A Safe, Effective BALANCE

Prescribing both generic and branded drugs, physicians weigh efficacy, adherence, and cost

According to a 2016 survey of the eyecare market sponsored by Allergan, eyecare practitioners prescribe mostly generic medications; however, they are more likely than other doctors to prescribe branded products. About 75% of all prescriptions in the U.S. are generic, compared with 66% of eyecare prescriptions, and eyecare practitioners and other doctors prescribe preferred brands 22% and 14% of the time, respectively.¹ What makes ophthalmologists less likely to prescribe generics?

“Ophthalmology is unique compared with other fields where generic medications are concerned,” explains John A. Hovanesian, MD, FACS, of Harvard Eye Associates in Laguna Hills, Calif. “Many doctors in other fields are prescribing systemic medications that go through the entire body to reach the target, whereas we prescribe mostly topical medications, so all of the active and inactive ingredients go directly to the target organ — the eye. This makes the variables involved in generic medications, particularly inactive ingredients and their concentrations, very important.”

What’s the Difference?

In a field in which eye drops make up 81% of all prescriptions,¹ eyecare practitioners face a unique challenge as they work to ensure that generic medications — even those with the same active ingredient — have low toxicity and similar efficacy. These factors can be very difficult to evaluate.

Mitchell A. Jackson, MD, of Jackson Eye in Lake Villa, Ill., explains, “In a generic drug, just the active molecule has to be the same, so manufacturers can use a cheap preservative with that ingredient — without testing how it affects efficacy. Blurring the picture even more, some of the ingredients in generic products are not listed, so we can’t predict how well patients will tolerate them. That unpredictability is the last thing I want, especially for acute conditions and surgical patients.”

Michael Harris, MD, of Livingston Eye Associates in Livingston, N.J. agrees. “A generic drug used to be the exact composition of the branded drug, such as generic timolol for branded Betimol (timolol ophthalmic solution, Akorn). Now, payers and pharmacies promote substitutions that go well beyond unbranded medications to include drugs with ‘similar chemistry,’ ” says Dr. Harris. “For example, when I prescribe a fourth-generation antibiotic, such as Vigamox (moxifloxacin, Alcon), payers tell me I should choose gentamicin or Neosporin ophthalmic (neomycin/polymyxin B sulfates/gramicidin), which causes red eye in many cases.”

“There is a persistent assumption that the efficacy and side effect profile of a generic is the same as a branded drug, and the only difference is cost,” says Francis Mah, MD, a cataract and refractive surgeon at Scripps Health in San Diego, Calif. “But without clinical trials of the generic, it does not touch a human eye until its launch. That is a significant concern.”

Which Do You Choose?

Given the unique challenges of prescribing ophthalmic medications, physicians choose with care. Survey respondents said they consider efficacy and adherence the most important factors in selecting a medication, and generic prescriptions win on those merits 66% of the time.¹ When are generic medications the best choice, and when do doctors go with the branded option?

“The best way to describe the decision between generic and branded medications is that there are real differences between the two. Sometimes those differences matter, and sometimes they don’t,” Dr. Hovanesian says. “When a patient has a common infection that requires an antibiotic for a week, a generic may be appropriate; but, if a patient needs to take an anti-inflammatory drug long term, I recommend a branded drug for better tolerability and predictability. I recommend branded drugs for all of my cataract patients as well, and I explain the differences to them. The differences resonate most strongly with premium lens patients who have the highest expectations for vision and comfort.”

Dr. Jackson recommends branded medications for acute and post-surgical cases as well. “For acute cases, I want the best. If a patient has a corneal ulcer or other acute sight-threatening condition, I only want branded medications that offer efficacy and a low side effect profile,” he says. “With generic medications, recovery from cataract surgery may be slower and less comfortable. If premium lens patients aren’t wowed by the results pretty quickly, they will let me know. I explain that the branded medications I recommend are part of that premium outcome.”

Eric D. Donnenfeld, MD, FAAO, of Ophthalmic Consultants of Long Island, N.Y., prefers branded medications for certain patients as well. “I prescribe branded medications for cataract patients and other acute cases, as well as for many problems requiring long-term treatment, because certain drugs show a palpable difference in quality, toxicity, and healing response,” he says. “I use branded drugs when a patient needs an extremely strong medication, a topical corticosteroid that won’t raise intraocular pressure, or a long-term medication with low toxicity and a realistic dosing regimen (for example, one versus four times per day).”

Of course, efficacy and adherence aren’t the only considerations for prescribing physicians. “There are times when I think branded is clearly better, and times when cost effectiveness swings my choice toward generic. So, I prescribe both branded and generic medications,” says Dr. Donnenfeld. “I approach prescribing as an informed consent decision with patients. I give them a list of the branded and generic drugs for their condition, so they know what to expect at the pharmacy. In situations in which a branded medication is significantly better, I explain that recommendation. I also tell patients if I think the generic alternative is acceptable. My patients know that my job is to do what’s in their best interest, so they usually follow my recommendations.”

What Are the Risks?

The doctors interviewed for this piece prescribe both generic and branded medications. Knowing that many generic medications can save patients money, they may only specify a branded medication when clinical advantages outweigh cost savings. Although they carefully explain their reasons for recommending a branded drug, patients may still choose generic drugs for financial reasons. Unfortunately, this decision can lead to complications.

“If patients yield to the pharmacist’s pressure and get the generic ketorolac after surgery, many of them will develop corneal staining, sensitivity, and rebound inflammation,” warns Dr. Hovanesian. “Although the generic formulation’s toxicity may play a role in these problems, the primary reason for complications is that patients must use ketorolac four times a day for a month, instead of using the branded NSAID once per day. Being human, they naturally skip drops at some point, which puts them at risk for inflammation.”

Dr. Donnenfeld sees problems with NSAID substitutions as well. “Patients who use generics tend to have issues with NSAIDs in particular, including superficial punctate keratitis or corneal breakdown, as well as problems with comfort and visual acuity,” he says. “It’s obvious that these patients aren’t receiving an identical product. Some generic medications have the same active ingredient with a different vehicle or preparation, whereas other generic substitutes are a completely different molecule. They are not equivalent, which can impact efficacy and tolerability.”

Finally, Dr. Jackson identifies a problem that lingers in all prescribers’ minds: the payer or pharmacist may want the patient to use a generic, but the physician is ultimately responsible for the patient’s outcomes.

“Although my preference is branded over generic, I can be forced to change for cost reasons alone,” he says. “Before I allow a substitution for any of my surgical patients, I have them sign a waiver. This protects me if they experience a corneal melt or severe keratitis as a result of using a generic substitute, because they have acknowledged that the drug choice was their insurance company’s choice — not mine.” ■

Reference