June 11, 2019 Access to diabetes medications

Erin Krusky[00:03:07] Great. So we're going to get started today. Welcome everyone to diabetes Canada's 2019 spring webinar series. This is the second webinar of a series of four webinars. My name is Erin Krusky and I will be your host today. We are delighted that you are able to join us today for the webinar to learn about access to diabetes medications. Please note an evaluation will be available to fill out a couple of minutes after the webinar concludes today. Please return to the event page to complete the evaluation and view this event recording. You will need to fill out the evaluation survey in order to receive a certification of completion for participating in the webinar today. We thank you in advance for any feedback. Throughout the presentation you will have the opportunity to type in the Q & A box. We ask that you use this box for any questions you may have along the way for our presenter and our presenter we'll be happy to answer at the end of the presentation. If we don't get to all the questions asked then we will post the answers from our speaker in the TimedRight Diabetes 365 forum. We will also have some polling questions today. So please participate in those as well. The presentation itself will be about 30 to 40 minutes in length with about 10 to 15 minutes for questions at the end. It is important to note that this webinar will be recorded and posted on Diabetes Canada web site at a later date. Now I'd like to welcome our speaker Judith Glennie and thank her for joining us today. Before turning it over to Dr. Glennie I'd like to give you a brief introduction. Dr. Glennie is the president of J L Glennie Consulting Inc. providing a range of strategic advisory services to nonprofits government and industry clients. Dr. Glennie is a senior member of the health care community with over 25 years of experience in the national and international pharmaceutical policy world. A clinical pharmacist by background she has held roles in strategy, policy, teaching, research, and patient care in the payer regulator industry clinical and academic environment. Her public policy background includes a master's of science in community health science and roles such as the associate director of drug program branch at the Ontario Ministry of Health and Long Term Care manager and director role that Health Canada health products and food branch and a federal cabinet appointed to the Patented Medicine Prices Review Board. Prior to returning to the consulting role she was with Janssen Canada where she led HTA policy initiatives as well as post marketing effectiveness research strategic planning reimbursement submissions and market access strategy. So without further ado I present to you Judith Glennie. 

Judith Glennie: [00:03:08] Thanks Erin and good afternoon or morning depending on where you are. I really wanted to thank Diabetes Canada for this opportunity to discuss access to diabetic medications with our participants today and we're actually going to kick things off right from the get go with a polling question and Lindsay's going to put that poll up if you could answer please and I'll give you a little bit of background as to why why this is this is helpful to me in terms of my presentation because I'd like to get a sense of the background of our participants before we dive into to the details. 

Judith Glennie: [00:03:46] And once everyone's had a chance to respond Lindsay will show us the results. We need the Jeopardy theme song going now. But I'm not going to sing. 

Judith Glennie: [00:04:05] I'll Spare you that. 

Judith Glennie: [00:04:09] So do we have some results. Here we go. 

Judith Glennie: [00:04:14] There we go. So we've primarily got dietitians nurses and pharmacists and some nurse practitioners on the line. Thank you all for joining. Wonderful to have you on the on the WebEx with us today. And another quick polling question. To get us started. And the question is do you have difficulty in accessing diabetic diabetes medications for your patients and or clients. And again I'd like to get a sense of the group from this group as to how frequently access to medications is a problem and will help to provide some context for the comments that I'll make in the rest of the session. 

Judith Glennie: [00:05:07] I'm sure we'll have some results. Very shortly. 

