Download Forxiga (BC PharmaCare public input submission, February 2016)

Canadian Diabetes Association Submission to BC PharmaCare's Public Input
for drugs being reviewed under the B.C. Drug Review Process.
Drug under review: dapagliflozin (FORXIGA®) 3438.
Submitted: February 17, 2016
Respondent information
Confirmation of eligibility
1.
I am a resident of British Columbia, AND
I am an authorized member of a Patient Group that represents B.C.
patients who have the condition or disease for which this drug is used.*
x Yes
No
Contact Information
2. Patient Group Name and name of representative completing this
questionnaire*
Patient Group Name: Canadian Diabetes Association
Submitted by: Serge Corbeil, Director, Government Relations and Advocacy, BC and Alberta
3.
Organization's Address *
Canadian Diabetes Association, BC Office
360-1385 West 8th Avenue
Vancouver, BC
4.
Postal Code *
V6H 3V9
Conflict of Interest Declaration
5.
Do you have any Conflict(s) of Interest to declare?
(If you answer "yes," please complete Question 6 below.)*
X Yes
No
6.
Describe any Conflict(s) of Interest below.
(Complete this question only if you answered "yes" to the previous question)
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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 drug under review
7.
Have you read the PharmaCare information sheet for this drug?*
If you would like to read this information now, click on the "this drug's
information sheet" link in the What this drug is for column of the List of Drugs
Under Review. The information sheet will open in a new window.*
x Yes, I have read the information sheet
No, I have not read the information sheet
8.
Describe how the condition or disease for which this drug is used
affects the day-to-day life of 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. Diabetes 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. Poor glucose control can result in serious long-term complications.
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.
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.
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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 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”
9.
If the patients in your group have tried the drug under review,
please tell us about the effects they experienced.
The availability of dapagliflozin to offer an alternative treatment option for stabilizing blood glucose is
important to patients. Dapagliflozin belongs to a new class of drugs to lower blood glucose through
inhibition of subtype 2 sodium-glucose transport protein (SGLT2), which is responsible for at least 90% of
the glucose reabsorption in the kidney. The SGLT2 inhibition also causes a reduction in blood pressure and
weight loss.
Information presented below was originally gathered from a survey conducted in April 2015 about the
experience with the SGLT2 inhibitor drug dapagliflozin (Forxiga) to inform a patient input submission to
the CDR. Questions from these surveys included current drug therapy, previous experience with drug
therapy and experience with dapagliflozin (Forxiga). Data have been extracted from that survey for this
submission.
A total of 56 British Columbians completed the survey, 50 identified themselves as being diagnosed with
type 2 diabetes, 4 indicated they were caregivers for people with type 2 diabetes. Among the respondents,
15 have experience with dapagliflozin.
The majority of B.C. residents who have taken dapagliflozin noted its effectiveness in reducing blood sugar
levels and reducing weight, with little to no side effects. Those who have experienced side effects cited
increased hunger, dehydration and frequent urination.
Below are some direct quotes from B.C. residents with type 2 diabetes who have used dapagliflozin:
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“I've only been on Forxiga for a month ,but seems to be doing the job where the other was not quite
working . side effects seem to be nil”
“Easier to lose weight better for keeping my sugars in range. No lows”
“better energy, no harmful side effects, weight reduction. Some late evening hunger experienced. Works
well with other medications.”
“as a once a day med, it keeps life simple”
“instant reductions in sugar levels- my mom feels better on this medication and has lost 7 pounds. Has been
a very positive experience for her.”
Expectation for new drugs
Responded to the survey indicated the most important benefits of a drug include its ability to keep blood
glucose at target with minimized side effects. The majority of respondents indicated the following
benefits/side effects of therapy were “quite” or” very important”:
- blood sugars kept at satisfactory levels in the morning/after fasting (90%),
- blood sugars kept at satisfactory levels during the day/after meals (90%),
- avoiding fluid retention (90%),
- avoiding weight gain (87%),
- avoiding low blood sugar during the day/overnight (85%),
- avoiding GI effects (85%),
- reducing high blood pressure (85%),
- avoiding urinary tract infection (80%).
