Health economic policy and reimboursement

The personalised medicine field has made great advances. It has become a strategic activity within many organisations with significant investments made by large and small businesses worldwide.  Consequently, the focus of issues around personalised medicine has shifted from being a hypothetical to the real challenges of implementation of diagnostics and related therapies. Europe presents some very unique challenges for market access, evidence review, coverage, and payment.

EPEMED has become the lead organisation in Europe focused on advancing personalised medicine.  We have concentrated our efforts on informing and educating a variety of parties through the creation of educational events.  Furthermore, EPEMED has prepared a number of white papers on market access challenges, which are in press and a seminal European research study.

Personalised medicine requires a new mode of thinking with major impacts on how drugs and diagnostics are evaluated, valued and reimbursed. 

There is a need for multi - stakeholder discussions of HTA, Health Economics, Regulators and Payers allied to treating physicians, Pathologists, diagnosticians and patients.

In this context, the Health Economic Policy and Reimbursement committee of EPEMED focuses on the following:

• Advocate improvement and harmonization of companion Dx assessment across HTA bodies in Europe. Currently HTA bodies assess Dx either separately – NICE (DAP program), or not at all – TLV (Sweden). And those who do assess them in conjunction with the drug (NICE – in some circumstances) only take into account few characteristics, like cost, specificity and sensitivity. Engage with HTA bodies in individual countries, regionally and at EC
• Deliver a position paper on the inclusion of CDx into HTA programs which elements should be taken into consideration, how infrastructure/different practices in testing  could affect outcomes and how these uncertainties  should be included in economic modelling and recommendations.
• Address the issue of the variation of testing practices and quality of testing within the county and even selected labs; ‘All tests are not equal’ with HTA and Regulators
• Advocate improvement and harmonization of Health Economic Outcomes and Assessment across the EU for both Diagnostic and CDx modeling via interaction with local, regional and EC groups
• The data package that a manufacturer should be sharing with payers and HTA authorities could also be an area of interest. What kind of additional data would allow reduction in uncertainty – real life studies, registries etc and how these may be designed in order to answer personalized medicine questions.