Judith Glennie: [00:05:12] So about 60 percent of you have have experience challenges in getting access and hopefully for the other 40 percent of you you'll get a sense of what some folks are dealing with and how it can be problematic for patients in the long run. So just in terms of some disclosures I don't have an affiliation either financial or otherwise with any for profit or non for profit organizations related to today's topic of discussion. And I will not be making therapeutic recommendations for medications that have not received regulatory approval. And as you can see from my no commercial interests that are relevant to today's topic. And in terms of financial support disclosure this program has received financial support from Janssen in the form of an educational grant. And the program is also received in kind support from Diabetes Canada. In terms of logistical support I have not received an honorarium from Diabetes Canada scientific group and Diabetes Canada has no products. OK so just to dive into some of our objectives for today I'm going to provide a description of how access specifically to SGLT2 inhibitors compares in Canada. This is just really we're continuing the dialogue that we started with last week's session with the clinical side of SGLT2 and now we're going to talk a bit about the access challenges as SGLT2s. 

Judith Glennie: [00:06:46] However really you know our quite representative of some of the challenges that can arise in patients access to diabetes medications with large and I will be focusing in on public drug programs because they tend to be more restrictive in terms of diabetes medication access. Secondly we'll talk about how access to the right medications can impact the use of these medications by patients and or their prescribers. 

Judith Glennie: [00:07:17] We'll we'll talk about the connection between access and timely treatment of hypoglycemia in patients with diabetes and then talk a little bit about how health care providers can facilitate access to the right medications and advocate as well. So I wanted to just step back before we dive into the details of of access provide a bit of context for you. No surprise to anyone on the line today. We know that diabetes is a significant public health problem let alone the challenges it creates for individual patients with diabetes. 2015 Global Burden of Disease report spoke about the increase in diabetes prevalence and the major underlying causes of disability and death. As a result of diabetes a couple of key papers from a couple of years ago in the New England Journal of Medicine. On the one hand talked about the increasing incidence particularly of type 2 diabetes in young people particularly those who were in the workforce and in the workplace. But at the same time acknowledge that we have seen improvements over time in terms of treatment of diabetes care now beyond drugs and that has started to slow the rate of death and cardiovascular disease associated with diabetes. So that's kind of the good news. But in general if we take a look at the overall impact of diabetes on public health it's increasing almost exponentially. And you know the number of lives lived with disability associated of years with excuse me with disabilities is associated with diabetes has increased significantly by one third and of course Diabetes Canada has done some fabulous work over the last few years in particular putting numbers to a lot of these same trends that have been reported outside of Canada and made it put them into the Canadian context. So we have a problem with diabetes and we need to figure out the best mechanism by which to manage it. Obviously we know within that broader public health context I really want to talk about a patient access to medications and medications are only one tool. We know that they are not the only tool. They are not the perfect tool necessarily but they are a key tool in helping to manage helping patients with diabetes to manage their their disease. And you know a key focus of many health care professionals as they interact with with patients. This slide describes a schematic of all the steps between drug developments and actual use of drugs by patients in the Canadian environment. I just want to step through each of the boxes to clarify a little bit about you know what the purpose of each of these activities is what questions that each body is trying to answer and why they're trying to do that and all of this before the patient actually even gets to take the medication. So if we start with Health Canada of Canada's fundamentally answering the efficacy question they're looking at the safety. They're making sure these drugs are of high quality and whether or not they actually do something not necessarily do something better but that they do something that impacts the disease. And after Health Canada reviews the product that drug gets a Notice of Compliance or N.O.C. The next step in the Canadian environment is a health technology assessment or an HTA assessment where bottom line here is looking at the value of the product and the value of the product in the context of what payers are already paying for in the public system. Because of course CADTH is providing advice to public payers public drug programs across the country and so that means looking at and comparing clinical benefit and safety of drugs that are being paid for now versus the new drug that wants to be funded. Looking at the cost effectiveness so incremental clinical benefit for incremental cost but also taking a look at patient values. More recently a clinician input has also been part of the G8 process. One of the problems however with the HTA process is that some things that patients of value over the years have not been valued by CADTH. So for instance for the longest time nocturnal hypoglycemia was seen to be not a relevant issue to be concerned about when evaluating new medications. And it wasn't until patients input started back in early in 2010 that some of you know some of the mindset shifted of those reevaluating these medications to start to put more credence in something like patients concerns around nocturnal hypoglycemia etc. Similar to what we see now and this is specific to SGLT2s and the GLP-1 is the weight loss that is associated with these medications by virtue of the way that they work. From a clinician perspective that seemed to be a value because sometimes a patient with diabetes needs that. What's the word I'm looking for. Need that encouragement of the weight loss that may be coming from drug to them. Continue to help to better manage their diabetes their diet and exercise etc. to to get further weight loss particularly type 2 diabetes obviously I'm talking about that's not something that's valued through this HTA system. And one of many several many kinds of outcomes that again may be important to clinicians or to patients but are not given any value in this health technology assessment process. The next layer here is the pan Canadian Pharmaceutical Alliance. This is where pricing negotiations happen on a national basis now. This has been going on for about five years or so and they're really trying to address the question of affordability. It's one thing that the drug provides value but in diseases that are have such a huge burden on society like diabetes large numbers of patients we also have to look at the affordability question and negotiations happen at this level. And then last but not least a recommendation goes down. You know the funding recommendations of the Health Technology Assessment recommendation plus the negotiated price finally hits the province. They may or may not have their own local expert committee give them some additional advice and there may be some variability in different drug programs across the country have different policies in terms of who they serve whether they're 65 and over whether whether they have a catastrophic drug programs like the Trillium program in Ontario et cetera. So there is all the precedent that has come into play with earlier diabetes drugs may come into play when they make a final decision about how they're going to fund the new diabetes drug. So suffice it to say say it's complicated and as I'll show you in just a minute sometimes it can take an extremely long time. 

