Branded Drugs: Accept No Substitute?

Are generic drops the perfect solution to high copays, or a recipe for trouble?

By Samantha Stahl, Assistant Editor

As the cash-strapped public becomes less willing and able to shell out for expensive medical procedures and drugs, cost-saving generic prescriptions have, on the surface, seemed to be an ideal compromise. Where's the harm in treating a disease for less money? For systemic drugs, the potential for a downside is limited due to high regulatory standards for generic equivalence. Unfortunately, topical ophthalmic solutions are an entirely different story. The FDA's stringent standards for new drug approvals don't apply to generic drops, which can receive approval as long as they contain the same amount of active ingredient as the original formulation.

Ophthalmologists have varied opinions on whether or not generic eye drops are as safe and effective to use as their branded “equivalents.” In this feature, we'll discuss the pros and cons of both sides, and take a look at what major companies are doing to offset costs on their products.

Same Ingredient, Different Outcome

“Whenever possible, I prefer branded products because of the regulatory environment that we live in,” says Louis Cantor, MD, professor of ophthalmology and director of glaucoma service at Indiana University School of Medicine in Indianapolis. Ophthalmic generics manufacturers can tweak excipient ingredients, which may make up approximately 0.995% of the overall formulation. That leaves a whole lot of room for variability. “The manufacturer can show on paper that is has the same amount of active ingredient, but it doesn't have to show testing against a branded legend drug. That lumps ophthalmology drugs with skin creams and ear drops,” he says.

Dr. Cantor points to the generic diclofenac (Voltaren) fiasco of the late 1990s as evidence to be leery of generics. When the nonsteroidal came onto the market, the drug formulation triggered a spike in corneal melts. “Within a year the product was pulled, but not before a lot of patients had a severe reaction. It was a smoking cannon.”

What about low-income patients who don't want to, or aren't able to, pay for brand-name products? Very many cataract patients fall within this category. “If it boils down to the fact that they can't afford brand names, then certainly it's better to be on something rather than nothing. But the cost savings may not be as big as they appear.” Because of the lack of uniformity in generics, Dr. Cantor explains, patients may have diverse reactions to the drops.

“If a glaucoma patient goes from a brand to a generic, I need to check them, so there's an extra office visit. If they get a refill on a generic and the bottle looks different, they need to come into the office so we can check their pressure. If they're having problems with a generic, we may recommend surgery or laser treatment so we don't have to use the drug,” he says. “In the grand scheme of things, the extra visits may negate some of the cost savings of generics.” He concedes that generics often do work, but the patients must be brought in frequently to demonstrate progress.

Although estimates show increasing use of generics, the drugs haven't been subject to additional testing or postmarket evaluation. “Regulatory guidance issues haven't changed. Generic manufacturers will never voluntarily do testing,” he says. More unfortunate is that when a generic alternative is released, branded sales drop 50 to 90%. After that kind of profit loss, Dr. Cantor says it's hard for the brand-name company to justify spending money on studies to defend its product in a shrinking market, while generic manufacturers don't do research at all on their products. “In academics, we want to do that testing, but we can't get funding. So those studies, unfortunately, often don't get done.”

“Nine of out 10 of my colleagues don't realize that generics aren't tested. They treat a generic just like a branded product. I think the burden of testing has to fall on the clinician — they need to prove in each and every patient that the drug is working and is tolerated well enough.”

Mitchell Jackson, MD, of Lake Villa, Ill., agrees that brand-name drugs are the way to go. “My patient's safety is of primary concern, along with maximal efficacy. There is no variance in my prescription recommendations based on the patient's conditions. I only use branded ophthalmics due to potential side effects from inactive ingredients” that may be present in generic formulations. Because the cost difference for a 30-day supply of topical NSAIDs is minimal ($5 to $15 for a generic versus $20 to $30 for a tier 2 brand), he advises that generics aren't worth the risk, especially if they cause costly-to-treat problems in the future.

Generics: Not So Bad? It Depends

While strong opinions exist about the risks of generics, others believe that they are just as valuable as brand names — in some cases. Certain conditions will always require a higher-efficacy product.

