Technology Appraisal Committee Meeting (Committee D)

Transcription

1 Technology Appraisal Committee Meeting (Committee D) Minutes: Confirmed Date and Time: Wednesday 25 September 2013, 10:00 to 16:35 Venue: Level 1A, City Tower Piccadilly Plaza Manchester M1 4BT Present: 1. Professor Gary McVeigh, Chair 2. Dr Andrew Black 3. Dr Matthew Bradley 4. Dr Ian Campbell 5. Dr Ian Davidson 6. John Dervan 7. Professor Simon Dixon 8. Dr Martin Duerden 9. Christopher Earl 10. Dr Susan Griffin 11. Professor Carol Haigh 12. Dr Paul Hepple 13. Professor John Hutton 14. Professor Peter Jones 15. Dr John Radford 16. Dr Brian Shine 17. Dr Lindsay Smith 18. Dr Murray Smith 19. Paddy Storrie 20. Dr Alison Talbot-Smith Page 1 of 8

2 In attendance: Professor Adrian Bagust Donna Barnes Dr David Bottomley Meindert Boysen Zoe Charles Dr Ewen Cummins Dr John Graham Dr Janette Greenhalgh Joanne Holden Professor of Modelling in Health, Liverpool Reviews and Implementation Group Administrator, National Institute for Health and Care Clinical specialist nominated by British Uro- Oncology Group Programme Director, Technical Adviser, Lead Health Economist, Aberdeen Health Technology Assessment Group Guideline Development Group representative nominated by National Collaborating Centre for Cancer Research Fellow, Liverpool reviews and Implementation Group Technical Adviser, Helen Knight Thomas Lam Associate Director, Clinical Advisor, Aberdeen Health Technology Assessment Group Page 2 of 8

3 Nigel Lewis-Baker Mark Minchin Kate Moore Dr Craig Ramsay David Smith Dr Isabel Syndikus Nwamaka Umeweni Patient expert nominated by Prostate Cancer UK Technical Analyst, Project Manager, Programme Director, Aberdeen Health Technology Assessment Group Patient expert nominated by Prostate Cancer Support Federation Clinical specialist nominated by Royal College of Physicians Technical Analyst, Non-public observers: Ciara Donnelly Ann Greenwood Heidi Livingstone Seren Phillips Costing Analyst, National Institute for Health and Care Senior Medical Editor, Public Involvement Adviser, National Institute for Health and Care Associate Director, Scientific Advice, Present for notes all notes Page 3 of 8

4 Susannah Strong Medical Editor, National Institute for Health and Care Notes Welcome 1. The Chair welcomed all members of the Committee and other attendees present to the meeting. The Chair reviewed the agenda and timescales for the meeting, which included the appraisals of radium-223 dichloride for treating metastatic hormone relapsed prostate cancer with bone metastases and pemetrexed for maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small-cell lung cancer. 2. The Chair informed the Committee of the non-public observers at this meeting: Ciara Donnelly, Ann Greenwood, Heidi Livingstone and Susannah Strong. 3. Apologies were received from Dr Aomesh Bhatt, Professor Usha Chakravarthy, Tracey Cole, Gillian Ells, Professor John Henderson, Professor Paula Ghaneh, Professor Steven Julious, Dr Tim Kinnaird, Warren Linley, Professor Oluwafemi Oyebode and Professor Carolyn Young. Any other Business 4. None Appraisal of radium-223 dichloride for treating metastatic hormone relapsed prostate cancer with bone metastases Part 1 Open session 5. The Chair welcomed the invited experts: Dr David Bottomley, Dr Ewen Cummins, Thomas Lam, Nigel Lewis- Baker, Dr Craig Ramsay, David Smith, Dr Isabel Syndikus to the meeting and they introduced themselves to the Committee. 6. The Chair welcomed manufacturer representatives from Bayer to the meeting. 7. The Chair asked all Committee members to declare any relevant interests 7.1. Dr Andrew Black, Dr Matthew Bradley, Dr Ian Campbell, Dr Ian Davidson, John Dervan, Dr Martin Duerden, Christopher Earl, Dr Susan Griffin, Professor Carol Haigh, Dr Paul Hepple, Professor John Hutton, Professor Gary McVeigh, Dr John Radford, Dr Brian Shine, Dr Lindsay Smith, Dr Murray Smith, Paddy Storrie and Dr Alison Talbot-Smith all declared that they knew of no personal specific pecuniary interest, technologies to be considered as part of the appraisal of radium-223 dichloride for treating metastatic hormone relapsed prostate cancer with bone metastases. Page 4 of 8

