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Main Issue June 2011

Xalatan Goes Generic: a Landmark Event in Glaucoma

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HOW DO YOU THINK LATANOPROST’S GOING GENERIC WILL AFFECT GLAUCOMA MANAGEMENT IN THE UNITED STATES?

NL: I predict that the impact will be modest. Xalatan (Pfizer, Inc.) may have the best name recognition, but that gets lost with latanoprost. On the other hand, we live in the information age that has empowering and democratizing consequences. Informed patients will not mind that their eye drops are not labeled with the brand name anymore and may know that one version of gener- ic latanoprost is still produced at the same facility in Puurs, Belgium, so there is virtually no difference. Although apparently other generic versions of latanoprost are available online, the only one that is produced under the same good manufacturing practices and in the same facility is the one manufactured by Greenstone LLC, Pfizer’s generics division. This is different from other generics. For instance, bimatoprost is apparently also available from India as an online generic called Careprost (Sun Pharmaceutical Industries Ltd.). It is even more affordable than generic latanoprost but may be produced under different good manufacturing practices.

Some clinicians have predicted that generic latanoprost could initially generate increased costs if practitioners treat their patients as a trial of a new drop, requiring a return visit in 2 months. That approach could be less cost-effective than maintaining patients on their original drop, to which we know they respond.

TR: The availability of generic latanoprost represents a milestone in glaucoma therapeutics. When first launched in 1996, latanoprost was the first of a new class of drugs, and owing to its superior safety, efficacy, and convenience of dosing, latanoprost led the prostaglandin analogue (PGA) class to the forefront of the stepped therapeutic algorithm for glaucoma management. Now in 2011, with exclusivity at an end, latanoprost—ophthalmology’s first billion dollar drug—is available as a generic. For many uninsured and underinsured patients, this is welcome news indeed. Coupled with the recent availability of generic dorzolamide and the dorzolamide-timolol combination, there is now an affordable regimen of maximal medical therapy available comprised entirely of generic products.

JR: Generic latanoprost will have a huge impact on glaucoma management, because it will stimulate competitive pricing in the entire category of PGAs. Lower prices will improve care, because cost is one of the greatest barriers to compliance. A number of patients might elect generic latanoprost as opposed to timolol, because the price differential will eventually be minimal. Many patients in the past have requested laser and even invasive surgery, because they could not afford drops. I expect those types of decisions to become less common. Because many manufacturers will have a generic product available, it is conceivable that allergy to components of the vehicle may become more frequent and harder to track. Efficacy issues relating to plastics in the medicine bottles and issues of quality control may also appear. More office visits early on to detect unforeseen problems may be necessary.

BS:

DO GENERIC MEDICATIONS ACTUALLY ALLOW PHYSICIANS TO PROVIDE MORE COST-EFFECTIVE CARE TO GLAUCOMA PATIENTS?

NL: Having more affordable options at hand in the form of generics should allow more cost-effective treatment, in theory. A cheaper drop may improve compliance when something that patients perceive as a “necessary evil” is less expensive On the other hand, copayments might be adjusted quickly, negating this effect. It is to be hoped that generic latanoprost will provide another low-cost topical option that more insurers will be willing to cover for a reasonable copayment. I am not sure that generic medication is an issue in cost-effective care so much as the current insurance coverage environment. Over the past several months, as Xalatan seemed to be changed to a higher-tiered medication under some insurance plans, we have changed people to whichever other PGAs their insurance would cover in hopes that it would be as efficacious as the original one.

TR: Interestingly, the cost savings to be realized from generic medications is often inversely proportional to insurance status. Uninsured and underinsured patients will benefit greatly from the availablility of generic latanoprost. Insured patients, however, may find that branded travo- prost and/or bimatoprost have co-payments that are less than the price of generic latanoprost. JR: I have already seen a few patients in the office who were placed on generic latanoprost. Although we have been told that there would be little money saved during the first year, I have witnessed an incredible vari- ation in pricing. Recently, I had patients come in with generic latanoprost that cost them anywhere from $4 to $80 (all made by a subsidiary of Pfizer Inc.). Generic latanoprost is also available online at drugstore.com for $20 per bottle (even less for a 90-day supply). I antici- pate that generic latanoprost will improve care by allowing more patients to actually purchase the med- ication. In addition, a once-daily dosage has been shown to improve compliance significantly. The only increased costs associated with generic latanoprost might arise if problems with allergy and efficacy occur. In that case, there might be a need for more office vis- its to see, for example, if the IOP lowering is equal between two different versions of the drug. It will probably also be important for the physician and the patient to note the manufacturer of the medicines on the patient’s chart until we are sure that all these issues are ironed out.