“I have absolutely no problem with generics — other than prednisolone acetate,” says Mark Nelson, MD, MBA, of Winston Salem, NC. “The generic does not work for significant inflammation. If the patient can afford Pred Forte, I always suggest the branded option. If they cannot afford it, I recommend subconjunctival triamcinolone acetonide (Kenalog), which takes care of the financial issue as well as the medical problem.” He prescribes this remedy for patients who have uveitis with iritis, vitritis and/or cystoid macular edema. For those with external disease, however, he says that generics are fine.

Though Dr. Nelson defends generics in many cases, he finds it interesting that insurance companies are so reluctant to cover more costly products. “Inadequate treatment is equal to poor quality and poor quality always costs more. Insurance will pay for additional physician visits required because a generic medicine is not working, but they will not pay the additional money that the branded name costs. That is clearly a failure of imagination and intellect.”

Stephen Johnson, MD, of Newport Beach, Calif, shares similar sentiments. “I try not to let insurance companies' formularies or drug cost influence my medical decisions. If I think branded matters, I'll prescribe it. If I think it won't matter, then I don't care if it's generic or not.” For serious infections like corneal ulcers or anti-inflammatory drops after cataract surgery, he insists on branded drugs. Like Dr. Nelson, he says generic prednisolone acetate just doesn't work as well.

“On the other hand, for treating run-of-the-mill conjunctivitis, I may write for an earlier generation of fluoroquinolone, like Ciloxan, but don't care if it's filled generically or not.” He says that if a patient can tolerate only one generic version of a branded medicine, he instructs them to ask the pharmacist for a specific generic company.

Offsetting Costs

With generics giving brand names stiff sales competition, manufacturers and physicians alike are making efforts to get patients better quality products for less.

For example, Dr. Jackson says he saves increasingly-hard-to-come-by brand samples for financially-strained patients who don't have insurance at all. Dr. Jackson's practice also uses CoverMyMeds.com, a Web site designed to make it easier to do prior authorization for pharmaceuticals online. By simplifying coverage determination, more requests can be accepted. He concedes the system can be a struggle because “we only know medical coverage of the patient, but can't guess what is the correct form to use on the Web site for their particular formulary coverage. In the end, we find it easier to call the pharmacy and prior authorize, since they know that information for the patient.”

Allergan offers both a $20 rebate program and a patient assistance program for those that cannot afford full price prescriptions of their Restasis drops. “We believe limited financial means should not limit access to treatments. To help ensure that Allergan's products are available to all who need them, we participate in RxHope.com,” says Crystal Muilenburg, Allergan's senior manager of corporate communications. The site is an independent patient-assistance program that helps get reduced co-pays and free medications upon demonstrating financial need.

For patients at two times the current poverty level or below, Alcon offers a patient assistance program called Alcon Cares that provides medication free of charge to those without prescription insurance coverage.

Another Web resource is Epocrates Rx, a drug and formulary reference site for healthcare professionals. In addition to checking drug dosing and interactions, the program lets physicians look at pricing and insurance coverage so they know right away how much a patient will have to pay for a product. Alcon offered free subscriptions to the site at its AAO booth this year.

“Branded products have the newest, greatest technology formulations — they just serve the patient better,” says Tom Arens, the associate director of corneal marketing at AMO. The company makes their over-the-counter Blink Tears more affordable with promotional savings through retailers.

While some drugs, like Xalatan, have a once-daily dosage which may increase the likelihood of compliance, some patients still attempt to save dollars and stretch the life span of their bottles by skipping doses. Much to patients' dismay, cutting back isn't a viable option. “The dosage schedules are based upon their effective half life within the biologic system,” Dr. Johnson explains. “Using a medication less frequently than recommended just means that part of the time there is not an effective medication level and the patient is ‘uncovered’ for that time.”

Although he says there may be certain instances when a physician would only want partial coverage — for example, using pilocarpine for night driving only — dosing recommendations must be followed.

Giving a Second Thought

Though everyone is looking for ways to save, jumping for cheaper products may not be the best way to keep money in the bank. With a variety of potential risks, the total cost of care isn't as cut and dried as a set amount for a monthly prescription of eye drops. Ophthalmologists would be well advised to think twice before deciding on what to prescribe to patients who are reluctant about brand names.

“Insurance companies and the government are concerned about money. All communications from them about drugs stem from wanting to cut their costs, not about care,” says Dr. Johnson. “They would have us believe that generics are the same as branded drugs. Sometimes, yes, they are. But sometimes no, they are not.” OM