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The strategies should take into account evidence-based prognostic factors and treatment regimes. Many current strategies, including variations of treat-and-extend and treat-to-target, are based on limited clinical trial results. Yet, the reasoning behind the methodologies and analyses of such trials is not always clear; nor are the methodologies comparable from one study to another. In addition, clinical trial results are often presented in relative rather than absolute terms. To provide better evidence for treatment strategies, clinicians need clinical trials that are better designed, better analyzed, and more transparent.
In conclusion, wet AMD is a highly disabling condition that relies on technology for diagnosis. Therapies vary in efficacy and safety, and are administered in a variety of treatment strategies. The evidence base is presently available at an early stage and therefore limited. The standard of care using anti-VEGF agents within ophthalmology continues to evolve. Clinicians who want to provide optimal AMD care to their patients continue to face many challenges, and many questions about the disease and its treatment remain unanswered.
Yet the therapies have limitations, which impact the value ascribed to them by patients, clinicians, payers, and other AMD stakeholders.
In clinical trials, the value of AMD treatments are primarily determined by improvements in vision quality, as measured by eye charts.
Patients, however, tend to use broader criteria especially factors related to quality of lifeto assess a treatments value. After the opening presentations, summit participants turned their focus to defining and improving value in the treatment and management of AMD from the perspectives of the diseases various stakeholders.
The Perspective of Patients and Caregivers Above all, patients want and value improved vision, but not necessarily the kind of improvement that is only measured by the number of lines that can be read on an eye chart, as the summit experts had pointed out. An AMD treatment is most valuable to patients when it enables them to maintain independent activities of daily living, such as reading and dressing oneself.
Patients also want to be able to continue with their hobbies and interests and to retain their social contacts. The ability to recognize faces is a particularly important treatment outcome, summit participants stressed, as it means patients are able to continue to interpret nonverbal as well as verbal communication.
Patients also value treatments that minimize the physical and financial burden of careboth for themselves and for their caregivers. Thus, they want easy and equitable access to retinal specialists, therapies, and rehabilitation services. They also want more affordable treatments, as well as ones that require fewer visits to medical clinicians. The transportation and time burdens associated with current treatments are substantial for both patients and caregivers alike, and often act as barriers to timely and effective care, the summit participants pointed out.
AMD patients also want and value empathetic and individualized care from their cliniciansthe type of care that requires physicians to spend more time with them than medical-care systems often permit. In addition, 12 patients want clear and thorough information about AMD and its treatment, including information about rehabilitation services. Such information can be empowering and may help alleviate certain fears particularly of going blind as well as enable patients and their caregiversto plan better for the future.
Clinicians, like patients, also want treatments that require fewer injections or, preferably, no injections at all and that have minimum side effects. Clinicians would like to have access to all drugs that they believe would help each individual patient, rather than be restricted. Summit participants also stressed that clinicians place high value on well analyzed, unbiased, and timely information about wet AMD treatments.
They discussed the need for researchers to provide access to complete data sets from studies to ensure that the results are reliable. Clinicians also value research with realistic treatment protocols that are applicable to real-life clinical situations.
The summits participants also discussed how current treatments and systems of care place a burden on the quality of the professional life of clinicians who care for patients with wet AMD. As populations age, an increasing number of people are seeking treatment for the disease, and that treatment usually requires a long series of injections as well as extended follow-up care. Clinicians would like the delivery of wet AMD treatments to be more widely distributed; they would also like better coordination and collaboration of patient management among the various clinicians involved in each patients care.
Many patients with wet AMD have co-morbidities concomitant but unrelated medical conditions that make coordination and collaboration among clinicians particularly crucial for successful patient care. In addition, clinicians want payment systems that reward quality of care over quantity of care in particular, systems that allow clinicians to spend more time with individual Copyright The Angiogenesis Foundation patients. Minimizing the bureaucratic and administrative burden associated with the care of wet AMD patients would help free up more time for clinicians to spend on individual patient care, the summit participants agreed.
In addition, clinicians would like better access to authorities hospitals, regional authorities, health ministers, payers, and government regulators to talk about how to improve the clinical treatment of patients with wet AMD and how to lift the burden of the disease for all stakeholders, especially for patients.
