Participatory​

Health care insurers and other organisations paying for health care  Health care is differently organised in different countries. I will focus on the German system in this blog.  How is this group defined? The term “Krankenkassen” is used to describe all insurers for health care operating in Germany. There are two different groups operating in parallel: The so-called “gesetzliche Krankenkassen” (GKV) which are the providers tasked with the mandatory health insurance everybody with a job has to subscribe to. They cover the whole family even if there is a single job-holder in a family of 10. The monthly premiums are based on a percentage of the income and not on the number of persons insured. Therefore, this model is called a solidarity community where the more affluent pay for the less well off. On the other side there are private health insurers (PKV) that operate on a different model. Here the premiums are determined solely by the age and (initial) health status of the individual insured and each family member needs a separate contract. This is much cheaper for individuals than public insurance but adds up dramatically for families. On the upside private health insurances cover a wider range of treatments and medications than public insurances. However, there is a minimum wage level to be eligible for opting out of the public system and entering the private system.  What are the major roles of this group in personalized medicine? The GKV has a central umbrella organisation called “GKV Spitzenverband” which takes care of the major issues of all GKVs. This includes negotiating prices for medical services with the GKV-registered MD associations, fixing the pricing on medical services in the whole country. The same goes for drug reimbursements, where pharma industry is legally bound to reach an agreement with the GKVs. There are number of other topics also covered by the GKV umbrella organisation including negotiations about the services covered by the - also mandatory - nursing care insurance.  In summary the GKVs and PKVs are the stakeholders shelling out the vast majority of the money to cover health care expenses in Germany and they were armed by the legislation with negotiation powers to control health care costs at least in part (they have to negotiate with Pharma and the MDs, they cannot dictate pricing). Fig 28: Health care Insurers What is the major impact of this group on the development of personalized medicine?  Of course, their decisions which services and drugs to cover and to which percentage (not always 100%) has a great influences both on pharma developments as well as which treatment regimes MDs will focus on. GKVs are legally bound to insure coverage of almost the whole population of the country and also to cover adequate and state-of-the-art treatments. However, they have developed their own elaborate procedures to define what adequate and state-of-the-art means. Their feedback to the politicians in heard because the state must pick up any costs the health public insurers cannot cover on their own. Thus, they are the main deciders what kind of health care is available to the general public.  With whom has this group the most important interactions? Pharma industry, MD-organisations, hospitals and hospital groups, are the mandatory partners which which the GKVs and the PKVs have to interact constantly. The health insurers get their directives from the parliament in form of specific legislation and they lobby the politicians to expand their financial means and decision powers.  What is required of this group to further the development and application of personalized medicine? Personalised medicine by definition is a field where there are no large-scale statistically significant study results on the efficacy of drugs and treatments. Currently, health insurers approach this field by issuing individual agreements to cover special costs for personalised medicine treatments, patient by patient. or in limited pilot studies (e.g. the Cologne model).  While this natural limits the number of patients that are eligible, I was told by some leading MDs that so far requests by MDs for personalised medicine for individual patients are usually granted. This is the only way to gain a sufficient database of efficacy of personalised treatments in retrospect as success and followup data for more and more cases is documented. In the end, health care insurers are bound to restrict the increase in overall costs as the state only kicks in in acute emergencies. By and large the GKVs have to manage within their budgets. Therefore, there will always be a balance between newer and more expensive treatments and drugs and the requirement to limit treatment costs - not individually but in general.   What’s coming up next? Next week I will focus on the money side of heath care, especially the cost for personalised medicine and the money saving potentials.​