Respondents also indicated their expectations for new drugs, including affordability (“reducing the cost to
retired persons with limited budgets”), better blood glucose control, less side effects (“such as low blood
sugars”, “side effects that harm lungs, heart or other organs”), not having to depend on insulin (“keep away
from the needle”, “reduce/eliminate need to injected insulin”), not having to depend on as many drugs
(“reduce the dependence on drugs or number thereof”). One respondent hopes the new drugs will “allow
[him/her] to lead as normal life as possible” and many express their wish for a cure.
10. What drugs or other treatments have the patients in your group used,
or are currently using, for the condition or disease for which this drug is
used?
Please list all of the drugs and tell us about the experience of the patients in
your group with each treatment.
Three-quarters of the respondents reported current use of metformin, half of them reported current use of
insulin, and one-third are using a sulfonylurea. Below we provide the list of drugs that the survey
respondents indicated they are currently using, and the percentages of people using these drugs, based on
30-44 responses:
- dapagliflozin (32%)
- empagliflozin (3%)
- canagliflozin (6%)
- alogliptin+metformin (3%)
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-
DPP-4 inhibitors (11%)
Saxagliptin+metformin (6%)
Sitagliptin+metformin (8%)
Linagliptin+metformin (6%)
Rosiglitazone+metformin (3%)
Metformin (75%)
Sulfonylurea (31%)
Meglitinides (3%)
TZDs (6%)
GLP-1 agonists (12%)
Insulin (51%)
Some people had to stop use of certain medications for reasons other than end of clinical trials; these
medications include canagliflozin (3%), DPP-4 inhibitors (14%), sitagliptin+metformin (6%), metformin
(5%), sulfonylurea (13%), meglitinides (3%), TZDs (15%), GLP-1 agonists (3%), and insulin (3%).
Experience with current treatment
While the majority of the respondents indicated satisfaction with their current treatment (60%), 21%
indicated they are dissatisfied with the treatment, and 19% reported they are neither satisfied nor
dissatisfied. Patients that answered our survey expressed preference for oral drugs (“hopefully [the drug
can] reduce/eliminate need for injected insulin”) and for fewer pills needed for a day. One respondent
reported weight gain associated with the insulin regimen.
The majority of surveyed respondents (with use or without use of dapagliflozin) reported the treatment
improved blood glucose and A1C levels. A large proportion reported their hypoglycemia and side effects
(such as weight gain, GI effects, dehydration and urinary/yeast infections) did not improve with current
therapies. Below are survey responses on effectiveness of current therapies, presented as % and number of
responses in brackets ( ).
Meeting target blood
glucose (fasting)
Meeting target blood
glucose (postprandial)
Meeting target blood
glucose (upon waking)
Avoiding hypoglycemia
Meeting target A1C
Weight control
GI effects
Dehydration
UTI or yeast infection
Worse
9% (4)
Same
14% (6)
Better
75% (33)
9% (4)
14% (6)
70% (30)
4% (2)
11% (5)
78% (35)
11% (5)
10% (4)
12% (5)
2% (1)
13% (5)
2% (1)
22% (10)
20% (8)
35% (15)
48% (21)
50% (20)
48% (20)
44% (22)
56% (33)
47% (20)
41% (18)
25% (10)
24% (10)
11. Please tell us why your organization believes this drug should be
included in the BC PharmaCare program.
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Diabetes requires intensive self-management. To achieve optimal blood glucose levels, individualization of
therapy is essential, including selecting the drug or combination of drugs, route of administration (oral,
injection, pen or pump), 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 any new drugs should offer good blood glucose control to prevent
hyperglycemic and hypoglycemic episodes, as well as longer term control, with minimal side effects or
long term damage to organs, at affordable costs, and reducing dependency on other drugs including insulin
injections. The patients who have experience with dapagliflozin described good results in terms of glucose
control and less side effects compared with other drugs.
Different people living with diabetes require different options in terms of medications to help effectively
manage their disease; some people had to stop treatment for reasons other than clinical trials as seen in
survey results. As noted by a respondent: “every person has their own response to a drug ... The [doctor]
needs to be able to prescribe what is best for that patient (in regards to efficacy & or side effects.)”. Their
clinical profile, preference and tolerance of therapy can direct physicians to the most appropriate drug
therapy. The availability of dapagliflozin (Forxiga) thus provides an important option for patients.
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