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`Brand vs. generic: Which is best cataract
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`due to safety, efficacy
`
`May 01, 2014
`
`By Cheryl Guttman Krader
`
`Take home
`
`Substituting generic products for brand name innovators in cataract surgery
`medication regimens can bring tradeoffs in efficaq/, safety. and convenience,
`perhaps with just modest savings in cost.
`
`By Cheryl Guttman Krader; Reviewed by Eric D. Donnemeld, MD, Stephen 5. Lane,
`MD, and Francis 8. Man, MD
`
`Brand name medications may oost more than generic alternatives,
`but the extra money spent is well worthwhile oonsidering the many
`other ways innovator products differ from generic pharrnaceuticals.
`according to leading cataract surgeons.
`
`
`
`~. A
`
`Dr- Donnenfield
`
`Eric D. Donnenfeld. MD. Stephen s. Lane. MD, and Francis s. Mah,
`MD, discussed why they prefer to write prescriptions for brand name
`antimicrobial and anti—inflammatory products in their cataract surgery medication regimens.
`
`titpjlqfltdmdogjtimes modarnneddmwmmflflmdqfimwwwl/mwaduadwwmc-mmmfi-<xam :ffT IT 60
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`PAGE 1 OF 6
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`LUPIN V SENJU
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`IPR20l5—01105
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`

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`1(Y27/2015
`
`Brand vs. generic: Which is best cataract surgery medicine? | Ophtha|mologyTimes
`
`Dr. Mah acknowledged that generic products do provide a service by virtue of their lower
`
`upfront cost. However, he emphasized that decisions on medications should also take into
`
`account efficacy, safety, and dosing convenience.
`
`Low cost not always most important
`
`ketorolac. lm~::;‘*wvrestuvfm, O tr‘l\”t'lr'1"'dJ W2,‘
`
`Interior corneal stalnlrg following cataract
`surgery In a patient treated with topical generic
`
`“You really can't put a price on the benefits of better safety and efficacy," said Dr. Mah,
`
`director, cornea and external disease. and co-director, refractive surgery, Scripps Clinic. La
`Jolla, CA.
`
`The bottom line. Dr. Donnenteld said, is that the branded products of the medications used
`
`in cataract surgery offer significant advantages over their generic counterparts. and the
`differences translate into better outcomes.
`
`“Achieving premium outcomes with cataract surgery requires the use of premium
`
`pharmaceuticals,” said Dr. Donnenfeld, clinical professor of ophthalmology. New York
`
`University, New York, and founding partner, Ophthalmic Consultants of Long Island and
`Connecticut, Rockville Centre, NY.
`
`Similarly, Dr. Lane— adjunct professor of ophthalmology, University of Minnesota,
`
`Minneapolis. and medical director, Associated Eye Care. Stillwater. MN— summed up his
`
`preference for prescribing brand name products as being based on a focus to provide the
`
`best possible care.
`
`"Patients must be educated so that they understand that saving money is not as important
`
`as taking care of their problem.‘ he said. “Patients should be made aware that use of a
`
`less expensive generic medication may be done at some risk."
`
`lnequivalence of generic equivalents
`
`U3
`
`According to FDA policies, ophthalmic generic products
`introduced prior to 1992 did not have to match the inactive
`
`ingredients of the innovator. Beginning in 1992, newly approved
`
`generic ophthalmic solutions had to contain the same active and
`
`inactive ingredients as the innovator and in the same
`concentrations otherwise manufacturers had to demonstrate
`
`clinical bioequivalence. Demonstration of bioequivalence is also
`
`required for all generic ophthalmic products that are not
`
`solutions. regardless of whether the ingredients are the same as
`
`D|'- line
`
`the innovator.
`
`..
`_
`,
`,
`PAGE20F6,_
`http://ophthalmoIogytrmes.modernmedrcrne.com/ophthalmologytlmeslcontentltagslbrandlbrarxivsegenerrc-whrclrbest-cataract-surgerymedic:ne?page=ful|
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`2/6
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`10/27/2015
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`Brand vs. generic: Which is best cataract surgery medicine? | OphthalmologyTimes
`
`The key is that there are no requirements for generic manufacturers to conduct studies
`proving that their product is clinically equivalent to the innovator in terms of efficacy and
`safety. The unfortunate consequences of this situation are well­known to ophthalmologists
`through the experience with the generic topical diclofenac product that was responsible for
`corneal melts. Subsequently, reports have also emerged describing corneal melts and
`epithelial defects associated with the use of other generic nonsteroidal anti­inflammatory
`drugs (NSAIDs), the surgeons noted.
