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SMC Minutes: Tuesday 2 November 2010

Minutes of the SMC Meeting
held on Tuesday 02 November 2010
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present: 
Professor Ken Paterson (Chairman), Dr Keith Beard, Mrs Margo Biggs, Dr Keith Brown, Dr Jennifer Burns, Professor Scott Bryson, Mr Robert Calderwood, Dr Dominic Culligan, Dr David Dunlop, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie, Dr Jan Jones, Dr Chris Lush, Dr Alan MacDonald, Dr Frances Macdonald, Dr John McElhinney, Dr James McLay, Mrs Sandra McNaughton, Dr Simon Maxwell, Mrs Veronica Moffat, Ms Aileen Muir, Dr Anthony Ormerod, Dr Mercia Page, Dr Andrew Power,  Mr Michael Pratt, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker, Professor Tony Wells

In Attendance:
Ms Helen Anstruther, Mrs Corinne Booth, Ms Ailsa Brown, Mrs Alison Campbell, Mrs Susan Downie, Mr Stephen Ferguson, Dr Gordon Forrest, Mrs Anne Lee, Ms Alex Robertson, Mrs Maureen Stark, Professor Matthew Walters

Apologies:
Mrs Laura Ace, Professor James Barbour, Mr Colin Brown, Mr Dave Carson, Ms Jane Davidson, Dr Sara Davies, Dr Jacqui Howes, Ms Marie McHenery, Dr Paul McNamee, Ms Rosie Murray, Professor Dilip Nathwani, Dr Robert Peel, Mr Andrew Powrie-Smith, Dr Brian Robson, Mrs Catherine Tait, Dr Sarah Taylor, Mr Keith Thompson, Mr Alistair Thorburn, Professor David Wray


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 Ms Helen Anstruther, Scottish Government Health Directorate, who was observing the meeting, and to the following NDC members/Lead Assessors,  who were presenting submissions to SMC:

  • Mrs Alison Campbell
  • Dr Gordon Forrest
  • Professor Matthew Walters

1.3 Regrettably, Mr Andrew Powrie-Smith has terminated his membership of SMC.  He has recently moved to a new post within ABPI and due to conflicting pressures he is no longer able to attend SMC. The Chairman thanked Mr Powrie-Smith for his enthusiasm, commitment and active contribution to SMC, the SMC User Group (UGF) and the Patient and Public Involvement Group (PAPIG). 

The Chairman was pleased to welcome Mrs Sandra Auld, Operations Director, ABPI Scotland, who will replace Mr Andrew Powrie-Smith on SMC, UGF and PAPIG.

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 (05 October 2010)

3.1 The minutes of the SMC meeting held on 05 October 2010 were accepted as an accurate record of the meeting.

The Chairman drew members’ attention to the method for recording NICE decisions in SMC’s minutes.  The minutes will now provide a concise note but full details of the NICE decision will be recorded in an appendix to the SMC minutes.

4. Matters Arising

Full Submissions

4.1 glucosamine sulphate 1,500mg powder for oral solution (Glusartel®)
SMC No. (647/10) Rottapharm Madaus

4.1.1 The SMC advice for glucosamine sulphate 1,500mg powder for oral solution (Glusartel®), for the relief of symptoms in mild to moderate osteoarthritis (OA) of the knee, will be published on the SMC website on Monday, 08 November 2008.

4.2 eculizumab, 300mg concentrate for solution for infusion (Soliris®)
SMC No. (436/07)  Alexion Pharma UK Ltd
   

4.2.1 The SMC advice for eculizumab, 300mg concentrate for solution for infusion (Soliris), for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), will be published on the SMC website on Monday, 08 November 2008.

4.3 oxycodone hydrochloride 50mg/ml solution for injection or infusion (OxyNorm®)
SMC No. (648/10)  Napp Pharmaceuticals Limited  

4.3.1 The SMC advice for oxycodone hydrochloride 50mg/ml solution for injection or infusion (OxyNorm®), for the treatment of moderate to severe pain in patients with cancer, will be published on the SMC website on Monday, 08 November 2008.

