Germany Tops TAVI Table, But Room for Growth Remains

November 02, 2011

November 1, 2011 (London, United Kingdom) — The introduction of transcatheter aortic-valve implantation (TAVI) into clinical practice has varied dramatically around the world, due to differences in the approval process and reimbursement policies for the procedure, a series of speakers told the recent PCR London Valves 2011 meeting.

Currently, Germany heads the league for most TAVIs; doctors there have performed around 12 000 of the estimated 40 000 procedures so far around the world, Dr Nicolo Piazza (German Heart Center, Munich) said during an overview on the worldwide use of TAVI. Piazza explained that most procedures are being performed in Europe, because the US is some four years behind in terms of clearing the devices for marketing--US approval of the first TAVI device, the Sapien valve (Edwards Lifesciences) is expected any day now--and in other parts of the globe, TAVI programs are ongoing, but only in isolated pockets.

In Asia, said Dr Paul Chiam (National Heart Centre, Singapore), only a handful of places are performing TAVI, although a trial of the Edwards Sapien valve is ongoing in Japan. He relayed his experience in a single center in Singapore, where other issues have emerged, such as the fact that the sizes of the valves currently approved are turning out to be too large for many Asian patients.

Meanwhile, Dr Tom Mabin (Vergelegen Medi-Clinic, Somerset West, Western Cape, South Africa) described the struggle to pioneer TAVI in an economically challenging environment such as South Africa, where the average health expenditure per capita in the public sector is only €220 per year.

TAVI Penetration Low, Even in Europe

One of the major factors determining how much TAVI is performed is the funding criteria in each nation, Piazza explained, noting that variable reimbursement policies exist across Europe.

In France, for example, the payment for the TAVI diagnosis-related group (DRG) is €28 477, and its use is restricted to only 33 centers around the country. But in contrast, in Spain, TAVI is performed according to hospital budget. And payments for the DRG in other countries vary, from €25 308 in Italy to €34 080 in Germany, he explained.

TAVI across Europe [Source: BIBA Medical]

However, even this does not tell the whole story. "In Germany, there is a form that is filled in for every patient who undergoes TAVI based on the labeling indication for the device," Piazza explained. "But there are patients being treated by TAVI who don't fall within the labeling indications, so how the authorities take control of this, I'm not sure."

Right now, more than 40% of the TAVI performed in Europe is done in Germany, followed by France and Italy, which both perform around 11% of European procedures; the UK and Spain, which have 7% of the market each respectively; the Netherlands, with 6%; and Switzerland with 4%. But even in Germany, the penetration rate for TAVI is still less than 20% and so there remains much room for growth, he noted.

Attendees commenting after Piazza's talk thanked him for the presentation. One said, "This is the type of information we as doctors like; it helps us to understand that one of the Achilles' heels to expand the procedure is financial. But I'm not sure what role we can play; it's a little bit frustrating."

Expensive, Even for Lady Gaga, But Market Forces Will Prevail

Continuing with the financial theme, Mabin relayed his experiences with regard to setting up a pilot TAVI program in South Africa. In a country ravaged by HIV infection, where the probability of dying before 60 is 62%, the only initial option has been to set this up in the private sector, he explained. But even this has been a struggle, with some "uncomfortable arithmetic," he admitted.

The funders have been worried we would be doing TAVIs willy-nilly in everyone with aortic stenosis.

The private sector in South Africa covers around eight million individuals with some 100 insurance companies, Mabin said. So far, in two years, from October 2009 to October 2011, 125 TAVI procedures have been performed (120 Edwards valves and five Medtronic CoreValves) by three countrywide teams, with the most popular means of paying for it a "global fee" covering the prosthetic, the hospital fees, and cath lab costs and a "modest" professional fee for the teams; this mode of payment was utilized in 70% of cases, he noted.

In some areas, there was a limitation on the prosthetic cost; in these cases, copayment by the patient became an important component of getting the procedure performed, he noted.

At this point, he displayed a photo of the international pop star Lady Gaga, who, he said, "has made $95 million in five years." When asked in a recent interview what the most expensive things she had spent her money on were, she had replied that two things stuck in her mind [1]: "First, a Rolls Royce for her parents, and second, she sponsored her father's TAVI," Mabin remarked.