Judith Glennie: [00:15:03] So. 

Judith Glennie: [00:15:04] Now despite this very well-defined process whose goal actually is to try to increase equity or sameness in terms of patient medication access across the country. Well the reality of what we see is a disconnect in terms of that equitable access from one end of the country to the other. This case again I'm just looking at the SGIT2 but this you see this in other different categories of drugs for again specifically for type 2 diabetes. This slide is taken from a report that Diabetes Canada itself does update on a regular basis. This is updated as of last month and it gives you a sense of of the different kinds of access for SGLT2s across the country. So for instance in Ontario patients and clinicians basically have access to general benefit access to the major SGLT2s that have come out onto the market over the last four or five years. That means that these drugs are on the formulary the physician just has to write a prescription and the patient gets the drug. There may be some therapeutic criteria that are provided as advice. But bottom line is the physician can write the or the nurse practitioner or whomever can write the prescription for the patient for whom he or she thinks an SGLT2 or where these three SGLT2s are the appropriate medication. In a province like British Columbia you can see that there's not so much access at all. And according to our our guide here the SGLT2s aren't not listed at all. In Nova Scotia we'll talk about this a little bit more so in more detail in just a moment but SGLT2s are restricted in their access. There's been a slight change over the last few months but up until recently you could not get access to an SGLT2 unless you had maximized your metformin and sulfonylurea dose and had failed on insulin. It was only that at that point that which you could get access to one of the SGLT2s. They said that has changed recently and we'll look at that in a little bit more detail. So a bottom line here is one can hardly come to the conclusion that there is equal access for patients with diabetes to these SGLT2s across the country. It's highly variable and and the reasons for that variability are even are different as well. And I don't want to go political here so we'll just stick with the facts. So what I wanted. You know if you if you if you agree that medication access is one tool not the only tool but a key tool for addressing the diabetes challenge that I spoke about earlier the previous book table tells us that a good part of the Canadian Patient Access landscape has these these restrictive health policy frameworks for for drugs that are actually undermining what we want to do from a public health perspective. So if we look at today's state you know we've got a real disconnect between our drug policies vs. and access to medications for diabetes versus each and every province pretty much having some kind of a diabetes strategy and understand understands that diabetes is a significant challenge not only to patients obviously but to the public health system at large. And if we don't manage diabetes well we will end up costing the health care system more in the long run. And so there's a real disconnect and a restriction on this key tool the medication tool to address individual patient needs and that as I said that really undermines or my thesis is that that really undermines our ability to address this significant public health problem. Where would we want to be what would our desired state be. It really would be to to have more much more tailored approach to diabetes care so that we could align a patient schools and their needs with the most current evidence. But do that in a timely manner and I'll show you in my case study on the next slide how timeliness is not the watchword when we're talking about getting access to some of these these new medications. So this is a case study on Empaglifozin. I've never worked on this drug with company with a company. So this is I but I've been following this case for for many years because I think it it really articulates well some of the challenges that come up when you're when when clinicians are trying to get access to newer medications for patients yet we have the the drug policy system creating some barriers to enabling to enabling the optional optimal care. So I'm going to start in October 2015 when Empagliflozin first came through the Health Technology Assessment Process CADTH for type 2 diabetes and it was recommended as an add on to metformin and Sulfonylurea for patients with inadequate glycemic control where insulin is not an option. When we look at what the individual and I'm just using select provinces for for purposes of illustration. But when we look at what different provinces did or different jurisdictions did with that in Ontario. Empaglifozin was listed as a general benefit based on criteria. Similarly you know leveraging those CADTH recommendations add on to metformin where an SU is contraindicated or not tolerated as well as an add on to met and Sulfonylurea where insulin is not an option. So they went one step further actually. And we see the first recognition of Sulfonylurea is really not being an ideal drug for certain patient populations particularly because of cardiovascular challenges that may occur in certain sub-groups. Non insured health benefits is the drug program for First Nations people run at the federal level and because non insurers health benefits has made diabetes the diabetes