Resubmissions

4.4 eslicarbazepine acetate 800mg tablet (Zebinix) SMC No. (592/09)  Eisai Ltd

4.4.1 The SMC advice for eslicarbazepine acetate 800mg tablet (Zebinix), as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation, will be published on the SMC website on Monday, 08 November 2008.

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

 
The SMC advice for trabectedin, 0.25mg and 1mg powder for concentrate for solution for infusion (Yondelis®), for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents, will be published on the SMC website on Monday, 08 November 2008.

Non Submissions

4.6 canakinumab 150 mg/mL powder for solution for injection (Ilaris®)
SMC No. (658/10)  Novartis Pharmacuticals

4.6.1 The SMC advice for canakinumab 150 mg/mL, powder for solution for injection (Ilaris®), for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older with body weight above 15 kg, will be published on the SMC website on Monday, 08 November 2008.

4.7 docetaxel 20 mg/1mL and 80 mg/4mL and 160 mg/8mL concentrate for solution for infusion (Taxotere ®)
SMC No. (659/10)  Sanofi Aventis

4.7.1 The SMC advice for docetaxel 20 mg/1mL and 80 mg/4mL and 160 mg/8mL concentrate for solution for infusion (Taxotere ®), for the treatment of adjuvant treatment of patients with operable node-negative breast cancer, will be published on the SMC website on Monday, 08 November 2008.

4.8 amifampridine (Firdapse®)
SMC No. (660/10) BioMarin

The SMC advice for amifampridine (Firdapse®), for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults, will be published on the SMC website on Monday, 08 November 2008.

Deferred Advice

4.9 Nothing to report.

Amended Advice

4.10 Nothing to report.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes of the  PAPIG Meeting (05 October 2010)

The minutes of the PAPIG Meeting held on 05 October 2010 were tabled and noted.

6.2 European Platform  for Patient Organisations, Science and Industry (EPPOSI)

Mrs Tunstall-James will participate in the November meeting of EPPOSI, in Brussels, to discuss patient engagement in health technology appraisals (HTAs).

6.3 Recruitment of Public Partners

A recruitment exercise is currently underway to replace two of our Public Partners.

7. New Drugs Committee: Chairman’s Report

7.1 NDC/SMC Work Programme

Dr Jones advised members that, over the past few months SMC has received a significant number of submissions therefore, NDC and SMC agendas will be heavier than normal for the next few months.   

Due to the increased workload and resource issues, SMC has had to defer some submissions by up to three months.  Most of the deferred submissions have now been scheduled with the remainder to be scheduled in November.  It is therefore hoped that standard timelines for assessment will be resumed in early 2011.  

Dr Jones also highlighted the large size of some of the submissions received, with some running to more than 300 pages.  She asked whether there is anything that industry members can do to educate companies on the need to provide a concise, focused submission.

7.2 The German Federal Joint Committee for Health (G-BA) meeting in Berlin in October, 2010

The German Federal Joint Committee for Health is currently studying the SMC process with a view to introducing a similar health technology appraisal (HTA) system in Germany.  Dr Jones and Mrs Biggs (SMC Public Partner) attended a meeting with the G-BA in October to share experience of patient and public involvement in an HTA setting.

8. Chairman’s Business

8.1 Appointment  of NDC Chairman

Dr Jan Jones’ term of office, as Chair of NDC, ends in January 2011.  Following a selection process Dr Jonathan Fox, Consultant Nephrologist at Glasgow Royal Infirmary, has been appointed as her successor.  Dr Fox will chair NDC from February 2011.

The Chairman thanked Dr Jones for the huge commitment she has given to NDC and SMC and congratulated Dr Fox on his appointment.
 
8.2 Appointment  of SMC Chairman

Professor Paterson’s term of office as Chair of SMC will end in April 2011. Nominations have been requested and a selection process to secure his successor will follow. 
 
8.2 SMC Website

The redeveloped SMC website went live on Friday 1 October, 2010.  Members’ feedback on the live site would be welcome and should be directed to the SMC Secretariat.

