Q &A: JACQUES KINSBERGEN
National Efforts to Rationalize Reimbursement May Lead to More-Harmonized Systems
If harmonization has a final frontier, reimbursement policy would be a good candidate. Policies and procedures vary widely among EU member states and, in some cases, within individual countries. Jacques Kinsbergen, CEO of the Belgium-based Jacoti consultancy, has wrestled with reimbursement issues since the mid-1980s when he marketed a multichannel cochlear implant that he helped to develop. The device is now available—and reimbursed—in the major European markets. Kinsbergen started Jacoti in 1994 to help other device manufacturers market products in Europe and to obtain realistic rates of reimbursement. Drawing on its years of experience, the firm recently published a series titled Insight Reports on medical device reimbursement policies and procedures in Germany, France, Italy, Belgium, and the UK. Reports on Spain, Sweden, and the Netherlands are forthcoming. Kinsbergen spoke with EMDM on the evolving reimbursement environment.
Q: As you may know, EUCOMED has established a funding and reimbursement working group to promote the harmonization of reimbursement procedures within the EU. Have you seen any evidence to suggest that this goal is attainable?
A: A regulatory framework that would establish a common reimbursement policy is currently prohibited by the lack of EU competence within this area. However, there is a grey area relative to the free movement of goods and services in which the European Court of Justice is developing jurisprudence. In some cases, the ECJ has ruled in favour of individuals who purchased reimbursable medical products or had procedures performed in a third country and who were initially denied coverage by their national insurance provider. More cases like these are coming up, and the development of a body of ECJ case law may indeed have a harmonizing effect. Other cross-border influences may also have an impact.
Q: Are you referring to the trend in favour of diagnosis-related groups (DRG)?
A: Yes, that is one example of how governments are seeking to rationalize their healthcare systems. The tendency among European healthcare systems to use DRG-based reimbursement makes it easier to compare rates. You have to remember, however, that an Italian DRG ultimately may look very different from its German counterpart. And it's important to note that the purpose of a DRG is to control the budget, not to harmonize procedures. But the advent of these schemes may facilitate comparisons among countries and indirectly result in a more level playing field. Another activity within Europe that has a harmonizing effect within certain fields of medicine is the growing cooperation on the EU level regarding public health and research programmes.
Q: Speaking of cost comparisons, do you agree with some observers who say that the euro may affect the pricing and reimbursement disparities that currently exist?
A: That is also going in the direction of transparency. When all items are priced in euros, it will be that much simpler for purchasers of healthcare products to compare costs with their counterparts in other countries. The euro will prompt increased awareness of cross-border rates. Because of this, we strongly encourage companies to set up a standardized European price list for their products, and then to negotiate country- and situation-specific deals as the need arises.
Q: Do you share the view that reimbursement policies can constitute a de facto market barrier within the EU?
A: I would not say that reimbursement policies as such constitute the main problem for medical device manufacturers. More frequently it is the complexity of the various reimbursement systems and a lack of transparency in the decision-making process that cause difficulties for the device industry. Reimbursement policies can be a barrier in situations where a technology is not cost-effective in comparison with competing technologies. In those cases, it is important to find the means to define the specific national indications that may be crucial for a successful reimbursement strategy, as well as to describe a relevant reimbursement policy. This will enable the manufacturer to match his technology with a specific policy.
There is a general trend throughout Europe toward more evidence-based systems, in which cost-effectiveness and quality of life considerations become part of the decision-making process in reimbursement matters. And we do believe that reimbursement policies in the future will be more harmonized and thus cause fewer problems for manufacturers.
Q: In the meantime, how should companies approach what has been called the reimbursement minefield?
A: It always surprises me that companies are not looking at reimbursement issues early on during product development. They need to find out what reimbursement officials are looking for and to compile what I like to call a defense package, which lists the strong points of a company's technology, to respond to the economic issues that will be raised within the reimbursement environment. This is an area where Jacoti supports manufacturers.
When you are developing a new-technology product that is competing with other products in the marketplace, it is critical to define the benefits of the technology in the early stages, first within your company and then to reimbursement officials and key opinion leaders. This must be done on a country-by-country basis. It is very important to identify those local opinion leaders who are supportive of the technology and willing to communicate their support to stakeholders in the reimbursement system.
When I started in this business 15 years ago, technology was the barrier—a lot of things could not be developed because the technology was not yet available. Today, economics, not technology, is the barrier.