challenge in First Nations people are priority from a public policy perspective. They too took a much more permissive approach to listing Empaglifozin. Remember this was just based on the initial indication back in 2015. They made it an open benefit with therapeutic notes. In other words you did not require special approval and they their criteria were insufficient glycemic control after an adequate trial of metformin plus Sulfonylurea. So third line therapy or or add on to that Sulfonlurea. In Nova Scotia there was a much more restrictive approach the drug was an exception status drug which means that you have to get prior approval and submit all kinds of paperwork. And it was only provided for patients with type 2 diabetes who had not only inadequate glycemic control on Meftomin and Sulfonylurea but also had to have failed insulin and needle phobia is not not a definition of not insulin not being an option. So they were very rigid in terms of the patient had to have tried insulin as a third therapy before being allowed to do try the SGLT2s. Fast forward to 2016 or actually not so fast forward, Empaglifozin based on the EMPA-REG outcome trial went back to the Common Drug Review to the Health Technology Assessment Agency and in October 2016 got a recommendation for use in patients with type 2 diabetes with high risk high cardiovascular risk. And again recommendations that that it could be used after an adequate trial of metformin so metformin add on SGLT2 if the patient had the established cardiac vascular disease as defined in the EMPA-REG outcome trial. It took you'll recall we talked about the Pan Canadian Pharmaceutical Alliance the PCPA. So after this recommendation came out in October 2016 this drug was under negotiation for this new indication for two years. So theoretically I'm sure some physicians were using it anyways but theoretically this drug was not available to be used in type 2 diabetics who had failed metformin who met the EMPA-REG criteria until October 2018 in Ontario. And went Ontario finally did list it. It was as a general benefit for add on to metformin with evidence of high cardiovascular risk similar outcome in non non insured benefits program. A similar kind of a criterion. And then and then in Nova Scotia we still see it as an exception drug status so tightly controlled. Have to make us a paper based submission. But at least they got rid of the insulin related requirements and for this specific subgroup of type 2 diabetic patients and were aligned with the Common Drug Review recommendation which is add onto metformin in patients with cardiovascular established cardiovascular disease. So at least there was some shifting away for some patients away from having to try insulin as well as Sulfonylurea but this is an inordinate amount of time to wait between health technology assessment recommendation and final lessening. So let's talk a little bit about the implications of these barriers. As I've said earlier I mean I think you know one could just using that Empaglifozin example. It would be hard. You'd be hard pressed to say that public players approach to access is not undermining efforts to improve diabetes care. Just on that example alone. And if we if we can't get that better alignment between policies related to managing diabetes as a public health issue and policies related to drug access at the time that patients need them we're not going to be able to mitigate those causes of disability and health care costs and death that come from diabetes especially particularly uncontrolled diabetes. We also see really perpetuation of some of these inequities not only inequities in terms of drug access but we already know again from Diabetes Canada work that there are a lot of inequities in terms of diabetes health related outcomes whether it's First Nations, Nova Scotia, Ontario B.C. et etc.. It's different in every province. And that's partially you know that could be related to a number of things but I would argue partially it's related to medication access. And then I'll speak to this on the next slide but it's you know we already have challenges enough making sure that we get patients treated in a timely manner or moving from monotherapy to double therapy to triple therapy when they need to. These public payer health policies are not helping. And so when I saw the example that I just talked about so is clinical inertia. So this comes from a slide from Stuart Harris in London who's talked a lot about the issue of clinical inertia. That being delayed time to adding on additional oral anti diabetic medications despite lack of despite having to have lack of A1C control and not going to go into the details here. But you can see that this is from a specific study but you can see that the more medications that the patient needs to delay they're. Sorry to treat their diabetes the greater the delay there appears to be in comfort level of adding on another oral agent or another agent to treat their their diabetes. These data are are quite dated. They come back you know back to almost eight years ago or thereabouts but when when I chat with clinicians and people who are in this space it sounds like it hasn't changed very much. So the lab as I said the last thing we need is drug plan policies exacerbating what is already a challenge in terms of moving on from first line therapy to second line therapy to third add on and managing patients diabetes well you know just generally we don't need drug program policies exacerbating that. 

