Dr Hagen Pfundner
Dr Hagen Pfundner, Chairman of the German Association of Research-Based Pharmaceutical Companies (vfa) and General Manager of German Roche Pharma AG

Hagen Pfundner: Personalised healthcare has to reach the patient

The use of diagnostic testing is at the centre of Personalised Healthcare (PHC), not only for classifying a disease but also for determining which therapy will be most suitable for an individual patient or a stratified group of patients suffering from that disease. It is all about improving outcomes and tolerability.

This concept keeps transforming oncology, and has made its debut in other therapeutic areas like neurology as well. PHC represents not only medical progress, but also highlights the potential to improve cost-efficiency of healthcare delivery by helping to avoid ineffective or even harmful therapies. To fulfill this potential, however, it must find its way into routine healthcare practice. Until now, this has all too often remained a long and winding road.

The European Medicines Agency (EMA) and the European Commission embraced the concept of PHC from the beginning, and continue to encourage manufacturers to include up-front testing (patient stratification) in clinical trials design and subsequently in labelling for new drugs, provided the scientific evidence is sound.

However, drug approval by the European and national health authorities is only one step on the “road to the patient”. Delays most often occur when it comes to including newly-defined tandems of a drug and a diagnostic test (companion diagnostic) in national reimbursement schemes. Procedures and processes for this step are different in every European country, but there appears to be a common theme: no healthcare system is prepared to handle the situation in a synchronised fashion or within a reasonable time frame. In the out-patient setting, a newly-approved drug is reimbursed following health authority approval, but a new companion diagnostic test – even if mandatory by label – is not. These reimbursement decisions are made by a different body made up of health insurance companies and associations of office-based physicians that organise physician fees. In the past, decisions have often taken several years.

In the US, the Food & Drug Administration (FDA) is moving towards encouraging regular testing as the preferred model for companion diagnostics in PHC. It has issued guidance focusing on the dependency of Rx and Dx co-approval, while the tests have been provided as a service by specific laboratories.

So while PHC is meant to shorten the time it takes for a patient to receive the most suitable treatment, in practice medical treatment is often delayed for many patients due to a misalignment of the two divergent reimbursement systems for drugs and companion diagnostics. This is unacceptable for modern European healthcare systems, and provides a disincentive for pharmaceutical and diagnostic companies. The irony is that while the scientific advances of PHC have opened the door to significant improvements in therapeutic and cost efficiency, the current healthcare systems are not equipped to benefit from them. Last but not least, the barriers also run counter to government efforts and support aimed at making Europe the leader in PHC research.

There is no “one size fits all” approach in Europe when it comes to including innovative PHC treatments in national reimbursement schemes. But national stakeholders should increase their efforts to resolve this in their countries – and not just in their own interest. Patients, physicians and innovators deserve it! 

Hagen Pfundner

joined Roche Pharma AG in Germany in 1992. Since 2006, he has held the post of General Manager at Roche Pharma AG in Germany. Since 2008, he has also been a member of the executive board of the German pharma association vfa.