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Ophthalmologists and Patients Demand Quality Compounded Drugs at Affordable Prices
Access to compounding medications critical for ophthalmologists, patients
Ocular Surgery News U.S. Edition, May 25, 2015
Richard L. Lindstrom, MD
The decisions the FDA makes are critical to ophthalmologists and patients, especially in the anti-VEGF category. As I mentioned above, no generic anti-VEGF injectables are available. Lucentis (ranibizumab, Genentech) and Eylea, branded and patent-protected drugs, are excellent therapeutic agents but quite expensive, at approximately $1,100 and $1,800 per treatment. Avastin (bevacizumab, Genentech), shown to have good efficacy for several similar indications, is only available from compounding pharmacies at a price point near $50 per treatment. In the era of high deductible insurance and increasing patient responsibility for the cost of care, this price difference is extremely important for many patients. Loss of this drug would likely result in many patients being unable to afford treatment for potentially blinding conditions such as wet age-related macular degeneration and diabetic macular edema.
Most retina specialists use a treat-and-extend approach with anti-VEGF treatments, meaning they need to see and examine the patient before they know whether the patient will need an injection. A 503A compounding pharmacy approach requiring a patient specific prescription simply will not work in this setting, requiring the patient to return for another appointment for the injection, which is expensive as well as time-consuming for the doctor, patient and patient’s family. This is definitely not in the patient’s best interest. A 503B approach can work, allowing the physician to keep an adequate supply of drug on hand to meet their patients’ needs, but only if the physician has a reasonable number of days to utilize the drug. The currently proposed 5 days is way too short. More reasonable beyond-use dates (BUD) would be, in my opinion, 30 days at a minimum. Of course, 503B compounding pharmacies would need to confirm shelf-life stability and sterility for their products through the BUD period, but the loser will be our patients if unreasonable standards are applied.
So, the biggest elephant in the ophthalmology compounding pharmacy controversy is Avastin, but there are others. As an anterior segment surgeon, I am finding the use of intracameral antibiotics for infection prophylaxis, intravitreal antibiotic/steroid injections for infection/inflammation prophylaxis and treatment, and intracameral epi-Shugarcaine for pupillary dilation to be good options for my patients. Based on significant clinical experience, these compounded drugs appear safe and effective, and they are also a great value when compared with branded or even generic topical therapy alternatives. The 503A patient-specific prescription works, but a 503B outsourcing approach with a month or more to use the drugs would be far superior. Access to topical drops not otherwise available in branded or generic versions is also of great benefit to patients to enhance safety (for example, non-preserved versions of drops such as latanoprost), efficacy (for example, higher concentrations of cyclosporine or unavailable drops such as vancomycin), compliance (for example, commercially unavailable combinations such as a steroid and an NSAID) and of course cost, in which compounded drugs are generally much cheaper than their branded or generic competitors.
My patients and I want broad choice, easy access and a fair value, meaning a reasonable cost. I am hoping the eventual FDA regulations for compounding pharmacies protect these critical issues. We also want reproducible quality assured by current good manufacturing practices (CGMPs), and FDA oversight is important to assure safety and CGMPs. I am hoping the FDA focuses on safety, allowing ophthalmologists and their patients broad access to a wide variety of compounded medications. I am confident we physicians, with extremely rare exception, will only use the therapeutics available to us in our patients’ best interest.
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