Participatory​

Pharmaceutical Industry How is this group defined?  There are two main groups of pharmaceutical companies: The large international corporation such as Roche, Novartis, Sanofi-Aventis and several others. The second group is the collection of producers of generica, drugs that ran out of patent protection and can be produced free of royalties. Therefore, generica can be offered a lot cheaper than newer patent-protected drugs because their producers do not have to bear the enormous costs of drug development. The downside is that generica do not represent the cutting edge of pharmaceutical development.  What are the major roles of this group in personalized medicine? Personalized Medicine, especially precision medicine, depends critically on specific, sometimes entirely new drugs, and their companion diagnostics. This its exactly what pharmaceutical development is all about. However, the pharmaceutical industry has traditionally had a hard time to fully embrace the new molecular technologies. But the managers of this industry have realised that there is no way around these technologies. The Association of the research-conducting pharmaceutical industry (in Germany), the vfa, states that on its website as follows:“The term Panomics relates to the complete sets of biological data from the genome, transcriptome, proteome, metabolome, and all the other “-omes” together with other patient-specific information. The American Society of Clinical Oncology (ASCO) defines the term as follows: “”The interaction of all biological functions within a cell and with other body functions, combining data collected by targeted tests ... and global assays (such as genome sequencing) with other patient-specific information.”…”The development in the field of -omics technologies holds a great potential for biopharmaceutical research. New approaches in diagnostics and stratified medicine become possible.”Fig 27 Pharmaceutical industry What is the major impact of this group on the development of personalized medicine? Currently, 51 drugs are available, which belong to personalized medicine. This includes only such drugs that either require a companion test or where such a test is recommended. 46 drugs have a mandatory test, for 5 more the specific test is recommended. This clearly shows the strong influence of the pharmaceutical industry on the development of personalized medicine. The top-management of parma-industry determines if and which new drugs become available for MDs for personalized treatments. With whom has this group the most important interactions? The pharmaceutical industry is subject to several legal requirements necessitating intense communication with several partners. Approval of new drugs for market entry is highly regulated, and the requirements are in part responsible for the steep increase in costs of drug development. Since 2011 Germany prohibits the pharma-industry from setting prices for new drugs on their own. Prices need to be negotiated with the GKV (the association of all health care insurers). That way the pharmaceutical industry is forced to negotiate with heath care insurers. Of coursde, MDs and scientists are also important partners for application and research, respectively. Direct patient contact on the other hand is not a major concern of pharma industry.  What is required of this group to further the development and application of personalized medicine? Basically this has been nicely summarised by Birgit Fischer, the chief managing director of the vfa: “The transition from debating distribution to debating care needs to be based on data. This way information technology in therapy becomes a power source for the benefit of the patients. However, currently too much relevant data is distributed to various locations within the health care system. Save and accepted interfaces are required for all players which are transparent for patients.”One could add that the part of preventive diagnostics is still in its infancy. This field requires more intense efforts. Unfortunately, this meets with strong sceptical views on the side of health care insurers who are still not convinced about the costs effectiveness of such measures.  Which in turn is caused at least in part by the lack of comprehensive data collections, see above.  What’s coming up next? Next week we come to the group, that has to foot the bills, literally: health care insurers.​

