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November 29, 2012

Renowned Diabetologist Dr. Dorothee Deiss Discusses Diabetes Care in Germany, the Future of GLP-1 and Type 1 Diabetes, and the Artificial Pancreas

By Lisa Vance, Adam Brown, and Alasdair Wilkins

As an endocrinologist specializing in pediatric endocrinology, diabetology, and neonatology, Dr. Dorothee Deiss divides her Berlin practice evenly between adults and children. She is an advocate for improved diabetes care, and last March she helped organize the first annual DiaTec conference in Berlin as an educational resource for health care professionals seeking to use new technology. In our interview Dr. Deiss talked about the reimbursement challenges for pump and CGM use in Germany, and the ways in which these technologies need to improve. Additionally, she discussed her hopes for the artificial pancreas and the closed loop, the potential for GLP-1 use in type 1 patients, and changes she expects to see in diabetes care over the next ten years. This interview offers a unique glimpse into how diabetes care and reimbursement work in a healthcare system very different from that of the United States. Indeed, for those looking for additional context, we have included a brief overview of the German healthcare system at the end of the interview.

PUMPS AND CGM – BIG PICTURE AND REIMBURSEMENT

Lisa Vance: To start off, I was wondering if you could tell us a little bit about the diabetes technology landscape in Germany. We were also curious about what percentage of type 1 and type 2 patients have pumps and CGM, roughly speaking, and how this has changed over time. As we understand it, CGM use is still very low – German blogger Finn Koester estimates it is about 300. Please tell us a little about the reimbursement process.

We physicians have to write a long, very detailed, very specific letter for the patient about why they need CGM... One really needs life-saving arguments... After all of this, patients must depend on luck.

Dr. Deiss: In Germany there are around eight million people with diabetes, around 5-10% of which have type 1. Although the number of insulin pumps is steadily increasing, there are only around 55,000 pump users total in Germany. Concerning the use of continuous glucose monitoring, yes, the number is still very low. We in Germany have been working with these technologies since the introduction of CGM 12 years ago. We know very well the benefit of CGM on metabolic control and reduction of hypoglycemia. We performed the very first study with real-time CGM here. The patients who already have had the chance to use CGM do not want to do without this critical help for their diabetes management. Nevertheless, and disappointingly, we still don’t have reimbursement for CGM. For the few patients that do have private insurance, it's much easier, and chances are greater that they would have CGM reimbursed - however, the majority of the patients don't have any private insurance.

These patients have to apply individually to their public insurance company [sickness fund]. We physicians have to write a long, very detailed, very specific letter for the patient about why they need CGM, including the history of this patient and what we hope to improve with the CGM. One really needs life-saving arguments. In the application, a patient needs to send three months of blood glucose values and a detailed description of what the problems are. After all of this, patients must depend on luck.

Usually the insurance companies give all these papers to the Medizinischer Dienst der Krankenversicherung (MDK). It's a medical department for all the insurance companies, and its central office is here in Berlin. Patients always get the same response letter back with the same decline saying that it's still not approved and so on. Only in a few cases are patients really lucky and deal with someone understanding in the insurance company – perhaps someone that also has diabetes or is more interested and engaged, someone who patients can communicate with more personally. Then there’s a bit more of a chance for reimbursement.

It's also a little bit tricky. If you argue that your condition is affecting your ability to work, then the insurance companies will tell you that they are not responsible for your ability to work safely. That’s why patients really have to think very precisely about what they use as an argument and what arguments to avoid. I have to write so many applications for all these patients, though I really don't have the time. And when applications are denied, patients need a lot of time to re-apply.

Lisa: Could you give us an example of a process you went through with a patient to get him or her a CGM where you really wanted the patient to have access to this technology?

We gave her a CGM. She paid for it on her own and she improved so dramatically; her quality of life improved so much. Her A1c came down from 9.5% to 6.9%, and she was so happy. So when we applied for insurance coverage and we had a lot of arguments, a lot of CGM graphs, everything together, and they refused it. 

Dr. Deiss: One patient of mine is a 55-year-old woman; she’s had diabetes for a long time. She had decades of bad control, and a high A1c, and when she reached her 50s, it got worse because of all the hormonal changes at that age. She has a very high position in the government here, and she never knew when she would have hypo during a meeting (and she really had to give a lot of talks). It was so worrying.

Finally, we gave her a CGM. She paid for it on her own and she improved so dramatically; her quality of life improved so much. Her A1c came down from 9.5 to 6.9%, and she was so happy. So when we applied for insurance coverage and we had a lot of arguments, a lot of CGM graphs, everything together, and they refused it.

Usually you have to reply that you don't accept their refusal, then you have to write again and collect arguments. We did that, and they refused again. Then she got a lawyer. In Berlin we have a lawyer – a woman who also has diabetes – and she's also very interested and engaged and now she tries to specialize in this kind of case. Together and they went to a court, and the patient switched to another insurance company, which is usually very difficult. I know this insurance company pretty well, and they are always denying everything, but she was lucky enough to get somebody there who was interested and now they pay for everything.