Judith Glennie: [00:29:43] So how do we overcome these barriers. Whoops sorry. Want to go back. There we go. Public policies and public drug plans don't change themselves. At the end of the day. 

Judith Glennie: [00:30:04] A lot of the changes that we've seen over time they have been slow but they've been driven by clinicians and I know anyone who's treating patients. So whether it's physicians, nurses, nurse practitioners, pharmacists, dietitians etc and all clinicians have a role in in making that case to get better access to care. And I'm not only talking medication although that is the topic today but other kinds of care. And again Diabetes Canada's work in this space has been very broad and very inclusive of all the tools that the clinicians need to help their patients. When it comes to medications understanding the reimbursement criteria if you have to do a special authorization for medication and making sure that all the criteria are addressed with detailed information and also engaging the patients to overcome some of that inertia having them ensure that they are being allowed they are being assessed in a timely manner so that they can progress from one medication from monotherapy to doublet therapy as they need to to manage their disease as opposed to waiting till till the next visit or meeting till the clinician may or may not see them for several months. Has the time to figure out what's what's the next best option. One of the things that has created change with public policy makers is research and if there are opportunities to do outcomes research that are linked to changes in drug policy that whether positive or negative. I think that that would be an important thing to do. It's hard to dispute facts that come out of a well-designed research and that doesn't have to be fancy research but a well-designed research. So partnering with universities or research groups in your area may be an opportunity as well. We need to do more and this is I think maybe partnering Diabetes Canada partnering with others but doing more comparisons of what outcomes we are achieving across the country and how that links to drug policy. I think it's time for us to do that because I don't think that that has been done to any in any depth. And when you really need to start looking at that and then from from an advocacy perspective and and we'll talk about this a little bit more in just a moment but certainly advocacy whether it's with Diabetes Canada or clinician groups or whatever at the political level and really talking about stories particularly with politicians they like stories stories about the impact of some of these policies on patient care on patient outcomes etc. Sometimes until those politicians hear things. Nothing changes as well. 

