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Compounding pharmacies play important role in ophthalmic care
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Ophthalmologists have several sources for the drugs they prescribe to treat their patients. First, there are the so-called branded proprietary patented drugs protected by nonexpired intellectual property typically manufactured and sold by a major strategic pharmaceutical company. Good examples in ophthalmology would be the branded antibiotics Vigamox from Alcon/Novartis and Besivance from Bausch + Lomb. These drugs have completed successful clinical trials confirming safety and efficacy resulting in FDA approval and specific labeling for their FDA-approved indications. They are available through a prescription written by a licensed provider for an individual patient and usually obtained at a local or mail-order pharmacy. When the patient has health insurance and has met his or her deductible, a significant portion of the costs are usually covered by third-party payers. The cost to navigate the FDA approval process for a branded pharmaceutical drug ranges from $500 million to as much as $2 billion just for approval. Significant human and financial capital is also expended to launch these products, educate doctors on their use and promote adoption.
As practitioners, we know we can use these drugs in our patient’s best interest either “on label” or “off label,” but the manufacturer can only promote their use on label. Once branded drugs’ patents expire, the original manufacturer can continue to make and sell the drug, and then these drugs are typically called branded generics. In addition, other generic pharmaceutical manufacturers can produce the drug with “equivalent” active ingredients to the prior approved product at the same concentration. These so-called generic drugs can have different bottles, different vehicles, different preservatives and different buffers, but they must have identical concentrations of the active ingredient.
Staying with the antibiotic class, Ocuflox (Allergan) and Ciloxan (Alcon) would be branded generics while 0.3% ofloxacin and 0.3% ciprofloxacin HCl would be generic versions. Generic drugs tend to be less expensive as there is usually increased competition once their patents expire. Again, using the antibiotic example and looking up prices on GoodRx.com for my zip code, the cost at Walgreens with a GoodRx coupon for a bottle of Vigamox is $171.36 and for Besivance $162.31. The cost for generic 0.3% ofloxacin at Walgreens is $22.61 and for generic 0.3% ciprofloxacin HCl is $23.19. Most third-party payers are highly motivated to encourage the use of generic drugs, and overall in medicine about 80% of prescriptions are generic and growing in frequency of use every year. Ophthalmology is a bit of an outlier here, as we ophthalmologists prescribe more branded drugs than our primary care colleagues, but generic use dominates and is growing. There are, of course, also over-the-counter drugs, and the primary examples in ophthalmology include nutritional supplements such as vitamins, omega 3s, and a large variety of topical lubricants, decongestants and anti-allergy drops. There are also branded and generic over-the-counter drugs, much like in the generic channel. Alcon’s Zaditor is a good example of an allergy drop that was once a branded proprietary, patented drug and is now available as a branded over-the-counter medication. The cost for a bottle of Zaditor on Amazon.com is $12.90. In comparison, the branded proprietary patented market leader from Alcon/Novartis, Pazeo, is $181.17 at Walgreens.
Finally, we physicians and our patients also have access to compounding pharmacies. Before 1950, nearly all drugs were “compounded” at a local pharmacy with a doctor’s prescription. In ophthalmology, Allergan and Alcon were market leaders in developing the earliest prescription drops manufactured by a pharmaceutical company and distributed widely, starting in the 1950s. Compounding pharmacies remain a critical source of drugs that are not otherwise available from any of the three sources mentioned above. According to the Professional Compounding Centers of America, pharmacy compounding is the art and science of preparing personalized medications for patients.
Compounded medications are made based on a practitioner’s request in which individual ingredients are mixed together in the exact strength and dosage form required for the patient. The ingredients used are controlled by the FDA and primarily include medications that have previously completed FDA clinical trials and achieved FDA approval with decades of clinical experience. In the antibiotic class, examples would include gatifloxacin and tobramycin. The compounding pharmacist by law is allowed to work with the patient and the prescriber to customize a medication to meet the patient’s specific needs. The drugs needed are not readily available in the three distribution channels described above and would usually be in a different concentration, combined with other drugs to simplify delivery, delivered through a different route (for example, intracameral vs. topical), may be non-preserved and the like.
Compounded drugs may be covered by third-party payers, but many are cash pay. As mentioned in the accompanying cover story, compounding pharmacies are regulated and regularly inspected by both the state pharmaceutical boards and the FDA. Tighter regulatory oversight is applied to 503B than 503A compounding pharmacies, but both are facing ever-increasing regulatory scrutiny. I consult for and serve on the board of directors of Imprimis Pharmaceuticals. Imprimis makes custom compounded pharmaceutical products for the ophthalmologist in both a 503A and 503B manufacturing facility. A recent FDA inspection of the Imprimis 503B manufacturing facility lasted more than 10 weeks with several FDA agents participating. This inspection was intense, comprehensive and identical to that performed in a branded pharmaceutical manufacturing facility.
Custom compounded pharmaceuticals remain an important part of my therapeutic options. I spent 10 years as the director of the cornea service at the University of Minnesota from 1980 to 1989. Our University of Minnesota pharmacy compounded many custom drugs for our patients. These included non-preserved artificial tears based on cellulose gum and sodium hyaluronate as well as prednisolone acetate added to these base vehicles. In addition, well before topical cyclosporine was available commercially, we had it available from our compounding pharmacy and in concentrations up to 2%. We also prepared serum tears, 5-fluorouracil and mitomycin C for ophthalmic use as well as many other single and combination drugs not commercially available. When I entered private practice, I joined the staff of Phillips Eye Institute. The Phillips Eye Institute pharmacy custom compounded dozens of useful formulations for our patients as well as our glaucoma and vitreoretinal colleagues.
Through the years I have also utilized Leiter’s, and more recently I extensively use products from Imprimis for my cataract, glaucoma and soon-to-be-available dry eye patients. My patients and I especially like the Imprimis intracameral moxifloxacin/dexamethasone/ketorolac ($25) used in combination with topical non-preserved gatifloxacin/prednisolone acetate/nepafenac or bromfenac dosed twice daily until gone. This combination drop uses well-known products, costs $33, lasts 4 to 6 weeks, enhances compliance with a single bottle, and replaces (depending on surgeon choice and insurance plan) as much as $500 worth of drops. I use generic latanoprost as my first-line therapy in primary open-angle glaucoma as it is quite inexpensive and highly effective ($16.31 at Walgreens), but my patients and I like the Imprimis triple glaucoma drop containing non-preserved timolol, brimonidine and dorzolamide for a second drop twice daily. It again reduces preservative exposure, enhances compliance and is very cost-effective. Ten mL lasting 2 months when used in both eyes is $118. The custom drugs available from compounding pharmacies are a critical component of most ophthalmologists’ treatment options, including the compounding pharmacy elephant in the room, Avastin injections (Genentech).
All major ophthalmic societies including the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery as well as the Retina Society and the American Society of Retina Specialists are supportive of and advocate for the availability of high-quality custom medications available only from compounding pharmacies. Of course, quality is job No. 1 for any pharmaceutical company, and we ophthalmologists must represent our patients’ best interest by ordering our custom compounded medications from high-quality reputable pharmacies. Both physicians and their patients desire and deserve access and choice to therapies that are cost-effective and appropriate for their personalized needs. I find for many of my patients a custom compounded pharmaceutical is an important option, and I am prescribing them more frequently to reduce cost, avoid toxic preservatives, enhance compliance, and provide my patients with a medication customized for their individual needs.
Disclosure: Lindstrom reports he is a consultant for Alcon; is a consultant for, an investor in and receives royalties from Bausch + Lomb; and is a consultant for, investor in and on the board of Imprimis.