But that took two years and so much paperwork. If you don't have the money to pay a lawyer you can’t do this.

Lisa: How similar is the process for getting pumps reimbursed?

Dr. Deiss: Pumps are much easier, but problems are starting. Usually, when you go on a pump, you need to be on MDI and evidence that you are willing to measure blood glucose several times per day and really manage your diabetes carefully.

At least the Diabetes DE, an advocacy group for Germans with diabetes, had a huge success a few years ago: they made it so that we need only to give a prescription to kids below six, and then these kids can get a pump. So you don’t need all this ugly paperwork.

Then, you give all these papers to the insurance company. I also have to write a letter, but that's much less complicated than for CGM. In nearly all cases, they allow it. But now, for example, I have a patient – he is a biker and before he got on his pump, he had several severe hypos per year. Since getting on a pump, he hasn’t had any severe hypos. Everything improved.

But now the insurance company says they aren’t going to pay for the pump anymore. Instead, they wrote in a letter, which I saw yesterday: “You should discuss going to a hospital for several weeks for a rehabilitation program with your diabetologist.” That doesn't make any sense! It's much more expensive. Everybody in the diabetes area knows when you send somebody into the hospital, that's a totally artificial surrounding. You can get a very nice blood sugar, but when you leave the hospital, it's totally different. So that doesn't help anything and that's really ridiculous and that's now the new development in Germany.

At least the Diabetes DE, an advocacy group for Germans with diabetes, had a huge success a few years ago: they made it so that we need only to give a prescription to kids below six, and then these kids can get a pump. So you don't need all this ugly paperwork.

Lisa: So all in all, what percentage of your patients are on pumps or a CGM?

Dr. Deiss: The percentage of type 1 and type 2 together on CGM continuously is not large. We have 5%, 10%. For gestational diabetes, it’s different. There, you can get it more easily, at least for the nine months of pregnancy.

INTEGRATED PUMPS AND CGM, AND THE POTENTIAL OF THE ARTIFICIAL PANCREAS

Lisa: In terms of specific products, can you tell us about what it is like to use the Medtronic Veo and Animas Vibe with your patients?

Dr. Deiss: Of course, the Veo is great. We have nearly all the pumps available, and patients can choose which one they would like to get. But I always recommend that if a patient is interested in CGM, that patient should try to get the Veo or the Animas pump because of the integration of CGM. The patients who use the Veo with a sensor like it a lot. They feel so much safer knowing that in case of hypoglycemia, the basal rate will be stopped. When I download the data I see this happen so frequently, and not only at night. For parents, especially, it such a relief having the low glucose suspend in their kids pumps.

I have been convinced for years in the possibilities of the artificial pancreas based on the algorithms we already have. They work much better than the majority of patients do on their own.

Lisa: As a follow-up to the integrated technology, we were also wondering what your perspective was on the studies on the artificial pancreas. What do you think the biggest barriers are? And if a prototype was developed, do you think Germans would be able to wear it?

Dr. Deiss: I think so – definitely! I have been convinced for years in the possibilities of the artificial pancreas based on the algorithms we already have. They work much better than the majority of patients do on their own. Really it’s all this legal stuff we now have to go through. Hopefully they won’t think it has to be perfect. I mean, it is already a little bit more perfect than the usual patient, so I'm totally convinced that we will use it here.

Lisa: Whose work excites you the most on the artificial pancreas front?

Dr. Deiss: I appreciate a lot the artificial pancreas initiatives of the JDRF bringing together the best researchers and clinicians in this field. What I don’t like that they only focus on one “algorithm philosophy”, the MPC. Excellent research groups who have a huge expertise in the PID algorithm, for example, are excluded. Therefore, I am always very excited about the work of Bruce Buckingham in Stanford. He works with different algorithms, always open for new ideas, with the only goal that the closed-loop system will become real.

Lisa: What do you think the upcoming JDRF Control-to-Range trial will show?

Dr. Deiss: It will show what we already know from previous studies years ago: that closed-loop is superior to minimize the time spent in the hypoglycemic and hyperglycemic ranges in individuals with type 1 diabetes compared to open-loop. What is still not solved is the fact that the wearer would still need to manually tell the pump to deliver insulin at times, such as around meals, and adjust insulin delivery rates based on activity, illness, and other variables.

GLP-1 – WHAT IS THE POTENTIAL IN TYPE 1?

In the next 10 years, hopefully, we will have the closed loop for everybody who wants it – definitely in the next 10 years.

Lisa: Speaking of the future, on a broader note, what do you think is going to change the most with diabetes technology in the next 10 years?

Dr. Deiss: In the next 10 years, hopefully, we will have the closed loop for everybody who wants it – definitely in the next 10 years. I think that's the most important thing. And also in the field of GLP-1s and SGLT-2s… I think we will have more of all new kinds of treatment possibilities for people with type 1 diabetes.

