Respondent information

Transcription

1 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 canagliflozin-metformin (Invokamet). Date of submission: July 20, 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* West 8th Avenue 4. City* Vancouver 5. Postal Code* V6H 3V9 1/6

2 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 longterm 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. Uncontrolled diabetes and the stigma associated with the disease can result in reduced quality of life. Weight gain adds to the sense of failure and anxiety in this patient population who frequently blame themselves for their health status. 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 2016 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. Some of the biggest impacts of diabetes include the need to change overall lifestyle and establish a routine to manage diabetes which can be very challenging for the individuals as well as their families: This condition has changed my eating habits, as I have to eat every 4 hours. I have to stay on schedule, count carbs, exercise & sleep better! Basically it's an awful experience, experience highs and lows. Exercising can make my sugars low so I have to always 2/6

3 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. It has changed the focus of my and my wife's live to center around diabetes. It effects almost every facet of our life as it requires attention during all our waking and to some extent or sleeping hours. Most of the survey respondents stated that diabetes had negatively impacted all aspects of their lives and limited daily activities, as well as travel, work and social life. They described being unable to walk due to kidney problems and neuropathy, having to give up driving due to diabetic macular edema, feeling fatigue and low energy and not being able to enjoy life anymore. Direct quotes from patients underscore the impact of diabetes on overall quality of life: I tire too soon, need breaks to complete simple chores. I am unable to work night shifts. I am unable to eat and rest like normal healthy people. 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. Diabetes and the need to manage the disease can be very stressful. Some people felt they were held captive by diabetes, that diabetes was overwhelmingly debilitating, and were frustrated that they cannot lead a normal life. For many, diabetes management was a constant struggle and an ongoing burden ( I am a diabetic 24 hours a day, with no holidays. ) One respondent described having diabetes as having a huge truck going down a hill and you are trying to stand in front of it and slow it down. Compounding the challenges is mental stress over how diabetes is perceived in society from people with diabetes: I feel guilty for having D. Stigma of being lazy. Diabetes is the emotional roll coaster you experience, feeling guilt that you brought diabetes onto yourself, since most people and doctors treat you that way. Across our surveys, a high proportion of respondents with diabetes appeared to have advanced disease; they reported complications and/or comorbidities, including neuropathy, foot complications, cardiovascular disease, eye problems or loss of vision, kidney complications, pancreatitis, skin ulcers, erectile dysfunction, amputation and depression. These complications can significantly reduce quality of life through physical and mental illness, and add burden to their families/caregivers. Some reported: I have reduced mobility, depression, reduced vision, the list goes on. It is tremendously difficult to live with diabetes day in and day out. I have peripheral neuropathy... It is painful and disturbing especially when laying down and going to bed. I also have a problem with diabetic ulcers on my toes which resulted in a toe amputation in April of I have diabetic neuropathy and have no feeling from my feet all the half way up my calf. I am not able to go for walks like I once did. It has also given me Stage 4 kidney failure. Having witnessed their family members suffer from diabetes complications also adds to their fear and stress. Managing diabetes with medications contributes to the challenges. People with type 2 diabetes often struggle with weight control and many medications contribute to weight gain. Weight gain and requiring add-on therapies creates a sense of failure and feelings of anxiety. Many respondents found various side effects of medications hard to tolerate, and became depressed when the drug therapies did not work: 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. Dealing with high fasting numbers; taking multiple medications throughout the day at different times and in different amounts; side effects have included coughing to the point of vomiting in the morning, dizziness when I stand after long periods of sitting, emotional frustration on managing my medications in the hopes that things will even out. Diabetes has changed how my life works I suffer from depression and have done for many years. Before I was told that I had to start insulin injections, everything I tried to control my BS did not work. That was very stressful and I was distracted trying to control them, exacerbating the depression. I felt like a failure. 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?) 3/6

