Scottish Health Technologies Group Date 18 February :00-16:30 Venue Delta House, Glasgow

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Scottish Health Technologies Group Date 18 February 2016 14:00-16:30 Venue Delta House, Glasgow Present Iain Robertson Andrew Marsden Mark Cook Deirdre Evans Karen Facey Mike Higgins Scott Johnstone Gordon McLaren Paul Mce Daniel McQueen William Moore Neil Smart Sara Twaddle Hugo van Woerden Hester Ward Louise Wilson Derek Yuille In attendance Ed Clifton Sara Davies Karen Macpherson Audrey McPetrie Susan Myles Moray Nairn Representing Chair SHTG Vice Chair SHTG Association of British Healthcare Industries representative National Planning Forum representative (by teleconference) Evidence Based Health Policy Consultant Scottish Association of Medical Directors representative Scottish Life Sciences Advisory Board representative (deputy for John A Brown) NHS Fife Health Economics Research Unit, University of Aberdeen (teleconference) Public Partner NHS Grampian NHS Greater Glasgow and Clyde NHS Highland (by teleconference) NHS National Services Scotland NHS Orkney (by teleconference) Directors of Finance Group representative, NHS Lanarkshire Title Senior Health Economist, Scottish Government Health and Social Care Directorates Lead Health Service Researcher, Temporary Administrative Officer, SHTG Unit Head/Lead Health Economist, Healthcare Improvement Scotland, Scottish Intercollegiate Guideline Network File : Draft minute of 18 February 2016 v0.1 Version: 1.0 Date: 21 October 2016 Produced by: Page: 1 Review date: n/a

Observers Christine Gregson Sarah Harley Olivia McDougall Apologies Dawn Carmichael James Cowan Carol Davidson Jane Davidson Sara Davies James Miller Lynne Nicol Fiona Ramsay Ralph Roberts Brian Robson Elizabeth Sadler Lorna Wiggin Title Representing NHS Borders (deputy for Jane Davidson) NHS Lothian NHS Ayrshire & Arran/Directors of Public Health Group NHS Borders Scottish Government National Procurement Scottish Government Health and Social Care Directorates NHS Forth Valley/Directors of Finance Group NHS Shetland/Board Chief Executives Group Scottish Government Health and Social Care Directorates NHS Tayside Item no Item Action Opening business 1 Welcome, introductions and apologies for absence The Chair welcomed members present and those participating by teleconference. He welcomed Audrey McPetrie, Temporary Administrator who would be with the group until 31 March 2016, in addition to Christine Gregson, Sarah Harley and Olivia McDougall, all from HIS, who were observing the meeting. Lorna Thompson and Sasha McKaig were in attendance for the Mitraclip Advice Statement. Apologies for absence were noted. 2 Declarations of interest One potential declaration of interest had been submitted in advance of the meeting relating to Mitraclip. This was from the industry member working in the field of cardiac medicine. However, as Medtronic has no comparable technology and does not produce a product to rival Mitraclip, it was agreed there was no conflict of interest. 3 Minutes and matters arising from 10 December 2015 File : Minute of 18 February 2016 v1.0docx.docx Version: 1.0 Date: 21 October 2016 Produced by: Page: 2 Review date: n/a

