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Drug-eluting stent penetration in Europe

Thursday, 02 Sep 2004 00:00

Since we wrote about this issue in Cardiovascular News Issue 3 last year there has been an explosion in the market for drug-eluting stents (DES). Penetration in Western Europe has now reached over 30% and has already reached 70% in the US, buoyed by FDA approval of the TAXUS stent on March 4th of this year. The next big frontier is Japan where the Cordis CYPHER stent has already received approval from the Japanese Ministry of Health, Labor and Welfare, and where government approval is likely to be gained by mid-year. TAXUS approval is also imminent in Japan, where some commentators, prior to the recent recall of TAXUS, suggested that revenues could reach $500 million in 2005, which is the first full year of sales.

In Europe the adoption of DES has been a lot more gradual than in the US or indeed what is expected to occur in Japan and revenues could be as little as $200 million this year. Cordis and Boston Scientific are the main players, though Medtronic should have a DES available by the end of the year and Guidant shortly after. Furthermore Abbott Vascular Devices has had its Dexamet DES available on the European market for quite a while now. Increased competition is having some effect on prices and it is now very rare to spend over €2,000 on a drug-eluting stent, with €1,500 becoming commonplace in some countries such as the UK, which have higher rates of penetration than the European average.

However, Europe's largest coronary stent market, Germany, also remains the market with the lowest penetration rate (around 10%). One reason for this is the extremely competitive market for bare metal stents, with prices of €200 or even lower commonplace. Also we are aware of bundling deals taking place where bare metal stents are sold even cheaper.

Maciej Lesiak
Maciej Lesiak

The main reason for the lack of take-up of DES in Germany remains the reimbursement situation. The change over to the DRG system in Germany has meant that hospitals will be reimbursed by procedure. Hitherto a major element has been costs of hospitalization. In Germany the situation exists at the moment where an angioplasty with DES costs €6,000 and is not reimbursed. However a CABG operation that costs €12,000 is reimbursed. The system is changing because modern treatment allows more day cases, which do not require patients to be hospitalized and it will focus more on the costs of devices. Cutbacks in health service spending have made it very difficult for clinicians to justify the use of DES, except where absolutely clinically necessary. This is likely to remain the case until DES prices are closer to those of the bare metal version.

Another country where DES penetration remains low is Belgium (around 25%). This is because only patients with certain indications such as diabetes get full reimbursement from the Belgian health reimbursement authority (INAMI). However increased use of DES in the neighboring Benelux countries of The Netherlands and Luxembourg is influencing higher take up of DES in Belgium. Also there was a reimbursement change on June 1st where all DES stents will be reimbursed but only at the bare metal stent rate. This, according to Professor Desmet at the University of Leuven could mean that DES penetration "could go as high as 40% in the near future". Professor Bosman from Antwerp was more conservative and thought that 30% was more realistic as he believed DES would be used mainly with patients with a "high risk of restenosis".

Patrick Serruys's total adoption of DES at the Erasmus Center in Rotterdam has been one influence in the higher take up of DES in the Netherlands, which currently lies at around 35%. Dr Suryapranata at the Ziekenhuis de Weezenlanden felt that the Erasmus Center "Did not have much influence on practice in the rest of the Netherlands" and that as a result DES penetration was strongly influenced by budgetary and reimbursement issues. He felt, however that DES penetration would reach around 40% for Q2 2004.

Elsewhere in Europe DES adoption has significantly increased in several countries. The highest penetration rates of over 66% can be found in Switzerland and Portugal, which have full reimbursement of DES. Scandinavia and the UK are also showing high DES penetration rates, as are Austria, Greece and Spain. Scandinavia should not be taken as a homogenous grouping. Both Norway and Sweden have significantly lower penetration rates than Denmark and Finland due to the per procedure rather than per device reimbursement. We spoke to

Dr Rune Wiseth who works at Trondheim University Hospital, who said that DES penetration in hospitals in Norway varied a lot between 10% and 60%, with an average of 30%.

The UK is worthy of particular mention as high take up in the private sector, in particular, is driving up DES penetration to over 40%. Spain is quite similar in that DES take up in the private sector is driving take-up of drug-eluting stents and also in that DES penetration is now over 40%.

A peculiarity of the UK health system is that the Scottish system is run independently to that of England and Wales. This has led to an interesting phenomenon, that of DES not being reimbursed in Scotland but having a high penetration rate in England. Not surprisingly Scottish interventional cardiologists are not happy about this situation and several patients are rumored to have sought private treatment in England after advice from their doctors. We may well investigate this situation further in the next edition of Cardiovascular News.

In France, there is now full reimbursement in the private sector, which means that overall DES penetration is over a third. However reimbursement for the public sector is less easy and it is not until the tarification a l'acte process takes place later in the year that we will see more widespread adoption of DES in the public sector's large CHU hospitals. Only when this process is complete will we see DES penetration rise to over 50% in the French market.

In Italy we see large regional differences with DES penetration well up in areas in the prosperous North such as Tuscany, Piemont and Lombardy, where Milan is situated. However DES penetration is well below the European average in Southern areas reflecting the economic situation of these regions. There is also a far higher use of DES in private centers rather than public ones. We suspect that pressures on health budgets will continue to slow down take up of DES, especially in public centers in the South. However even in the South of Italy there are differences in DES usage. Some private centers have a penetration rate as high as 60-70%. Sicily also differs from the rest of Southern Italy in that DES penetration in public centers reaches levels more common in the North.

In Central Europe drug-eluting stent penetration remains low. However, DES manufacturers are aware of the potential of these markets, especially Poland, which has a higher population than all the other EU entrants combined. We spoke to Dr Maciej Lesiak, who works at Poznan Hospital. He told us that only 900 of the 35,000 stents implanted in 2003 were drug-eluting stents, which represents a DES penetration rate of only 3%. He also said " I don't see reimbursement being a obstacle. However budgets for hospitals are fixed. We simply need more money spent on the healthcare system." He also said that reimbursement for CABG was quite generous in Poland and that this was putting a brake on DES usage and PTCAs in general.

Elsewhere in Central Europe, the Czech Republic and Hungary are also regarded as potentially lucrative markets for DES as is Slovenia, which could prove a gateway to other members of the former Yugoslav confederation. However DES penetration in these countries is low as well and remains under 10%.

Device manufacturers are also realizing that there are extra benefits to DES apart from profits in this area. Balloon use has increased so this means a higher potential market for balloons throughout Europe, which is benefiting all coronary balloon manufacturers. Ratios have gone up from approximately 1.1 balloons per stent when only bare metal stents were implanted to 1.2 when drug-eluting stents are used. This may seem insignificant but grossed up across Europe, this represents a significant market opportunity.

There remains a large potential increase in the market for drug-eluting stents, although this may have been impacted by the recent problems experienced by a number of companies. Some commentators believe that universal use is unlikely as they are not suitable for all indications. However a penetration rate of 80% is a possibility and will be achieved once the stent design and the polymers are optimized.

If you would like to comment on this article or are interested in research on drug-eluting stents, please contact: Jonathan Sheldrake of BIBA Medical at jonathan@bibamedical.com

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