by Peter O'Donnell
BRUSSELS, Sep 26 (APM) - Within weeks, a start will be made to the third - and almost certainly the final - phase of the EU's attempt to promote on-the-ground collaboration among the many national and regional health technology assessment bodies in Europe.
EUnetHTA3, the largely EU-funded joint action programme, has now formally come into being, and will run until 2020. It will go public with meetings in Brussels on October 20-21, including its inaugural general assembly and a joint forum with DG SANTE.
The 20 million euro programme aims to define a sustainable model for scientific and technical cooperation on HTA in Europe - and to put that model into operation.
Real cooperation, the EU has repeatedly stressed in its health strategy, will not only reduce unnecessary duplication of assessments, but increase their quality, and consequently make life easier for healthcare payers and the healthcare industry.
After a decade of supporting these exploratory programmes, the European Commission made it clear in the consultation it launched in mid-September that it is high time some conclusions were reached (APMMA 49625).
The Commission's bottom line is, in effect, that if the voluntary cooperation of EUnetHTA proves unable to deliver, it may be necessary to impose some mandatory collaboration.
Preliminary discussions over recent months with national authorities, the European Medicines Agency, the European Commission and industry representatives, have identified some of the main challenges that EUnetHTA3 will face - particularly how to build trust among all the partners, and how to ensure that the joint work envisaged will actually feed into national procedures.
EUnetHTA3 brings together 77 HTA organisations from 29 countries, and has a secretariat in the Dutch healthcare agency, ZIN.
The programme will operate within a decentralised structure through seven distinct work packages.
One package will focus on producing joint health technology assessments that - according to EUnetHTA3's formal plan - "are fit for purpose, of high quality, of timely availability, and cover the whole range of health technologies."
The work of refining the processes for producing joint assessment reports will draw heavily on lessons learned from the predecessor programme, EUnetHTA, which concluded earlier in 2016.
The choice of which products should be the subject of joint assessment will be informed by a new emphasis on horizon-scanning and prioritisation.
Another work package will conduct early dialogues with companies producing pharmaceuticals, medical devices and diagnostics to advise how their product development plans can generate evidence suitable for HTA.
This will aim to align joint assessments for pharmaceuticals with EMA processes such as early access to data during the agency's scientific assessments of new products.
Over the five years of the programme, the plan is to produce 80 joint assessments and 35 early dialogues.
The target is to produce 50 assessments per year by 2020.
Tools and methodologies necessary for efficient joint production at EU level of quality HTA information will be developed in other work packages, as will mechanisms to make it easier for joint work to be actually used at national, regional level and in hospitals at local level.
Provision is also made for systematic coordination of the work with national authorities and with the European Commission, and for making the results of the programme know to the general public and other stakeholders.
Fundamental to EUnetHTA3 is the continual development of recommendations for a sustainable model of European collaboration after 2020.
For the European Commission, the underlying motivation is to improve policy and decision-making in member states' health systems, as a way of protecting citizens against unsafe or ineffective technologies and boosting access to high-value health technologies.
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