Eyeworld

EW INTERNATIONAL 80 February 2016 by Matt Young and Gloria D. Gamat EyeWorld Contributing Writers "There are many procedures in the United States that we have been doing for years now to treat glau- coma and not allow it to progress to the advanced stage," Dr. Weiner said. In Israel, the Ministry of Health has not yet allowed this procedure to enter the Health Basket. "They don't realize that if you solve the problem earlier, you can actually lower the cost because it is much more expensive to treat the advanced glaucoma patients," he said. "If we miss the train and the patient loses much of his/her vision, the care for such a patient is much more expensive than doing earlier procedures like the Trabectome that can help prevent the patient from getting to such an advanced stage," he said. While ophthalmologists in Israel can recommend Trabectome, patients have to pay for it them- selves. "Otherwise, there is no other MIGS procedure available in Israel— not counting ALT and SLT, which are of very limited benefit—and most patients with need for surgery end up with a full trabeculectomy," Dr. Weiner said. Patients are left with no choice but to opt for traditional procedures. Whether a procedure like the Trabectome is covered by health insurance or not, Dr. Weiner said, doctors should be aware of its bene- fits to their patients and recommend it to those who can afford it. "Granted Trabectome does not always solve the problem, but when it works, patients gain tremendous- ly," he said. "As demand grows, the proce- dure will eventually be approved for the Health Basket," Dr. Weiner said. "Doctors and patients should be made aware of the huge difference in quality of life for patients be- tween the MIGS procedure and the traditional trabeculectomy, which is a high-risk and extremely limiting procedure," he concluded. EW Editors' note: Dr. Weiner has no finan- cial interest related to this article. Contact information Weiner: aweiner7@gmail.com Almost any procedure that is already approved by the U.S. FDA, according to Dr. Weiner, is likely to get ap- proval in Israel. The first Trabectome surgery seminar was conducted in Israel in April 2012. "Trabectome is no exception and can be, and has been, performed in Israel by qualified doctors," Dr. Weiner said. The main issue, he said, is getting approval for the procedure in Israel's National Health Basket. Health Basket challenge The U.S. FDA's rigorous device approval standards have been well documented, and both ophthalmol- ogists and industry regularly com- ment on associated challenges. In the November 2011 issue of EyeWorld, the "International outlook" column sought to place that understanding in the context of regulatory environments around the world, noting for example that in many ways China's regulatory body is more stringent than the U.S. FDA's. In Israel, meanwhile, a major challenge appears to be with the Health Basket. "The problem is that [Trabectome] is not in the Health Basket, although we have applied for it for both 2015 and 2016 approval committees; the reason is simply that we are competing with hun- dreds of other medicines and tech- nologies for a very small budget," Dr. Weiner said. "Unlike the United States, Israel's health system pays only for procedures and medicines that are included in the Health Basket, which is funded each year after a process through a special commit- tee of the Health Department," he explained. Each year, Dr. Weiner said, the health department committee sorts through close to 1,000 applications for new medicines and technologies with a budget of only $300 million USD at present. "The result is that mainly life-saving medicines and technologies are approved, and many are left out," he said. When a procedure like the Trabectome is left out of the Health Basket, Dr. Weiner said, patients have to fund it themselves, and not many can afford it. "It is much better to solve the problem or help the problem in ear- lier stages with lower-risk procedures than only act in the advanced stage with higher-risk procedures that also demand a lot of the patients (i.e., postop visits, manipulation of the eye, costly to the patient and society, etc.)," said Asher Weiner, MD, Albany, N.Y. Dr. Weiner, who completed medical and ophthalmol- ogy training at the Hebrew Univer- sity and Hadassah Medical School, Jerusalem, Israel, in addition to his training in the U.S., is well versed on Israel's national healthcare system. While procedures that are approved in the U.S. or Europe can often achieve regulatory approvals in other parts of the world, getting them included and covered within the respective country's national healthcare systems isn't as easy. For countries with stringent bureaucratic processes, patients ben- efiting from the latest procedures are determined, unfortunately, by the ability to pay out of pocket. In Israel, for example, there is no problem with performing Trabectome surgery as the procedure is currently approved in the country. While ophthalmologists lament the U.S. FDA's rigidity, Israel's healthcare administration poses its own challenges W hile traditional glaucoma surgeries are often performed on patients with advanced glaucoma, these are not always recommended in patients with early stage disease because the surgeries are often high- risk procedures. However, there is another school of thought that recommends early intervention in order to pre- vent patients from getting to the advanced stage of the disease. Available in the U.S. since the Food and Drug Administration (FDA) approved it in 2005, the Trabectome (NeoMedix, Tustin, Calif.) is one such procedure. It can be applied to patients in the early and moderate stage of glaucoma, and to some cases of advanced glau- coma, and prevent the condition from progressing. Trabectome in Israel: When red tape gets in the way International outlook

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