Judith Glennie: [00:33:23] So last but not least before I hand back over this this call to action really comes from a paper that I did with Paul 

Judith Glennie: [00:33:33] Oh and Kathy Kovak Burns a couple of years ago where we really felt that you know there there was definitely at that point in time it's that two years ago more than enough evidence that we really need to start to look at realigning our health technology assessment and reimbursement processes and policies with health policy priorities such as the priority of of getting diabetes managed more effectively so that patients benefit from treatments and can delay if nothing else delay some of the effects of diabetes. Focusing on individualized care as opposed to cookie cutter approaches. For instance you know forcing people to use insulin in Nova Scotia as a third line therapy and improving the equity and fairness of medication access. 

Judith Glennie: [00:34:26] I think I've beaten that one to quite a bit that drama a lot today and I haven't even touched on the differences between public and private. That's a whole other discussion. 

Judith Glennie: [00:34:38] And last but not least I think the real issue here is to get action we need people need to work together. It's not one sector that's going to be able to move things. It's collaboration in a Diabetes Canada again does a good job of this in terms of bringing people together trying to foresee what kind of policy changes could be required. And looking at how we can measure achievements and I think so that was that was our call to action to try to bring some improvement to how this whole medication is an important tool in the management of diabetes could get better aligned with our goal of of more getting diabetes better managed and improving patient outcomes. So on that note I'm going to pass back over to Erin. 

Erin Krusky: [00:35:35] Thank you Dr. Glennie for that excellent session. I know we've all learned a lot. We will be getting to a Q & A. But before we do that. So do put your questions if you have any questions in the Q & A. And we might be able to get to them today. But before we get to that I'd like to introduce my colleague at Diabetes Canada Ann Besner who is the Manager of Research and Public Policy and Ann is going to speak about the Diabetes 360 strategy. 

Ann Besner: [00:36:07] Thanks so much Erin. And thank you Dr. Glennie for that very insightful presentation. That was really terrific. Diabetes is a national epidemic with nearly 11 million Canadians living with diabetes or pre diabetes in 2019. So that's one in three people in this country. Treating the disease will cost our healthcare system approximately 30 billion dollars this year. Diabetes prevalence is rising at a rate of about 40 percent per decade. And shows no signs of slowing down. Every 24 hours six hundred and twenty Canadians receive a diagnosis of diabetes. Fourteen people have lower limb amputations as the result of a diabetes complication. More than 20 Canadians die of diabetes related complications and our health care system spends about 79 million dollars treating diabetes and again that's every day. The World Health Organization recommends that every country implement a national diabetes strategy. And since 2013 Canada has been without one despite having one of the highest rates of diabetes prevalence among the world's most developed nations. We must do better. Diabetes can only be addressed by committed and coordinated leadership with the national diabetes strategy the federal government can help to prevent a million cases of diabetes and avoid hundreds of thousands of hospitalizations for diabetes consequences in the next 10 years. Diabetes Canada has been very actively working on developing a nationwide strategy with many stakeholders over the past couple of years. And we're calling this nationwide strategy Diabetes 360. If we implement Diabetes 360 we can have 90 percent of Canadians living in an environment that prevents the development of diabetes. Ninety percent of Canadians are aware of their diabetes status. Ninety percent of Canadians with diabetes engaged in preventing complications and 90 percent of those Canadians achieving improved health outcomes. So the Diabetes 360 strategy would revolve around these measurable targets that would help to improve the management of diabetes as well as work towards prevention of diabetes. Diabetes 360 can be implemented by a task force that brings metrics best practices and continuous improvement as well as expertise through partnership with the provinces territories and municipalities to address key needs for people with or at risk of diabetes. That task force would need about seven years to do this work in our estimation at a total cost of one hundred and fifty million dollars. So an investment of one hundred and fifty million dollars by the federal government as well as some other partners will save 20 billion according to our calculations in a very short period of time with seven hundred and seventy fewer cases of Type 2 diabetes. Two hundred and forty five thousand fewer hospitalizations for diabetes and 34000 fewer lower limb amputations. So in terms of a call of action what we're asking you all to do today is to visit our Web site at W W W W diabetes dot CAA slash strategy to learn more information about diabetes 360. And to sign our petition. So recently we've opened a petition and in signing that you will add your voice to the thousands of Canadians who are calling on all political parties to commit to implementing a nationwide strategy to end the diabetes epidemic. So we ask you to go ahead after this webinar and to sign the petition and then to spread the word. So tell your family friends colleagues clients and patients. Let everybody know about Diabetes 360 and how they can help to advocate for a diabetes strategy in Canada. Spread the word far and wide if you each tell 10 people then that will really go a long way to helping to promote this cause. And if you're active on social media let people know about the position. The petition there as well. So on Twitter Facebook whatever other platforms that you're a part of and help us to make Diabetes 360 a reality. Thank you. 

