Do you have age-related macular degeneration (AMD)? Then, this story matters to you. Do you care about fair and equitable access to safe medications? Then, this story matters to you too. This story matters to Canadians living with AMD because it could enable regulators to restrict access to sight-saving drugs across the country. But, this is actually a much bigger story that stands to effect all Canadians because it could set a new precedent regarding the regulation and reimbursement of off-label medications.
The Foundation Fighting Blindness has been working closely with the CNIB and the Canadian Council of the Blind to be sure that patients’ perspectives and experiences are factored into an ongoing review led by the Canadian Agency for Drugs and Technologies in Health (CADTH) regarding the use of anti-VEGF drugs for the treatment of retinal conditions. Today, we are sharing this update because we want our communities to know that we have taken a firm stance together and formally asked CADTH to suspend the review process until adequate safety data is available. We made this request because of our shared concern that CADTH will recommend the widespread use of an off-label drug with sparse safety data as a first line of treatment. We are concerned that this decision is driven by economic constraints rather than the health and safety of Canadians.
Inequitable Treatment across Canada
Age-related macular degeneration (AMD) is the leading cause of blindness in people over the age of 50. There are two forms of AMD – dry AMD and wet AMD. Dry AMD is the most common form of the disease and is characterized by the gradual loss of central vision. Sometimes, this dry form of AMD will progress into the wet form of AMD, which is when most vision loss occurs. Fortunately, there are effective sight-saving treatments for wet AMD called anti-VEGF drugs. Vascular endothelial growth factor (VEGF) is normally produced in our bodies and is involved in the growth of blood vessels. However, the uncontrolled growth of blood vessels in the eye causes vision loss in wet AMD. Anti-VEGF therapies prevent (and even reverse) vision loss by removing excess VEGF from the eye. In Canada, there are two anti-VEGF drugs, Lucentis (ranibizumab) and Eylea (aflibercept), which have been approved to treat a variety of retinal diseases, including wet AMD. Avastin (bevacizumab) is an anti-VEGF drug that was designed to treat cancer, but is used “off-label” to treat retinal diseases.
Notably, Avastin is significantly cheaper than both Lucentis and Eylea. In addition, some studies have shown that it functions effectively as a sight-saving treatment. For these reasons, many doctors have opted to use Avastin as a first line of treatment, especially when their patients cannot afford the alternative.
Who pays for your medications?
In Canada, we consider health care to be right. Across the country, many of us are fortunate to receive excellent medical care, paid for by Canadian taxpayers. Accessing medically necessary drugs, however, is less straightforward. Some people have private insurance while others depend on publicly-funded drug programs, such as the Ontario Public Drug Program, which is widely used by people over the age of 65.
If the public drug program in your province covers the drugs that you need, then everything usually works out well. Unfortunately, not all drugs are covered, and different provinces cover different drugs. This means that you have access to different drugs depending on where you live. In Alberta, for example, the newest anti-VEGF drug for treating wet-age related macular degeneration (Eylea) is not covered by the public drug program.
Comparing Different Treatment Options to “Optimize” the Approach
Regardless of where you live, your access to anti-VEGF drugs to treat retinal diseases, including wet AMD, is at risk. This is because the Canadian Agency for Drugs and Technologies in Health (CADTH) is currently evaluating the monetary cost and clinical efficacy of different anti-VEGF drugs (including Lucentis, Eylea and Avastin). They are conducting this “Therapeutic Review” with the goal of making recommendations to “optimize” how these drugs are covered by provincial drug plans. The word “optimization” is used to signify that decision makers are looking for ways to save money without having a negative impact on health outcomes. Optimization implies that decisions are being made within constraints; for example, each province has a limited amount of money to spend on its public drug program. If you are interested in the fine details of the review, you can learn more on the CADTH website.
In brief, CADTH is conducting this review because they realize that the prevalence of people living with wet AMD and other retinal diseases will increase significantly as the population ages, and they are aware that Avastin is considerably less expensive than the other anti-VEGF drugs. In addition, there are now some results from clinical studies that compare the effectiveness of the different available anti-VEGF drugs.
Patient Evidence Matters
At the beginning of this review process, the Foundation Fighting Blindness was invited by CADTH to submit patient evidence. To do this, we collaborated with the CNIB and the Canadian Council of the Blind to share the experiences of people who are taking anti-VEGF drugs to treat their eye diseases. To learn more, we developed a short survey and invited people to share their stories. Thank you to everyone who provided feedback! Because of you, we were able to develop a patient evidence submission that contained a diversity of experiences with voices from across country.
In the patient submission, we emphasized that patients care about safe and equitable access to drugs. We told CADTH that some people were having difficult experiences in British Columbia, where access is more restrained. We told CADTH that although many people shared positive experiences with taking anti-VEGF drugs, others also shared more negative experiences. Because people had different experiences with different anti-VEGF drugs, we emphasized the importance of patient choice. You can read the full collaborative submission of patient evidence on the CADTH website here.
Recently, CADTH released a Draft Science Report that summarized the evidence that they considered (including our patient submission). As a patient group, we were invited to provide feedback on this Draft Report.
After reading the Draft Science Report, we were surprised by the lack of safety data that was available to evaluate Avastin. We were therefore concerned that even though the report repeatedly acknowledged this lack of safety data, it concluded that the drugs have equivalent safety risks. To us, this was a red flag because safety is so important to patients. In fact, sufficient safety data is a necessary criterion for embarking on a Therapeutic Review.
For these reasons, we have asked CADTH to suspend making any further recommendations until there is sufficient safety data available to justify the analysis. We sincerely hope that CADTH will consider our feedback because we believe that patient evidence is an essential component to effective decision making for the health of Canadians.
Your voice still matters. Please take the AMD survey or call to let us know about your experiences with anti-VEGF drugs. There will be additional opportunities for patient input before recommendations are made. As a patient group, our job is to bring your voice to the table. We are honoured to have this responsibility.