Project manager Christian Luley and Kai Martens, the new managing director of Grünenthal's German division since August 1, explain why the pharmaceutical company Grünenthal is investing in a broad health care research study on the subject of pain in an exclusive interview with “Monitor Health Care Research” (MVF).

>> DAK and Grünenthal GmbH recently announced the start of a broad health care research study for chronic pain patients. Is this the first healthcare research study of this kind that your company has undertaken?
Luley: Grünenthal has already worked intensively on the care of pain patients in the past. Together with a committee of experts - consisting of representatives from specialist societies, patient representatives, professional associations, science, medical practice and health insurance companies - we have already initiated a disease management program for back pain, the results of which were published in 2006. We are also conceptually involved in the area of integrative care for pain patients. For us, this is actually the first health care study with such a broad focus.

Why has the pharmaceutical industry not yet used the importance of health services research or only used it insufficiently?
Martens: Industry, service providers and also payers, i.e. health insurance companies, are equally part of the care. All three are striving within the new political framework to improve the quality of care for pain patients and to make the use of resources more efficient. Everyone involved still lacks valid information about the current supply situation, the quality provided and the costs incurred. Health insurance companies have only had comprehensive data on outpatient care for patients since 2004. Corresponding projects have therefore only recently become possible. In addition, the quality of outpatient data in particular has improved significantly since 2004.
What is certainly unique is the breadth and depth of the analysis now being pursued. For the first time, we will get an overview of the care situation for pain patients throughout Germany. And the partnership between health insurance companies, science and industry is certainly not an everyday occurrence in this context.

One reason for this may be the current orientation of the clinical studies as well as the approach of IQWiG, which only wants to recognize randomized study designs (and therefore based on almost artificial collectives). One possible solution here may be health care research, because recently an RCT study in the area of diabetes was not recognized by NICE because it did not adequately describe the care process. Could this lead to a breakthrough for health services research?
Martens: Controlled clinical studies are undoubtedly the “gold standard” in the clinical development of drugs. However, important questions about the benefits of medications under everyday conditions can only be investigated to a very limited extent in this type of study. This applies, for example, to the question of patient compliance, long-term adherence to therapy and doctor behavior. If the benefits of a therapy are to be tested in the “real world”, the scope of the investigation must be close to the conditions that doctors and patients encounter in everyday care. The knowledge from clinical studies must be supplemented by findings from everyday life in order to enable an objective benefit and cost-benefit assessment of a drug.

Health care research is able to depict health care realities. So not what was researched in randomized studies in collectives of any kind, but rather the reality of care as it is received by the patient. This could be a great opportunity for pharmaceutical companies if they could suddenly position their products in a completely different way and with completely different arguments.
Martens: The Grünenthal company is an expert in the field of pain therapy. One of the pillars of our success is the development of innovative medications, and our focus as a research-based pharmaceutical company is the intensive search for new ways to relieve pain better, more sustainably and with fewer side effects than before. Of course, we have to ask ourselves how our medications fit into the reality of care in Germany. For us, it is particularly interesting to ask in which structures and in which therapeutic context patients are cared for today, what the quality of this care is and what direct and indirect costs are incurred as a result of the therapies. The study will provide us with insights into this and of course we – just like the health insurance companies involved – expect a corresponding gain in know-how. This will certainly also have an impact on our further activities in research, development and marketing.

Grünenthal wants to investigate the care situation of pain patients in collaboration with the DAK. Why start with DAK data? And then only in a main study with other health insurance companies?
Luley: Grünenthal has been active for some time with various projects and events relating to the care of pain patients and in this context is in regular contact with a number of players in the healthcare system. The idea for this special project met with great interest from potential partners even in the planning phase. We were keen to find a partner with a large pool of insured people for the pilot study. We were very pleased that DAK was the first health insurance company to not only show interest, but also to be available as a partner for the pilot study.
The analysis of the pseudonymized DAK routine data as part of the pilot study pursues three goals: First, we would like to demonstrate the basic feasibility of such a study. We will also work out specific characteristics in order to be able to identify as many pain patients as possible in the insured population and to obtain an epidemiological overview of the distribution of the different forms. Finally, the identified pain patients are divided into different clusters. These clusters and the associated patient profiles are the starting point for further analyzes as part of the subsequent main study. The integration of additional health insurance funds is not yet necessary in the pilot phase of the study. If the main study is specifically about gaining an overview of the care situation for pain patients in Germany, the inclusion of other health insurance companies is of course sensible and necessary. In addition to the DAK, other health insurance companies have already announced their cooperation.

Which alternative therapy concepts for the care of pain patients should actually be evaluated?
Martens: A key goal of the entire study is to develop greater knowledge about the current status of the care situation for pain patients. Only then can the parties involved gain a more concrete idea of the quality of the current care, as well as insights into the costs incurred. The common opinion is: There is no single therapy concept for pain patients. You are dealing with a heterogeneous group and with correspondingly different therapy requirements. The first step is to record the current status in order to define and evaluate care goals and therapy options against this background. To come back to your question: therapy variants involve the interaction of several actors. Of course, innovative drugs are also an important part of these therapy options. So we as an industry also face this assessment.

They estimate the economic costs caused by chronic pain at 20.5 to 28.7 billion euros. How did you arrive at this number? Are there any insights into this from health services research studies?
Luley: These figures are based on calculations by Neumann, published in the Federal Health Gazette 2002.* Figures based on broad healthcare studies are not yet available. Pain in its chronic form should be viewed in the healthcare system as an independent disease and no longer as a pure symptom. There are already some studies, particularly on the widespread disease of back pain - including on follow-up costs. However, a broad examination of different pain patterns often fails due to the identification of patients in the data pool. The current ICD-10 does not offer a satisfactory way to code the diagnosis “chronic pain”. For this reason, it has so far been very difficult to directly allocate the costs incurred in the benefit system. There is currently no clear marker, and the introduction of a corresponding ICD number is not planned until next year.

How did you choose your partner to carry out the care study?
Martens: Of course, scientific independence and transparency in data analysis must be guaranteed in a project like this. We have therefore transferred this to the pharmafacts institute, which has two recognized health care research institutions, Professor Gerd Glaeske and the IGES Institute. The pseudonymized data from the health insurance companies is processed exclusively by the pharmafacts institute and remains protected.

How much does your company invest in health services research?
Martens: Our investments start with this project, which is scheduled to last about two years. The costs for the entire study, the implementation of which of course also depends on a successful pilot phase, will certainly be in the six-figure range. We will only be able to quantify this more precisely as the project progresses. <<

The interview was conducted by MVF editor-in-chief Peter Stegmaier.