"The pros and cons of TAVI have been a very concerning factor for the funders, who have been worried we would be doing TAVIs willy-nilly in everyone with aortic stenosis," he explained. "The challenge we have had to overcome is to persuade them that the prosthesis makes the whole procedure worthwhile." But with an incremental cost-effectiveness ratio (ICER) of $50 000 from the PARTNER cohort B trial, "TAVI just about makes the hurdle in terms of what is acceptable [economically]," he noted, "so we still have some persuading to do."

The first drug-eluting stent was an enormous price, but the costs came tumbling down very quickly when competitors came to the market.

But Mabin said the outcomes in the pilot procedures in South Africa have been good, comparable with what has been reported elsewhere, and he is confident that with competition, the prices of transcatheter aortic valves will come down. Medtronic has recently entered the South African market with the CoreValve, he noted, and "is very keen to get into the public sector, so has come in with some huge cost reductions just to allow the public sector to afford it, although it's still limited so far."

"We do have a challenge to try to make these new technologies affordable," he observed, but added that he is confident that market forces will prevail. "The first drug-eluting stent was an enormous price, but the costs came tumbling down very quickly when competitors came to the market."

Gap Between TAVI in Europe and US Helped Generate Important Info

Dr Jeffrey Popma (Beth Israel Deaconess Medical Center, Boston, MA) explained the differences in approval procedures that have led to an almost four-year difference between the approval of TAVI devices in Europe and the US. While industry bemoans the 54 months it takes from an initial conversation with the FDA to gaining approval for a device, "if there weren't this requirement, we wouldn't have the PARTNER A and B studies, and these randomized controlled trials are critically important to give us the evidence base we need for TAVI," he observed.

We are paying a lot [with TAVI] for quality of life, and it's the quality of the end of life.

He also spoke about the financial constraints that will govern the use of TAVI in the US, where the impending approval of the Sapien valve is focusing the minds of payers on how to fund the procedure. He said that, there, the actual prosthesis price constitutes a big part of the difference in cost between TAVI and surgical aortic-valve replacement (SAVR). A transcatheter aortic valve currently costs around $30 000 in the US while a surgical valve is just $5000, he noted.

And while an ICER of $50 000 for TAVI from PARTNER B is routinely compared by proponents with the cost of dialysis to justify its use--which is in a similar ballpark--"we don't put 90-year-olds on dialysis," he commented.

"We are paying a lot [with TAVI] for quality of life, and it's the quality of the end of life," he remarked.

Other Challenges in Asia: Smaller Sheath Sizes and Smaller Valves

In Asia, while the cost of TAVI also undoubtedly plays a role in uptake, there have been other challenges as well, Chiam told the meeting. There is "a tendency for the elderly to take a very fatalistic approach there," he said, "so they believe when their time has come, it is time for them to go," leading to some reticence among patients to undergo TAVI.

As such, only a couple of hundred TAVI procedures have been performed around Asia outside of trials, he said: China began a program but had some regulatory issues, so it has stopped, and India has yet to begin. In Japan, although there is a randomized controlled trial ongoing with the Sapien valve, "recruitment is going pretty slowly," he noted.

We do need a smaller valve for Asian patients and smaller sheath dimensions.

And the patients who are receiving TAVI have a different profile from those in the West, he noted. In his center in Singapore--where 40 TAVIs have been performed in the two years since the Edwards and Medtronic valves have been approved--the average age of the patient is only 72 years, he noted. Most undergo TAVI because they have been rejected for SAVR by at least two surgeons; many are very low-weight, frail patients, particularly the females, he explained. Some have previous CABGs or have had previous double mastectomies and consequent scarring, for example.

So patients are smaller than their counterparts in the West and require the smallest Edwards (23-mm) valve and the smallest CoreValve (26 mm). Another consequence of this is that the recipients have smaller femoral arteries, and at first, because of the sheath sizes available for the delivery systems, only around half of all cases could be performed transfemorally, Chiam noted, although a new system now enables arteries of just 6 mm to be used, so uptake of transfemoral access has now improved to around 80% to 90% of cases.

The results so far have been encouraging, "and we can expect the same results [as the West] if we choose the patients carefully," he said. "But we do need a smaller valve for Asian patients, and smaller sheath dimensions are also important to extend the amount of TAVI performed by transfemoral access," he noted, adding that a 20-mm diameter Edwards Sapien valve is being tested in Japan. On November 2, Medtronic announced that operators in Japan had implanted the first CoreValve in a clinical trial evaluating the safety and effectiveness of the device in Japanese patients.

Chiam declared no conflicts of interest.

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