July 01, 2006
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Without equivalent to U.S. ruling, newest IOLs face slow acceptance in Europe

Many surgeons prefer less expensive IOLs due to lack of insurance coverage of multifocal and accommodative IOLs in the EU.

Although a wide variety of IOLs are now available to ophthalmologists in Europe and Asia, the lack of a ruling equivalent to the one made in the United States last year has meant their use has been minimal, according to a number of surgeons.

The ruling last year by the U.S. Centers for Medicare and Medicaid Services allowed patients to pay part of the cost of advanced-technology IOLs such as multifocal and accommodating lenses. No similar policy exists for countries in Europe, according to surgeons interviewed by Ocular Surgery News.

Multifocal lenses such as the ReSTOR (Alcon) and the Tecnis multifocal (American Medical Optics) received the CE Mark and are in use in Italy among other EU countries, but the lack of reimbursement for the lenses means they are passed over for less expensive IOLs, according to Francesco Carones, MD.

“The issue is related to the status of the government reimbursement, which is totally different from what is in the United States,” he told Ocular Surgery News. “Because hospitals pay more for a multifocal or an accommodative IOL, these IOLs are implanted very, very rarely.”

Even in private practice in Italy, multifocal and accommodative IOLs make up at most 30% to 35% of all procedures, he said.

Dr. Carones said that this has meant doctors are implanting aspheric IOLs such as the Acrysof HOA (Alcon) more often because they are less expensive and are provided in public hospitals.

Recently, STAAR Surgical received the CE Mark for its preloaded aspheric silicone IOL, the KS-3Ai.

“I would say that the standard of care for IOLs are aspheric, monofocal IOLs at this moment, in a ratio which could be one out of 10,” he said.

Manfred Tetz, MD, an Ocular Surgery News Europe/Asia-Pacific Edition editorial board member based in Germany, echoed Dr. Carones’ opinions on aspheric IOLs.

“I certainly did change my entire lens stock into the aspheric lenses,” he stated. “I strongly believe in the intelligent aspheric IOLs.”

Choosing between procedures

Because specialty lenses can be up to three times more expensive than standard monofocal lenses by some estimates, there is a large gap between the number of cataract procedures being done and the number of refractive lens exchanges.

“In terms of total implants comparing refractive lens exchange vs. cataract, [the market is] still 89% cataract,” Dr. Tetz said. “Refractive implants are not up really high against the cataract business yet.”

Emanuel S. Rosen, FCOphth
Emanuel S. Rosen

“If there was a law like in the U.S., … the market would explode,” he said.

This gap is even more pronounced in the United Kingdom where the National Health Service has been trying to decrease waiting lists for cataract surgery.

“Private cataract work has dropped precipitously in this country now that health services offer us short-term solutions,” OSN Europe/Asia-Pacific Edition editorial board member Emanuel S. Rosen, FCOphth, said during an interview.

Use of multifocal and accommodating lenses is also low because the new programs also forces hospitals to keep costs down.

“It’s typical of health departments in hospitals and the outside agencies to get the keenest price possible and that means not using the more modern lenses such as aspheric lenses and so on, because those come at a premium,” Dr. Rosen said during the interview.

Improving bioptics

On top of learning the best candidates for refractive IOLs, European ophthalmologists are improving on bioptics, which Dr. Tetz said is the best path to follow.

“Maybe now with the improved design and the development of the IOLMaster (Carl Zeiss Meditec), and the option of bioptics, we are now in range to optimize current multifocal lens technology in terms of refraction for patients,” he said.

For more information:
  • Francesco Carones, MD, can be reached at Via Pietro Mascagni 20, 20122 Milan, Italy; +39-02-7631-8174; fax: +39-02-7631-8506; e-mail: fcarones@carones.com. Dr. Carones is a paid consultant for Alcon Laboratories.
  • Manfred Tetz, MD, can be reached at Klinik für Augenheilkunde – Universität zu Berlin Augeustenburger Platz 1, D 13353 Berlin, Germany; +49-30-4505-4011; fax: +49-30-4505-911; e-mail: mtetz@charite.de.
  • Emanuel S. Rosen, FCOphth, can be reached at 33 George St., Wakefield, Yorkshire WF1 1LX, United Kingdom; +44-161-848-1500; fax: +44-161-848-1519; e-mail: erosen5640@aol.com.
  • Jared Schultz is an OSN Staff Writer who covers all aspects of ophthalmology. He focuses geographically on Europe and the Asia-Pacific region.