HTA in Norway- HTA - international challenges

Transcription

1 NVTAG Symposium Drugs: An international perspective HTA in Norway- HTA - international challenges Berit Mørland, President HTAi Deputy director, The Norwegian Knowledge Centre for the Health Services

2 My agenda to-day Establishing a national HTA agency International HTA collaboration Health Technologies and Decision Making - OECD Project - The 4th Hurdle system

3 HTA - Visions A.Cochrane:All effective treatment must be free Council of Europe: It s a human right not to be exposed to non-effective treatment Evidence-based medicine: The use of current best evidence from medical research to make decisions about the care of individual patients Globilize the evidence, localize the decisionmaking; John Eisenberg, AHRQ, USA

4 HTA in Norway Ministry of Health, 1996 Norway will need a permanent organization evaluating new as well as established technologies or methods used in the health care; and assessing their effectiveness, risks, costs in a systematic way

5 SR versus HTA The scientific evidence forms the documentary base of an HTA report Assessment Appraisal SR HTA Systematic review of available scientific documentation on clinical effect and cost-effectiveness Grading the evidence overall documentation Possible consequences economical ethical organisational legislational

6 Experts reviewing groups: Hip replacement therapy Influenza therapy Smokeless tobacco Term breech delivery PCI for acute myocardial infarction HTA dep. Project leaders, search strategy, editing etc. Palliative cancer surgery ADHD Hospital volume and quality of health outcome Palliative medic. for cancer patients Treatment of ovarian cancer Indoor climate/ allergy

7 Cost-effectiveness National data on costs only Data from published studies of cost-effectiveness International models modified to Norwegian data Building an economic model from original data Increased use of cost-effectiveness in public refunding of health costs, or introducing new methods.

8 Judgements of values: Towards a procedure for integrating ethical issues in HTA ( checklist ) Questions related to general moral issues Questions related to stakeholders Questions related to technologies Questions related to methodological choices Questions related to technology assessment

9 Early Warning Hospitals Medicines Control Agency International Sources Horizon Scanning Centre (UK) Euroscan Inahta National Experts Evaluating the international information Suggesting new topics

10 New organisation from Ministry of Health Directorate for Health and Social Affairs Suggestions Ministries Hospitals Clinicians Patients Norwegian Knowledge Centre for the Health Services Products: HTA reports Early warning reports Systematic reviews (Cochrane) Performance Indicators Clinical indicators Health Service Research Advice and Guidance Governmental centre Monitoring quality

11 Public drug regulation

12 Use of HTA (From Kent Woods, UK) Health Technology Assessment /HTA Politics Clinical research Assessment Scientific documentation Clinical effect Cost-use Appraisal Consequences: Organization Patient perspective Ethics/Law Resources/- economy Education Reimbursement Guideline Priority Clinical practice

13 Trends? - PwhC

14 Drivers

15 Medical Devices and Reimbursement Primary Total hip prosthesis in Norway different prostheses brands 66 different femoral components Examples: 62 different acetabular components Revision rate: about 13-14% Hip fracture prostheses 50 variants on the Norwegian hospital market. Marketing authorisation is granted (only) on the basis of CE-approval. Unrestricted selection of prosthesis for routine use in Norwegian hospitals (no guidelines). Debate to start on marketing authorisation of devices Drug-eluting stents Rapid diffusion after USA /EU approval, clinicians enthusiasm asking for reimbursement, HTA performed on second thoughts?

16 WHY need for HTA?? Technology drive Expectations Information overload New technology 15 new products every day New models every 8-9 mths Fergal, FDA, June 2001 Health budgets GNP

17 WHY need for HTA?? Information overload > medical journals >2 mill. biomedical articles/yr health related web-sites Grey literature Published RCT -1960ies : 100/year ies :10.000/year Information rich but knowledge poor i.e. find arguments for any decision i.e. find arguments for any decision-

18 International activities; Globilize the evidence HTAi Research - Doers and users INAHTA International Network of Agencies Exchange of methodology and reports EUROSCAN Early warning, horizon scanning, OECD Survey /Health project New technologies WHO / HEN Information EUNetHTA Network

19 HTA-international Missions / Membership HTAi is the only professional scientific society focusing specifically on HTA HTAi embraces all who do HTA and use HTA They may be from academic institutions, health care systems, industry, business, the voluntary sector or government HTAi have subgroups on: Clinicians, Scientists, Industry, Developing countries, Decision-makers, Students, Communication specialists, etc. HTAi is a membership organisation, run for individuel members, and also welcome organisational members.

20 HTAi-membership offers: Meeting places Annual scientific conferences International Journal of HTA (IJTAHC) web HTAi, including Newsletter, blackboard for discussions, job opportunities, members interests etc. Knowledge Education Vortal HTAi Online access to other Journals Support Fellowships Visits Travel grants

21 HTAi Policy Forum To handle Industry relations on behalf of the public Forum for discussions between senior decision makers in industry and health care systems on the use and development of HTA Membership by invitation First meeting in London in February 2005: Promoting Clinically Relevant Innovation and Managing Uncertainty: the Role of the HTA Process Next meeting in Washington in February 2006, Topic to be discussed, meeting with FDA HTAi has been involved in international discussions on 4th hurdle mechanisms; the use of HTA (costeffectiveness) in public refunding of health costs; with OECD on introducing new methods