All matters arising from the minutes of 10 December were complete or in hand. The Advice Statements on COPD and hypertension were endorsed by members in January and publication/dissemination is pending upon finalisation of the associated evidence notes. It is expected these will be completed in mid/early March. Work is ongoing on the IMTO process. SHTG Advice Statements 4 What is the clinical effectiveness, safety and cost-effectiveness of the MitraClip transcatheter mitral valve repair system in patients with moderate to severe or severe mitral regurgitation who are at high surgical risk or are non-surgical candidates? For the benefit of new members, the Chair reminded everyone of the purpose/status of Advice Statements. The Chair directed members to paper 16-03, the draft Advice Statement on the Mitraclip transcatheter mitral valve repair system. The Health Services Researcher and Health Economist gave the presentation embedded below: 20160108MitralValve LT SM.pptx The Advice Statement had been drafted based on the findings from an evidence note. The evidence note was based on a EUnetHTA rapid review on transcatheter implantable devices for mitral valve repair in adults with chronic mitral valve regurgitation, following consultation with the Scottish Cardiac Society. The topic introducer took the committee through the draft Advice Statement paragraph by paragraph and a number of points were discussed as below: Cost effectiveness The cost in the Advice Statement of 16,000 was quoted excluding VAT, it was noted that several devices may be required per patient and staff time to perform the procedure was not included. VAT is payable on all medical devices. The cost of the device would be modified to include VAT. There had already been a number of referrals to the NHS in Scotland for Mitraclip so the member from the National Procurement Forum offered to investigate this further. A member sought clarification on whether the gold standard to which Mitraclip was being compared to was surgery. The researchers clarified that the comparator is medical management as the research Deirdre Evans File : Minute of 18 February 2016 v1.0docx.docx Version: 1.0 Date: 21 October 2016 Produced by: Page: 3 Review date: n/a

focused on patients either at high surgical risk or who were not surgical candidates. Context. Clarification was sought on the commissioning criteria that would be applied if considering development of a national service for NHS Scotland. A member commented that a key criteria required to commission a national service is proven effectiveness and Mitraclip is not yet proven. It was suggested that details of this could be added to the Evidence Note rather than to the Advice Statement. After some discussion, it was agreed to: Delete the hyperlink to the European study Delete the hyperlinks to the RCTs Delete the last paragraph regarding the anticipated application to establish a national service for Mitraclip It was agreed that the link to the NICOR registry should remain as NICOR is the main vehicle for ongoing data collection. The Chair reminded members that if further amends/endorsement of the Advice Statement is required post-shtg consideration, these will be circulated to members by email. It will be assumed that members are content to endorse unless we hear from them to the contrary. Special business 5 International reflections on innovation in HTA Karen Facey delivered a presentation entitled International reflections on innovation in HTA. This was based on a paper entitled Improving effectiveness and efficiency in HTA which she had co-authored and which had been circulated with the papers for information. HTAi PF 2015 SHTG meeting presentation. 6 Presentation on A report for the Innovation Board Partnership June 2015 Philip Rutledge delivered a presentation entitled International reflections on innovation in HTA which was a summary of the results of his research and report commissioned by the Innovation Partnership Board (IPB) to consider whether there was a better way of presenting and using evidence to introduce beneficial innovations into NHSScotland. Is there a better way pptfinal to SHTG The four recommendations outlined in the report were discussed by File : Minute of 18 February 2016 v1.0docx.docx Version: 1.0 Date: 21 October 2016 Produced by: Page: 4 Review date: n/a

the committee. There was agreement to explore how SHTG could take these forward accepting that some elements such as the status of SHTG Advice Statements was not directly controlled by the group. The Chair thanked both speakers for their wide ranging and thought provoking presentations and assured Dr Rutledge that SHTG would consider the recommendations in his report. 7 Summary of post publication feedback on evidence reviews The Chair reminded members that as per our standard process, feedback is sought from stakeholders following publication of all Advice Statements. A number of responses had just recently been received relating to recent publications so on this occasion members would receive an update by email. Committee governance 8 Revised standing orders Further to the members development day in December, the secretariat had reviewed and refreshed the standing orders for SHTG. The standing orders had also been reviewed by the SHTG Executive Group and would be circulated to SHTG following the meeting for members to review and note the content and adopt. Any observations/comments should be directed to the secretariat. All 9 Risk management The Chair directed members to paper 16-5 Risk management which had been circulated for information. In February 2015, members endorsed the proposal that management of the risk register be devolved to the Executive Group and that regular updates would be provided by the Chair in his update report with only high or very high risks being reported. The full risk register would be shared with SHTG on an annual basis. During the period February 2015 2016, the Executive Group had reviewed the risk register four times (11 May 2015, 22 June 2015, 5 October 2015 and 25 January 2016). The secretariat also reviews and reports against this on a monthly basis. A number of new and closed risks were detailed in paper 16-05. The Risk Management Strategy has been updated for 2015 2017, and was approved by the Board on 25 November 2015. There were no substantive changes to the strategy. A copy of the new strategy is available from the secretariat on request. Definitions of the risk categories, likelihood, risk appetite and impact are provided in Appendix 2 of the paper. File : Minute of 18 February 2016 v1.0docx.docx Version: 1.0 Date: 21 October 2016 Produced by: Page: 5 Review date: n/a