BS: Clearly, generic medications do promote cost- effective care from the perspective of our patients. I see patients on a daily basis who tell me how pleased they are to see a significant decrease in the cost of their med- ication. I saw two patients recently who had previously refused treatment with PGAs due to cost but are now willing to use this class of medication. I counsel my patients, however, that we still do not know if the generic latanoprost formulations are equivalent in IOP lowering and tolerability to Xalatan. I have some patients with severe glaucoma whom I will not approve for generic substitutions until I have more experience with these agents, since there are at least five different manufactur- ers of generic latanoprost (Apotex, Inc.; Mylan Pharmaceuticals, Inc.; Bausch + Lomb; Greenstone, LLC; Falcon Pharmaceuticals). These are patients who are sta- ble on their current regimen, which includes Xalatan, and are at high risk of progression and vision loss if we lose control of their disease or cause ocular surface reactions from poor tolerability. I am taking a “wait and see” approach with high-risk patients.

In addition, the generic latanoprost is not necessarily available at great savings. A survey of pharmacies in my area revealed prices from around $10 to $80 per bottle. The potential for cost savings varies greatly.

HOW DO YOU TALK TO YOUR PATIENTS REGARDING DECISIONS OF USING GENERIC VERSUS BRANDED GLAUCOMA MEDICATIONS?

NL: I point out that, unless there are specific sensitivi- ties to certain inactive compounds or preservatives, generic latanoprost should be just as good as Xalatan, because the active compound is the same. I often make comparisons to Aspirin (Bayer AG) and ask my patients whether they would use the brand name over a generic, given a significant difference in price. This is a good example, because the brand name, Aspirin, is still trade- mark protected by Bayer in 80 countries. Its name is such a commonplace generic, however, that few would recog- nize it by acetylsalicylic acid.

TR: I routinely recommend using generic medications. The cost savings are real; the potential for diminished efficacy or tolerability is theoretical until proven. Generics are generally equivalent in efficacy and safety to branded products. I look for reasons not to prescribe generics rather than reasons to do so.

JR: Patients often initiate a discussion regarding the use of generics because of cost or insurance-related issues. Occasionally, patients are very resistant to going on a generic medication, because they perceive those products as likely to be inferior to the branded ones. Decisions to prescribe generics are often based more on the patient’s personality and pocketbook than on solid scientific analysis. Some generics such as ß-blockers seem well tolerated, whereas others such as brimonidine may cause more allergic reactions. Until we have a better sense of how the generic PGAs will behave in clinical practice, my colleagues and I will advise our patients to return at an early date and to be aware of potential allergic reactions.

BS: When a generic is new on the market, I counsel my patients that we do not yet know if it is truly equiv- alent to the branded medication that they have been using. In the case of generic latanoprost, I have prepared a handout for my patients explaining that there are several different companies manufacturing generic latanoprost. I ask them to bring in their medication to each visit so we can record which generic they are taking. I can then track each type of generic and watch patterns in efficacy and tolerability. Efficacy is the most difficult parameter to follow. We have to take into account the normal variability in IOP measurements and look for a pattern of or dramatic changes in IOP that are unacceptable.

HOW DOES YOUR OFFICE MANAGE INSURANCE- RELATED MATTERS THAT AFFECT THE SELECTION OF GLAUCOMA MEDICATIONS?

NL: We treat every change of a PGA—whether dictated by insurance or intolerance—as a new medication that mandates a return visit in 2 months. It is an opportunity to recommend selective laser trabeculoplasty (SLT) instead if not already done and to discuss other PGAs and their formulations (eg, with reduced preservatives).

Personally, I will not ask for such a return visit for generic latanoprost now that I have learned that it is real- ly the same product when purchased at a pharmacy.

TR: I have added a statement to my prescriptions for PGAs that gives the pharmacist permission to substitute any of the three available drugs based on insurance coverage. I still write for my preference, but based on headto-head trials, I realize that the potential efficacy differences are miniscule and do not justify large cost differences.

