Blog: Geographic atrophy: An unclear road to success
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Another landmark moment in eye care occurred this year with the approval of pegcetacoplan, known as Syfovre from Apellis Pharmaceuticals, allowing treatment for the geographic atrophy form of macular degeneration.
Treatment requires monthly intravitreal injections, and clinical trials have shown clear efficacy. Given the predictably rapid progression of geographic atrophy (GA) disease to visual loss without treatment, both the cost and the effort to begin and maintain treatment with these agents are certainly justified. As other products like avacincaptad pegol (Iveric Bio) move toward approval, our understanding and ability to manage disease will only improve as our options expand.
The cover story in this issue of Healio/Ocular Surgery News highlights some of the so far unanswered questions about how this disease will now be approached clinically, and there are other real-world challenges we must face before our patients can consistently access these medications. The first challenge may be how to pronounce their names. For a funny look at this, listen to the annual drug name awards given by Jim Mazzo and me on the Eyeluminaries podcast.
We also face serious questions, like how do we identify at-risk patients developing GA before the first eye loses vision? With GA, once vision loss develops in the first eye, the second eye is likely to progress quickly. Ideally, we need to intervene when both eyes still retain functional vision. But many of these patients, if they know they have a problem at all, know it only as “dry AMD,” a disease for which they have been told there is no current treatment. Many have already undergone cataract surgery, so they may not be receiving regular complete exams with a careful retina exam. Even if patients are under annual eye care, many primary eye care providers (both optometrists and ophthalmologists) may lack the confidence or eagerness to refer patients for injection treatment. Educating everyone on who will benefit from treatment will be essential.
Next, even if we identify a patient with early GA, will those with fairly normal vision be willing to undergo monthly injections? As with wet AMD patients receiving injections, many will have transportation challenges or cost barriers. Many of those with a short life expectancy, presented with the prospect of monthly visits to forestall a disease that takes years to progress if untreated, will ask if they should “cross my heart and hope to die, or stick a needle in my eye?” as I suggested in a 2021 blog post.
Finally, what barriers will payers place before coverage of these expensive new drugs? We’re still struggling to identify which GA disease patterns are the ideal treatment targets. Where uncertainty exists, payers will look to save a buck, creating roadblocks to coverage. How many times have we clinicians faced rejections of treatment authorization on the basis of “unproven benefit” or “investigational treatment” for an FDA-approved therapy that is being used squarely on label? Retina practices are already about as busy as they can be. How much harder can they work to battle uncooperative third-party payers?
Without question, pegcetacoplan and avacincaptad pegol bring enormous value to our patients as new treatments that are revolutionary. But their adoption may occur on a time scale that is more evolutionary if we do not address these barriers. Our job as medical providers, industry and third-party payers is to accelerate their appropriate adoption as though our own loved ones were afflicted by this most cruel disease.
References:
BLOG: Cross my heart and hope to die, or stick a needle in my eye? https://www.healio.com/news/ophthalmology/20211117/blog-cross-my-heart-and-hope-to-die-or-stick-a-needle-in-my-eye. Published Nov. 17, 2021. Accessed April 10, 2023.
The latest news and notes, plus conversation with Richard L. Lindstrom, MD. https://www.healio.com/news/ophthalmology/resources/eyeluminaries/episode-12. Published Feb. 20, 2023. Accessed April 10, 2023.
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