Innovative approaches needed to make the most of intravitreal therapies
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Studies in several countries show a trend toward reduced age-related macular degeneration-related blindness, thanks to the widespread introduction of anti-VEGF injection therapies. However, not all countries are doing equally well.
“We have a powerful weapon, but not all health care systems seem to be able to make the best use of it. Regulatory obstacles and inefficient management of human and technological resources hinder regular access to therapies and lead to suboptimal outcomes,” Paolo Lanzetta, MD, said in an interview with Healio/OSN.
In a review published in Graefe’s Archive for Clinical and Experimental Ophthalmology, the PubMed and Scopus web platforms were used to identify the most significant epidemiological studies evaluating the progress made in fighting AMD-related blindness. The positive effect of the introduction of anti-VEGF therapies was apparent in most of the countries where these studies were performed.
“In Denmark, the incidence rate of legal blindness secondary to AMD declined from 52.2 cases per year per 100,000 citizens in 2000 to 25.7 cases per year per 100,000 in 2010, corresponding to a decline of 50%. In Scotland, cases dropped by 57% between 2006 and 2011 following the introduction of intravitreal ranibizumab. A similar decrease by almost 50% was seen in Germany,” Lanzetta said.
A recent publication examined the annual incidence of AMD-related blindness in Australia over a period of 21 years. The incidence peaked at 77% in 2006 and declined to 41% by 2016.
“A steady decline started from 2007 when intravitreal therapy replaced [photodynamic therapy] as preferred treatment for AMD,” Lanzetta said.
Equation between results and treatment frequency
In the AURA study, the real-world outcomes of anti-VEGF therapy from 2009 to 2011 were retrospectively assessed in 2,227 patients from Canada, France, Germany, Ireland, Italy, the Netherlands, the U.K. and Venezuela. Substantial differences were observed between countries with regard to injection frequency and visual outcomes.
“Overall, the curve of visual gain showed a tendency to go up initially and then decline over time. Worse results were correlated with fewer visits and fewer injections, not comparable with the regimens used in clinical trials,” Lanzetta said.
However, there were countries that did better than others, such as the U.K. and the Netherlands, where the highest number of injections per patient was administered. In both countries, visual acuity gains were maintained over the follow-up. This was not the case with France, Germany and Italy.
“Among countries where more than 400 patients were enrolled, Italy had the lowest mean number of injections within the time frame of the study. Only five injections were given on average, leading to a decrease of three letters at year 2, while the U.K. had a gain of four letters,” Lanzetta said.
Data from the Italian Medicines Agency (AIFA) show that the consumption of intravitreal pharmacotherapies for retinal diseases has remained substantially stable over the past 7 years, with a defined daily dose per 1,000 inhabitants of 19.9 in 2014 and 21.1 in 2020, he said.
“If we look at anti-VEGF agents in particular, the per capita expenditure here is 1.5 ($1.7), the same as in 2014, with a significant decrease from 2019 to 2020. The AIFA registry also shows that the use of aflibercept and ranibizumab has substantially decreased in favor of the off-label drug bevacizumab. In 2013, out of 48,484 patients treated for AMD, 47.5% received ranibizumab, 25.9% aflibercept and 26.3% bevacizumab. In 2020, 1,880 new eyes were treated per month with bevacizumab, 871 with aflibercept and 568 with ranibizumab,” he said.
Breaking free from old patterns
Of note, Italy was among the first countries in Europe to authorize reimbursement of bevacizumab for AMD, and the cost of all three drugs is currently covered by the public health service. The reasons for the suboptimal outcomes of anti-VEGF therapies therefore lie elsewhere.
“Anti-VEGF therapies were introduced in the early 2000s, but our national health care system has failed to create the conditions for developing and implementing adequate models of care,” Lanzetta said.
Due to obsolete regulations, intravitreal injections can be delivered only in operating rooms, highly specialized hospitals selected by regional authorities or “comparable facilities.”
“What is required to be ‘comparable,’ however, has not yet been defined,” Lanzetta said.
These restrictions have created a significant barrier to access to timely, regular treatment and have affected the possibility to maintain regular dosing schedules during the ongoing COVID-19 pandemic. As shown in a recent report, during the first lockdown, attendance was reduced by almost 50%.
Today, there is consensus within the international scientific community that intravitreal injections do not need hospitals and operating rooms to be delivered safely. In many countries, they are routinely administered in outpatient surgery rooms or even in an office setting.
There are examples of good practices that should be more widely adopted to improve efficiency and optimize the outcomes of therapies, according to Lanzetta. In Israel, the increased demand for novel treatments for AMD was met by increasing the number of ophthalmologists dedicated to intravitreal injections, and a new model of home administration was adopted during the lockdown period. In the U.K., local projects were implemented for shared care with optometrists and nurses, nurse-led rapid access clinics and virtual review clinics, telemedicine, and a mobile eye care clinic equipped with diagnostic tools as well as an intravitreal treatment clean room.
“This is just to mention a few,” he said. “In the time of artificial intelligence, home-based OCT monitoring, office-based and even home-administered intravitreal therapies, it is our duty to do everything possible to protect our patients’ sight.”
For more information:
Paolo Lanzetta, MD, can be reached at European Institute of Ocular Microsurgery (IEMO), Via M.A. Fiducio 8, 33100 Udine, Italy; email: paolo.lanzetta@iemo.eu.
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Lanzetta P. Graefes Arch Clin Exp Ophthalmol. 2021;doi:10.1007/s00417-021-05451-2.
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