22 Politics Reimbursement Clinical research Industry HC-systems Scientists Technology- Innovators Assessment Scientists HTA-Agencies Appraisal HTA-Agencies (involving Clinicians Patients, Industry) Governments Guideline Priorities Clinical practice Policy makers Regulators HC Professionals Industry Journalists,Patients

23 HTA centers AETMIS AHFMR CCOHTA AHRQ CMS VA TAP INHEM CRD IAHS NCCHTA NHS QIS NHSC NICE ANAES CEDIT AETS AETSA CAHTA OSTEBA UETS GR CVZ ZonMV KCF NorHTA SBU & CMT FinOHTA HSMTA DACEHTA & DSI DAHTA HunHTA ITA MTU /SFOPH ITA ETESA MSAC Asermip NZHTA

24 DACEHTA EUNetHTA Objectives The general objective of the proposal: To establish an effective and sustainable European Network for Health Technology Assessment EUNetHTA - that informs policy decisions The general strategic objective of the Network: To connect public national HTA agencies, research institutions and health ministries, enabling effective exchange of information support to policy decisions by the Member States

25 DACEHTA EUNetHTA Partners 59 partners 35 Associated Partners including Main Partner (DACEHTA) 24 Collaborating Partners (e.g. WHO, OECD, HTAi) 24 EU countries ( Slovakia) 2 EEA (Norway, Iceland) Switzerland 4 countries outside Europe (Israel, Australia, Canada, USA)

26 Euroscan; 13 agencies, secretariat at National Horizon Scanning Center Searching for information on new technologies: Patents Journals FDA-licences Drug and biotechnology companies Medical devices companies Media Conferences Experts

27 EUROSCAN New technologies 234 Devices (incl. Imaging) 51 Diagnostic markers 11 Drug 111 Procedure 43 Programme 7 Vaccine 4 Other 7 EUROSCAN Nov. 6, 2002

28 Criteria for Early warning - HTA Requires the attention or action of politicians, hospital and health care administrators within certain time limits It is deemed important ; cost-demanding, controversial It is expected to spread more rapidly than desired - with respect to current scientific knowledge-base It is expected to spread more slowly than desired - with respect to the method s potential benefit But what is the minimum dataset/ the minimum evidence expectations to evaluate the benefit?

29 OECD: project on New and Emerging Health Related Technologies (NEHRT) Part of OECDs Health Project Technologies studied: - PET - Telemedicine - Prostate cancer screening - Stroke - Hepatitis C genotyping Published 2005: Health Technologies and Decision Making

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31 Key findings from the NEHRT report HTA is of significant value in aiding evidence-based decision making. It needs to come to terms with some significant challenges in the delivery of timely and relevant information that reflects the dynamics of the technology and the health-care system The ways in which health-care decisions are made require greater clarity, transparency and be more conducive to the incorporation of evidence Greater stakeholder involvement can facilate improved implementation of decisions and policy, and manage uncertainty whilst enabling access to safe technologies

32 OECD: Biomedicine and other Innovations in Health Care Follow-up Workshop, Berlin 2004 Can HTA be a barrier to innovation? HTA is unfriendly to innovation- Innovation is hard enough, even if you do not have HTA HTA is linked to policy and to save money HTA should be improved to provide the answers There is a need for better dialogue between the doers and the users of HTA in decisionmaking

33 OECD workshop 2004: Innovations in health care Advances in biomedicine will have enormous impact on the prevention, diagnosis, and treatment The advances may however not be at their optimum in delivering effective and safe products Unlike other sectors, health care tends to view new technologies as cost escalators, not good solutions There is need for greater corresponence between the actual needs of the health care system, and innovation

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35 Project funded by Pfizer, with a panel of international experts: A Framework for Describing and Classifying Decisionmaking Systems Using HTA to Determine the Reimbursement of Health Technologies (4 th Hurdle Systems)

36 Need to clearly define the boundaries of what we call a (country) fourth hurdle system The requirement to justify the reimbursement of pharmaceuticals by health systems has been labelled the 4th hurdle - an additional barrier to market access, following demonstration of quality, efficacy and safety Is it just the reimbursement decision? Based on cost- effectiveness analyses Is it the entirety of the process and decisions in between licensure and final utilisation of publicly funded technologies?

37 HTA asks 4 questions: Does it work? For whom? At what cost? Compare to alternatives? Coverage Decision asks: If? When? For whom? How?

38 Issues from Country Interviews (Edward Bramley-Harker, MEDTAP Inst.UK) System England/ Wales France Germany Ontario Sweden Weaknesses in description The most complete template though still questions about some areas of detail (NICE). Information about most of the areas is available, but system appears relatively complicated, and it is difficult to pinpoint the role of economics (ANAES HAS) Gaps due to infancy of the system, in particular to the practical operation of the system, impact assessment, appeals, reappraisals. Decision making process appears intransparent (IQWIG) Information about practical operation (Ontario pharma) based often on interviews more than documents. Info about other bodies is not close to the same level of detail. Information about the (pharma) and SBU (broader analysis) is relatively complete (though still some gaps re: impact/performance assessment, evidence and methodology, - and appeals.

39 Next steps? More ( and better) country - specific information; - on the policy implementation leve - on the individual technology decision level Identify relationship between legal constitutions and actual decision-makings Is there an ideal model of the use of HTA in reimbursement decision-making? Can general recommendations be formulated on the use of HTA in this context? Or will the system always be determind by the actual health policy and health system context?