Download Eylea (Ontario Patient Evidence Submission, April 2015)

Ministry of Health
and Long-Term Care
Ontario Public Drug Programs
5700 Yonge Street, 3rd Floor
Toronto ON M2M 4K5
Submission of Patient Evidence
Please send completed submission and/or any additional relevant information to the Ontario Public Drug Programs, Patient
Evidence Submission, 5700 Yonge Street, 3rd Floor, Toronto ON M2M 4K5, fax to 416 327-8123 or email to
[email protected].
Section I – Author Information
Date (yyyy/mm/dd)
Drug and Indication
2015/04/24
Eylea (aflibercept), Diabetic Macular Edema (DME)
Author
Patient Advocacy Group
Jane Tsai
Canadian Diabetes Association
Unit No.
Street No.
Street Name
45
Montreal Road
City/Town
Province
Ottawa
ON
Telephone No. (incl. area code)
Email address
(613) 688-5940
[email protected]
PO Box
Postal Code
K1L 6E8
Section II – Conflict of Interest Declaration
The Author and the patient group must declare any potential conflicts of interest that may influence or have the
appearance of influencing the information submitted. Examples of conflicts of interest include, but are not limited to,
financial support from the pharmaceutical industry (such as educational/research grants, honoraria, gifts, and salary), as
well as affiliations or personal/commercial relationships with drug manufacturers or other interest groups.
The Canadian Diabetes Association (the CDA) solicits and receives unrestricted grants from multiple manufacturers/vendors
of pharmaceuticals, supplies and devices for diabetes and its complications. These funds help the CDA to support community
programs and services for people with diabetes, fund research and advocacy, across Canada. Sponsors were not involved in
developing this submission. The CDA did not have any conflicts of interest in the preparation of this submission.
Section III – Impact of the Disease/Condition
What symptoms and problems do patients have as a result of the disease/condition? How does the condition affect dayto-day life? For example, are there activities that patients are not able to do as a result of the condition?
Information presented in this submission is derived from two surveys conducted by the Canadian Diabetes Association (the
CDA), distributed through social media and email blast. The first survey, conducted in November 2014, gathered information
from 320 Ontarians with type 2 diabetes and their caregivers about the reality of living with or caring for someone with type
2 diabetes. The second survey, conducted in April 2015, gathered Ontario-specific information about the impacts of Diabetes
Macular Edema (DME) and the use of Eylea from 163 people with diabetes and 26 caregivers residing in Ontario. Among
them, 47 respondents indicated they have been diagnosed with DME or supporting someone with DME.
Impact of diabetes
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Type 2 diabetes is a chronic (progressive) condition that occurs when the pancreas does not produce enough insulin or when
the body does not effectively use the insulin that is produced. Insulin is a hormone that controls the amount of glucose in the
blood.
Diabetes is a disease that requires considerable self-management, including healthy eating, regular physical activity, healthy
body weight, taking diabetes medications (oral and/or injection) as prescribed, monitoring blood glucose and stress
management. The majority of patients surveyed indicated that daily fluctuations in blood sugar were the most important
aspect of diabetes to control during the day and overnight. The fluctuations impact the ability to work, interactions with
friends and family, causes stress and worry as well as ability to participate in normal activities of daily living. Uncontrolled
diabetes and the stigma associated with the disease can result in reduced quality of life. Maintaining control of diabetes has
potential to reduce anxiety and avoid or delay complications as well as improve overall quality of life.
Below are some direct quotes from Ontarians with diabetes regarding the impact of their disease:
“Having diabetes makes me useless. I have no energy or strength to enjoy life anymore. I can't do partial jobs around house. I
can't enjoy sports anymore. Diabetes has instill[sic] a fear in me.”
“It is a life altering disease that impacts every aspect of life. There is constant blood monitoring, diet, level of activity, cost of
expensive supplies and medication.”
Diabetes is also a risk factor for other conditions, including heart disease, stroke, kidney disease, and amputation. One of the
most dreaded complications of diabetes is vision loss and blindness.
Impact of DME
Diabetic retinopathy is a major cause of vision loss in people living with diabetes, and the most common cause of new cases
of blindness in people of working age. Without treatment, DME, a form of diabetic retinopathy, can cause permanent vision
loss or even blindness. People with DME and vision loss may experience inability to work and loss of income, decreased selfesteem, changes to family relationships, loss of ability to drive and participate in leisure activities. The loss of these activities
can negatively impact quality of life, and independent living.