5 7.2. Professor Simon Dixon was absent from the meeting as he had a personal pecuniary interest. Simon has undertaken work for Astellas, relating to enzalutamide in metastatic castration resistant prostate cancer for which he received payment. Whilst this manufacturer isn't listed as a comparator on the matrix, it is a direct comparator to abiratarone which is listed and is currently being appraised by NICE Professor Peter Jones was absent from the meeting as he had a personal pecuniary interest. Peter received payment from the manufacturer for providing scientific advice on this particular treatment. 8. The Chair asked all NICE Staff to declare any relevant interests All declared that they knew of no personal specific pecuniary interest, technologies to be considered as part of the appraisal of radium-223 dichloride for treating metastatic hormone relapsed prostate cancer with bone metastases. 9. The Chair asked the Guidance Development Group representative to declare any relevant interests Dr John Graham declared a personal non-specific pecuniary interest as he was a Principal Investigator for pharmaceutically funded trials of custersin in prostate cancer for Oncogenex Pharmaceuticals and orteronel in prostate cancer for Takeda Ltd It was agreed that this declaration would not prevent Dr John Graham from participating in this section of the meeting. 10. The Chair asked all other invited guests assessment group/erg and invited experts, not including observers) to declare their relevant interests All declared that they knew of no personal specific pecuniary interest, technologies to be considered as part of the appraisal of radium-223 dichloride for treating metastatic hormone relapsed prostate cancer with bone metastases. 11. The Chair introduced the lead team, Dr Andrew Black, John Dervan and Professor John Hutton who gave presentations on the clinical effectiveness and cost effectiveness of radium-223 dichloride for treating metastatic hormone relapsed prostate cancer with bone metastases. 12. The Committee then discussed the clinical effectiveness, patient perspective and cost effectiveness of radium-223 dichloride for treating metastatic hormone relapsed prostate cancer with bone metastases on the basis of the evidence before them, and potential equality issues raised in this appraisal. They sought clarification and advice from the experts present: Dr David Bottomley, Dr Ewen Cummins, Thomas Lam, Nigel Lewis- Baker, Dr Craig Ramsay, David Smith, Dr Isabel Syndikus. The discussions included: Page 5 of 8

6 12.1. Clinical need for treatment and current practice in the management of hormone-relapsed prostate cancer with bone metastases; including the relevant comparators for radium The clinical effectiveness of radium-223 plus best supportive care compared with placebo plus best supportive care based on the evidence from the ALSYMPCA trial; including generalisability of the trial The cost effectiveness of radium-223 plus best supportive care compared with best supportive care alone including: the model assumptions, model data sources, model outputs and results, uncertainty and sensitivity analyses The ERG s exploratory analyses Aspects of innovation associated with radium Potential equality issues 13. The Chair asked the manufacturer representatives whether they wished to comment on any matters of factual accuracy. 14. The Chair explained that representatives of the press and other members of the public be excluded from the remainder of this meeting having regard to the confidential nature of the business to be transacted, publicity on which would be prejudicial to the public interest" (Section 1(2) Public Bodies (Admission to Meetings) Act 1960) and all public attendees left the meeting. 15. The Chair then thanked the experts and manufacturer representatives for their attendance, participation and contribution to the appraisal and they left the meeting. Part 2 Closed session 16. Discussion on confidential information continued. This information was supplied by Bayer. 17. The Committee instructed the technical team to prepare the Appraisal Consultation Document (ACD) in line with their decisions. Appraisal of pemetrexed for maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small-cell lung cancer Part 1 Open session 18. The Chair welcomed the invited experts: Professor Adrian Bagust and Dr Janette Greenhalgh to the meeting and they introduced themselves to the Committee. 19. The Chair welcomed manufacturer representatives from Lilly UK to the meeting. 20. The Chair asked all Committee members to declare any relevant interests Dr Andrew Black, Dr Matthew Bradley, Dr Ian Campbell, Dr Ian Davidson, John Dervan, Professor Simon Dixon, Christopher Earl, Dr Page 6 of 8

7 Susan Griffin, Professor Carol Haigh, Professor John Hutton, Professor Peter Jones, Professor Gary McVeigh, Dr John Radford, Dr Brian Shine, Dr Lindsay Smith, Dr Murray Smith, Paddy Storrie and Dr Alison Talbot- Smith all declared that they knew of no personal specific pecuniary interest, personal non-specific pecuniary interest, non-personal specific pecuniary interest, non-personal non-specific pecuniary interest, personal specific family interest or personal non-specific family interest for any of the technologies to be considered as part of the appraisal of pemetrexed for maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small-cell lung cancer. 21. The Chair asked all NICE Staff to declare any relevant interests All declared that they knew of no personal specific pecuniary interest, technologies to be considered as part of the appraisal of pemetrexed for maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small-cell lung cancer. 22. The Chair asked all other invited guests assessment group/erg and invited experts, not including observers) to declarations their relevant interests All declared that they knew of no personal specific pecuniary interest, technologies to be considered as part of the appraisal of pemetrexed for maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small-cell lung cancer. 23. The Chair introduced the key themes arising from the consultation responses to the Appraisal Consultation Document (ACD) received from consultees, commentators and through the NICE website. 24. The Committee proceeded to discuss the clinical effectiveness and cost effectiveness of Pemetrexed for maintenance treatment following induction therapy with pemetrexed and cisplatin for non-squamous non-small-cell lung cancer on the basis of the evidence before them. The discussions included: The manufacturer s updated revised base case The ERG s response to the manufacturer s updated revised base case The requirement for extrapolating overall survival Calculating end of life population sizes Potential equity and equality issues 25. The Chair asked the manufacturer representatives whether they wished to comment on any matters of factual accuracy. 26. The Chair explained that representatives of the press and other members of the public be excluded from the remainder of this meeting having regard to the confidential nature of the business to be transacted, publicity on which would be prejudicial to the public interest" (Section 1(2) Public Bodies (Admission to Page 7 of 8

8 Meetings) Act 1960) and all public attendees left the meeting. 27. The Chair then thanked the experts and manufacturer representatives for their attendance, participation and contribution to the appraisal and they left the meeting. Part 2 Closed session 28. The Committee instructed the technical team to prepare a third Appraisal Consultation Document (ACD) in line with their decisions. Date, time and venue of the next meeting 29. Tuesday 29 October 2013, 10:00 to 12:30 to at Health and Care, Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BT. Page 8 of 8