`
`l
`
` 
`
`“I 
`
`i  NSAID  been tested in clinical trials, the
` 
`  h  h d  h
`ld 
`BUSINESS
`EDUCATION
`CAREERS
`PUBLICAT ONS
`g  
`id Dr. Mah. “However, in  he
` 
` 
` 
` 
` 
`y 
`absence of clinical data, we have no idea how the efficacy and safety of generic products
`compare with the brand name medications.”
`
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`Dr. Donnenfeld noted that he has seen many patients using a generic ketorolac product
`who complain of decreased vision following cataract surgery. Slit­lamp examination reveals
`the presence of superficial punctate keratitis in the visual axis, a problem that resolves
`upon cessation of the generic NSAID, he said.
`
`Inferior substitutions
`
`Due to patent protection, the latest brand name products have no generic equivalent.
`Therefore, when generic substitutions for these products are made at the pharmacy, the
`dispensed medication will be within the same broad class as the product prescribed (ie.,
`corticosteroid, NSAID, antibiotic), but may represent an entirely different entity in a
`different, suboptimal vehicle and with different dosing directions.
`
`Discussing NSAIDs, Dr. Donnenfeld noted that the most recent generation of products
`within this class—nepafenac 0.3% suspension (Ilevro, Alcon) and bromfenac 0.07%
`(Prolensa, Bausch + Lomb)—are safer, better tolerated, and have dosing regimens that are
`easier for patients to comply with relative to older brand name and generic NSAIDs.
`
`“The newest agents offer once a day dosing,” he said. “That is a tremendous convenience
`advantage that enables compliance and therefore increases efficacy. At the same time, the
`decreased drop burden reduces the risk of epithelial toxicity.”
`
`Dr. Mah also noted that the reduced dosing frequency with the newest NSAIDs has safety
`value because it minimizes ocular exposure to preservatives. In addition, the newest brand
`name ophthalmic products are more likely than the generic agents to be formulated with an
`advanced, “gentler” preservative or at least with a lower concentration of benzalkonium
`chloride, he said.
`
`Dr. Lane mentioned that due to ingredient differences, the generic NSAIDs are associated
`with higher rates of stinging on instillation than the latest brand name products. That factor
`combined with their increased dosing frequency—up to 4 times a day—can compromise
`compliance and therefore the benefit of treatment.
`
`“The consequences of not using an NSAID as directed after cataract surgery include
`increased anterior chamber inflammation and even cystoid macular edema,” Dr. Lane said.
`
`He noted that the problem of substituting one chemical entity for another is also an issue
`with generic substitutions for corticosteroids and antibiotics as the newest and best
`products within these classes have no generic equivalent.
`
`“A branded drug like loteprednol etabonate 0.5% gel (Lotemax Gel, Bausch + Lomb) may
`be substituted with a generic prednisolone acetate. While both medications are steroids,
`
`http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/content/tags/brand/brand­vs­generic­which­best­cataract­surgery­medicine?page=full
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`Brand vs. generic: Which is best cataract surgery medicine? | OphthalmologyTimes
`
`they are very different compounds with a different safety profile, and their formulations are
`markedly different,” he explained.
`
`Discussing antibiotics, Dr. Lane noted that when substituting for a branded fluoroquinolone,
`patients might be given a generic aminoglycoside or sulfonamide.
`
`“The spectrum of antimicrobial coverage of these two antibiotic classes is vastly different
`than with the latest generation fluoroquinolones,” he said.
`
`Dr. Mah also highlighted concerns about antibiotic substitutions. He noted that compared
`with both non­fluoroquinolone ant biotics and earlier generation fluoroquinolones
`(ciprofloxacin, ofloxacin, and levofloxacin), the latest generation fluoroquinolones,
`besifloxacin 0.6% (Besivance, Bausch + Lomb), moxifloxacin 0.5% (Vigamox/Moxeza,
`Alcon), and gatifloxacin 0.5% (Zymaxid, Allergan), have more potent activity against
`important endophthalmitis pathogens along with an advantage of less frequent dosing. In
`addition, the propensity for development of bacterial resistance is lower using the newer
`fluoroquinolones than the older entities, and that is an important consideration recognizing
`that antimicrobial resistance is a growing global concern.