The Perspective of the Payer and Society-at-Large The summit participants discussed how advances in the prevention and treatment of age-related diseases that cause vision loss are a major reason why being 70 years old does not mean the same thing, in terms of quality of life, as it did half a century ago. More people now have the possibility of experiencing old age with their vision intact.
Making sure that all individuals have access to that possibility, however, comes with a significant financial cost. Private and government payers, therefore, place high value on AMD-related therapies that are both effective and efficient. In addition, payers, like clinicians, want unbiased and timely data about those therapies so that they have more accurate information for costbenefit analyses.
For society-at-large, the value of AMD-related therapies comes from the contribution of vision-saving treatments to the quality of life of a growing elderly population.
Societies benefit most when such treatments are affordable and accessible to all. Persuading societies that more resources should be allocated to saving the vision of their elderly populations is challenging, however, because so many other and more visible age-related chronic diseases are also asking for those resources. Yet, patients with wet AMD often have chronic co-morbidities, such as heart disease or diabetes, so treatment to help them maintain their vision can also retain a higher quality of life.
Still, AMD patientadvocates, including clinicians, need to press forward rather than relent on their efforts to convince societies of the importance of helping AMD patients get the care they need.
Figure 8. They discussed the entire continuum of AMD-related care, from awareness and diagnosis through treatment and follow-up. Current State of Awareness The discussion started with participants summarizing their countrys overall level of public awareness about AMD.
France has a designated week each year that focuses on AMD screening. In addition, there are public-service announcements on French television to raise awareness about AMD.
As a result, many people in France are familiar with AMD and its symptoms.
These efforts have also increased public awareness of other retinal diseases. Public awareness in Germany about AMD is minimal. There is an awareness campaign in the country, but the effort has been underpowered and not very effective.
As a result, few Germans have an understanding of the seriousness of the disease. They think its like a cold that you get and then fix, one summit participant noted. Switzerland is similar to Germany in terms of its publics level of awareness about AMD, but many patient organizations do not have enough resources to fund awareness campaigns.
In recent years, however, information about the disease and its symptoms has begun to reach the public, and awareness is growing, although slowly. In Italy, most public awareness campaigns about AMD are regional initiatives. Tuscany, for example, has made efforts, with the help of a local association for the blind, to make older Italians and their families aware of the disease and its symptoms. A few public-service announcements about AMD have recently run on Italian television, but there is no large-scale national initiative underway.
As a result, most Italians known very little about the disease. Public health officials are planning, however, to increase AMD screening through mobile clinics set up in public spaces. In Poland, an AMD advocacy group has organized public awareness initiatives, which have included placing information on billboards and in popular magazines.
The group has also used the media to distribute AMD selftests. No proper research exists, however, on whether these efforts are leading to more people seeking early diagnosis and treatment for the disease. Awareness about AMD is generally quite low in Singapore.
As a result, most Singaporeans have late-stage disease by the time they visit an eye specialist. Singapore does have an annual AMD awareness week. The campaign is not very effective, however.
It tends to reach young, educated individuals rather than its intended audience: Singapores older and often illiterate population. There is a week-long AMD awareness campaign each year in Columbia. Yet public awareness about AMD remains low.
AMD patient-advocates and clinicians have recently undertaken new efforts to change that situation. Early in , a group of advocates and clinicians met with government officials to talk about issues related to AMD, including raising awareness. An effort is underway to find a popular and well known Columbian who would be willing to serve as a national spokesperson during national awareness campaigns.
In Argentina, the level of awareness about AMD is much higher in urban areas than in rural ones. In Buenos Aires, for example, awareness of the disease and its symptoms is probably comparable with that in most parts of Europe. In Argentinas rural areas, however, raising awareness about AMD must compete with other pressing health priorities, such as alleviating tuberculosis and malnutrition. Argentina runs an AMD awareness campaign every year, but its difficult to know if that effort has had much of an impact.
These and other awareness efforts have been somewhat successful in reaching and educating older Americans, but much more needs to be done. AMD receives significantly less attention from the U. High-profile individuals are needed as advocates and spokespeople, but most seem reluctant to step into that role, probably because of the aging and disabled stigmas attached to the disease. Each subgroup was instructed to discuss and map the various stages of the typical AMD care pathway.
