Download Trulicity - Canadian Diabetes Association

Canadian Diabetes Association Patient Input Submission to
B.C. PharmaCare for drugs being reviewed under the B.C. Drug
Review Process.
This patient group submission is for dulaglutide (Trulicity).
Date of submission: May 18, 2016
Respondent information
Confirmation of Eligibility
1.
I am a representative of a patient group that represents patients in British Columbia who have the medical condition
or disease which the drug under review would be used for AND
The patient group which I represent has registered with PharmaCare to give input.*
Yes
Contact Information
2.
First and Last name*
Serge Corbeil, Director, Government Relations and Advocacy, BC and Alberta
3.
Home Street Address*
360-1385 West 8th Avenue
4.
City*
Vancouver
5.
Postal Code*
V6H 3V9
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Conflict of Interest Declaration
6.
Does your patient group have any Conflicts of Interest to declare? *
Yes
7.
Describe any Conflicts of Interest below.*
(You should complete this question only if you answered "yes" to question 6, above.)
The Canadian Diabetes Association (the Association) solicits and receives unrestricted educational grants from
manufacturers/vendors of medications, supplies and devices for diabetes and its complications. These funds help the
Association to support community programs and services for people with diabetes, fund research and advocacy, across
Canada. Sponsors were not involved in developing the content of this submission.
Questions on the drug under review
8.
Have you read the PharmaCare information sheet for this drug?*
Yes, I have read the information sheet.
9.
Describe how the medical condition or disease which the drug under review would be used for affects the day‑to‑day
life of the patients in your group.
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.
Common symptoms of diabetes include fatigue, thirst and weight change. High blood glucose levels can cause long-term
complications such as blindness, heart disease, kidney problems, nerve damage and erectile dysfunction. Managing diabetes
can require considerable self-management, including healthy eating, regular physical activity, maintenance of healthy body
weight, taking diabetes medications (oral and/or injection) as prescribed, monitoring blood glucose and stress management.
Poor glucose control can result in serious long-term complications. The majority of patients surveyed indicated that daily
fluctuations in blood sugar and weight gain were the most important aspects 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 and weight has potential to reduce anxiety and avoid or delay
complications as well as improve overall quality of life.
Information presented in this section is derived from surveys conducted in 2014 and 2015 by the Canadian Diabetes
Association (the CDA), distributed through social media and email blasts. These surveys asked about the reality and challenges
of living with type 2 diabetes.
There was a frequent emphasis on the psychological and emotional impact of diabetes on the lives of respondents (effect on
stress, anxiety, adjusting to changes in diet and lifestyle, medication and treatment management as well as relationships with
family). Respondents also described fatigue and lack of energy.
Management of diabetes includes lifestyle changes (diet, exercise and stress management). Inevitably, most patients are
prescribed one or more medications to achieve glucose control. This usually starts with metformin (oral agent) and, if target
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glucose levels are not met, other medications are added. Over time most patients will be treated with multiple diabetes
medications in order to achieve glycemic control.
Below are selected quotes from respondents to our surveys when asked about challenges related to diabetes:
“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.”
“Basically it's an awful experience, experience highs and lows. Exercising can make my sugars low so I have to always have a
snack with me. Eating anywhere besides home is a challenge as you don't know how things are made. I'm constantly checking
my blood and I take 13 pills a day.”
“The most distressing side effect of all of the diabetes drugs is they make you gain weight or prevent weight loss. It is annoying
to be told to lose weight then handed a drug that prevents weight loss”
10. What drugs or other treatments have the patients in your group used, either now or in the past, to treat the medical
condition or disease which the drug under review would be used for?
(Please list all of the drugs or other treatments and tell us about their experience with each. In particular, did they
consider any of the drugs or treatments to be successful and why?)
Note on information gathering: Response to this question was primarily based on a national survey conducted in December
2015 for four weeks, which gathered information from Canadians with type 2 diabetes (n= 352) and their caregivers (n=34)
about current drug therapies and experience with dulaglutide and/or other GLP-1 agonists, as well as aspects of diabetes they
would like medications to address. Below we present information provided by British Columbians with diabetes (n=52) and
caregivers (n=3) who responded to the survey and indicated any diabetes drug experience. Information from previous surveys
on other drug classes is also presented.
At the time of the national survey (December 2015), 12 respondents indicated current use of GLP-1 receptor agonists, SGLT2
inhibitors, DPP-4 inhibitors or DPP-4 and metformin combination, sulfonylurea drugs, insulin and metformin. Several has past
use of Thiazolidinediones. The majority was satisfied with the medication or combination of medications they were taking.
In terms of specific outcomes, 28 out of 40 respondents (70%) felt the medications improved their fasting blood glucose levels,
around half felt postprandial levels improved, 23 out of 42 (55%) reported improvement in levels upon waking, hypoglycemia
improved according to 15 out of 40 people (38%), 25 out of 42 (60%) reported improvement in A1C levels. Regarding side
effects, 14 out of 41 (34%) felt the medications help them with weight management, but 9 out of 41 (22%) reported worse or
much worse outcome in weight gain associated with their drug therapy. Improved GI effects were reported by 10 out of 40
(25%) while 6 out of 40 experienced worse outcomes. In terms of dehydration and UTI, the percentage of respondents who
reported better outcomes was about the same as those who experienced worse outcomes.
