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46 EW GLAUCOMA February 2011 July 2012 Pharmaceutical focus Glaucoma brand standing: Deciding how generics stack up in practice by Maxine Lipner Senior EyeWorld Contributing Editor G one are the days when you could scrawl "Xalatan" on a prescrip- tion and know exactly what the patient would receive. Today, in addition to the branded Xalatan (latanoprost, Pfizer, New York) formulation, there are six different generic formulations of this drug, according to Louis B. Cantor, M.D., chairman and profes- sor, Eugene and Marilyn Glick Eye Institute, Indiana School of Medicine, Indianapolis. There is in fact a tug-of-war going on between brand name glaucoma medications and their generic counterparts. EyeWorld asked leading practitioners about their strategies when deciding what's best for patients. As a rule, Dr. Cantor prefers to use branded medications. Many times he finds this happens by de- fault since he will start patients on samples to ensure that the medica- tion works for them. "The only sam- ples that we carry are the branded products because as soon as the generics are available, the sampling disappears of that branded product," Dr. Cantor said. When patients return a month or so later to see if that class of medication is working, he has a discussion about what is best for them. The majority of time he finds that patients prefer to remain on a branded product. A low bar Dr. Cantor points to the fact that the regulatory bar for generics is not very high since these must only prove formulary, not therapeutic, equivalency. "Generic products are not required to be tested against the branded product in a therapeutic head-on-head trial unless there is some substantial change in the formulation," Dr. Cantor said. "But if they can show on paper that they have the same active ingredients and preservatives, the FDA will approve the formulation based upon that submission of formulary equiv- alency." He worries that the drugs may not function the same and likens it to giving six chefs the same ingredients and finding that they all come up with something a little different. He is also concerned about the fact that there can be so many dif- ferent generic formulations avail- able. As a result, even if one generic is working well for a patient, there is nothing to say that the same will be true for all. "I tell my patients that when they get their refill, if the bottle looks different or the label looks different it means that they got switched to a different generic, so call the office, schedule an ap- pointment, and we'll check to make sure they're doing OK," he said. Imagined cost savings for those on generics may fall short as well. "Sometimes the cost of the bottle is not the most important thing," Dr. Cantor said. "It's the cost to the sys- tem of the extra visits." In addition, there may be side effects, and even the bottles themselves are some- times a little different. "The drop size from the generic formulation may not be the same as the drop size from the branded, and patients may go through medication quicker and use it up," he said. "Then they have gaps in treatment because they can't get a refill because they ran out of their drops." Nathan M. Radcliffe, M.D., assistant professor of ophthalmol- ogy, Weill Cornell Medical College, New York, likewise pointed out that the generic containers can be prob- lematic. "Most of our elderly pa- tients are not comfortable [with the containers], and they can end up delivering more or less of the drop, and it can affect tolerability and efficacy if the drop doesn't get into the eye," he said. He added that potentially there can be differences in efficacy, citing a study led by Malik Kahook, M.D., published in the February issue of Current Eye Research, that compared concentrations of active ingredients and preservative in brand name and generic medication placed under heat stress. While both brand name and generic Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution, Merck, Whitehouse Station, N.J.) did well under stress, this was not the case for latanoprost. While brand name Xalatan fared well after exposure to 25-50 degrees Celsius, the two generic formulations studied had significant loss of active ingredient concentration. He finds that there is also intrinsic value in the familiarity of the brand medication and the lack of confusion with this. "I have been disappointed with the generic Cosopt to see how many of my patients now think that they're taking timolol or dorzolamide and are reporting that incorrectly to their primary care doctors," he said. "As far as I'm concerned if it causes them to miss a drop one day or to take a double drop because they're confused, that's clinically impactful." Financial talk Dr. Radcliffe's approach is to ask patients what is important to them. "I ask them how their copays are," he said. "We also have a conversa- tion about their vision and where that fits into everything." Based on that feedback, together they decide whether it makes sense for them to use generic medication or not. Dr. Radcliffe stressed that you can't predict by looking at someone if the issue will be an important one. "It is not correct to assume that all patients want generics—in fact you will find that some of your patients are offended," he said. It's also not a safe assumption that patients will save money with generics. Dr. Radcliffe finds that particular fixed combinations of generics can be very expensive. One strategy that he sometimes uses is to consolidate therapy, moving a patient from, for example, four generics to two brand name medications. "I find that often I'm able to decrease how many drops that they have to use in a day but keep the copays very similar, maybe the same," he said. One central tenet that he bears in mind is not to fix things when they aren't broken. "I do not believe in changing happy, stable patients who are not complaining of any- thing just to save their insurance company a few dollars," he said. Jeffrey A. Kammer, M.D., assistant professor, Vanderbilt Eye Institute, Nashville, likewise tries to be attuned to what his patients want. "There are some patients who perceive brand names as superior, and I'll readily go toward the brand name products if I think that's what they're interested in," Dr. Kammer said. "Or if they come in with significant concerns about cost and economics of affording all of these medications, I'm more likely to go toward the generics." Given the number of generics, he acknowledged that these may not all be equal, but he isn't too concerned about this. "My gestalt is that in most cases there are minimal differences, and for patients with milder glaucoma, that is not a big deal," Dr. Kammer said. "I'm certainly much more concerned when they have more advanced glaucoma and that one millimeter of mercury may make a bigger differ- ence." That said, Dr. Kammer pointed out that you have to consider com- pliance. "If they can't afford it then that trumps the slightly increased efficacy of the medication," he said. Still, he urges patients toward the likely stronger brand name medication if they can afford it. He generally does not give patients an option, only bringing up generics if the patients voice a concern— something that usually doesn't hap- pen unless a pharmacist brings it to their attention. Pharmacists, he finds, can be economically incen- tivized to do this. Dr. Radcliffe echoed a quote from Robert Fechtner, M.D. "His point, and I agree with it strongly, is that you take money out of the equation and no one would choose a generic," Dr. Radcliffe said. "So you get some people who may feel that the generics can be similar, but you really have no one who prefers generics." EW Editors' note: Dr. Cantor has financial interests with Alcon (Fort Worth, Texas), Allergan, and Merck. Dr. Kammer has financial interests with Alcon and Allergan. Dr. Radcliffe has financial interests with Alcon, Allergan, and Merck. Contact information Cantor: 317-278-2651, lcantor@iupui.edu Kammer: 615-936-1455, jeff.kammer@vanderbilt.edu Radcliffe: 201-925-0476, drradclifffe@gmail.com