Article Date: 11/1/2011

Generics in Practice
Branded vs. Generics

Generics in Practice

Optometrists recommend a proactive approach for ensuring patients receive the best possible care.

Generic pharmaceuticals have been part of the medical landscape for decades, but the slumping economy and need to reduce healthcare costs have made them a major topic in the national conversation. Ongoing issues, such as the FDA's implementation of the Biologics Price Competition and Innovation Act of 2009 and patent expiry for several blockbuster drugs in the next year (e.g., Lipitor and Advair), will likely keep the dialogue going for the foreseeable future. In eye care, the latest discussion has centered on the six generic latanoprost products that became available when the patent on brand-name Xalatan expired earlier this year. Optometrists wonder whether the generic alternatives will prove to be just as effective as the brand they have been prescribing successfully for years.

Among doctors, eyecare specialists included, there have always been differing opinions about whether generic drugs are truly equivalent to their brand-name predecessors, also known as “innovator drugs.” All seem to agree that cutting healthcare costs is necessary and generic drugs are one means of accomplishing that goal. However, adequately powered studies to compare the efficacy of generics with their branded counterparts have never been, and likely never will be, done. Therefore, doctors have only experience with patients to guide their treatment decisions. In this article, several optometrists talk about how they manage the related issues, which include pressure from prescription drug insurance plans and pharmacists to switch patients to generic drugs.

Clinical Experience Raises Questions About Equivalency

Problems with generic ophthalmic medications have arisen in the past. Perhaps the most well-known and serious were the corneal complications traced to one generic version of the nonsteroidal anti-inflammatory drug (NSAID) Voltaren (diclofenac, Novartis). That generic product was removed from the market, but some optometrists point to problems with other generics available today. They say their patients have reported tolerability issues, such as intense stinging and burning, as well as unsatisfactory pain control with generic NSAIDs. Some glaucoma specialists say they've seen inconsistent IOP control with some topical generic medications. They also say their patients frequently experience tolerability issues with generic carbonic anhydrase inhibitors, and they see a high number of ocular allergic reactions among patients who use a generic brimonidine product, which has a 0.2% concentration rather than the 0.1% or 0.15% of the two-branded Alphagan P (Allergan) products.

Generic prednisolone acetate drops are widely prescribed (or at least widely dispensed at the pharmacy). However, a number of optometrists say they're not always as effective as brand-name steroid drops, especially in severe inflammatory conditions. They also say unless the generic bottles are shaken excessively, the drops don't dispense correctly and often clog the tip, suggesting that too much medication will be left in the bottle instead of doing its work in the eye. Some information about these experiences has been published.1,2 Doctors who spoke with Optometric Management acknowledge that the offending product(s) may have been discontinued, but they also say there are so many generic prednisolone acetate products that it's difficult to keep track, let alone ensure their patients receive any specific one consistently from the pharmacy.

Commenting on generic ophthalmic medications in general, Kelly K. Nichols, OD, MPH, PhD, Houston, Texas, says “Just because a medication is generic doesn't mean it's ineffective. In most cases, a generic is in a patient's best interest. However, in some cases it's not, so that's where the challenge comes in.”

Douglas K. Devries, OD, Sparks, Nev., agrees and adds, “Anecdotally, I think most optometrists notice a difference between some generics and their brand-name counterparts. While a generic may make a therapy affordable, it is often not the exact therapy we want the patient to have. We don't know what variations we might run into. The FDA requires generic drugs to contain the same active ingredient as the branded drug, have the same route of administration and be the same dosage form and strength, but that doesn't mean there can't be differences in inactive ingredients. Differences in these ingredients, such as preservatives, buffers or thickening agents, can have an impact on how a drug works in the eye and can also make a drug less tolerable for the patient.” (For more information on generic medications and the eye, see “Eye Presents Unique Challenges for Drug Evaluation” of this issue.)

As Dr. Devries and others explain, some ophthalmic formulations are more complicated than others and are therefore harder to duplicate exactly. With some drug classes, less drug could get into the eye if the overall formulation is altered, or more drug could get in if, for example, the pH level is lowered. “Some generic suspensions, such as the prednisolone acetates, seem to suffer from formulation inconsistencies,” says Ben Gaddie, OD, FAAO, Louisville, Ky. “Depending on the size of the drug particles in a suspension, how they are manufactured, they may not be completely soluble in the vehicle. It's a pretty exact science to create a suspension that produces consistent dosing.”

Furthermore, testing in patients to ensure a generic drug performs the same as the innovator drug it's based on may or may not be required for FDA approval. (For more information on the FDA approval process, see “Pathway to Approval” of this issue.) “These are frustrations with generic drugs,” Dr. Devries says. “Not only might a generic be different than its brand-name predecessor, with implications for tolerability and efficacy, but because many drugs have multiple generic alternatives produced by different manufacturers, we just don't know what we're going to get every time.”