4 Note on information gathering: Response to this question was based on a survey conducted in March 2016 about current and past drug therapies, experience with canagliflozin, or combination medication of canagliflozin and metformin, and aspects of diabetes patients would like medications to address. A total of 82 people with diabetes in British Columbia indicated having taken medications for their diabetes in this survey. When asked about drug experience (69 82 people answered the questions), 53 were using metformin at time of survey, about 41 respondents indicated use of canagliflozin in addition to metformin, 25 were using insulin, 9 taking sulfonylurea, 7 taking GLP-1 receptor agonists, 6 using DPP-4, 6 using DPP-4 combination with metformin, 3 using meglitinides, and 2 using acarbose. Among respondents, 12 people had to stop using sulfonylurea, 12 had to stop TZDs or combination with metformin, 9 had to stop using DPP-4 or combination with metformin, 6 had to stop metformin, 6 had to stop insulin, 4 had to stop GLP-1 agonist. The majority of respondents (60 people out of 82 respondents) were satisfied with the medication or combination of medications they were taking, and 15 were neither satisfied nor dissatisfied. In terms of specific outcomes, 57 out of 81 respondents (70%) felt the medications improved their fasting blood glucose levels, 52 out of 80 respondents (65%) felt improvement in postprandial BG levels, 56 out of 81 (69%) reported improvement in levels upon waking, hypoglycemia improved according to 33 out of 80 people (41%), 59 out of 80 (74%) reported improvement in A1C levels. Regarding side effects, 33 out of 81 (41%) felt the medications help them achieve weight loss or prevent weight gain, while 43% did not feel the difference. GI effects were improved because of medications for 16 out of 80 (20%) while 41% didn t feel any difference and 20% experienced worse outcomes. Between 18 23% reported improvement in preventing incidences of lung or respiratory infections, bone fractures and organ damage. 11. If the patients in your group have tried the drug under review, please tell us about the effects they experienced. Canagliflozin 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. As the combination medication canagliflozin and metformin is not yet available on the market, it is likely that the very few people with type 2 diabetes have had experience with this medication. Since many surveyed people indicated current use of both canagliflozin and metformin, we believe it is relevant to present these patients experience while stressing the potential for the new combination medication to reduce the burden of having to take multiple medications. The majority of B.C. residents with type 2 diabetes who have taken canagliflozin with metformin (with or without other drugs) noted significant improvement blood sugar levels, A1C and weight loss, within a short period of time taking this medication. Some mentioned reduced dependence on insulin, which was seen as a desired outcome. Respondents generally did not report side effects. Side effects reported with canagliflozin use are frequent urination yeast infection. Direct quotes from patients: Weight loss of 15 Kg in first three months. Increase urination. Decreased ACR extensively. Gradual decrease of HbA1C person aged years with type 2 diabetes for years, currently using single combined medication of canagliflozin and metformin, had to stop sulfonylurea, DPP-4 and TZD (including combination with metformin) I love this medication - it helped normalize my blood sugar, brought my A1C down, and helped me lose weight! It is fabulous person aged years with type 2 diabetes for more than 20 years, currently taking a GLP-1 agonist, metformin and canagliflozin, meglitinide, and insulin, had to stop using TZD and sulfonylurea for reasons other than clinical trials 4/6

