Researching New Drugs "Needs Research into New Pricing Systems"

March 31, 2015
Peter O'Donnell
Applied Clinical Trials

In yet another demonstration of how far drug pricing concerns are invading the hitherto sacrosanct territory of drug development, a consortium of national advisory bodies on pricing have written to the chief official responsible for European Union drug research.

In yet another demonstration of how far drug pricing concerns are invading the hitherto sacrosanct territory of drug development, a consortium of national advisory bodies on pricing have written to the chief official responsible for European Union drug research, seeking funding for studies into how clinical and economic considerations can best interact.

Finn Børlum Kristensen, who is the key figure in the European network for Health Technology Assessment, has just asked Ruxandra Draghia-Aklia, the director of health research in the European Commission, to give priority to funding its work in the upcoming phase of the EU's multi-billion Horizon 2020 research support strategy. The network faces running out of money at the end of this year, and it wants to enlist the EU's research program to ensure it can keep going, and make its contribution to sustainable health care. "EUnetHTA has identified a number of methodological issues that are of high importance and require further research to develop successful solutions to these challenges", says Børlum Kristensen in his letter.

One of the issues that he identifies is the need to align the use of health technology assessment across different settings – from hospitals’ decision-making on the availability and pricing of new technologies, to regional and national level decisions on reimbursement of health technologies. "Joint assessments performed by cross-border teams have great potential to make the national health technology assessment production process more efficient, thus contributing to improving effectiveness of the national decision-making processes", says the letter. In particular, this will help maximize the flow of information, reduce unnecessary duplication, and permit more informed decision-making on purchasing or reimbursement in European healthcare.

Another top question Børlum Kristensen raises is patient data collection, to feed into the confirmation process for the conditional marketing authorization and reimbursement that novel therapies often receive. "More action must be taken in order to address this need", he writes. "Health technology assessment has a crucial role in developing the process and methodologies to clarify and guide the use of real world data".

And inevitably, that thorny issue of the overlap – or not – between developing clinical data and data for health technology assessment has a prominent place in the appeal for new funding. "A closer methodological alliance of those activities may ensure more consistency in reporting and should subsequently lead to more consistent promotion of appropriate use including control of over- and underuse of care. This may be organized by strengthening collaboration between health technology assessment organizations and clinical excellence centres that are responsible for developing guidelines", says the letter.

The integration of innovations in healthcare delivery – or, more simply put, outcomes - comes in for attention too in the EUnetHTA letter. "A successful implementation of technologies with proven efficacy depends on research-based assessment of the context, i.e. the specific system and organization of care, where it is introduced", says Børlum Kristensen. While health interventions have become more complex and integrated across health systems, he says, health technology assessment constantly confirms that healthcare organization and systems is an under-researched field. So, he concludes, more empirical research and development of applied methodology is needed, comparing existing healthcare interventions. Similarly, the use of advanced innovative medical devices and other advanced technologies needs closer scrutiny, particularly since market access and reimbursement of many of them "is not very clearly controlled".

"Further attention should be given to developing the scientific basis of health technology assessment, by building on the results achieved so far by European collaboration and by involving research centres of excellence with a focus on specific scientific and policy challenges", the plea from Børlum Kristensen ends.

There is more than methodological perfectionism behind the EUnetHTA initiative. The harsh truth about the EU's timid approach to health technology assessment is that there is less cash than consensus behind the project. It was the EU's 2011 legislation on cross-border rights for patients that provided the first legal base for this joint exercise – an inspired piece of political opportunism. But inspiration stopped short of finance. There is almost no budget for progressing this work – and without budgets, not much can come of even the most refined reflections. So now the search for funding shifts to the EU's research program.  A curiously ironic fate for a project that is itself aimed at getting the best value for money.