The study completion is scheduled for end of January 2016. Preliminary results and methodology will be introduced at the PMWC conference on the 27th of January in Silicon Valley. The report and final results will be shared through a European event gathering EU stakeholders and EPEMED members within Q2 Q3 2016, and we are expecting to present the results at key conferences, such as ISPOR.

This work directly addresses some reflections made at the July High Level European conference endorsed by the Luxembourg Ministry of Health as a priority of the EU Presidency. It provides an opportunity to extend our contribution beyond this major event and implement collectively concrete and practical solutions to facilitate better access to personalised medicine diagnostics for European patients.

As clearly articulated then, the economic evaluation of health technology innovations must be based on the value they bring to patients, citizens and health systems as a whole.

From this point of view, the social value of diagnostics in general is very broad. However, recent experience shows that for personalised medicine diagnostics, the value is thought to lie primarily within the increased ability to identify and predict treatment safety and efficacy.  This is critical given the value to payers remain within the realm of avoidance of the cost of unnecessary interventions and more efficient use of limited healthcare resources.  The operating assumption of this work is that information related to a patient’s risk of disease, speed of progression and understanding the performance of treatments are of substantial value as well. 

Consequently, economic assessment in its strict sense stands at the forefront of the performance evaluation of such technologies. In contrast, broader societal value resulting from the improvement in availability of information for complementary diagnostics is poorly studied and even less integrated as a vector of added value.

As matter of fact, the increase of the value of "knowing", or the benefits for the patient and his/her family of an earlier and more accurate knowledge of the diagnosis and its associated medical protocol, do not fall within the criteria of evaluation.

However, it is possible to categorize and analyze the components behind the production of value that are regarded as less tangible in the economic sense (planning, mental well-being, quality of life) and integrate them into standard assessment practices.

This study thus aims to emphasize the lack of attention in currently applied HTA practices to measuring the “value of certainty” / “value of knowing” delivered by complementary diagnostics while addressing:

- How to define the parameters of value

- How to articulate a value based evaluation per its economic, medical and full social appreciation,

- How a broader conception of value can be the path toward improving the HTA process.

As part of the study, a European overview of current practices with practical case analysis in France and England (BRCA1 BRCA2, gene expression profiling for breast cancer, procalcitonin) will be provided as well as key recommendations.

The steering group is looking to recruit partners to join the final review and dissemination efforts. Reach out to ebenzimra@epemed.org for more information.

Access previous study here EPEMED 2014 EU Patient Access Study ,  « Enhancing Patient Access To Pharmaceutical Drug-Diagnostic Companion Products ».

Access 2011 white paper "market access challenges in the EU for high medical value diagnostic tests" here