New Technology and Medical Decision Making: Ethics, Incentives, Regulation, and the Role of Health Policy

Transcription

1 Panel Discussion on New Technology and Medical Decision Making: Ethics, Incentives, Regulation, and the Role of Health Policy with Speakers from the Conference and High-level Representatives from Health Policy, Biomedical Industry, and Health Care Practice in Germany as part of the closing day program of the ESF-IfW Conference on New Technology and Medical Decision Making: Normative Models and Empirical Practice, at Salzau Castle, October 9, 2006 Protocol: Andrea Pfennig, MD, MSc Alex Goehler, MD, MSc Introduction of the panelists: J.-Matthias Graf von der Schulenburg, Moderator: Professor of insurance and health economics, University of Hannover, Germany (VDS) Hans-Peter Dauben: a former cardiac surgeon, now at Deutsches Institut für Medizinische Dokumentation und Information (DIMDI), Cologne, Germany (HPD) Joseph S. Pliskin, Professor for Health Policy Management, Operations Management in Health, Ben-Gurion University of the Negev, Israel (JP) Ian H.K. Scott, a former surgeon, now National Clinical Lead Hospital Doctors, NHS Connecting for Health, Ipswich, UK (IS) Don E. Detmer, University of Virginia, President and CEO of the American Medical Informatics Association (AMIA), and a former vascular surgeon who has been working in health policy for 20 years (DED) David O. Meltzer: Internist, MD and PhD in economics, Professor at the University of Chicago, US (DM) Steffen Wahler: internist and economist, German Association of Research-based Pharmaceutical Companies, Verband der forschenden Arzneimittelhersteller, Berlin, Germany (SW) VDS: To open the discussion, VDS asks for policy recommendations to help Germany move ahead with health care reform. SW: The following process is planned for Germany: o We don t get a new NICE; we get what politicians believe could be a NICE. o We get a new board that will be able to adjust prices (sickness funds) to the incoming money; i.e. if expenditure exceeds that value, prices will be lowered. o IQWIG will only assess effectiveness. If there is a proven effect, then a cost-effectiveness analysis will also be performed; however, not according to international standards.

2 2 o Audience: When should health technology assessment (HTA) start and who should be responsible? Where should it start? European level? Industry level? Country level? HPD: Every market entrant has to do it because everyone is subject to the regulations; it can be started at some international level however, in the end it has to be done within a given health care system because each one is different. Decisions that rely on the same evidence in different countries with different health care system can indeed lead to different decisions. Example: In the Netherlands some drugs are reimbursed for ethical reasons which we don t reimburse in Germany. Audience: Germany wants to base these decisions on clinical and outcomes evidence; however they are not willing to pay for it. Who will pay for it? The sickness funds? SW: Nobody will pay. Not regulated yet. We don t know. DED: This is a very complex situation. This is a big challenge. You need a finegrained information structure to be able to ask different questions regarding the different stakeholders aspects. You should try to do that as globally as possible in order to avoid parallel initiatives. Maybe the EU could provide some resources. IS: As a byproduct of the our national effort, we will have the opportunity of using secondary user databases (as a standard dataset of treatment information). JP: There are 2 issues: o Consider whether you have evidence o suppose you have the evidence, how should a decision be made? o what could be suitable for one country might not be for the other? o evidence can most likely be transferred between countries; cost cannot. o Threshold depends on the GDP. o Getting there is one thing. Deciding how to prioritize it is another point? VDS: I would like to ask the panel to go more into detail. Please comment on the need of evidence and the need of methods for evaluation. Should models be used? Should we use surrogate endpoints? Should we use patient reported data? QALYs? Audience: The question about the tools is very much related to the context. More flexible tools related to the patient preferences? DM: If HTA is reduced to a single CE number on which negotiation is based, this would be sad. Reference to Steve Pauker; cost-consequence analysis is the right way to go; Pauker does not care so much about the outcome, he rather cares for the process. Health care is a very complex system. We need

3 3 as many tools as we have goals. HTA is only one tool with one goal which is not sufficient to answer all questions. o How do we prioritize? o Where should we focus on? DED: I feel it is already changing now and we start focusing in several aspects. Audience: Should we model long-term? Short term? What time-frame should we use? How thoroughly should the first decision be done? VDS: I would like to raise the question which perspective to use. SW: Societal. Definitively more than just the sickness fund perspective. HTA should be started when the product is already in use since this allows using real data. o HTA is dead according the new German law. DM: We should use several perspectives, at least societal and sickness fund. Regarding the question on the number of HTA per device, I think doing it at least once would be a good start. SW: Societal perspective. The time frame that NICE has adopted has chanced due to pressure from physicians and patients. o Patient groups had the most impact; they wanted to have drugs available to public as early as possible. JP: The frequency of the up-date is just one aspect, the process of delivering the technology is also important. In addition to an HTA, a constant continuous process is necessary to identify bottlenecks. HPD: HTA does not necessarily include costs. Focusing on costs is wrong. Guidelines of 2003 only address efficiency. When a new product enters the market, the producer should contact the HTA agency to speed up the process. The approach should be done in parallel. The Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWIG) should care for process optimization. Example: In NRW there are local groups for health need assessment. Audience: I argue against openly setting a threshold value because the public s resistance would be enormous. VDS: Will a threshold make it easier? Do we need a threshold? HPD: Maybe in specific disease areas never one overall threshold. DM: Let me be the economist for a second. If we really want to reduce cost, it is mainly a question of management there is the most waste it is only a smaller question for CEA. We need competition. We also assume that the new