JR: Our office receives a flood of faxes from insurance companies requesting that a patient exchange one PGA for another, most commonly Xalatan for Travatan Z (Alcon Laboratories, Inc.). If one cannot demonstrate that the patient has failed therapy or has developed an intolerance to the suggested medicine, then the patient must switch or pay more to remain on his or her current drop. We currently agree to most switches in medicine (unless contraindicated), because any other course of action would take too much staff time. Originally, we discussed the change individually with each patient, but the burden became too much to bear. Occasionally, a patient with severe glaucoma (split visual fields) will ask us to write a letter asking the insurance company to allow him or her to remain on the current medications. A stock letter that informs the insurance carrier that a patient has “severe, sight-threatening glaucoma” and has been stable on his or her current regimen has never failed to do the trick. Although requests for a change to generics are much less common, it seems inevitable that they will become the next wave. To date, however, patients have been informed about the availability of generics by mailings to their homes and the subsequent savings that would ensue.

BS: Dealing with formulary issues is very time consum- ing for my office staff. When an insurance company refuses to pay for a specific medication due to formulary issues, we generally offer the patient the option of using the lower-cost drug but inform him or her that we do not know if it will be as effective or if they will suffer side effects from the change. If the patient then decides to go with the lower-cost alternative, we prescribe it and set up earlier-than-usual follow-up.

HOW DO YOU THINK THE ARRIVAL OF MORE GENERIC GLAUCOMA MEDICATIONS WILL AFFECT HOW YOU TREAT YOUR GLAUCOMA PATIENTS?

JR: The arrival of more generic glaucoma medications will change how I practice. The pressure to achieve excel- lent outcomes for a reasonable cost will provide a consid- erable incentive to switch patients to a generic. This, in fact, has already happened. Until we are familiar with potential side effect and efficacy issues, we will see the patients at more frequent intervals and will record drug manufacturers’ names on our charts. Ultimately, patients’ improved compliance because of once-a-day dosing and reduced price barriers may lead to better long-term out- comes and less surgical intervention.

TR More generics mean that more patients can have highly effective and safe medications regardless of their insurance status. This is a win-win for everyone.

NL: It will not affect my practice that much. I stick with evidence-based medicine, and as the first line of treatment, I prefer an even more affordable, more effective, more com- fortable, safer, and long-term approach than PGAs. I almost always recommend SLT. The benefits of SLT over PGAs were highlighted by recent publications that found that PGAs can not only cause permanent discoloration of the skin and the iris but may also cause rather dramatic orbital fat atrophy and lid tightening that are especially noticeable when used in only one eye.1-3 (See article on page 50.)

BS: That has yet to be determined. If generic latanoprost proves to be equivalent to Xalatan, I hope it will reduce the number of formulary switches that my office has to contend with and improve patients’ compliance due to cost issues. That would be a relief to us all!

Nils A. Loewen, MD, PhD, is an assistant pro- fessor in the Department of Ophthalmology and Visual Science at the Yale University School of Medicine in New Haven, Connecticut. He acknowledged no financial interest in the prod- ucts or companies mentioned herein. Dr. Loewen may be reached at (203) 737-5746; nils.loewen@yale.edu.

Tony Realini, MD, MPH, is an associate profes- sor of ophthalmology at West Virginia University Eye Institute in Morgantown. He acknowledged no financial interest in the products or compa- nies mentioned herein. Dr. Realini may be reached at (304) 598-6884; realinia@wvuh.com.

Jon M. Ruderman, MD, is an associate profes- sor of ophthalmology at the Feinberg School of Medicine at Northwestern University in Chicago. He acknowledged no financial interest in the products or companies mentioned herein. Dr. Ruderman may be reached at (312) 475-1000; jonruderman@me.com.

Barbara Smit, MD, PhD, is a glaucoma con- sultant at the Spokane Eye Clinic and a clinical instructor at the University of Washington School of Medicine in Spokane, Washington. She is a consultant to Pfizer Inc. Dr. Smit may be reached at (509) 456-0107; bsmit@spokaneeye.com.

  1. Jayaprakasam A, Ghazi-Nouri S. Periorbital fat atrophy—an unfamiliar side effect of prostaglandin analogues. Orbit. 2010;29(6):357-359.
  2. Park J, Cho HK, Moon JI. Changes to upper eyelid orbital fat from use of topical bimato- prost, travoprost, and latanoprost. Jpn J Ophthalmol. 2011;55(1):22-27. 3. Filippopoulos T, Paula JS, Torun N, et al. Periorbital changes associated with topical bimatoprost. Ophthal Plast Reconstr Surg. 2008;24(4):302-307.

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