Diabetes management can also be more challenging for a person who has difficulties with vision. These include activities
such as self-monitoring of blood glucose, managing multiple medications, and reading directions/labels of medications. Thus,
DME can mean decreased ability to manage blood sugar control. Some patients with DME may also face challenges
performing foot checks (as recommended by the clinical practice guidelines) to prevent limb- or life-threatening infections.
Additional challenges for people with diabetes with vision loss include the need for accessible transportation to medical
appointments and accessible literature to learn about diabetes and self-care (for example, large print, audio). Healthy eating
and getting enough exercise can also be challenging. They may require additional support from rehabilitation staff to learn
how to make their kitchen accessible and how to travel and perform exercise activities safely.
A total of 47people with diabetes surveyed indicated they have DME or caring for someone with DME. People who have
DME noted blurry vision as a symptom of this condition. Major challenges as a result of DME are related to employment,
particularly computer-based, reading, driving (especially in the dark), social activities, sports as well as diabetes management.
Below are direct quotes from people with DME or caregivers that describe how this condition has affected their lives:
“Slowly losing or having distorted vision is very difficult as it makes it difficult to read, drive, work or to live life in general.
It is hard to measure up insulin and fill cartirdges[sic].”
“DME has affected my work. It reached a point where letters were missing from printed words (e.g.: Dia etic Mac lar E em)
and my work is 100% computer base. It has also affected … reading (used to read a lot) for the same reason.”
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“DME has had an impact on my work capabilities as I work with computers all day, driving limitations (found difficulty in
drive after sun down sunset) which restricted my movements and was [de]pendent on family to drive me around. This
impacted on our social interactions with friends and family.”
“I cant walk very fare had to stop going on bus trips witch we went on once a year. Hard to participate with family do to the
need to sit because of feet to sore” (sic)
“It impacts everything I do. It makes it extremely difficult to read, Watching TV or looking at pictures is difficult. Driving is
negatively[sic] affected. In other words, DME negatively impacts all aspects of life and takes many of lives pleasure.”
Having DME and vision deterioration also causes emotional stress, as some respondents indicated they experience
“anxiety/stress/worry” and “fear of progression.” The following quote sums up the impact of the DME and treatment on daily
life as well as financial burden:
“Both my brother and I have type 1 DM, he has significant DME … Being treated with injections every other week (both
eyes being treated). … the injections are painful [and] the impact on his work life …, with respect to aspects of daily living,
he is not able to drive in less than optimal light …, his family life is dampened by the fact that his young daughters (8,12) do
not know the seriousness of his imminent blindness and not aware of what the treatments are actually for, he is slowly not
able to golf, play hockey and teach/coach the sports that have been his livelihood for most of his 46 yrs and for the topping on
the cake - the payments for the injections were initially not paid for because they were done off-label (so our mother cashed
in RRSPs to help out) and now the insurance company has a habit of holding back on the re-imbursements … when my
brother has to pay cash/cheque out of pocket at time of treatment.... Needless to say, all of these issues are better than the
alternative of premature blindness…”
Treatment outcomes that matter most to patients
What are the most important aspects of the condition that patients would like to see addressed by treatments?
In terms of treatment efficacy and side effects, what are patients getting from the existing treatments and what would
patients like new treatments to do differently?
Are there other practical implications to be considered in determining the value of a treatment? For example, how do
treatments impact patients’ or caregivers’ daily routine or lifestyle?
In addition to the drug cost, are there other financial implications to patients or caregivers (e.g. traveling cost, time away
from work, drug disposal issues, drug administration supplies)?
A total of 34 respondents with DME are currently or have previously received treatment, including laser therapy,
ranibizumab, bevacizumab, aflibercept (Eylea), vitrectomy, steroid, cataract surgery, varilux, ozurdex and MacuHealth.
Among them, 42% indicated they are satisfied or very satisfied with the treatment, while 32% indicated they are unsatisfied
or very unsatisfied; 25% remain neutral.
When asked to describe how their lives have changed as a result of the DME therapy, respondents noted improvement in
vision and ability to resume driving and other activities. Many mentioned the loss of time due to appointments, travel time
and recovery, and the need to juggle work schedule live close to a treatment centre– however, some respondents indicated the
inconvenience is “justified when ‘the alternative’ is considered,” and “At the moment, I am simply inconvenienced by having
to get the needles. I am overwhelmingly grateful to have them, however!” Some indicated that the treatments have stopped
further deterioration or seem to have “stabilized” vision.
Cost is indicated by some as a barrier: “cost of preferred treatment exorbitant for person on fixed income;” “The financial
burden of these drugs is hefty;” “[cost a burden for someone] not having a drug plan being a senior and retired.”
