discussion followed and the group agreed that sunitinib (Sutent®) is accepted for use within NHS Scotland, for treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults.  Treatment with sunitinib improved progression-free survival compared with placebo in patients with well-differentiated neuroendocrine carcinoma of the pancreas who were receiving best supportive care, including somatostatin analogues if required for symptomatic control.  This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of sunitinib. 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.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 April 2011. 

9.4 ticagrelor 90mg film-coated tablets (Brilique®)  AstraZeneca  SMC No. (699/11)

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

9.4.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company. Detailed discussion followed and the group agreed that 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).  As dual therapy with aspirin, ticagrelor demonstrated a significant reduction in ischaemic events compared with another antiplatelet drug without significantly increasing the incidence of study-defined major bleeding.  Alternative treatments are available at a lower drug acquisition cost.  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, 08 April 2011.

RESUBMISSION

9.5 quetiapine, 25mg, 100mg, 150mg, 200mg, 300mg tablets (Seroquel®), quetiapine, 50mg, 150mg, 200mg, 300mg, 400mg sustained release tablets (Seroquel XL®) AstraZeneca SMC No. (549/09)

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

9.5.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.   A member of PAPIG presented patient interest group submissions from Support in Mind Scotland (operating name of National Schizophrenia Fellowship (Scotland)) and Bipolar Scotland.  Detailed discussion followed and the group agreed that quetiapine (Seroquel/Seroquel XL®), should not be recommended for use within NHS Scotland, for treatment of major depressive episodes in bipolar disorder.  In monotherapy studies quetiapine was superior to placebo and compared favourably with two active comparators. Efficacy relative to current practice for the management of depression of bipolar disorder in NHS Scotland involving combination therapy with a mood stabiliser or an atypical antipsychotic plus an antidepressant was not demonstrated.  The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.  Quetiapine (Seroquel/Seroquel XL®) is also licensed for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. The manufacturer’s submission related only to use in the treatment of major depressive episodes in bipolar disorder. Therefore, SMC cannot recommend its use for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. 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, 08 April 2011.
 
NON SUBMISSION

9.6 tadalafil 20 mg film-coated tablets (Adcirca ®) Eli Lilly and Company Limited SMC No (710/11)

9.6.1 In the absence of a submission from the holder of the marketing authorization, tadalafil (Adcirca ®) should not be recommended for use within NHS Scotland, for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. 

9.6.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 08 April 2011.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. Area Drug & Therapeutics Committee (ADTC) Issues

11.1 Mr Alistair Thorburn advised that there has been some discussion in his own committee regarding individual patient requests and the use of unlicensed medicines, and asked whether there was any feedback from other ADTC committees.

Mrs Anne Lee advised that this is still work in progress with the Directors of Pharmacy and could be possibly be discussed at a future meeting.

12. SMC User Group Forum

12.1 Update from UGF Meeting

Dr Frances Macdonald advised she had nothing to report.

13. Any Other Business

13.1 Update on SAPG

Professor Dilip Nathwani will attend the SMC meeting on 03 May 2011 and provide a presentation and update on the work of SAPG. 

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 03 May 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 05 April 2011

Item 8.4 NICE (Multiple Technology Appraisal Guidance No.217 - Donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease (review of NICE  technology  appraisal guidance 111)

The review and re-appraisal of donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer’s disease has resulted in a change in the NICE guidance. Specifically:

• donepezil, galantamine and rivastigmine are now recommended as options for managing mild as well as moderate Alzheimer’s disease, and
• memantine is now recommended as an option for managing moderate Alzheimer’s disease for people who cannot take AChE inhibitors, and as an option for managing severe Alzheimer’s disease.

Guidance

1. The three acetylcholinesterase (AChE) inhibitors donepezil, galantamine and rivastigmine are recommended as options for managing mild to moderate Alzheimer’s disease under all of the conditions specified in 3 and 4.

2. Memantine is recommended as an option for managing Alzheimer’s disease for people with:

• moderate Alzheimer’s disease who are intolerant of or have a contraindication to AChE inhibitors or
• severe Alzheimer’s disease. Treatment should be under the conditions specified in 3.