Judith Glennie: [00:40:54] Thanks Ann. 

Erin Krusky: [00:40:55] Yeah. Great. Thank you so much Ann for that information about Diabetes 360 and that call to action to sign the petition. So now we'll get into the Q and A period for today. Please note for all questions that we are unable to answer today please send us an email at webinars at diabetes dot ca and we will get back to you as soon as possible. 

Erin Krusky: [00:41:18] So we do have some questions. So the first one that we can tackle here for Judy is a question about what exactly qualifies as failing on insulin. I think you talked about that. 

Judith Glennie: [00:41:35] Yes. No. Very very good question. I think the short answer is It depends. It depends on which province you're in. If so if it's the province that you're in still requires the use of insulin as an add on to met and met, SU then even what they say in an insulin failure is independent. As I said I think very very quickly. You know in some provinces if a patient has a needle phobia that's you know in some provinces that that's not accepted as a reason not to use insulin. In other cases where you know I could in a situation where a patient has had challenges with hypoglycemia with Met, SU. That may be a sufficient justification for not using insulin because of the higher risk of hypoglycemia. In other cases it could be you know having a failure on insulin because of either lack lack of efficacy or inability to you know certainly with older patients and the inability to even manipulate pens may be maybe an issue and they just may not be able to handle that. So that's the long answer. It's going to it varies from jurisdiction to jurisdiction unfortunately and it's. Typically it's it's for Nova Scotia. It's typically been you know the patient just hasn't been able to manage using it but they've had to try to use it. The the insulin or they've had a hypoglycemic episode with the insulin and therefore can't use that. 

Judith Glennie: [00:43:36] So long answer to what should be a simple question but it's not. 

Erin Krusky: [00:43:41] Great. Thanks Dr. Glennie. We do have another audience question. So I'll read it out. How much value do cost effective publications have? And then there's a secondary question. Do these publications impact CADTH etc? I'm not sure if that's one that you can answer today or. 

Judith Glennie: [00:44:09] Yeah. I mean just in general cost effectiveness is one of the metrics that CADTH or the specific sub part of CADTH which is the Common Drug Review does look at when evaluating a new medication. So first and foremost they compare the clinical they compare the safety they compare the quality of life outcomes with the new drug versus what's already being funded and then they will look at the cost effectiveness. So if there is and then cost effectiveness basically means what's the clinical difference so how much more hemoglobin A1C control do I get and how much more does that cost me. That's a typical cost effectiveness kind of question. Most of the time it's the Common Drug Review those cost effectiveness evaluations are submitted by the manufacturer because they do have to be tied to the clinical trial for the new product and use because you need to use the data from that clinical trial. Having said that there there certainly is an opportunity for other cost effectiveness kinds of reports to be included in that submission that goes to CADTH. So for instance what's the cost effectiveness of you know of of drug therapy versus diet therapy or I'm just making this up. So. So there are those publications. If a company would certainly often include them if a company doesn't include them. The Common Drug Review does a literature search and would capture relevant cost effectiveness studies but the primary cost effectiveness study that is used to evaluate new medications is the one that is specific to the new drug and the clinical data for that new drug in comparison to the what is currently being funded. 

