Consider our recommendations

If the promise of personalised medicine is to be realized, appropriate public sector reimbursement practices that acknowledge the important co-dependency between drug development and companion diagnostics must be established to ensure Europeans fully benefit from these breakthrough treatments.

Europe, with its primarily centrally managed healthcare systems, has the potential to be a leader in the emerging Personalised Medicine field. However, a complex, non-harmonised reimbursement process with a lack of health technology assessment transparency, decentralization of review and occasionally complete lack of associated funding set a heavy impediment to innovation and the broad market uptake of Personalised Medicine. These general inefficiencies must be addressed.

Usually a diagnostic test for one biomarker is associated with one pharmaceutical drug. In the current regulatory framework, diagnostics and pharmaceutical drugs follow separate routes to patient access. This, associated to suboptimal cost-based payment procedures and the virtual absence of value based reimbursement, must be reviewed to stimulate development.

To foster local innovation and patient access in the EU

  • More process clarification
  • Review of centralization
  • Demonstration models and clarifica¬tion of economic and other utility criteria

are required.

  • Reimbursement decisions for drugs must include funding for companion diagnostic testing.
  • Temporary funding pathways that enable funding of the companion diagnostic tests at the time of drug launch should be considered until reimbursement systems are permanently updated.
  • Inconsistent Health Technology Assessment (HTA) processes within countries must be centralized, coordinated and synchronized for drug-diagnostic companion products.
  • Minimum Europe-wide requirements for companion diagnostics should be established and all labs performing companion diagnostic tests should be accredited.
  • A more focused and coordinated effort should be established to make use of patients registries, patient biological samples, and patient outcome data in a targeted personalized medicine development program with results published in a timely manner.

To engage the realization of the above propositions elaborated in 2011 through EPEMED White Paper on European Market entry barriers, and to grow awareness and support by decision makers for market access to personalised medicine products across Europe, EPEMED and La Charité launched an extensive European market access study in 2012-2013.

Released in 2014, the report study will be first presented along the year through a series of external meetings with European and National institutions. It will then be the subject of a publication in a peer-reviewed journal. Wider public dissemination will finally be made upon the article release and members distribution. We trust that this seminal work will serve as an evidence-based learning platform to provide vital insight and informed recommendations “from citizen to politician”.

“Personalised Medicine in Europe: Enhancing Patient Access to Drug-Diagnostic Companion Products” is an exhaustive report:

  • analyzing patient access pathways to pharmaceutical drug-diagnostic companion products from a patient’s perspective in the 5 most populated EU countries (Germany, England, France, Italy and Spain).
  • relaying factors impeding and facilitating patient access
  • and, based upon identified factors, introducing country specific as well as European recommendations for improved patient access post-approval

Stay tuned on incoming further updates

Read EPEMED White Paper 2011 on European Market Entry Barriers