Participatory​

Clinical Laboratories Guest author of this entry: Dr. Hanns-Georg Klein Personalized medicine relies on knowledge about the specific genetic and physiological conditions of patient groups or even individual patients. Naturally, all these sophisticated test have to be carried out by somebody sufficiently qualified for the job. These are the clinical laboratories, which operate either as part of a hospital or on their own respectively in networks of laboratories. One member of our board of directors, Dr. Hanns-Georg Klein runs such a laboratory himself. Of course, he is far better qualified to describe this partner in personalized medicine that I ever could. Therefore, I am more than happy that he wrote an entry himself, which I would like to present in translation in the following. How is this group defined? Clinical laboratories can only carry out all tests in larger networks. However, individual tests are carried out in a decentralised mode of operation usually lacking data integration and overarching interpretation of the findings. Smaller facilities - such as ours - attempt to master projects of interdisciplinary and holistic laboratory diagnostics ranging from genetics all the way to morphology.  What are the major roles of this group in personalized medicine? “Precision Diagnostics” or Companion Diagnostics” as part of personalized medicine are so far only carried out selectively in specialised departments of laboratories or laboratory networks. High costs often prevent a holistic approach. The primary goal is not serial standardised work but a variety of diagnostic views on an individual basis.  Fig 26: Clinical laboratories - diagnostics What is the major impact of this group on the development of personalized medicine? Since increasing individualised therapy necessitates also refined individual diagnostics, clinical laboratories have a high potential of influence on the development of personalised medicine. This also remains true against the background of cost-efficiency: An innovative cancer or HCV treatment can cost 50,000 to 150,000 € per year. Our health care system is willing to bear these costs in order to save on the cost of inpatients. However, in such cases the system needs to be prepared to also accept 10% - 20% of the therapy costs as additional costs for “precision diagnostics” including therapy monitoring. This ensures that expensive therapies are actually applied to those patients that will profit from the treatment.  With whom has this group the most important interactions? The major partners are medical directors of large laboratories, but also the pharma and diagnostics industry. It became common sense that all the new compounds, in part developed based on genome research, will increase therapy costs beyond reason. “Precision diagnostics” will restrict such treatment to smaller patient groups. “One drug fits all” is no longer true for new generations of drugs. Unfortunately, cost-saving strategies of huge umbrella organisations often curb the possibilities of clinical laboratories. Germany is among the lowest clinical laboratory costs in international comparisons. This does no leave much room for innovative diagnostic procedures, which often original from smaller laboratories and not from industry.  What is required of this group to further the development and application of personalized medicine? To achieve some impact that will further also the cause of patients a centralised representation will be required. This should include public relations, medical specialists from laboratories, pathology, human genetics, microbiology, virology and transfusion medicine. Such an umbrella organisation would also have the political clout to make itself heard. Unfortunately, different associations of MDs disagree as soon as subject-specific budgets or - in plain English -  money is the issue. A common stand on politics and public relations between professional associations and institutions has not yet been reached, preventing an unified appearance. It would be important to start with education: two years of joint education for medical specialists for all these groups of MDs followed by a three-year specialisation phase. Corresponding changes could be introduced into the organisation of congresses and symposia: e.g. a joint meeting every two years of all groups involved. The diagnostic industry is represented by a powerful umbrella organisation (association of diagnostic industry, VDGH). Unfortunately, this association focuses on its own agenda.  What’s coming up next? Next week is about the partner, without whom there would be no new drugs, the pharmaceutical industry.​

Participatory​

Medical Doctors (MDs) in academia & industry How is this group defined? Medical doctors (MDs) are almost synonymous with applied medicine.They represent the front line treating patients, deciding on treatment strategies and patient care. There are several categories of MDs listed here in descending order with respect to patient contact. First of all there are the practitioners, MDs working in medical practices and surgeries across the country. The often fulfil a role as family doctor and are usually the first MDs to whom patients turn upon any new health concern. The second group is defined by the many MDs working in hospitals where more sophisticated high-tech medicine is available for conditions beyond the means of a standard medical practice. Surgeons are a prominent part of this group of MDs. The third group of MDs sees patients only occasionally as this group is working in research, especially in pharma research. They are more tasked with the development and improvement of new forms of drugs than with direct patient care. And last, not least, there is an army of MDs working in agencies, health care providers, legal departments, parliamentary committees and other institutions that do not see patients at all but provide the required expertise for medical regulations, drug safety rules and procedures, etc. This is the group setting the stage and the boundaries within which all the patient-caring MDs have to work.  What are the major roles of this group in personalized medicine? If anybody sees the impact of personalised treatment first hand then it’s the MDs. They not only provide the first expert feedback about any personalized treatment (if allowed to do so by their patients). They are the ones deciding whether a patient gets a personalised treatment or not in the first place.  Fig 25: Medical doctors (MDs) are the central hub of medicine  What is the major impact of this group on the development of personalized medicine?  Personalised medicine is based on genetic traits of the patient and uses all kinds of measurable parameters to decide on the best treatment and judge treatment results. However, a human being is far too complex to be reduced to measurable parameters, regardless how many are measured. In the end the complete picture needs to be seen and taken into account when drawing conclusions about the success or failure of a treatment. This its exactly what MDs bring to the table. Their experienced and expertise in seeing beyond mere measurements is a huge advantage. However, being humans as the rest of us, they also fall prey to prejudice, errors, and misjudgements. I believe that by and large the positive impact of MDs outweighs whatever the imperfect human nature may take away from it. Neither “objective” measures nor experts are infallible, which we should never forget when coming across controversial results or opinions.  With whom has this group the most important interactions? Patients come to mind first, of course. However, MDs spend a lot more time than they like dealing with heath care providers too get reimbursed for decisions they made. They need to keep up with the latest developments spending precious time on their own education, taking away time from patients. However, most current MDs have not been exposed to personalised medicine during their studies as the topic is rather recent. Therefore, education is their only chance to catch up. MDs must know the legal rules they have to play by, they also must and do consider ethical aspects seriously and their feedback is crucial for new research. MDs are the central hub of medicine and personalised medicine is no exception. What is required of this group to further the development and application of personalized medicine? Keeping abreast with the development of new drugs and treatment schemes based on the novel concept of patient genetics requires jumping over their own shadow for MDs. It costs time (MDs are always short on time) eventually requires to venture outside their familiar area of expertise. It also brings new challenges since the genetic and molecular measures cannot be directly interpreted like a clinical symptom. Yet without the engagement of numerous MDs, personalized medicine will never reach the majority of patients.   What’s coming up next? Next week we will look briefly into he role of medical laboratories, the places where most of the measurements and tests are carried out.​