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Below are direct quotes from respondents who have noted positive effects including improved vision and ability to resume
activities:
“Ever since I have been receiving [treatment] for the past one year… my vision has improved. I am now mobile even after
sun down and am able to work longer hours on the computer without having trouble with my vision. My doctor has found a
considerable improvement on my DME condition.”
“I was first diagnosed with DME in July 2013. … I was noticing my sight was not so clear and that I experienced chunks
missing out of my image. I began [treatment] monthly and I noticed my sight improved and the chunks that were missing
were not as large. Today, I work on my computer, I can thread the needle on my sewing machine and I enjoy reading my
books better than I was experiencing before the injections... I am very grateful that my sight has not deteriorated any further
and has improved.”
“[Prior to the treatment] letters were missing from printed words…now thanks to the treatment, one eye has shown drastic
improvement while the other one just minimal improvement but letters no longer disappear.
“…my ability to read has improved and I have renewed hope that this terrible condition will continue to improve or at least
be contained.”
Many respondents emphasized challenges associated with the administration of the drugs and recovery afterwards:
“Pain of the injection with seeing black spots for the first 24 hours; have to relax with eyes closed for a couple of hours when
I come home.”
“Side effect I have noticed is ache in eye that I got injection. If laser, it’s pretty painful for day. When I rub my eye, it feels
like something is in it where the injection was made.”
“The side effects experienced have been a minor feeling of 'bruising' and 'dryness' when the eyes are returning to their normal
state after the trauma”
When asked about the gaps in current therapy and what advances new treatments can offer, patients responded they expected
the new treatments to:



Further delay the progression of DME;
Reverse effects of DME;
Require fewer/less frequent injections for treatment.
Information from patients who have used this drug
For patients who have used this drug as part of a clinical trial or from a manufacturer’s compassionate supply or have
purchased it through other means (private insurance or patient out of pocket).
What positive and negative impacts does the drug have on the condition?
Which symptoms is the drug best or worst at treating (advantages and disadvantages)?
What difference does the drug make to patients’ long-term health and wellbeing?
What are the side effects of the drug, which ones are patients prepared to put up with, and which ones do they find
unacceptable?
How does the drug compared with other available treatments in terms of efficacy, side effects and other practical
implications (e.g. administration, time, costs)?
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Among people who have DME or supporting someone with DME, seven respondents had experience with Eylea – some
noted positive differences as a result of the treatment:
“very successful, standard trearment was not effective, we pay 1700 a shot and althought the cost hurts, eylea has brought a
new level of vission and happynesd.” (sic)
“One thing I've noticed … is that Eylea seems to be clearer and absorbed more quickly.”
When asked about the importance of making Eylea available to patients with DME, an overwhelming majority (80% of
respondents who answered this question) indicated it is important or very important. However, the cost of Eylea and other
DME drugs was cited as a main barrier to the use of these drugs, especially for people who do not have medical insurance.
While respondents were encouraged by the positive results of this drug, they worried about not being able to afford these
drugs. As one respondent put it, “One major block is the cost to the patient. Those with no or limited drug plans may not be
able to take advantage of this drug as early as they should. It is very frustrating to know that there is something out there that
will make a major difference in the quality of life, but it not avsilsble[sic] due to finances.”
In summary, DME and the associated vision loss have serious impact on the lives of people with diabetes and their families;
people with DME are forced to withdraw from daily activities such as reading, driving, computer use and social activities.
Treatments can improve eyesight as well as the patient’s capability to resume daily and social activities and remain
independent. However, many cited the frequent (monthly) injections and affordability as key challenges in receiving
treatments. Respondents indicated their interest in trying or staying on Eylea as this treatment requires less frequent injections
and potentially better results, and many even willing to shoulder the financial burden so as to prevent or delay blindness. As
the prevalence of people with diabetes in Canada continues to increase, the need for safe and effective treatment for DME is
increasingly important, especially given the devastating impact of DME and associated loss of vision to the people suffering
from this condition as well as their families. As one respondent noted, “Words can't decsribe[sic] the limitations and feelings
of losing one's vision, especially if there are drugs that could make a difference. Even saving some vision would make a huge
difference in being able to live independently.” The most appropriate treatment for a patient will depend on the individual’s
clinical profile, responses to treatment as well as preferences; therefore, the availability of Eylea provides an important option
for patients with DME.
Confirmation of Authorship:
 I declare that I am the sole author of this submission
and confirm that no other parties had input into the
submission.
4717-87E (2010/04)
Signature
Date (yyyy/mm/dd)
2015/04/24
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