It was suggested that having meetings in public from April was a risk which should be added to the register. There were no Advice Statements due to be tabled at the April meeting so the Chair was due to propose a different format to the April meeting in his Chair s Update see below. The first meeting in public would therefore be held in July and whether this should be added to the risk register was under discussion at the Executive Group. The Chair pointed out that a typing error in the second operational risk relating to the health and social care integration agenda in Appendix 1. The Current Risk Level should read Medium - 9, not 1. Any queries on the risk register should be directed to the secretariat. All Standing business 10 Chair s update report The Chair spoke to paper 16-06 and highlighted some issues in particular: Non Medicines Technologies (NMT) strategic plan The draft plan has now been published on the website and issued for external consultation with key stakeholders. The consultation would run from mid-february until Friday 11 March 2016. Health Innovation Assessment Portal (HIAP) The HIAP was launched in April 2014 as a single entry point for all forms of innovative technology to NHS Scotland. The model is a webportal which allows manufacturer submission and subsequent assessment by expert assessors supported by the HIAP review panel. The HIAP was currently hosted by NHS National Procurement (NHSNP) but there had been approaches from NHSNP suggesting that HIS/SHTG should take primary responsibility for providing and developing the HIAP. The SHTG Executive Group had undertaken a SWOT analysis and had decided SHTG was not best placed to take this on at the current time. Copies of the SWOT analysis were available on request and a copy would be sent to Jim Miller in National Procurement. SHTG meeting scheduled for 28 th April 2016 There were no Advice Statements due to be considered at the next meeting on 28 th April 2016 so the Chair proposed that the meeting take the format of a workshop to consider the Landing Zone commission (as outlined in Paper 16-07) and the NMT outcomes planning evaluation (OPE) framework. All members were encouraged to attend if possible in order to give their input into these pieces of work. 13 Other update reports Innovation Partnership Board and Scottish Government innovation activities The Chair directed members to paper 16-07. File : Minute of 18 February 2016 v1.0docx.docx Version: 1.0 Date: 21 October 2016 Produced by: Page: 6 Review date: n/a

SHTG Work Programme The SHTG work programme update outlined the projects until the end of the calendar year. It has now been expanded to report on strategic/operational developments in addition to the evidence review work programme. Any comments should be addressed to the by email. A written update would be circulated with the minutes. Verbal updates were given on the following: NICE There were no updates since the last meeting. National Planning Forum There were no updates since the last meeting. Closing business Industry User Group Forum (IUGF) The IUGF Chair noted he would produce a written report for circulation in the next few weeks. 14 Any other business The Chair announced that Doreen Pedlar would be leaving HIS at the end of March. He thanked her for all her hard work for SHTG and also for the invaluable support she had given him when he had taken over as Chair of the committee. 15 Date and time of next meeting The next meeting would take place on Thursday 28 April 2016 in Meeting rooms 6A/6B, 6 floor, Delta House, Glasgow. As reported, this meeting would not be held in public and would take the format of a workshop to consider the Landing Zone commission and the NMT outcomes planning evaluation (OPE) framework. Contact: shtg.hcis@nhs.net File : Minute of 18 February 2016 v1.0docx.docx Version: 1.0 Date: 21 October 2016 Produced by: Page: 7 Review date: n/a