To use? To use! Or benefit? – What are we talking about?

25.11.2010 16:11

Focus on oncology: Current expert discussion at the German Cancer Society puts the patient's perspective at the center of decisions

What is benefit in oncology? Experts investigated this question at the 2nd Oncology Focus of the German Cancer Society in Berlin. The only consensus in the group was that the benefit assessment would have to move closer to the reality of care in the future in order to place the level of action and decision-making on a common basis.

Private lecturer Stefan Lange, deputy head of IQWIG, argued against the endless expansion of medical services. The cost-effectiveness requirement in SGB V speaks of the need for therapy. So it demands that the emergency be addressed. According to Lange, he wonders whether a progression-free survival of a cancer patient for six to eight weeks will reverse their suffering.

The use of “patient reported outcomes” (PROs), assessments of the effects of disease or therapy in a standardized form by the patient themselves, has become increasingly important in recent years and would also be the instrument of choice for benefit assessment in oncology , emphasized Dr. Johannes Bruns, Secretary General of the German Cancer Society. Because the patient, as a contributor, should also decide how the money is spent and what he perceives as a benefit. The evidence generated by PROs is already being used both in the context of approvals of new therapies by regulatory authorities and in the area of political decisions and activities of the pharmaceutical industry, so that PROs can impressively demonstrate the advantage of a therapy, precisely because the quality of life of the patients, whose improvement or maintenance is the goal of any therapeutic intervention, can be recorded as a central variable.

The benefit assessment within the framework of the Medicines Reorganization Act (AMNOG) is currently intended to be carried out on study data. Studies to determine the benefit of a therapy have so far been carried out as randomized clinical trials (RCT), often in the form of cross-over designs. Requirements from the approval authorities and, above all, ethical concerns can already influence the methodology of the studies, so that any additional benefit of new therapies cannot be fully proven. Since cancer in many cases takes a lengthy and individual course, the longer the disease drags on, the more often there is a lack of comparable standard treatment. “It may be difficult to apply benefit assessments equally to all stages of the disease progression and its treatment options. Study data cannot always be brought into line with the patient context,” reported Prof. Dirk Arnold from the University Cancer Center Hamburg. “The evidence from studies should therefore be checked through appropriate health services research. Studies only represent a portion of therapeutic reality.” The group was able to quickly reach agreement on this.

Ms. Barbara Braun from the House of Cancer Self-Help strongly supported this: “We no longer want people to talk about perceived patient benefits, but rather we demand that patient-relevant endpoints be taken into account in the study designs for evaluation.”

You can find a video summary of the focus on oncology at:

www.krebsgesellschaft.de/pr_bp_onkologie_20101027_video1,171096.html