8.3 NICE Single Technology Appraisal (STA) No.206 – bendamustine for the treatment of indolent (low grade) non-Hodgkin’s lymphoma that is refractory to rituximab (terminated appraisal)

NICE is unable to recommend the use of bendamustine for the treatment of indolent (low grade) non-Hodgkin's lymphoma that is refractory to rituximab or a rituximab-containing regimen because no evidence submission was received from the manufacturer or sponsor of the technology.
SMC is in discussion with the manufacturer on their intention to make a submission for bendamustine for the treatment for non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM).   Dependant on the outcome of the discussions, SMC will consider issuing 'not recommended' advice based on a non-submission for this indication.

There is no material difference between the current status of this product at SMC and   NICE.  Detailed information in relation to the above is provided in the attached appendix.

8.4 NICE Single Technology Appraisal (STA) No.207 – temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma (terminated appraisal)

NICE is unable to recommend the use of temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma because no evidence submission was received from the manufacturer or sponsor of the technology.
In the absence of a submission from the holder of the marketing authorisation, SMC published a non-recommendation for temsirolimus (Torisel), for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL), in April 2010.
There is no material difference between the current status of this product at SMC and   NICE.  Detailed information in relation to the above is provided in the attached appendix.

8.5 The Role of NICE in Assessing the Cost Effectiveness of Medicines

SMC noted the recent Department of Health statement on the role of NICE in assessing the cost effectiveness of medicines for use in England and Wales and the subsequent consultation on proposed changes.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 moxifloxacin hydrochloride intravenous, 400mg/250mL, solution for infusion (Avelox IV)  Bayer Schering  (No. 650/10)

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

9.1.2 The NDC 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 moxifloxacin hydrochloride in sodium chloride for infusion (Avelox IV), should be accepted for restricted use in NHS Scotland, for the treatment of community acquired pneumonia (CAP).  Moxifloxacin hydrochloride in sodium chloride for infusion (Avelox IV) should only be used on the advice of microbiologists or specialists in infectious diseases.   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, 05 November 2010.

9.2 denosumab 60mg solution for injection in a pre-filled syringe (Prolia) Amgen (No. 651/10)

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

9.2.2 The NDC 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 the National Osteoporosis Society.  Detailed discussion followed and the group agreed that denosumab (Prolia), should be accepted for restricted use in NHS Scotland, for the treatment of osteoporosis in postmenopausal women at increased risk of fractures.  Its use should be restricted to patients with a bone mineral density (BMD) T-score < -2.5 and ≥ -4.0 for whom oral bisphosphonates are unsuitable due to contraindication, intolerance or inability to comply with the special administration instructions.    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, 05 November 2010.

9.3 dexamethasone 700 microgram intravitreal implant (Ozurdex) Allergan Ltd (No. 652/10)  
 
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 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 RNIB Scotland.  Detailed discussion followed and the group agreed that dexamethasone intravitreal implant (Ozurdex), should not be recommended for use in NHS Scotland, for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).  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, 05 November 2010.

9.4 prucalopride 1mg and 2mg tablet (Resolor) Movetis UK (653/10)

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 Lead Assessor provided an overview of the assessment, draft advice, expert comments, and comments received from the company. Detailed discussion followed and the group agreed that prucalopride (Resolor), should not be recommended for use in NHS Scotland, for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief.  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, 05 November 2010.

9.5 tapentadol 50, 100, 150, 200 and 250mg prolonged-release tablets (Palexia) Grunenthal Ltd (654/10)

9.5.1 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.

9.5.2 The NDC Lead Assessor provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from Pain Concern.  A further submission was received from Action On Pain and was noted.  Detailed discussion followed and the group concluded their advice for tapentadol (Palexia), for the management of severe chronic pain which can be adequately managed only with opioid analgesics. 

