Horizon scanning.

Transcription

1 Horizon scanning to ensure timely HTA

2 Topics The National system for managed introduction of new health technologies in Norway Horizon scanning as part of The System - experiences from the first two years The need for collaborative initiatives on devices

3 Norwegian hospitals 4 Regional Health Authorities (RHA) 29 Public owned Health Trusts (HT) 19 HTs = Hospitals 1 HT = HT for national procurement of hospital technologies Northern Norway RHA Central Norway RHA Population: 5 millions Western Norway RHA South-Eastern Norway RHA May 3, 2017

4 The National System for Managed Introduction of New Health Technologies within the Specialist Health Service Aims: Systematic use of health technology assessments (HTA) to inform decision-making introduced in 2013 Improve patient safety Timely and equal access to new technologies proven be effective, safe and cost-effective Ineffective and/or harmful technologies are not introduced Obsolete health technologies are disinvested Appropriate platform for priority setting based on HTA Rational use of resources A systematic, predictable and transparent process

5 Horizon scanning as part of the system introduced in January 2015

6 Three categories of HTA Full Health Technology Assessment (Full HTA) National level decisions All types of technologies -Norwegian Institute of Public Health (Clinical evidence assessment based on a comprehensive systematic review of litterature and models for cost effectiveness) Singel Technology Assessment (STA) National level decisions Pharmaceuticals Norwegian Medicines Agency Devices - Norwegian Institute of Public Health (Clinical evidence and cost effectiveness models provided in company submission files) Hospital based Technology Assessment (Mini-HTA) Local level decisions Restricted to non-pharmaceuticals Individual Hospitals (Budget impact -no cost effectiveness database for publication and support by Norwgian Institute of Public Health)

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8 Aims of the early awareness function Identify new and emerging technologies (any type) Produce short (two page) alerts serving as proposals for STA or full HTA Track technologies to ensure timeliness Provide a database ( for open access to information Prepare stakeholders for the HTA process

9 Main target: The commissioning forum for HTA 4 medical directors from regional health authorities 2 representatives from the Directorate of Health Observers: HTA-agencies Topic selection for national HTA based on alerts and/or proposals

10 Decision Maker` s Forum 4 directors of the regional health authorities 1 patient representative (observer status) Decision-making on introduction of new health technologies based on HTA

11 Information provided by an Alert Information on: The technology Developmental status Indication (putative) Current treatment (in Norway) Epidemiological data (in Norway) Availability of evidence (HTA/SR/Clinical trials) Suggestions for HTA (STA/Full HTA/Hospital based HTA) Source of information The alert is no assessment, no results from trials or analysis are presented

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13 Sources of new and emerging technologies ( ) European medicinal agency (EMA) Ludwig Boltzmann institut (LBI) Health policy advisory committee on technology (HEALTHPACT) D Canadian Agency for Drugs and Technologies in Health (CADTH / CETAP) D National Institute for Health and Clinical Excellence (NICE) D (Interventional procedure guidance) Sahlgrenska Universitetssjukhuset D Statens beredning för medicinsk utvärdering (SBU) D Janusinfo, Stockholms Läns Landsting Euroscan D *National Horizon Scanning Research and Intelligence Centre (HSRIC) at the University of Birmingham, UK HSRIC (until April 2017) D *Agency for Healthcare Research and Quality (AHRQ) (until august 2016) D D= covers devices * No longer available as source

14 Criteria for Pharmaceuticals - All new Hospital Pharmaceuticals are identified by alerts and prioritized for National HTA in Norway The alerts ensure a timely HTA process

15 Process - Pharmaceuticals New pharmaceuticals are identified when they enter the EMA process: - Draft alerts are used to contact the companies when the information is public The final alert is a proposal for, and provides recommendations for HTA A STA will be available 180 days after receival of a company submission file A full HTA may take until one year, -can be requested at any time for comparative analyzis Identification Alert STA MA in Norway Full HTA European MA Time

16 Criteria for medical devices (and other non-pharmaceuticals) Check list: New technology? Innovative technology? Sufficient evidence for performing HTA? At least one clinical study Large budget impact? The disease is serious Loss in future QALYs Potential effect? Assessment at national level All pharmaceuticals National screening programs Highly specialised treatments Health economic model is necessary High risk technologies Class III, active implantable, list A (IVD) Ethical consequences All other devices: Mini-HTA

17 Process -non-pharmaceuticals Identified new technologies Norwegian titles (with link to sources) published in Filtration of technologies (NIPH) Alerts suggestions for National HTA Prioritization ohta (Commissioning forum) HTA A STA will be available 180 days after receival of a company submission file A full HTA may take until one year, -can be requested at any time for comparative analyzis

18 Major challenges with regard to devices Only a fraction of innovative Hospital devices are identified and of these only a small fraction will be prioritized for National HTA Lack of public accessible and structured information at the time of Marked authorization (CE marking) The CE mark unlike the MA-process for pharmaceuticals does not reflect that the company actually is selling the product and may provide a submission file for STA The CE mark is in general provided on very low evel of clinical evidence even for high risk and iplantable devices

19 Some results Alerts on Hospital related technology Year Alerts total Pharmaceuticals Devices Other : 130 alerts planned: 100 on Pharmaceuticals (including non-hospital pharmaceuticals), 30 on non-pharmaceuticals

20 Proposals for national HTA nonpaharmaceuticals ( ) Decision Comissioning Forum Total Full HTA 11 STA 24 No HTA indicated 17 No HTA indicated at this time (to early) 15 More information needed 6 Hospital based HTA indicated 5 Directly to decision on implementation 2 Decision is pending 3 Total 83

21 Some examples of CE marked devices and their faith Device First alert Decision commisioning forum ROX Coupler for Treatment-resistant Hypertension Nov 2015 Jan 2016 To earlythe method should be tracked Next step March 2017 Alert updated HTA Pending Pulsed xenon ultraviolet disinfection device Aug 2015 August 2015 STA (s) commissioned No submission of file Jan 2017 commission terminated Sutureless valves for treating aortic stenosis Sep 2015 Oct 2015 STA (s) commisioned Oct 2016 Submission file from one company May 2017 HTA completed

22 Need for collaborative initiatives Production and sharing of a minimal dataset based on information from marked authorizations processes on devices in particular high risk and implantable devices Tools for disinvestment and horizon scanning including systematically and effectively explore trial registries, systematic reviews and other public available sources as information Tools for early assessment (pre- clinical trial statues) of potential value of emerging technologies (eg. Tools for calculation of innovative potentials) Sharing information of particular technologies through global non-profit networks [Collaboration within existing networks like Euroscan and EUnetHTA, disinvestment]

23 Contributers and contact adresses Ellen Nilsen, senior advisor, Norwegian Directorate of Health Brynjar Fure, Norwegian Institute of Public health, Research leader, Head of The Department for Specialist Health Services Vigdis Lauvrak, senior researcher, Head of The National function for Horizon Scanning, Norwegian Institute of Public Health, The Department for Specialist Health Services