Scot Morris, OD, FAAO, Conifer, Colo., cites another reason a generic medication could be a disadvantage in some cases. “Usually they're older drugs, so they just may not be as efficacious as newer branded drugs,” he says. For example, new medications often contain more recently discovered molecules that provide improvements in characteristics such as potency or sideeffect profile. Also, newer drugs may be more specifically designed. For instance, some of the newer ophthalmic steroids and NSAIDs were tested in clinical trials in ocular surgery patients and are specifically labeled for the treatment of inflammation in those situations.

“It's not true that all generics are worse than their branded counterparts,” says Alan G. Kabat, OD, FAAO, Miami/Fort Lauderdale, Fla. “But we can't say they're all exactly equivalent either. Usually, there's better quality in some aspect of the branded medication. At the very least, the brand may be buffered better, be more pH-balanced or have a gentler preservative.”

Make Proactive Treatment Decisions

Dr. Kabat continues, “That said, in many cases a generic medication is a perfectly fine option.” The decision to specifically prescribe a brand-name drug or acknowledge that a generic alternative is OK needs to be made on a case-by-case basis, he says. “Stay current with the literature, know which drugs are the newest and best, and understand which drug best fits which condition. Then judge the severity of each situation. For a selflimiting condition, such as episcleritis, where the main objective is making the patient comfortable, a generic steroid drop should work well. In contrast, an acute uveitis can be sight-threatening and should therefore be treated with the most potent and fast-acting drug available, which is not going to be a generic.”

Dr. Nichols uses a similar strategy. “We can't separate the generic vs. brand issue from the ‘doctoring’ we should always be doing. It's in each patient's best interest for us to consider whether we really need ‘newer and better’ for what we're treating or whether a generic option would be appropriate.” Diagnostic skills are key in the decision-making process, Dr. Morris says. “When we know exactly what we're dealing with, we can start with what we expect will be an effective treatment, whether that be a generic or brand medication. What we should definitely not do is automatically prescribe a drug just because it's new or try a certain drug first just because it is less expensive. If the latter doesn't work, the patient ends up having to pay for the brand anyway — on top of what they spent on the generic — to get results. Even worse, a delay in effective treatment could adversely affect vision.”

Best Possible Care Hinges on Communication

Unfortunately, in today's pharmaceutical environment, the medication the doctor wants the patient to use isn't always the medication the patient gets. Pharmacists have been given significant responsibility by government and via their contracts with commercial prescription drug plans to help control costs by appropriately substituting generic drugs for what has been prescribed. In all states, pharmacists are either permitted or mandated to dispense a generic if “brand necessary” or similar notation isn't indicated on the prescription. In some states, even when “brand necessary” is indicated, the pharmacist need only ask the patient, not the doctor, if he or she will accept a generic.

“We deal with this issue every day, the pharmacist calling to say that the insurance plan only covers a generic or the drug we prescribed is in a formulary tier the patient says is too expensive,” Dr. Gaddie says. (For more information on the economics of generic medications, see “Generics Make Their Mark in Healthcare System” of this issue.)

“Last time I checked, insurance plans didn't go to school to learn which medicine is best for patients,” Dr. Morris says. “So it's no longer enough for us to make a clinically sound prescription recommendation. We also have to think through the brand vs. generic aspect of it so we can defend our choices when they're called into question by third parties.”

Dr. Kabat finds that the best way to ensure patients get the recommended drug is to clearly communicate the rationale behind the recommendation. “Even if it's necessary to write the pharmacist a note to clarify our request in addition to the required notation on the pad,” he says. “Patients need to understand why we don't want to compromise based on cost in their particular situation — why this is the drug we would use if it were our own eye. Armed with information, I find that patients are split right down the middle. About 50% will spend the extra money to follow my recommendation. For those who hold onto cost as their main concern, or truly can't afford the drug, we move to the next best alternative.”

Digging deeper into the actual financial details makes sense, too, Dr. Gaddie says. A brand drug may end up costing the same as a generic if the brand can be dosed less frequently. Or, additional office visit copays might be needed if more follow-up is required to verify that a generic drug is working effectively, essentially erasing its cost advantage.

All of the issues, clinical and financial, should be discussed directly with patients, Dr. Nichols says. “If a generic version of a drug is available, we need to be aware of that and explain to the patient why we are or are not prescribing it. This saves time and money in the long run. It also improves the odds that the patient will receive the best possible treatment, more so than if information is coming only from the pharmacist.” Dr. Devries concurs. “The majority of the time, the pharmacist will say there is no difference between a branded drug and a generic, which as we know is not the whole story.”

References

1. Roberts CW, Nelson PL. Comparative analysis of prednisolone acetate suspensions. J Ocul Pharmacol Ther 2007;23(2):182-187.
2. Fiscella RG, Jensen M, Van Dyck G. Generic prednisolone suspension substitution. Arch Ophthalmol 1998;116(5):703.



Optometric Management, Issue: November 2011