They were asked to consider such questions as: How do patients become aware of their disease? Who typically diagnoses the disease? To whom are patients referred after diagnosis? What treatments do patients typically receive, and in what order? Who pays for those treatments, and how much? What follow-up care and services do patients receive? A summary of these discussions follows. Stage 1: Awareness Most patients become aware of their disease when they experience visual abnormalities, particularly vision loss that interferes with daily activities.
Most patients, therefore, delay seeking care. Many optometrists and ophthalmologists are also unaware that patients with early symptoms need a swift diagnosis followed by immediate treatment. When someone has a chest pain, everybody knows what to do, said one summit participant. Thats not true with vision problems. Patients with wet AMD symptoms may go to an optometrist, a general practitioner, a general ophthalmologist, or a retinal specialist for their initial consultation, depending on such factors as where they live, who is paying for their medical care, and how aware they are about the disease.
Patients rarely visit a retinal specialist first, however. Although getting a quick and accurate diagnosis is imperative for effective treatment of the disease, some countries have complex systems for routing patients with wet AMD symptoms to a retinal specialist. A patient may visit two, three, or even four clinicians before being diagnosed.
Long wait times for appointments, administrative and reimbursement barriers, and misdiagnosis by non-retinal specialists can also delay the diagnosis of wet AMD. In others, however, general ophthalmologists can also provide the treatments, and they are doing so in increasing numbers. That trend is welcomed in areas of the world where there are few retinal specialists or where retinopathy is not an official medical sub-specialty , but it has also raised concerns about quality of care.
The on-label anti-VEGF drug used to treat wet AMD ranibizumab or aflibercept is determined by its approval status in a particular country as well as by the patients payer or by the ability of the patient to self-pay. Drug choice also depends on whether the clinician and the patient have access to off-label therapies.
The preferences of the clinician and the patient may also play a role; a patient may choose aflibercept over the other two drugs, for example, because it requires less frequent injections.
At the time of diagnosis, patients are often fearful of becoming blind and thus rely on their clinician to present them with their best treatment option. Some clinicians, however, are financially incentivized to use a particular drug or dosing schedule, a factor that is usually hidden from the patient.
Financial factors are, of course, also part of the cost-benefit analysis that payers consider when approving anti-VEGF drugs and dosing schedules for patients. In some countries, the payer approval process of drugs, whether private or pubic, can be complicated and lengthy, and thus serves as a barrier to timely and effective treatment; in others, the process is simple and swift.
In France, for example, wet AMD patients generally receive their first anti-VEGF injection within a week of diagnosis; in Switzerlands large eye clinics, the first injection is frequently given to the patient during the diagnostic appointment.
In many regions of the world, however, patients have to chase reimbursement for wet AMD treatments or find the money to pay for the treatments themselves, processes that may cause them to delay or cut short their prescribed series of treatments. Copyright The Angiogenesis Foundation Stage 5: Follow-up Care Wet AMD is a chronic disease, and patients need to have their vision closely monitored and possibly treated for the rest of their lives.
Many patients, however, do not complete their initial dosing schedule, let alone participate in ongoing assessments, treatment, and care. The cost, frequency, and burden of anti-VEGF treatments play a role in patients dropping out of care.
Better medical-administrative systems are needed to ensure that wet AMD patients complete their dosing schedule and receive other follow-up services. In addition, clinicians need to help patients become better informed about what to expect from anti-VEGF treatment. Patients also need easy and timely access to rehabilitation services. Getting a referral to rehabilitation services is difficult for many patients, however. Their clinician may be unaware of how or where to refer patients, and in some regions, particularly rural ones, such services may not even exist.
In addition, rehabilitation services may not be reimbursable. Often it is the patients family who must find, access, and pay for rehabilitation services. For some families, a lack of financial and other resources makes such services prohibitive. Patients with wet AMD may also need mental health services. The prevalence of depression among patients with wet AMD is high, primarily due to activity restrictions caused by the loss of vision.
Professional counseling, particularly counseling that complements visual rehabilitation services, can greatly help patients who feel overwhelmed and frustrated with the challenge of maintaining their independence.