5 Immediate benefit was a response in my A1C, the two meds dropped my blood sugar appears to be maintained at about a 6-7 point range (previously over 7). Side effects I've noticed are headaches, frequent thirst, thinning hair, low libido. Overall I feel ok/good. person aged years with type 2 diabetes for 6 10 years, currently taking metformin with canagliflozin Taking canagliflozin with metformin has gotten my blood sugar back to almost normal range. Before, with just metformin, my blood sugar wasn't very good That combination is better than just Metformin and gizgliburide[sic] alone. person aged years with type 2 diabetes for years, currently taking metformin with canagliflozin and a sulfonylurea (glyburide) Slow weight gain after an initial weight loss after diagnosis (2007). Lately the weight gain ( ) has been making it more difficult for me to keep my blood sugars below 8, (whereas to begin with it was not so difficult). It has been a long time since I have been below 7 for a1c. Stress seems to largely affect my ability to keep things in line. As a result my doctor has suggested I try canagliflozin in conjunction with my metformin, rather than move on to other combinations. I have seen a dramatic reduction of my blood sugars, taken upon waking. This tells me that I should have much better a1c readings by April I feel a lot better about getting the blood sugar under control, and have experienced a steady but slow weight loss since Jan 12, 2016 person with type 2 diabetes for 6 10 years, years old, currently taking metformin and canagliflozin Some patients reported side effects, among whom some found the side effects from taking canagliflozin or metformin intolerable: Initially very itchy perineum leading to skin irritation and breakdown needing to use Vagilsil and Hydrocortisone creme. Initially had weight loss but gained back. Increased edema in legs but not sure if related to the new medication person aged years with type 2 diabetes for years, currently taking metformin and canagliflozin I was not able to tolerate the invokana well as I had almost immediate and constant yeast infections I believe it is most important to consider the side effects as part of the overall effect on the individual and not only blood sugar maintenance - it's one thing to prescribe medication, it is quite another to have to live with taking it all the time person aged years with type 2 diabetes for more than 20 years, currently using metformin and insulin, had to stop using TZD, sulfonylurea and canagliflozin Severe side effects - caused diabetic ketoacidosis and put me in ICU for 6 days person with type 2 diabetes for years, years old, currently taking metformin and insulin, had to stop canagliflozin, TZD and sulfonylurea. I felt generally very unwell, I tried it on two separate occasions, both times were the same result, I stopped taking it altogether person with type 2 diabetes, over 70 years old, living with diabetes for years, currently not using any medication, had to stop canagliflozin and metformin Metformin causes severe stomach upset (cramps, diarrhea) in larger doses; could not leave the house due to that person aged years with type 2 diabetes for more than 20 years, currently taking GLP-1, had to stop using metformin and TZD Survey results have shown patients taking metformin and canagliflozin were able to achieve desired outcomes. Some have expressed wish to reduce the number of pills taken: It would be great if instead of 3 different meds, it could be combined into 1. Single dosing - easier to remember to take. The availability of the combination medication metformin and canagliflozin, as a single fixed dose, for people with type 2 diabetes stabilized on metformin and canagliflozin, with or without a sulfonylurea or insulin, would serve the purpose of offering effective therapy while reducing pill burden and promoting adherence to prescribed therapy. This would offer a significant advantage for doctors and patients working together to achieve optimal treatment with the lowest effective dose. 12. How do you think the patients in your group could benefit from using the drug under review? 5/6

6 (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 responses from CDA s national survey conducted on patients experience with canagliflozin, this drug has been shown to be effective in helping achieve glycemic control and weight reduction. Respondents to our survey generally did not report side effects associated with canagliflozin or SGLT2 inhibitors. The majority of respondents across Canada (out of 549 people) indicated satisfaction with their current combination of therapy including canagliflozin, 56 65% reported better glycemic and A1C control, 34% reported better weight control, and 44% said their hypoglycemia had improved. About 20% reported improvement in GI side effects. Across surveys that we have conducted so far, respondents with type 2 diabetes consistently emphasized the importance that the medications help 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 better blood glucose control to prevent hyperglycemic and hypoglycemic episodes, as well as longer term control, with minimal side effects and long term damage to organs, at affordable costs, and reduced dependency on other drugs such as insulin. Given the challenge that many patients have with weight loss and the enormous sense of failure experienced with weight gain, diabetes drugs that promote weight loss can be an important part of care. Based on the experience of diabetes patients in B.C., many of these expectations were met by canagliflozin in combination with metformin in providing better control of blood glucose levels and of diabetes in general. Some people did not have a positive experience and others had to stop using certain medications; this reinforces the understanding that different people living with diabetes require different options in terms of medications to help effectively manage their disease. Their clinical profile, preference and tolerance of therapy can direct physicians to the most appropriate drug therapy. Combining medications which would reduce the number of medications taken is seen as a benefit. The availability of a combined medication of canagliflozin and metformin may promote adherence to prescribed treatment by reducing pill burden and can offer some patients a good alternative for effective management of diabetes. 6/6