`
`Minimal savings
`
`The only potential benefit of a generic medication is lower cost, but Dr. Lane pointed out
`that significant savings usually only come when there is a substitution for an entirely
`different medication. Furthermore, the price of generic medications may be much higher
`than patients expect. Although generic manufacturers do not need to recoup drug
`development costs, the manufacturing process itself may be complex, and its expense will
`be reflected in price paid at the pharmacy counter, Dr. Lane said.
`
`Furthermore, prices of generic medications have been on the rise recently, narrowing the
`cost difference between branded and generic medications, and that trend may continue if
`more rigorous FDA standards for generic medications are implemented, Dr. Mah said.
`
`He noted that in his geographic region, patients without prescription insurance coverage
`could expect to pay between $40 and $50 for generic prednisolone acetate 1% and $100
`for generic fluorometholone, if they can find it at all.
`
`“With the use of manufacturer­supplied coupons, brand name products may actually be
`cheaper than the generic, and with branded products, we can sometimes provide patients
`with free samples,” Dr. Mah said. “That is an opportunity that simply does not exist with
`generic products.”
`
`Patient education
`
`As a bottom line, all three surgeons said that while they are sensitive to the costs of some
`brand name medications and leave the final decision to the patient, they still recommend
`the brand name products.
`
`“My recommendation is based on what is best for the patient,” Dr. Donnenfeld said. “That
`starts with safety and efficacy but also includes cost. However, I give patients the choice of
`deciding what they think is best for them.”
`
`Dr. Lane noted that patients in his practice receive written materials with information
`detailing why the branded medications are preferred.
`
`“We encourage patients to fill their prescriptions as written, but at the end of the day, it is
`
`http://ophthalmologytimes.modernmedicine.com/ophthalmologytimes/content/tags/brand/brand­vs­generic­which­best­cataract­surgery­medicine?page=full
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`10/27/2015
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`Brand vs. generic: Which is best cataract surgery medicine? | OphthalmologyTimes
`
`the patients who choose what they want to use for their treatment,” he said.
`
`Dr. Mah said he also counsels patients about the concerns accompanying the use of
`generic products.
`
`“I essentially have an informed consent discussion in which the patient is told the generic
`products may require more frequent dosing, have not been demonstrated safe and
`effective in FDA clinical trials, and do not have to defend product­specific safety information
`in their labeling since the label is taken from the branded drug without trials,” he explained.
`“Therefore, I tell patients that I cannot guarantee the results they will get using a generic
`product. I offer patients the coupons for branded medications if the cost is an issue, and
`even have the patients call for samples if the coupons do not bring down the costs to a
`reasonable level.”
`
` 
`
`Eric D. Donnenfeld, MD
`
`E: ericdonnenfeld@gmail.com
`
`Dr. Donnenfeld is a consultant to Alcon, Allergan, and Bausch + Lomb.
`
` 
`
`Stephen S. Lane, MD
`
`E: sslane@associatedeycare.com
`
`Dr. Lane is a consultant to Alcon, Bausch + Lomb, Kala, Nicox, Ocular Therapeutix, Omeros, and PRN.
`
` 
`
`Francis S. Mah, MD
`
`E: mah.francis@scrippshealth.org
`
`Dr. Mah is a consultant to Alcon, Allergan, Bausch + Lomb, Foresight Biotherapeutics, Nicox, and Ocular
`Therapeutix.
`
`TAGS
`
`brand
`
`brand vs. generic
`
`Cataract Surgery
`
`Eric D. Donnenfeld, MD
`
`Francis S. Mah, MD
`
`generic
`
`Modern Medicine Feature Articles
`
`Stephen S. Lane, MD
`
`Ophthalmology
`
`Cheryl Guttman Krader
`
`Cheryl Guttman Krader is a contr butor to Dermatology Times, Ophthalmology
`Times, and Urology Times.
`
`MORE
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`Brand vs. generic: Which is best cataract surgery medicine? | OphthalmologyTimes
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