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

RESUBMISSIONS

9.6 ranolazine 375mg, 500mg and 750mg prolonged-release tablets (Ranexa)
A Menarini Pharma UK SRL (No. 565/09)
 
9.6.1 There were no declarations of interest 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 British Cardiac Patients Association.  Detailed discussion followed and the group agreed that ranolazine (Ranexa), should not be recommended for use in NHS Scotland, as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta blockers and/or calcium antagonists).  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, 05 November 2010.

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

9.7.1 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.

9.7.2 The NDC 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 the Roy Castle Lung Cancer Foundation.  Detailed discussion followed and the group agreed that gefitinib (Iressa), should not be recommended for use in NHS Scotland, 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).  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, 05 November 2010.

ABBREVIATED SUBMISSIONS

9.8 etonogestrel 68mg implant (Nexplanon) Merck Sharp & Dohme (No. 655/10) 

9.8.1 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.

9.8.2 The NDC Vice Chair provided an overview of the assessment and draft advice. Detailed discussion followed and the group agreed that etonogestrel 68mg implant (Nexplanon), should be accepted for use in NHS Scotland, for contraception.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.8.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 November 2010.

9.9 atazanavir 150, 200 and 300mg capsules (Reyataz) Bristol Myers Squibb Pharmaceuticals Ltd (No. 656/10)

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

9.9.2 The NDC Vice Chair provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group agreed that atazanavir (Reyataz), should be accepted for use in NHS Scotland, co-administered with low dose ritonavir, for the treatment of HIV in paediatric patients 6 years of age and older in combination with other antiretroviral medicinal products.  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, 05 November 2010.

9.10 tacrolimus granules for suspension (Modigraf) Astellas Pharma Ltd (No. 657/10)

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

9.10.2 The NDC Chair provided an overview of the assessment and draft advice. Detailed discussion followed and the group agreed that tacrolimus granules for suspension (Modigraf), should be accepted for restricted use in NHS Scotland, for the prophylaxis of transplant rejection in kidney, liver or heart allograft recipients and for the treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.  Its use should be restricted to patients for whom tacrolimus is an appropriate choice of immunosuppressive therapy and where small changes (less than 0.5mg) in dosing increments are required (e.g. in paediatric patients) or seriously ill patients who are unable to swallow tacrolimus capsules.  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, 05 November 2010.

NON-SUBMISSIONS

9.11 diclofenac 4% spray gel (Mobigel Spray ®) Goldshield Group Plc (No: 667/10)

9.11.1 In the absence of a submission from the holder of the marketing authorisation, diclofenac 4% spray gel (Mobigel Spray ®), for the relief of pain following acute blunt trauma, 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, 05 November 2010.

9.12 fondaparinux sodium (Arixtra ®) GlaxoSmithKline (No: 668/10)

9.12.1 In the absence of a submission from the holder of the marketing authorisation, fondaparinux sodium (Arixtra®) for the treatment of spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep vein thrombosis, should not be recommended for use within NHS Scotland.

9.12.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 November 2010.

9.13 denosumab (Prolia) Amgen (No: 670/10)

9.13.1 In the absence of a submission from the holder of the marketing authorisation, denosumab (Prolia), for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, should not be recommended for use within NHS Scotland.

9.13.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 05 November 2010.

10. Forthcoming Submissions

10.1 A list of forthcoming submissions was tabled and noted. 

11. Area Drug & Therapeutics Committee (ADTC) Issues

11.1  SMC Advice for dronedarone (Multaq) (No.636/10)

A member indicated that SMC’s advice for dronedarone (Multaq) for atrial fibrillation (AF) is proving confusing for cardiologists.  SMC has accepted Multaq for restricted use however the restriction appears open to more than one interpretation. 

The Chairman noted the point and agreed that SMC should revisit the advice and provide clarification for ADTCs and cardiologists.

11.2 Calcium Supplements

Physicians have alerted SMC to an issue relating to calcium supplements and cardiovascular risk associated with additional vitamin D.  Boards already have established treatment guidelines, based on at least 2 systematic reviews.   However, a recent abstract from a BMJ meta analysis provides conflicting evidence which is provoking some debate amongst clinicians.   

