Horizon scanning to ensure timely HTA...2017/05/03 · Proposals for national HTA...
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Transcript of Horizon scanning to ensure timely HTA...2017/05/03 · Proposals for national HTA...
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
• 4 Regional Health Authorities (RHA)
• 29 Public owned Health Trusts (HT)
19 HTs = Hospitals
1 HT = HT for national procurement of
hospital technologies
Population: 5 millions
Northern Norway RHA
Central Norway RHA
Western Norway RHA
South-Eastern Norway RHA
Norwegian hospitals
May 3, 2017
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
Horizon scanning as part of the system introduced in January 2015
Three categories of 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)
Full Health Technology Assessment(Full HTA)
•National level decisions
•Pharmaceuticals –Norwegian Medicines Agency
•Devices - Norwegian Institute of Public Health(Clinical evidence and cost effectiveness modelsprovided in company submission files)
Singel Technology Assessment (STA)
• Local level decisions
•Restricted to non-pharmaceuticals – IndividualHospitals (Budget impact -no cost effectiveness –database for publication and support by Norwgian Institute of Public Health)
Hospital basedTechnology Assessment(Mini-HTA)
Aims of the early awareness function
• Identify new and emerging technologies (anytype)
• Produce short (two page) alerts serving as proposals for STA or full HTA
• Track technologies to ensure timeliness
• Provide a database (www.mednytt.no) for openaccess to information
• Prepare stakeholders for the HTA process
Main target: The commissioning forum for
HTA
– 4 medical directors from regional healthauthorities
– 2 representatives from the Directorate of Health
– Observers: HTA-agencies
Topic selection for national HTA based on alerts and/or proposals
Decision Maker` s Forum
– 4 directors of the regional health authorities
– 1 patient representative (observer status)
Decision-making on introduction of new healthtechnologies based on HTA
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
Sources of new and emergingtechnologies (2015-2016)
• 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) DD= covers devices* No longer available as source
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
Process - Pharmaceuticals
• New pharmaceuticals are identified when they enter the EMA process: - Draft alerts are used to contact the companies when theinformation 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 companysubmission file
• A full HTA may take until one year, -can be requested at any time for comparative analyzis
European MA
MA in NorwayAlertIdentification
STA
Full HTA
Time
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
Process -non-pharmaceuticals
Alerts suggestions for National HTA
HTA
Identified new technologies
Filtration of technologies (NIPH)
Prioritization oHTA (Commissioning forum)
Norwegian titles (with link to sources) publishedin www.MedNytt.no
• A STA will be available 180 days after receival of a companysubmission file
• A full HTA may take until one year, -can be requested at anytime for comparative analyzis
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 doesnot 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 clinicalevidence even for high risk and iplantable devices
Some results
Alerts on Hospital related technology
2017: 130 alerts planned: 100 on Pharmaceuticals (including non-hospital pharmaceuticals), 30 on non-pharmaceuticals
Year Alerts total Pharma-ceuticals
Devices Other
2015 64 28 24 12
2016 71 51 17 4
Proposals for national HTA non-paharmaceuticals (2013-2016)
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
Some examples of CE marked devicesand their faith
Device First alert Decisioncommisioningforum
Next step HTA
ROX Coupler for Treatment-resistantHypertension
Nov 2015 Jan 2016 To early-the method shouldbe tracked
March 2017 –Alert updated
Pending
Pulsed xenon ultraviolet disinfection device
Aug 2015 August 2015STA (s) commissioned
No submissionof file
– Jan 2017 commissionterminated
Sutureless valves for treating aorticstenosis
Sep 2015 Oct 2015 STA (s) commisioned
Oct 2016 Submissionfile from onecompany
May 2017 HTA completed
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]
Contributers and contact adresses
• Ellen Nilsen, senior advisor, Norwegian Directorate of Health [email protected]
• Brynjar Fure, Norwegian Institute of Public health, Research leader, Head of The Department for SpecialistHealth Services [email protected]
• Vigdis Lauvrak, senior researcher, – Head of The National function for Horizon Scanning, Norwegian Institute of Public Health, The Department for Specialist Health Services [email protected]
