Using European Joint HTAs in local settings to adopt or to adapt, that is

Transcription

1 Using European Joint HTAs in local settings to adopt or to adapt, that is Katrine Frønsdal, BASc MSc PhD Norwegian Institute of Public Health (NIPH) Third WHO Global Forum on Medical Devices Centre International de Conférences, Genève (CICG) May 2017

2 The first step in an assessment is to look after what others have done HTA-agencies

3 ... because we want to be efficient We are therefore using other s HTAs to: Spare time Avoid work duplication Make best use of limited resources NIPHNO Handbook

4 Among the overarching aims of EUnetHTA is «efficiency»

5 But what is actually meant by «USING» other s HTAs? «National uptake» is the general implementation of any EUnetHTA output: Joint HTAs Guidelines POP-database HTA Core Model Etc. «National adaptation» is a specific type of national uptake, i.e. the use of joint HTAs produced by EUnetHTA in a national/regional setting

6 «Adopting» and «adapting»

7 Within the system for introducing new technologies we have so far used three EUnetHTA reports. Abdominal aorta aneurysm (AAA) screening (published Jan. 2013) Renal denervation systems for treatment-resistent hypertension (published Dec. 2013) Endovascular therapy using mechanical thrombectomy devices for acute ischemic stroke (published Dec. 2015) CORE HTA Rapid assessment (REA) Rapid assessment (REA) Description of health problem Current use of technology Clinical effectiveness Safety Economic evalution Organisational consequences Juridical aspects Social aspects Ethical aspects Description of health problem Current use of technology Clinical effectiveness Safety Description of health problem Current use of technology Clinical effectiveness Safety

8 to carry out local assessments Effect of abdominal aorta aneurysm screening (published March 2014) Renal nerve ablation (communicated January 2014) Mechanical thrombectomy for acute ischemic stroke (published May 2016)

9 by adopting and adapting From Full HTA to REA: AAA-screening From REA to REA: renal denervation From REA to Full HTA: mechanical thrombectomy (+ written own local organisation and ethics chapters)

10 Why were these EUnetHTA reports used? AAA-screening RELEVANT: this report was not directly commissioned through the «new system», but proposed by cardiologists via the National Council for Priority Setting in Health Care (established by the Norwegian Ministry of Health to give advice on decisions in health care concerning priority setting). TIMELY: aware of the interest in this topic in Norway, NOKC proposed the topic (together with other agencies) to do a full Core HTA back in 2011 within EUnetHTA JA1 were NIPHNO was responsible for the Clinical Effectiveness domain Renal denervation RELEVANT: to do a HTA was decided following an early warning submitted to the Commission Forum TIMELY: EUnetHTA JA2 had this topic prioritised for a REA and NIPHNO carried out the «Clinical effectiveness» domain Thrombectomy RELEVANT (via the Commission Forum) and TIMELY as above, but NIPHNO was not involved in the production of the EUnetHTA report from JA2

11 How were the EUnetHTA reports used? AAA-screening (in English with Norwegian executive summary) The domain on clinical effectiveness was more or less directly and fully adopted The domain on safety was partly adopted and partly adapted, i.e. selected parts of results and reformulated conclusions Some information from the domains on the use of the technology and the health problem was adopted, but Norwegian «numbers» and context added Nothing from the other domains (economical, juridical, social and ethical) Published on NIPHNO s website Renal denervation (in Norwegian) The report sent as it was to the Decision Forum: whole report fully adopted + brief summary in Norwegian (one page) No official publication Decision by the Decision Forum: wait for more data and do reassessment in one year Thrombectomy (in Norwegian) The domains on clinical effectiveness and safety was mainly adopted, but parts were adapted, i.e. some results and conclusions were reformulated Some information from the domains on the use of the technology and the health problem was used, but Norwegian «numbers» and context added Neede to write own chapters for organisation and ethics (checklist of important assessment elements from the REA was not very helpful) Published on NIPHNO s website Awaiting decision by the Decision Forum for New Methods

12 What were the outcomes? AAA-screening: no decision yet (and non in sight..) Renal denervation: waiting for more evidence and reassess in one year Thrombectomy: no decision made by the Decision Forum yet, but expected to be implemented

13 What did the EUnetHTA-reports help us with? Scoping done Literature search done Description of studies done Evidence quality assessed and summarized Tables and evidence tables available Ongoing studies listed

14 What were the challenges? For clinical effectiveness, there were cases were we disagreed on: the grading of the quality of evidence on how evidence was interpreted on the final conclusions drawn For safety aspects, there were cases we: had difficulties in understanding what was stated did not agree on how evidence was interpreted did not agree with the conclusion drawn or would have concluded differently would have highlighted certain safety issues more, because we thought they were more important than the ones highlighted in the EUnetHTA-report Some parts (sometimes large) of the description of the health problem and the current use and description of the technology were not necessary to our assessment

15 Conclusions Our experience with these three HTAs have been positive, and we have definitely spared time and resources We need to adapt more EUnetHTA-reports to get a clear picture of what possibly can be improved in terms of transferability Assessing safety issues on medical devices is challenging and risks of reporting these differently among agencies is therefore higher, which necessarily will affect the adoption of the safety assessment too How to express uncertainty is challenging. Thus to agree on standards how to express it so that information can be directly adopted is even more challenging We need to be in corcordance in terms of interpreting evidence and drawing conclusions both for the assessment of clinical effectiveness (GRADE) and safety issues Good and clear language increases chances of adoption: writing in English is still a challenge for some of us