The majority of respondents in British Columbia who indicated experience with SGLT2 drugs noted their effectiveness in
reducing blood sugar levels and reducing weight, with little to no side effects. Weight reduction was cited as an important
outcome for these patients. Those who had experienced side effects cited increased hunger, dehydration and frequent
urination. Comparatively, the majority of those with DPP-4 inhibitor experience reported they were mostly satisfied with drug
therapy and with the fact that their blood sugar levels were kept at target. There were no specific side effects experienced with
DPP-4 inhibitors and respondents qualitatively indicated satisfaction with control and but some indicated frustration with lack
of control.
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11. If the patients in your group have tried the drug under review, please tell us about the effects they experienced.
The availability of dulaglutide to offer an alternative treatment option for stabilizing blood glucose is important to patients.
Dulaglutide, a once-weekly type 2 diabetes medication, belongs to a class of injectable drugs known as glucagon-like peptide 1
(GLP-1) receptor agonists, which lower blood glucose by mimicking the functions of natural incretin hormones; these hormones
stimulate the release of insulin after eating, inhibit the release of glucagon, and slow glucose absorption into the bloodstream.
We report patient experience with this GLP1 receptor agonist class of medications. A total of 12 British Columbians had
taken liraglutide and 1 had taken exenatide. Most of these respondents were over age 55 and had been diagnosed with
diabetes for over 11 years. Among those with GLP-1 receptor agonist experience, 8 people were using metformin at time of
survey, 5 using a sulfonylurea, 5 using insulin, 4 using a SGLT2 inhibitor (and 1 had had to stop use), 3 had used TZDs but had
stopped, 1 using a DPP-4 inhibitor (and 3 had had to stop use), 1 using combined sitagliptin and metformin (and 1 had had to
stop use). Seven people indicated satisfaction while 3 were dissatisfied. One respondent commented on the effectiveness of
liraglutide: “Since I started (GLP1 receptor agonist) I have felt much, much better. I don't have severe feelings of hunger every
four hours and I have feelings of fullness during eating so it is easier to prevent over eating…my quality of life and day-to-day
feelings of wellness have dramatically improved since being on this drug.”
12. How do you think the patients in your group could benefit from using the drug under review?
(For example: relief of existing symptoms; improvement in quality of life; or improvements to their condition and
long-term health and well-being. Please provide details.)
Based on studies and the CDA national survey conducted on patients’ experience with GLP-1 receptor agonists, this class of
drugs has been shown to be particularly effective in helping achieve glycemic control and weight reduction. In the national
survey we conducted, respondents generally did not report side effects associated with using this class of drugs. Over 60% of
respondents across Canada indicated satisfaction with their current combination of therapy including GLP-1 receptor agonists
(out of 80) , especially with better glycemic control (fasting, upon waking, postprandial) and A1C control. About half reported
better weight control, and close to half said their hypoglycemia had improved. Between 16-23% reported improvement in
other side effects such as GI, UTI/yeast infection, and dehydration.
Respondents with type 2 diabetes who answered our surveys on different diabetes medications consistently emphasized the
importance that the medications helped them achieve glycemic targets, reduce weight, and avoid hypoglycemia (which is a
particular concern for those also using insulin). When medications were effective in controlling glycemic levels, not causing
weight gain, with few side effects, respondents generally experienced increased confidence, optimism and positive attitude
related to diabetes management, as well as an overall sense of gaining control of diabetes.
13. Are there any additional factors your organization would like PharmaCare to consider during its review of this drug?
(For example: does the drug meet any special patient needs that have not been met by other drugs or treatments; is
the drug easier to use than other drugs; does the drug reduce visits to the hospital; does the drug reduce days off
work or school; or are the drug's side effects acceptable or intolerable?)
As “people with type 2 diabetes” is a heterogeneous group, treatment regimens should be individualized. Reponses from our
surveys reinforce the understanding that different people with type 2 diabetes require different drug options to help effectively
manage their disease. To achieve optimal blood glucose levels, individualization of therapy is essential, including selecting the
drug or combination of drugs, route of administration (oral or injection), how frequently the patient monitors blood glucose
and adjusts dosage, the benefits and risks that the patient experiences and/or tolerates, and the lifestyle changes the patient is
willing or able to make.
There are clear expectations that new drugs should offer blood glucose control to prevent hyper- and hypoglycemia, as well as
longer term control, with minimal side effects (particularly weight gain), at affordable costs, reduced dependency on other
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drugs and insulin, as well as less frequent injections required to maintain blood glucose control. These expectations were met
by respondents with experience using GLP-1 receptor agonists, in general. The availability of GLP-1 agonists including
dulaglutide provides an important option for patients with type 2 diabetes.
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