Stockholm 2018-02-07 – NDA Group, the world’s leading drug development consultancy, signals their appreciation of the EU Commission’s proposal for a new HTA regulation in EU. The particular focus on Relative Effectiveness Assessment, the establishment of a new Coordination Group of clinical experts from the Member States and the continuation of the practices established by the voluntary European HTA network were all cited as reasons for a promising future for the regulation.
On Wednesday January 31st the EU Commission released its proposal for a new regulation on HTA for all Member States of the EU. The new regulation builds on the long-standing activities of the Member States HTA agencies, and particularly the voluntary network and joint action programs hosted by the EUnetHTA network.
Based on the EUnetHTA recommendation and the Impact assessment report (1) that provides an in-depth analysis of four policy options, the Commission has chosen to propose the option 4, advocating permanent cooperation on common tools, procedures, early dialogues and joint HT assessments. In the proposed regulation, the use of joint assessment of clinical aspects of technology evaluation becomes mandatory; all other aspects, such as cost-effectiveness and economic assessment, legal, ethical and societal aspects, are left for the Member States to continue to manage.
While specifying that regulatory and HTA process will remain well separated, the regulation focuses on three particular areas of interest to the drug developing industry:
- Joint clinical assessments limited to innovative technologies,
- Provision of scientific advice and guidance to developers, and
- Identification of emerging health technologies.
The execution of these activities will primarily be carried out via a new Coordination Group of Member State experts, helped by specific sub-groups for each area of interest, and a new Commission Secretariat supporting the processes.
The regulation can be expected to be adopted in 2019, if successfully negotiated and approved by European Parliament and Council of Ministers, after which two subsequent three-year transition periods would kick in before it is fully adopted by the Member States.
The NDA Group has supported drug developing companies with joint regulatory and HTA assessment since 2011. Many of the experts employed by the company in this process have been involved in setting up the systems in place today, and the new regulation is no exception.
NDA’s Dr. Mira Pavlovic-Ganascia, who formerly coordinated the work on several EUnetHTA guidelines and work packages as well as the SEED (Shaping European Early Dialogues) sponsored by the Commission, commented:
“It is reassuring to see that the Commission has taken so much of the work of the [EUnetHTA] network on-board. I truly believe that a new Coordination Group will continue to profit from the actions achieved and structures already put in place, such as Early Dialogues Working Party and ED secretariat. As joint clinical assessments are the Commission’s key measure to promote market access for innovative technologies, Option 4 became the natural default position and with some minor modification this is what the Commission has chosen to go for.”
NDA’s Dr Thomas Lönngren, former Executive Director of the European Medicines Agency added:
“The work that was started over 20 years ago has now finally reached the legislative phase. This is a breakthrough, but the legislative process in Europe is difficult to navigate and it will take time before we eventually see this proposal adopted and implemented.”
When NDA established its Joint Advice service, it was to reduce the uncertainties inherent in drug development, particularly in gaining approval from regulators and efficiently ensuring that the product could be reimbursed by the national payers. One of the challenges has been the fragmentation and varying degrees of maturity across the Member States and an evolution towards the Commission’s proposal has been a favorite discussion topic in the consultancy over the last few years.
Johan Strömquist, CEO of NDA Group, commented:
“It’s quite incredible to see what we’ve expected, for such a long time, presented as a clear legislative proposal. Our experts predicted this development several years ago and the new regulation will certainly make the lives of hundreds of developers easier and more predictable.”
“As the leading experts in the field we welcome the Commission’s proposal. We stand at our clients’ disposal to support in the creation of the necessary submissions and preparation for engaging with the new Coordination Group to attain the best possible advice for their product.”