Boards are considering issuing individual statements relating to the new analysis but believe that a statement from NHS Scotland may be more appropriate and have therefore asked whether SMC could provide national guidance.

SMC agreed that approach seems sensible and suggested that SMC could issue national guidance after consultation with Area Drug and Therapeutic Committees.

12. SMC User Group Forum (UGF)

12.1 Verbal Update: Dr Frances Macdonald

The User Group Forum met on 26 October 2010 and minutes of the meeting will be available to SMC on 07 December 2010.   Work is progressing in all UGF Sub Groups, as the minutes will note.

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 07 December 2010 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 02 November 2010

8.3 NICE Single Technology Appraisal (STA) No.206 – bendamustine for the treatment of indolent (low grade) non-Hodgkin’s lymphoma that is refractory to rituximab (terminated appraisal)

Advice
NICE is unable to recommend the use in the NHS of bendamustine for the treatment of indolent (low grade) non-Hodgkin's lymphoma that is refractory to rituximab or a rituximab-containing regimen because no evidence submission was received from the manufacturer or sponsor of the technology.


Background
The manufacturer of bendamustine (Napp Pharmaceuticals) was invited to submit evidence for this single technology appraisal (STA) in May 2010.
In June 2010, the manufacturer informed NICE that it would not be making an evidence submission because it was unable to identify relevant sources of clinical evidence suitable for a NICE appraisal in people with rituximab-refractory disease. The manufacturer indicated that further research was ongoing but data would not be available in a time frame that would allow NICE to produce timely guidance.

NICE has therefore terminated this single technology appraisal.

Information from NICE
NHS organisations should take into account the reasons why the manufacturer did not make an evidence submission when considering whether or not to recommend local use bendamustine for the treatment of indolent (low grade) non-Hodgkin's lymphoma that is refractory to rituximab or a rituximab-containing regimen. If, after doing this, organisations still wish to consider the use of bendamustine for the treatment of indolent (low grade) non-Hodgkin's lymphoma that is refractory to rituximab or a rituximab-containing regimen, they should follow the advice set out in ‘Good practice guidance on managing the introduction of new healthcare interventions and links to NICE technology appraisal guidance' (www.dh.gov.uk/en/DH_064983)

Information from SMC
SMC is in discussion with the manufacturer on their intention to make a submission for bendamustine for the treatment for non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Dependant on the outcome of such discussions SMC will consider issuing a non- recommendation based on a non-submission for this indication.

There is no material difference between the current status of this product at SMC and   NICE.

8.4 NICE Single Technology Appraisal (STA) No.207 – temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma (terminated appraisal)

Advice
NICE is unable to recommend the use in the NHS of temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma because no evidence submission was received from the manufacturer or sponsor of the technology.

Background

The manufacturer of temsirolimus (Wyeth) was invited to submit evidence for this single technology appraisal (STA) in November 2009.
In January 2010, the manufacturer informed NICE that it would not be making an evidence submission. The manufacturer subsequently confirmed this in August 2010. Given the rarity of the condition, the complex clinical management of mantle cell lymphoma and the large number of comparator regimens used in the single randomised clinical trial, the manufacturer did not believe that an adequate assessment of the clinical and cost effectiveness of temsirolimus would be possible.
NICE has therefore terminated this single technology appraisal.

Information from NICE
NHS organisations should take into account the reasons why the manufacturer did not make an evidence submission when considering whether or not to recommend local use of temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma. If, after doing this, organisations still wish to consider the use of temsirolimus for the treatment of relapsed or refractory mantle cell lymphoma, they should follow the advice set out in Good practice guidance on managing the introduction of new healthcare interventions and links to NICE technology appraisal guidance which outlines the approach that should be adopted in circumstances where NICE guidance is unavailable.

Information from SMC
In the absence of a submission from the holder of the marketing authorisation, SMC published a non-recommendation for temsirolimus (Torisel) for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL) in April 2010.

There is no material difference between the current status of this product at SMC and NICE.