4 4 technology will be used appropriately in reality this is often not the case. HTA fails to detect this. DED: Centralizing decision making will lower competition. There will be multiple process changes. We also need decision support systems. Audience: Best safety process is known to be in the Veteran Administration (VA) system which is the least competitive it is the opposite to what David said and I believe in university hospitals, safety is often much worse. DM: VA has improved in the last 10 years so be careful when referring to the VA system. I think most data suggest a better outcome under competition. IS: We had reform in the NHS in the 90s introducing a patient-centered approach. This led to increase of competition and quality. This had most positive impact on patient care in the UK since the start of NHS in Prior to this, the main focus was on softer issues. The benefit resulted rather from process changes than products used. VDS: We don t have a competitive system in Germany. We have a centralized system. Decisions are made centrally. If we had a perfect market, we would not need these evaluations. My questions is how should we make this when a new technology is coming on the market? Audience: We are not an island. The cost for innovation can be quite high, but it can also result in high earnings on the world market. Audience: Politicians are only interested in being reelected. If we are really interested in improving healthcare, we need to introduce some methods. DED: More transparency, get more data to the people. Audience: What about incentives and disincentives? Even in centralized systems, some incentives may be given. HTA effects reimbursement decisions and therefore influences incentives. DM: I teach at one of the top 15 hospital. However until recently, there was nobody to be found who focused on health care policy. This changed within 6 months when they were embarrassed by newspapers showing the opposite from what they show on TV. HPD: HTA is a tool it is only as good as the user. Don t overestimate it. Audience: All models assume x amount for disease y. Have these data ever been summed up and would they match with actual expenditure. HPD: We hope to have better data available within the next 2 years. Then, we might be able to answer these questions.

5 5 Audience: Individual patient can make choices without having insights into the costs. Are there instruments to combine these to make the patient more pricesensitive? DM: Within the past few years, expenditure for healthy people went up and for sick people decreased. This led to an unfavorable outcome. We should focus on delivering adequate care for the sickest. Audience: What about the impact of individualized care on the cost and outcome? DM: It will hugely increase the expenditure of health care since only a smaller group will be known to profit from the treatment. Among those who are known to profit from the treatment, the WTP will increase. This leads to an unequal distribution. HPD: Individualized care will come, but not all at once. DM: If individualized care comes slowly, this will even more increase the WTP. Audience: Who should get the role of a stakeholder decision? SW: HTA should be used to inform physicians and guide them to the right decision for their patients. Audience: We are an aging society. Value of health is large. How could HTA be further developed to help decision making on spending on new interventions? DED: In the past, we took health as a societal good nowadays we take health also as an economic good. DM: There is no question that the value of health very high. What is the incremental value of investment in new technologies? ICER is not the answer. Whether on HTA is a good thing, completely depends on how you use it. HPD: We need more transparency in Germany we discuss between 14.3 and 14.6 percent tax for health insurance nobody will understand it. We should clarify what is needed and what it costs the patient should decide whether he is willing to pay for it. VDS: How do you communicate uncertainty to decision makers? DM: Give them your best estimate. Re-assess next year. JP: Lets move from uncertainty to variability variability is the biggest enemy of management, drives costs up, drives uncertainty up. Audience: Should standard or guidelines require to look into subgroups? Or is this the job for modeling?

6 6 Audience: Variability teaches us a substantial amount about CE which we can address in models. The RCTs randomize it obviously away. DED: Information systems will influence guidelines through data collection. HPD: There is no right or wrong answer. Structural changes are needed before implementing new technologies. VDS: Patient reported outcome I take QALYs as its outcome. DM: Maximizing societal preference is wrong to assess patients needs HTA is not needed to assess patients preferences. Physicians should critically appraise new technologies new before applying them. DED: Get rid of inadequate treatments and technologies HPD: IQWIG will only accept surrogate marker if the clinical relevance of the change is proven. Although we have centralized decision making, we don t have centralized planning. Audience: Is there a need for patient-stimulated research? Could that be a success? DM: Patients are involved in decision making for treatments, but not in stimulating research. In some HMOs, patients are members of the board committee. Audience: If we do not focus on new interventions, others will do, such as India or China. VDS: Thank you very much for this interesting discussion!