3. Treatment should be under the following conditions:

• Only specialists in the care of patients with dementia (that is, psychiatrists including those specialising in learning disability, neurologists, and physicians specialising in the care of older people) should initiate treatment. Carers’ views on the patient’s condition at baseline should be sought.
• Treatment should be continued only when it is considered to be having a worthwhile effect on cognitive, global, functional or behavioural symptoms.
• Patients who continue on treatment should be reviewed regularly using cognitive, global, functional and behavioural assessment. Treatment should be reviewed by an appropriate specialist team, unless there are locally agreed protocols for shared care.  Carers’ views on the patient’s condition at follow-up should be sought.

4. If prescribing an AChE inhibitor (donepezil, galantamine or rivastigmine), treatment should normally be started with the drug with the lowest acquisition cost (taking into account required daily dose and the price per dose once shared care has started). However, an alternative AChE inhibitor could be prescribed if it is considered appropriate when taking into account adverse event profile, expectations about adherence, medical comorbidity, possibility of drug interactions and dosing profiles.

SMC has previously issued advice for the following drugs and indications however, the NICE appraisal, published on 23rd March 2011, has been considered by NHS Quality Improvement Scotland through its revised procedure of processing of NICE appraisals.  No important differences were identified for this NICE appraisal and NHS Quality Improvement Scotland advises that the recommendations are as valid for Scotland as for England and Wales therefore the NICE MTA supercedes previous SMC advice.

NHSScotland should take account of the NICE appraisal and ensure that recommended drugs or treatments are made available to meet clinical need.

donepezil 5mg & 10mg orodispersible tablets (Aricept Evess) SMC Drug ID: 307/06; Manufacturer: Eisai Ltd; Indication: Mild to moderately severe Alzheimer's dementia; Submission Type: Abbreviated Submission; Status: Accepted; Date Advice Published:  26/02/2007;

http://www.scottishmedicines.org.uk/SMC_Advice/Advice/donepezil_307_06/donepezil_5mg___10mg_orodispersible_tablets__Aricept_Evess_

galantamine hydrobromide  Reminyl XLP®    SMC Drug ID: 139/04; Manufacturer: Shire Pharmaceuticals; Indication: Mild-to-moderately severe dementia in Alzheimer's disease; Submission Type: Abbreviated Submission; Status: Accepted; Date Advice Published:  13/06/2005;

http://www.scottishmedicines.org.uk/SMC_Advice/Advice/Reminyl_XL__174___for_the_treatment_of_dementia_in_Alzheimer_s_disease/Reminyl_XL_SMC Adv

rivastigmine 4.6mg/24h and 9.5mg/24h transdermal Patch   SMC Drug ID: 414/07; Manufacturer: Novartis Pharmaceuticals UK Ltd; Indication: Alzheimer’s dementia; Submission Type: Abbreviated Submission; Status: Restricted; Date Advice Published:  12/11/2007;

memantine (Ebixa)   SMC Drug ID: 57/03; Manufacturer: Lundbeck Ltd; Indication: Moderately severe to severe Alzheimer's disease; Submission Type: Resubmission; Status: Not Recommended; Date Advice Published:  12/01/2004;

http://www.scottishmedicines.org.uk/SMC_Advice/Advice/Memantine__Ebixa__-_Resubmission/Memantine__Ebixa_

Item 8.5 NICE Single Technology Appraisal Guidance No 218 – Azacitadine for the  treatment of myelodysplastic syndromes, chronic myelomonocytic leukemia and acute myeloid leukaemia

This NICE Guidance was published 23rd March 2011, as follows:

Azacitidine is recommended as a treatmentoption for adults who are not eligible for haematopoietic stem cell transplantation and have:
 
• intermediate-2 and high-risk myelodysplastic syndromes according to the International Prognostic Scoring System (IPSS) or
• chronic myelomonocytic leukaemia with 10–29% marrow blasts without myeloproliferative disorder or
• acute myeloid leukaemia with 20–30% blasts and multilineage dysplasia, according to the World Health Organization classification and
• if the manufacturer provides azacitidine with the discount agreed as part of the patient access scheme.

The web reference for the appraisal and other related documents is: http://guidance.nice.org.uk/TA218.

NHSScotland should note that:

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

2. NHS Boards should continue to adhere to the SMC advice.

The Scottish Medicines Consortium (SMC) published a Statement of Advice (589/09) on this medication for this indication in April 2010. This stated that:

Azacitidine (Vidaza®) is not recommended for use within NHS Scotland for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML).

3. There is a material difference between the recommendations of the NICE STA and the SMC. The NICE STA advice is based upon the application of a Department of Health agreed Patient Access Scheme and consideration of the medicine as a life-extending, end of life treatment.