Welcome to BC PharmaCare's Public Input Questionnaire for drugs being reviewed under the B.C. Drug Review Process.

Transcription

1 Welcome to BC PharmaCare's Public Input Questionnaire for drugs being reviewed under the B.C. Drug Review Process. This questionnaire is for Forxiga (dapagliflozin). Patient Groups have to register before completing the questionnaire. Not sure your group is registered? Check our list of registered groups. Your group can complete this patient group questionnaire only once. If you submit multiple questionnaires, only your last submission will be sent to the Drug Benefit Council for consideration. To protect the privacy of members in your group, please do not include in your response names of individuals or companies, locations, or any other information that might identify them or anyone else. Completing the questionnaire Mandatory questions are flagged with a red asterisk (*). If you decide not to provide the required information, click the CANCEL button at the bottom of this page to exit the questionnaire. To protect your privacy, your browser window will close. You do not need to answer all the optional questions. You need only answer those that you think apply to patients in your group. To protect your privacy, please close this browser window after you complete this questionnaire. Respondent information To have your input accepted, you must complete the Confirmation of Eligibility, Contact Information and Conflict of Interest Declaration sections of this questionnaire. Confirmation of eligibility 1. I am a resident of British Columbia, AND

2 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 Your organization's contact information will only be used to retrieve your submission if you submit a request under the Freedom of Information and Protection of Privacy Act (FOIPPA). It will not be used for any other purpose. Your organization's name, however, will be included as part of your submission to the Drug Benefit Council. 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 West 8th Avenue Vancouver, BC 4. Postal Code * V6H 3V9 Conflict of Interest Declaration To make sure the Drug Review process is objective and credible, everyone who provides input has to tell us about any possible conflict of interest. A conflict of interest exists if you, an immediate family member or your organization might benefit from the outcome of the review. For example, if you or your family own stock in the company that makes the drug, there could be a financial benefit IF PharmaCare decides to cover the drug. If your organization receives funding from the drug company, there could be a financial benefit (such as ongoing or increased funding) IF PharmaCare decides to cover the drug. Examples of conflicts of interest include, but are not limited to, financial support from the pharmaceutical industry (e.g., educational or research grants, honoraria, gifts and salary) as well as affiliations or commercial relationships with drug manufacturers or other interest groups. Even if you or an immediate family member, or your organization, has a conflict of interest, your input will still be considered as long as you declare the conflict of interest in your answers to the questions. All information you provide is protected under the Freedom of Information and Protection of Privacy Act. 5. Do you have any Conflict(s) of Interest to declare?

3 (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) 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 Question 7 is mandatory; all other questions in this section are optional. 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-today 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 blasts. These surveys asked about the reality and challenges of living with type 2 diabetes.

4 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 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.

5 Below are some direct quotes from B.C. residents with type 2 diabetes who have used dapagliflozin: 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. 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. 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. In addition to the benefits and side effects of Forxiga, one respondent reported weight gain associated with the insulin regimen. Below we provide the list of drugs that the survey respondents indicated they are currently using, and the percentages of people using these drugs: - Jardiance (3%) - Invokana (6%) - Kazano (3%) - DPP-4 inhibitors (11%) - Komboglyze (6%) - Janumet (8%)

6 - Jentadueto (6%) - Avandamet (3%) - Metformin (75%) - Sulfonylurea (31%) - Meglitinides (3%) - TZDs (6%) - GLP-1 agonists (12%) - Insulin (51%) Three quarters of the respondents are currently on metformin, half of them are currently on insulin, and one-third are using a sulfonylurea. While the majority of the respondents indicated satisfaction with their current treatment, 20% indicated they are dissatisfied with the treatment, and 18% reported they are neither satisfied nor dissatisfied. 11. Please tell us why your organization believes this drug should be included in the BC PharmaCare program. 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, 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. Conclusion Thank you for your organization's input to B.C. PharmaCare's review of this drug. Once the survey period for this drug ends, we will send everyone's responses to the Drug Benefit Council for consideration when they make their drug coverage recommendations. Before your input is forwarded to the Drug Benefit Council, we will remove all personal information, including the name(s) of patients and any other identifying details. The name of your organization, however, will be included as part of your submission.