Judith Glennie: [00:46:12] So hopefully that kind of answers your question. 

Erin Krusky: [00:46:15] Wonderful. Thanks Dr. Glennie. So we'll do another question. Why don't public drug plans fund all the diabetes medications approved by Health Canada? 

Judith Glennie: [00:46:29] The The The short answer is that. The drug either has has failed to demonstrate comparative clinical efficacy. At the Health Technology Assessment body so basically said well this is no better than what we have or sometimes manufacturers don't go to that health technology assessment body. They choose not to. And so if so for newer drugs. 

Judith Glennie: [00:47:06] If a company chooses not to go to the Health Technology Assessment body and they decide that they are only going to go to private payers or out of pocket customers then that may be one reason it doesn't happen too often. But it can happen. The other reason is that you know health technology assessment body has said that there's no in no additional value to the new product. Now the the most recent one that went through Steglatro, Ertuglifozin and I'm sorry I have not. I should have my apologies I should have taken a look at that one specifically to see why that is not listed across the country at all. So I'm not sure whether it's they they failed quote unquote at Common Drug Review. So they did not get recommended by the Common Drug Review or whether they just didn't go at all. And I'm not sure about that one but that I can follow up on that one. 

Erin Krusky: [00:48:16] OK. Thank you. That would be great. So we'll just do one more question if that's OK. Why are there differences in access to diabetes medications across Canada? 

Judith Glennie: [00:48:32] The the core rate there are two reasons. There is history and then there's the design of the programs. Is there really the two key reasons. History in terms of how has each individual drug program funded diabetes medications over time. What criteria have they used and each province has dealt with it differently. Some have been more permissive so some have put most of their you know their their diabetes drugs on but the general benefit of freely available on the formulary. 

Judith Glennie: [00:49:13] Others have taken that same drug and made it. 

Judith Glennie: [00:49:18] Made the access very restrictive Ontario which is the one I know best changed over time where they originally had a lot of the newer add on to metformin, Sulyonylurea drugs only available through what's called the exceptional access program. But the volume of patients who need these drugs it's a huge number of diabetic patients. So there's gonna be a lot of requests for them it just became unmanageable and they've had to find a different way to. 

Judith Glennie: [00:49:53] To stick to their principles of evidence based use out of therapy. So let's start with metformin you know add on a second drug which now can be SGLT2 if you have a high high risk cardiovascular. 

Judith Glennie: [00:50:09] But take it making trying to find ways to make sure that prescribers continue to follow the evidence around stepwise approach to treatments. But at the same time enabling them to make choices to tailor the drug based on major factors like high cardiovascular risk or established cardiovascular disease. Ontario choose chose that routes to put a little bit frankly more trust in the clinicians. Whereas other provinces have not have chosen to just still have their very rigid approaches to special authorization where clinicians have to write a letter and send in all kinds of data et cetera. So it's. And you know for some jurisdictions that level of trust is driven by you know how much of an impact these drugs have on the budget and how much how many patients there are. And a desire to make sure that patients who need the new drugs get them but that they are not being used in patients who may not need them yet. So it's that's a constant struggle for a drug plan is trying to figure out what's the best way to ensure that drugs are being used in an evidence based manner without having too many barriers for the clinician the prescriber to jump through so that the patient can get access and not everyone does that well not everyone has the resources as well to have these special authorization processes. So we continue to have differences unfortunately and it's not only diabetes medications it's other medications as well where there are lots of discrepancies in terms of how patients can access those medications from one province to another. 

Erin Krusky: [00:52:03] Great Dr. Glennie. Thank you for that thoughtful answer. So what we'll do now is if anyone thinks of any questions later on they can email us at webinars at diabetes dot ca and I'd like to sincerely thank Dr. Glennie for being here today and thank Ann for being here too to support us and to help provide this learning opportunity.