Transcatheter valve implantation (TAVI) penetration rates are under 20% in Europe, according to data presented on 17 October at the PCR London Valves congress in London, UK. Nicolo Piazza, Munich Heart Centre, Germany, told delegates that penetration rates are expected to increase in Europe as reimbursement for TAVI procedures becomes available in more countries.
“Market penetration is the degree to which a product is known and/or used. It is measured by the number of patients treated with the technique divided by the number of treatable patients,” Piazza said. “Some of the factors that can influence therapy the penetration of a technique are its safety and effectiveness, the unmet clinical need, device suitability for various patient groups, number of centres with adequate resources, scope of regulatory approval, per-capita gross domestic product, and reimbursement policies. “The scope of regulatory approval and reimbursement policies are the most important ones,” he stated.
Piazza made assumptions to calculate the number of patients who could be treated with TAVI in 14 countries in the European Union. “In these 14 countries, there are 36 million people aged 75 years or older – this represents 9.1% of the population. According to some publications, 2.4–2.9% of the population over 75 years has severe aortic stenosis. We assume, as there is no answer in the literature, that one out of two patients with severe aortic stenosis is symptomatic.
We have publications indicating that 30% of patients do not undergo surgery, and we have to make the assumption that approximately 5% of patients fit within the TAVI anatomical exclusion criteria,” Piazza said. “If we look at the number of patients over the age of 75 years in these 14 countries, and we apply these assumptions, we come to 144,344 patients who could potentially be treated with TAVI.”
There were 14,439 TAVI procedures in Western Europe in 2010 and 8,748 in the first half of 2011, according to data from the European TAVI Monitor produced by BIBA Research. Germany accounts for 43% of these, followed by Italy (11%), France (11%), UK and Ireland (7%), Spain (7%), The Netherlands (6%), Switzerland (4%) and others (11%).
“We know the number of patients that have been treated, and we have made some assumptions for the number of patients who can potentially be treated with TAVI. What we get in terms of penetration rate is a variation from less than 1% to 20%, with the highest rates in Switzerland, Germany, The Netherlands, and Austria,” Piazza said.
“As I said before, reimbursement is an important factor in the penetration of TAVI in Europe. In the UK, the National Institute for Health and Clinical Excellence approved TAVI for inoperable patients in July 2011. In Germany, TAVI is part of a diagnosis-related group (DRG) and is reimbursed at €34,080; in France it is part of a DRG valued at €28,477, but it is restricted to 33 centres. Austria will include TAVI in a DRG of €27,227 in January. In Italy, there is regional reimbursement and, in Lombardia, for example, the DRG pays €25,308 for a TAVI procedure. In Spain, it is according to hospital budget. Switzerland is set to include TAVI in a DRG in January 2012, but the tariff is still under discussion.
“There are variable reimbursement policies in Europe and also variable TAVI penetration rates. Penetration of TAVI will increase as reimbursement becomes available in more countries,” Piazza concluded.
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