Participatory​

Patients - these are all of us How is this group defined? Of course, we are not all patients in the strictest definition: A person seeking medical treatment for some kind of ailment. I prefer the definition found in Wikipedia: A patient is any recipient of services. This goes well beyond treatment of diseases. For example, your regular checkup at the dentist in the absence of any known problem is covered by the health services. This is a measurement of prevention, not treatment. Add cardiocvascular monitoring, colonoscopy to prevent colon cancer and many other things, that are covered by the health care providers (at least in part). Then it is easier to understand why the headline reads - these are all of us.  What are the major roles of this group in personalized medicine? Naturally this is the group at the receiving end of personalized treatments and preventive suggestions. However, patients (should) have a much more active role in personalized medicine than passive recipients. First of all, prevention requires a lot more action on the side of the patient than the advisors (doctors, physiotherapists, etc). But also during therapy patients should take an active role. Medication is a great aid for the body but no medication has ever cured anybody without the crucial efforts of the patient itself. Many of these occur subconsciously (such as the basic activity of the immune system) but can be boosted considerably by the mental and physical engagement of the patients. Consenting to the use of the medical data in research and clinical development is also an active role of patients that will have far reaching consequences, either way.  What is the major impact of this group on the development of personalized medicine? Patients interact with doctors and other people in health care and their questions and demands drive in part which strategies are being pursued in their treatments. It is mandatory that patients explicitly consent to any invasive treatment (including invasive diagnosis) and their willingness to participate in clinical studies is crucial for further development of drugs and treatments. Our choices in these topics seem exclusively personal but in summary are one of the biggest driving forces of medicine including personalized medicine. Or a major obstacle depending on how we as individuals make our decisions. Fig 24: Patients and their roles With whom has this group the most important interactions? MDs regardless whether as practitioners or in hospitals are the natural group to directly interact with. Other non-MD medical staff (nurses, assistants, physiotherapists, representatives from health care providers and sometime lawyers) are also among those groups that interact frequently with patients.  What is required of this group to further the development and application of personalized medicine? As already mentioned, taking an active role in one’s mixture of prevention, diagnosis and treatment depending on the stage. This goes beyond medical interactions, as we are the ones to influences politicians in their decisions regarding the legal framework within which medicine and personalised medicine can work.  What’s coming up next? Next week we look at the other of the main axis of personalised medicine, MDs.​

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