Lisa: Could you tell us more about the role for GLP-1 in type 1 diabetes?

Dr. Deiss: In general, of course, I see potential for both type 1s and type 2s. Unfortunately, it's still very slow, even for type 2s, to gain reimbursement. But I'm totally convinced about the usefulness, especially in patients on insulin. Slowly now you can use it together with insulin. I’ve tried to get a reimbursement for Victoza for type 2 patients already on insulin. For example, one patient was a truck driver and he couldn't work anymore with his truck because he had so many hypos and he was already on a pump as a type 2. It was really difficult. I gave him Victoza out of my pocket and he improved in four weeks with his A1c going down by 2%. The hypos disappeared and the fluctuations disappeared. It was so amazing. He lost weight. He was so happy.

One patient was a truck driver and he couldn’t work anymore with his truck because he had so many hypos, and he was already on a pump as a type 2. It was really difficult. I gave him Victoza out of my pocket and he improved in four weeks with his A1c declining by 2%...It was so amazing. He lost weight. He was so happy.

And then I said, “Okay, now we can ask the insurance company.” We can say, ‘Look, everything got better. Could you pay for the Victoza?'" And they refused. So that's really the same thing as with the new technologies.

But I'm very convinced in many of the patients that it helps, either in the normal type 2s without insulin, but also in type 2s already on insulin, and also in type 1s.

For instance, I know of a little type 1 boy with the pump and the sensor from the beginning, and although he had the sensor all the time, he had huge fluctuations. I mean, he's a little boy. It's normal. So his physician decided to try out Victoza (off-label, of course), but it helped.

His mother went into the physician’s office and said, "We finished our last Victoza." Immediately the fluctuations got worse. I’ve seen the graph and it was really—I mean, it was not perfect. But it was really worse without the Victoza. I'm looking forward until we have more studies in Type 1s that we also can use it.

Lisa: Bydureon came out earlier this year. Are you starting to use that with any type 2 patients?

Dr. Deiss: Yes. But honestly, I still can't really tell you if it's successful. I mean, with Victoza we have seen effects in many patients pretty much immediately, and it was amazing. Of course with Bydureon, you have to be more patient, patient for several more weeks to see the effect, but I still don't know. I mean, I probably have to see more patients on that. I think it's at least a nice opportunity only to have to inject it once per week. Some patients really don’t like to put in needles and therefore they want to go back to Victoza, because of the Bydureon needle’s size.

THE STANDARD OF CARE IN GERMANY

Everybody knows that A1c is not the only goal anymore. We have to look at the fluctuations and the quality of the patient’s life. I think in the UK, in the US, in Germany, all over, we’re better when we can provide the best technology and the best support for the families and the patients.

Lisa: Back in April, the National Health Service in the UK changed their diabetes treatment guidelines for children. They noticed that fewer than 15% of the children in the UK had an A1c of less than 7.5%, while over 50% of children in Germany do. What’s leading to those better results?

Dr. Deiss: I can't tell you the difference. I'm really surprised because a lot of my patients really struggle with their A1cs. I think in Germany we are still far away from good diabetes management. I think we still have to work a lot to improve it. Compared to the UK, it's probably because they still have fewer pumps than here in Germany. But in the US, you have more pumps than in Germany, so it’s hard to say. Everybody knows that A1c is not the only goal anymore. We have to look at the fluctuations and the quality of the patient’s life. I think in the UK, in the US, in Germany, all over, we're better when we can provide the best technology and the best support for the families and the patients. I think we are all far away from this.

Lisa: What is the standard of care for treatment of type 1 in Germany?

Dr. Deiss: Everyone should get multiple daily injection (MDI) or insulin pump therapy. Pediatric diabetes care is different from the adult field. I think we care a lot about the kids and the families and we spend a lot of energy and time supporting them, not only in diabetes management, but also in the social aspects of the condition. For instance, diabetes educators go with children at least once to the kindergarten and school to talk about diabetes with the educators, teachers and school mates.

POSTSCRIPT: A BRIEF INTRODUCTION TO THE GERMAN HEALTHCARE SYSTEM

Under German law, all citizens must have health insurance, and the vast majority of the population of Germany have what is known as “Gesetzliche Krankenversicherung” or “Statutory Health Insurance” (STI), which is effectively public insurance. Citizens with a high annual income, those who are self-employed, or those who are public officers, are exempt from STI and permitted to purchase private insurance, which many do. However, roughly 85% of Germans currently use STI.

STI is provided by around 150 autonomous, not-for-profit insurance groups that work within the mandates of the government and are commonly known as “sickness funds.” An important aspect of this system is that these sickness funds are “free choice” sickness funds, meaning that the German people have the ability to choose their provider.

For guidance in medical decisions, the sickness funds refer to the Medical Boards of the Sickness Funds (MDK) at a regional level, and the Federal Association of Sickness Funds at a National level (MDS). These advisory boards are tasked with determining the appropriate course of treatment for patients.

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